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CompletedNCT01910116Updated Dec 17, 2015Results posted

Efficacy of Shinabro in Hand Osteoarthritis

A Phase 2/3 interventional study of Shinbaro and Placebo in Hand Osteoarthritis, sponsored by Seoul National University Hospital. Completed at 3 sites in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-12-17.

Sponsored by Seoul National University Hospital · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

GCSB-5 ("Shinbaro capsule"), is a mixture of 6 oriental herbs that have anti-inflammatory and analgesic effects along with an excellent safety profile. This study is aimed at investigating efficacy of Shinbaro in the treatment of hand osteoarthritis which needs a long term treatment in a placebo controlled, double-blind randomized trial.

Read the detailed description

Osteoarthritis (OA) as a common musculoskeletal disease affects more than 30% of the elderly population. It frequently involves knees, hips, spines and hands. In hands, the distal and proximal interphalangeal and the first carpometacarpal joints are affected, leading often to significant disability and limitation in the daily activity. The chronic progressive nature of the disease requires a life-long treatment. The mainstay treatment of hand OA targets pain control. Non-steroidal anti-inflammatory drugs (NSAIDs) are often used. However, they are frequently associated with significant gastrointestinal side effects including gastritis, peptic ulcer diseases, and bleeding, especially with long term use. Further, they do not ameliorate pain completely, requiring additional medications such as acetaminophen or opioid-based analgesics.

Shibaro is a mixture of purified oriental herbs consisting of Ledebouriellae Radix, Achyranthis Radix, Acanthopanacis Cortex, Cibotii Rhizoma, Glycine Semen, and Eucommiae Cortex. These herbs have been used for the treatment of diverse inflammatory conditions in Chines traditional medicine. All 6 herbs show an excellent safety profile and their anti-inflammatory and analgesic effects have been studied in both animals and humans. As such, given the excellent safety profile, anti-inflammatory and analgesic effects, Shinbaro might be ideal in the treatment of OA.

This study will investigate the efficacy and safety of Shinbaro in the treatment of hand OA in a placebo-controlled, randomized, double-blind, multi-center trial.

02

Conditions studied

  • Hand Osteoarthritis

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Keywords

  • osteoarthritis
  • hand
  • Shinbaro
  • GCSB-5
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 220 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age of 40 years or older
  • Osteoarthritis according to ACR 1990 criteria
  • Mean joint visual analog pain score (VAS) > 30mm in the preceding 48 hours
  • Patients who are will to participate

Exclusion criteria

Exclusion Criteria:

  • Any prior surgery of hand joints
  • prior history of Shinbaro use
  • Intra-articular injection of glucocorticosteroid or hyaluronic acid in the preceding 3 months
  • Pregnancy or active breast feeding
  • Prior hypersensitivity reaction to herbal medications
  • AST or ALT elevation > 3 of upper normal limit
  • GRF (MDRD) \< 30 mg/min/1.73m2
  • Nephrotic syndrome, other signficant kidney disease
  • Patients who seem not to tolerate the study at investigator's discretion
  • Patients who refuse to participate
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
220 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Placebo 2 capsules, twice daily, for 12 weeks.

    Drug: Placebo

  • Active comparator
    Shinbaro

    Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks

    Drug: Shinbaro

Interventions

  • DrugShinbaro

    GCSB-5 (Shinbaro) is a mixture of six purified oriental herb extracts in a fixed ratio, namely, Saposhnikovia divaricata Schischk, Glycine max Merrill, Cibotium barometz J. Smith, Eucommia ulmoides Oliver, Achyranthes japonica Nakai, and Acanthopanax sessiliflorus Seem

    Also known as: GCSB-5

  • DrugPlacebo

    The study medication and placebo were identical in appearance.

06

What researchers measure

Primary outcomes

  1. AUSCAN Pain Change at 4 Weeks From Baseline

    Change in AUSCAN pain score at 4 weeks from baseline = Pain at 4 weeks (0-100) - Pain at baseline (0-100). AUSCAN Pain scale ranges from 0 (no pain) to 100 (worst possible pain). * Negative value means improvement from baseline * Positive value means deterioration from baseline

    Time frame: Baseline and 4 weeks

Secondary outcomes

  1. AUSCAN Pain Score at 8 Weeks From Baseline

    Change in AUSCAN pain score at 8 weeks from baseline = Pain at 8 weeks (0-100)- Pain at baseline (0-100). AUSCAN Pain scale ranges from 0 (no pain) to 100 (worst possible pain). * Negative value means improvement from baseline * Positive value means deterioration from baseline

    Time frame: Baseline, 8 weeks

  2. AUSCAN Pain Score at 12 Weeks From Baseline

    Change in AUSCAN pain score at 12 weeks from baseline = Pain at 12 weeks (0-100)- Pain at baseline (0-100). AUSCAN Pain scale ranges from 0 (no pain) to 100 (worst possible pain). * Negative value means improvement from baseline * Positive value means deterioration from baseline

    Time frame: Baseline, 12 weeks

  3. AUSCAN Pain Score at 16 Weeks From Baseline

    Change in AUSCAN pain score at 16 weeks from baseline = Pain at 16 weeks (0-100)- Pain at baseline (0-100). AUSCAN Pain scale ranges from 0 (no pain) to 100 (worst possible pain). * Negative value means improvement from baseline * Positive value means deterioration from baseline

    Time frame: Baseline and 16 weeks

  4. AUSCAN Stiffness at 4 Weeks Change From Baseline

    Change in AUSCAN stiffness score at 4 weeks from baseline = Stiffness at 4 weeks (0-100)- Stiffness at baseline (0-100). AUSCAN Stiffness scale ranges from 0 (no stiffness) to 100 (worst possible stiffness). * Negative value means improvement from baseline * Positive value means deterioration from baseline

    Time frame: Baseline and 4 weeks

  5. AUSCAN Stiffness at 8 Weeks Change From Baseline

    Change in AUSCAN stiffness score at 8 weeks from baseline = Stiffness at 8 weeks (0-100)- Stiffness at baseline (0-100). AUSCAN Stiffness scale ranges from 0 (no stiffness) to 100 (worst possible stiffness). * Negative value means improvement from baseline * Positive value means deterioration from baseline

    Time frame: baseline and 8 weeks

  6. AUSCAN Stiffness at 12 Weeks Change From Baseline

    Change in AUSCAN stiffness score at 12 weeks from baseline = Stiffness at 12 weeks (0-100)- Stiffness at baseline (0-100). AUSCAN Stiffness scale ranges from 0 (no stiffness) to 100 (worst possible stiffness). * Negative value means improvement from baseline * Positive value means deterioration from baseline

    Time frame: Basline and 12 weeks

  7. AUSCAN Stiffness at 16 Weeks Change From Baseline

    Change in AUSCAN stiffness score at 16 weeks from baseline = Stiffness at 16 weeks (0-100)- Stiffness at baseline (0-100). AUSCAN Stiffness scale ranges from 0 (no stiffness) to 100 (worst possible stiffness). * Negative value means improvement from baseline * Positive value means deterioration from baseline

    Time frame: Baseline, 16 weeks

  8. AUSCAN Function Change at 4 Weeks From Baseline

    Change in AUSCAN function score at 4 weeks from baseline = Function score at 4 weeks (0-100)- Function score at baseline (0-100). AUSCAN Function score scale ranges from 0 (no functional limitation) to 100 (worst possible functional limitation). * Negative value means improvement from baseline * Positive value means deterioration from baseline

    Time frame: Basline and 4 weeks

  9. AUSCAN Function Change at 8 Weeks From Baseline

    Change in AUSCAN function score at 8 weeks from baseline = Function score at 8 weeks (0-100)- Function score at baseline (0-100). AUSCAN Function score scale ranges from 0 (no functional limitation) to 100 (worst possible functional limitation). * Negative value means improvement from baseline * Positive value means deterioration from baseline

    Time frame: Baseline and 8 weeks

  10. AUSCAN Function Change at 12 Weeks From Baseline

    Change in AUSCAN function score at 12 weeks from baseline = Function score at 12 weeks (0-100)- Function score at baseline (0-100). AUSCAN Function score scale ranges from 0 (no functional limitation) to 100 (worst possible functional limitation). * Negative value means improvement from baseline * Positive value means deterioration from baseline

    Time frame: Baseline and 12 weeks

  11. AUSCAN Function Change at 16 Weeks From Baseline

    Change in AUSCAN function score at 16 weeks from baseline = Function score at 16 weeks (0-100)- Function score at baseline (0-100). AUSCAN Function score scale ranges from 0 (no functional limitation) to 100 (worst possible functional limitation). * Negative value means improvement from baseline * Positive value means deterioration from baseline

    Time frame: Baseline and 16 weeks

  12. Patient Global Assessment, Change From Baseline

    Change in Patient global assessment (PGA) at 4 weeks from baseline = PGA at 4 weeks (0-100)- PGA score at baseline (0-100). PGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition). * Negative value means improvement from baseline * Positive value means deterioration from baseline

    Time frame: Baseline and 4 weeks

  13. Patient Global Assessment, Change From Baseline

    Change in Patient global assessment (PGA) at 8 weeks from baseline = PGA at 8 weeks (0-100)- PGA score at baseline (0-100). PGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition). * Negative value means improvement from baseline * Positive value means deterioration from baseline

    Time frame: Baseline and 8 weeks

  14. Patient Global Assessment, Change From Baseline

    Change in Patient global assessment (PGA) at 12 weeks from baseline = PGA at 12 weeks (0-100)- PGA score at baseline (0-100). GPA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition). * Negative value means improvement from baseline * Positive value means deterioration from baseline

    Time frame: Baseline and 12 weeks

  15. Patient Global Assessment, Change From Baseline

    Change in Patient global assessment (PGA) at 16 weeks from baseline = PGA at 16 weeks (0-100)- PGA score at baseline (0-100). PGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition). * Negative value means improvement from baseline * Positive value means deterioration from baseline

    Time frame: Baseline and 16 weeks

  16. Physician Global Assessment, Change From Baseline

    Change in Physician global assessment (PhGA) at 4 weeks from baseline = PhGA at 4 weeks (0-100)- PhGA score at baseline (0-100). GPA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition). * Negative value means improvement from baseline * Positive value means deterioration from baseline

    Time frame: baseline and 4 weeks

  17. Physician Global Assessment, Change From Baseline

    Change in Physician global assessment (PhGA) at 8 weeks from baseline = PhGA at 8 weeks (0-100)- PhGA score at baseline (0-100). PhGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition). * Negative value means improvement from baseline * Positive value means deterioration from baseline

    Time frame: Baseline and 8 weeks

  18. Physician Global Assessment, Change From Baseline

    Change in Physician global assessment (PhGA) at 12 weeks from baseline = PhGA at 12 weeks (0-100)- PhGA score at baseline (0-100). PhGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition). * Negative value means improvement from baseline * Positive value means deterioration from baseline

    Time frame: Baseline and 12 weeks

  19. Physician Global Assessment, Change From Baseline

    Change in Physician global assessment (PhGA) at 16 weeks from baseline = PhGA at 16 weeks (0-100)- PhGA score at baseline (0-100). PhGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition). * Negative value means improvement from baseline * Positive value means deterioration from baseline

    Time frame: Baseline and 16 weeks

  20. Tender Joint Count, Change From Baseline

    Change in Tender joint count (TJC) at 4 weeks from baseline = TJC at 4 weeks - TJC at baseline.. * Negative value means improvement from baseline * Positive value means deterioration from baseline

    Time frame: Baseline and 4 weeks

  21. Tender Joint Count, Change From Baseline

    Change in Tender joint count (TJC) at 8 weeks from baseline = TJC at 8 weeks - TJC at baseline.. * Negative value means improvement from baseline * Positive value means deterioration from baseline

    Time frame: Baseline and 8 weeks

  22. Tender Joint Count, Change From Baseline

    Change in Tender joint count (TJC) at 12 weeks from baseline = TJC at 12 weeks - TJC at baseline.. * Negative value means improvement from baseline * Positive value means deterioration from baseline

    Time frame: Baseline and 12 weeks

  23. Tender Joint Count, Change From Baseline

    Change in Tender joint count (TJC) at 16 weeks from baseline = TJC at 16 weeks - TJC at baseline.. * Negative value means improvement from baseline * Positive value means deterioration from baseline

    Time frame: Baseline and 16 weeks

  24. Swollen Joint Count, Change From Baseline

    Change in Swollen joint count (SJC) at 4 weeks from baseline = SJC at 4 weeks - TJC at baseline.. * Negative value means improvement from baseline * Positive value means deterioration from baseline

    Time frame: Baseline and 4 weeks

  25. Swollen Joint Count, Change From Baseline

    Change in Swollen joint count (SJC) at 8 weeks from baseline = SJC at 8 weeks - TJC at baseline.. * Negative value means improvement from baseline * Positive value means deterioration from baseline

    Time frame: Baseline and 8 weeks

  26. Swollen Joint Count, Change From Baseline

    Change in Swollen joint count (SJC) at 12 weeks from baseline = SJC at 12 weeks - TJC at baseline.. * Negative value means improvement from baseline * Positive value means deterioration from baseline

    Time frame: Baseline and 12 weeks

  27. Swollen Joint Count, Change From Baseline

    Change in Swollen joint count (SJC) at 16 weeks from baseline = SJC at 16 weeks - TJC at baseline.. * Negative value means improvement from baseline * Positive value means deterioration from baseline

    Time frame: Baseline and 16 weeks

  28. Acetaminophen Rescue

    yes = AAP rescue use, no = no AAP rescue use

    Time frame: Baseline 4 weeks

  29. Acetaminophen Rescue

    yes = AAP rescue use, no = no AAP rescue use

    Time frame: 4 weeks and 8 weeks

  30. Acetaminophen Rescue

    yes = AAP rescue use, no = no AAP rescue use

    Time frame: 8 weeks and 12 weeks

  31. Acetaminophen Rescue

    yes = AAP rescue use, no = no AAP rescue use

    Time frame: 12 weeks and 16 weeks

  32. Number of OMERACT-OARSI Responder

    Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Number of patients who met OMERACT-OARSI criteria = significant clinical improvement in osteoarthritis symptom after treatment

    Time frame: Baseline and 4 weeks

  33. Number of OMERACT-OARSI Responder

    Number of patients who met OMERACT-OARSI criteria = significant clinical improvement in osteoarthritis symptom after treatment

    Time frame: Baseline and 8 weeks

  34. Number of OMERACT-OARSI Responder

    Number of patients who met OMERACT-OARSI criteria = significant clinical improvement in osteoarthritis symptom after treatment

    Time frame: Baseline and 12 weeks

  35. Number of OMERACT-OARSI Responder

    Number of patients who met OMERACT-OARSI criteria = significant clinical improvement in osteoarthritis symptom after treatment

    Time frame: Baselie and 16 weeks

07

Results

Posted Dec 17, 2015

Participant flow

Participant flow — Overall Study
MilestoneShinbaroPlacebo
Started110110
Week 4106102
Week 89899
Week 129796
Week 169694
Completed9694
Not completed1416
Withdrew: Adverse event03
Withdrew: Lack of efficacy34
Withdrew: Lost to follow-up10
Withdrew: Protocol violation12
Withdrew: Withdrawal by subject83
Withdrew: Uncertain allocation13
Withdrew: Incomplete data01

Outcome measures

PrimaryAUSCAN Pain Change at 4 Weeks From Baseline

Change in AUSCAN pain score at 4 weeks from baseline = Pain at 4 weeks (0-100) - Pain at baseline (0-100). AUSCAN Pain scale ranges from 0 (no pain) to 100 (worst possible pain). * Negative value means improvement from baseline * Positive value means deterioration from baseline

Time frame:
Baseline and 4 weeks
Reported as:
Median · units on a scale
AUSCAN Pain Change at 4 Weeks From Baseline
units on a scaleShinbaroPlacebo
AUSCAN Pain Change at 4 Weeks From Baseline-9.0 (-23.6 to -0.4)-2.2 (-16.6 to 6.0)
Statistical analysis
  • Shinbaro vs Placebo · Wilcoxon (Mann-Whitney) · p = 0.014
SecondaryAUSCAN Pain Score at 8 Weeks From Baseline

Change in AUSCAN pain score at 8 weeks from baseline = Pain at 8 weeks (0-100)- Pain at baseline (0-100). AUSCAN Pain scale ranges from 0 (no pain) to 100 (worst possible pain). * Negative value means improvement from baseline * Positive value means deterioration from baseline

Time frame:
Baseline, 8 weeks
Reported as:
Median · units on a scale
AUSCAN Pain Score at 8 Weeks From Baseline
units on a scaleShinbaroPlacebo
AUSCAN Pain Score at 8 Weeks From Baseline-13.4 (-26.2 to 0.0)-2.2 (-17.4 to 4.8)
Statistical analysis
  • Shinbaro vs Placebo · Wilcoxon (Mann-Whitney) · p = 0.011
SecondaryAUSCAN Pain Score at 12 Weeks From Baseline

Change in AUSCAN pain score at 12 weeks from baseline = Pain at 12 weeks (0-100)- Pain at baseline (0-100). AUSCAN Pain scale ranges from 0 (no pain) to 100 (worst possible pain). * Negative value means improvement from baseline * Positive value means deterioration from baseline

Time frame:
Baseline, 12 weeks
Reported as:
Median · units on a scale
AUSCAN Pain Score at 12 Weeks From Baseline
units on a scaleShinbaroPlacebo
AUSCAN Pain Score at 12 Weeks From Baseline-14.6 (-30.4 to 0.0)-8.0 (-25.0 to 7.8)
Statistical analysis
  • Shinbaro vs Placebo · Wilcoxon (Mann-Whitney) · p = 0.053
SecondaryAUSCAN Pain Score at 16 Weeks From Baseline

Change in AUSCAN pain score at 16 weeks from baseline = Pain at 16 weeks (0-100)- Pain at baseline (0-100). AUSCAN Pain scale ranges from 0 (no pain) to 100 (worst possible pain). * Negative value means improvement from baseline * Positive value means deterioration from baseline

Time frame:
Baseline and 16 weeks
Reported as:
Median · units on a scale
AUSCAN Pain Score at 16 Weeks From Baseline
units on a scaleShinbaroPlacebo
AUSCAN Pain Score at 16 Weeks From Baseline-15.6 (-28.2 to 0.0)-4.4 (-24.8 to 7.2)
Statistical analysis
  • Shinbaro vs Placebo · Wilcoxon (Mann-Whitney) · p = 0.014
SecondaryAUSCAN Stiffness at 4 Weeks Change From Baseline

Change in AUSCAN stiffness score at 4 weeks from baseline = Stiffness at 4 weeks (0-100)- Stiffness at baseline (0-100). AUSCAN Stiffness scale ranges from 0 (no stiffness) to 100 (worst possible stiffness). * Negative value means improvement from baseline * Positive value means deterioration from baseline

Time frame:
Baseline and 4 weeks
Reported as:
Median · units on a scale
AUSCAN Stiffness at 4 Weeks Change From Baseline
units on a scaleShinbaroPlacebo
AUSCAN Stiffness at 4 Weeks Change From Baseline-9.0 (-22.0 to 3.0)-6.0 (-23.0 to 6.0)
Statistical analysis
  • Shinbaro vs Placebo · Wilcoxon (Mann-Whitney) · p = 0.728
SecondaryAUSCAN Stiffness at 8 Weeks Change From Baseline

Change in AUSCAN stiffness score at 8 weeks from baseline = Stiffness at 8 weeks (0-100)- Stiffness at baseline (0-100). AUSCAN Stiffness scale ranges from 0 (no stiffness) to 100 (worst possible stiffness). * Negative value means improvement from baseline * Positive value means deterioration from baseline

Time frame:
baseline and 8 weeks
Reported as:
Median · units on a scale
AUSCAN Stiffness at 8 Weeks Change From Baseline
units on a scaleShinbaroPlacebo
AUSCAN Stiffness at 8 Weeks Change From Baseline-12.0 (-28 to 2)-6 (-27 to 4.0)
Statistical analysis
  • Shinbaro vs Placebo · Wilcoxon (Mann-Whitney) · p = 0.229
SecondaryAUSCAN Stiffness at 12 Weeks Change From Baseline

Change in AUSCAN stiffness score at 12 weeks from baseline = Stiffness at 12 weeks (0-100)- Stiffness at baseline (0-100). AUSCAN Stiffness scale ranges from 0 (no stiffness) to 100 (worst possible stiffness). * Negative value means improvement from baseline * Positive value means deterioration from baseline

Time frame:
Basline and 12 weeks
Reported as:
Median · units on a scale
AUSCAN Stiffness at 12 Weeks Change From Baseline
units on a scaleShinbaroPlacebo
AUSCAN Stiffness at 12 Weeks Change From Baseline-14.0 (-36.0 to 0)-11.0 (-29.8 to 5)
Statistical analysis
  • Shinbaro vs Placebo · Wilcoxon (Mann-Whitney) · p = 0.194
SecondaryAUSCAN Stiffness at 16 Weeks Change From Baseline

Change in AUSCAN stiffness score at 16 weeks from baseline = Stiffness at 16 weeks (0-100)- Stiffness at baseline (0-100). AUSCAN Stiffness scale ranges from 0 (no stiffness) to 100 (worst possible stiffness). * Negative value means improvement from baseline * Positive value means deterioration from baseline

Time frame:
Baseline, 16 weeks
Reported as:
Median · units on a scale
AUSCAN Stiffness at 16 Weeks Change From Baseline
units on a scaleShinbaroPlacebo
AUSCAN Stiffness at 16 Weeks Change From Baseline-10.0 (-27.0 to 2.0)-8.0 (-27 to 5.5)
Statistical analysis
  • Shinbaro vs Placebo · Wilcoxon (Mann-Whitney) · p = 0.347
SecondaryAUSCAN Function Change at 4 Weeks From Baseline

Change in AUSCAN function score at 4 weeks from baseline = Function score at 4 weeks (0-100)- Function score at baseline (0-100). AUSCAN Function score scale ranges from 0 (no functional limitation) to 100 (worst possible functional limitation). * Negative value means improvement from baseline * Positive value means deterioration from baseline

Time frame:
Basline and 4 weeks
Reported as:
Median · units on a scale
AUSCAN Function Change at 4 Weeks From Baseline
units on a scaleShinbaroPlacebo
AUSCAN Function Change at 4 Weeks From Baseline-6.8 (-18.9 to 3.6)-3.7 (-13.7 to 6.8)
Statistical analysis
  • Shinbaro vs Placebo · Wilcoxon (Mann-Whitney) · p = 0.122
SecondaryAUSCAN Function Change at 8 Weeks From Baseline

Change in AUSCAN function score at 8 weeks from baseline = Function score at 8 weeks (0-100)- Function score at baseline (0-100). AUSCAN Function score scale ranges from 0 (no functional limitation) to 100 (worst possible functional limitation). * Negative value means improvement from baseline * Positive value means deterioration from baseline

Time frame:
Baseline and 8 weeks
Reported as:
Median · units on a scale
AUSCAN Function Change at 8 Weeks From Baseline
units on a scaleShinbaroPlacebo
AUSCAN Function Change at 8 Weeks From Baseline-9.7 (-26.9 to 2.6)-4.8 (-18.6 to 7.7)
Statistical analysis
  • Shinbaro vs Placebo · Wilcoxon (Mann-Whitney) · p = 0.097
SecondaryAUSCAN Function Change at 12 Weeks From Baseline

Change in AUSCAN function score at 12 weeks from baseline = Function score at 12 weeks (0-100)- Function score at baseline (0-100). AUSCAN Function score scale ranges from 0 (no functional limitation) to 100 (worst possible functional limitation). * Negative value means improvement from baseline * Positive value means deterioration from baseline

Time frame:
Baseline and 12 weeks
Reported as:
Median · units on a scale
AUSCAN Function Change at 12 Weeks From Baseline
units on a scaleShinbaroPlacebo
AUSCAN Function Change at 12 Weeks From Baseline-11 (-27.8 to 0.8)-2.9 (-18.7 to 9.1)
SecondaryAUSCAN Function Change at 16 Weeks From Baseline

Change in AUSCAN function score at 16 weeks from baseline = Function score at 16 weeks (0-100)- Function score at baseline (0-100). AUSCAN Function score scale ranges from 0 (no functional limitation) to 100 (worst possible functional limitation). * Negative value means improvement from baseline * Positive value means deterioration from baseline

Time frame:
Baseline and 16 weeks
Reported as:
Median · units on a scale
AUSCAN Function Change at 16 Weeks From Baseline
units on a scaleShinbaroPlacebo
AUSCAN Function Change at 16 Weeks From Baseline-9.9 (-28.7 to 1.8)-4.8 (-18.7 to 9.1)
Statistical analysis
  • Shinbaro vs Placebo · Wilcoxon (Mann-Whitney) · p = 0.050
SecondaryPatient Global Assessment, Change From Baseline

Change in Patient global assessment (PGA) at 4 weeks from baseline = PGA at 4 weeks (0-100)- PGA score at baseline (0-100). PGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition). * Negative value means improvement from baseline * Positive value means deterioration from baseline

Time frame:
Baseline and 4 weeks
Reported as:
Median · units on a scale
Patient Global Assessment, Change From Baseline
units on a scaleShinbaroPlacebo
Patient Global Assessment, Change From Baseline-9.0 (-24.0 to 2.0)-3.0 (-15.0 to 6.0)
Statistical analysis
  • Shinbaro vs Placebo · Wilcoxon (Mann-Whitney) · p = 0.031
SecondaryPatient Global Assessment, Change From Baseline

Change in Patient global assessment (PGA) at 8 weeks from baseline = PGA at 8 weeks (0-100)- PGA score at baseline (0-100). PGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition). * Negative value means improvement from baseline * Positive value means deterioration from baseline

Time frame:
Baseline and 8 weeks
Reported as:
Median · units on a scale
Patient Global Assessment, Change From Baseline
units on a scaleShinbaroPlacebo
Patient Global Assessment, Change From Baseline-10.0 (-24.5 to 0)-6.0 (-18.0 to 12)
Statistical analysis
  • Shinbaro vs Placebo · Wilcoxon (Mann-Whitney) · p = 0.021
SecondaryPatient Global Assessment, Change From Baseline

Change in Patient global assessment (PGA) at 12 weeks from baseline = PGA at 12 weeks (0-100)- PGA score at baseline (0-100). GPA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition). * Negative value means improvement from baseline * Positive value means deterioration from baseline

Time frame:
Baseline and 12 weeks
Reported as:
Median · units on a scale
Patient Global Assessment, Change From Baseline
units on a scaleShinbaroPlacebo
Patient Global Assessment, Change From Baseline-11.0 (-30.0 to 1.0)-6.0 (-24.0 to 6.0)
Statistical analysis
  • Shinbaro vs Placebo · Wilcoxon (Mann-Whitney) · p = 0.049
SecondaryPatient Global Assessment, Change From Baseline

Change in Patient global assessment (PGA) at 16 weeks from baseline = PGA at 16 weeks (0-100)- PGA score at baseline (0-100). PGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition). * Negative value means improvement from baseline * Positive value means deterioration from baseline

Time frame:
Baseline and 16 weeks
Reported as:
Median · units on a scale
Patient Global Assessment, Change From Baseline
units on a scaleShinbaroPlacebo
Patient Global Assessment, Change From Baseline-10.0 (-29.0 to 3.0)-8.5 (-21.0 to 9.0)
Statistical analysis
  • Shinbaro vs Placebo · Wilcoxon (Mann-Whitney) · p = 0.221
SecondaryPhysician Global Assessment, Change From Baseline

Change in Physician global assessment (PhGA) at 4 weeks from baseline = PhGA at 4 weeks (0-100)- PhGA score at baseline (0-100). GPA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition). * Negative value means improvement from baseline * Positive value means deterioration from baseline

Time frame:
baseline and 4 weeks
Reported as:
Median · units on a scale
Physician Global Assessment, Change From Baseline
units on a scaleShinbaroPlacebo
Physician Global Assessment, Change From Baseline-12 (-21.0 to 0)-7.0 (-19.0 to 1.0)
Statistical analysis
  • Shinbaro vs Placebo · Wilcoxon (Mann-Whitney) · p = 0.174
SecondaryPhysician Global Assessment, Change From Baseline

Change in Physician global assessment (PhGA) at 8 weeks from baseline = PhGA at 8 weeks (0-100)- PhGA score at baseline (0-100). PhGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition). * Negative value means improvement from baseline * Positive value means deterioration from baseline

Time frame:
Baseline and 8 weeks
Reported as:
Median · units on a scale
Physician Global Assessment, Change From Baseline
units on a scaleShinbaroPlacebo
Physician Global Assessment, Change From Baseline-16.0 (-26.0 to -4.0)-11.5 (-25.3 to 0.0)
Statistical analysis
  • Shinbaro vs Placebo · Wilcoxon (Mann-Whitney) · p = 0.124
SecondaryPhysician Global Assessment, Change From Baseline

Change in Physician global assessment (PhGA) at 12 weeks from baseline = PhGA at 12 weeks (0-100)- PhGA score at baseline (0-100). PhGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition). * Negative value means improvement from baseline * Positive value means deterioration from baseline

Time frame:
Baseline and 12 weeks
Reported as:
Median · units on a scale
Physician Global Assessment, Change From Baseline
units on a scaleShinbaroPlacebo
Physician Global Assessment, Change From Baseline-19.0 (-29.0 to -5.0)-13 (-27.0 to 0.0)
Statistical analysis
  • Shinbaro vs Placebo · Wilcoxon (Mann-Whitney) · p = 0.128
SecondaryPhysician Global Assessment, Change From Baseline

Change in Physician global assessment (PhGA) at 16 weeks from baseline = PhGA at 16 weeks (0-100)- PhGA score at baseline (0-100). PhGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition). * Negative value means improvement from baseline * Positive value means deterioration from baseline

Time frame:
Baseline and 16 weeks
Reported as:
Median · units on a scale
Physician Global Assessment, Change From Baseline
units on a scaleShinbaroPlacebo
Physician Global Assessment, Change From Baseline-12 (-23.5 to 0)-6.5 (-20.0 to 1.0)
Statistical analysis
  • Shinbaro vs Placebo · Wilcoxon (Mann-Whitney) · p = 0.126
SecondaryTender Joint Count, Change From Baseline

Change in Tender joint count (TJC) at 4 weeks from baseline = TJC at 4 weeks - TJC at baseline.. * Negative value means improvement from baseline * Positive value means deterioration from baseline

Time frame:
Baseline and 4 weeks
Reported as:
Median · joints
Tender Joint Count, Change From Baseline
jointsShinbaroPlacebo
Tender Joint Count, Change From Baseline-1 (-4 to 0)0 (-3.0 to 1.0)
Statistical analysis
  • Shinbaro vs Placebo · Wilcoxon (Mann-Whitney) · p = 0.042
SecondaryTender Joint Count, Change From Baseline

Change in Tender joint count (TJC) at 8 weeks from baseline = TJC at 8 weeks - TJC at baseline.. * Negative value means improvement from baseline * Positive value means deterioration from baseline

Time frame:
Baseline and 8 weeks
Reported as:
Median · Joints
Tender Joint Count, Change From Baseline
JointsShinbaroPlacebo
Tender Joint Count, Change From Baseline-1.0 (-4.0 to 0)-1.0 (-5 to 0)
Statistical analysis
  • Shinbaro vs Placebo · Wilcoxon (Mann-Whitney) · p = 0.660
SecondaryTender Joint Count, Change From Baseline

Change in Tender joint count (TJC) at 12 weeks from baseline = TJC at 12 weeks - TJC at baseline.. * Negative value means improvement from baseline * Positive value means deterioration from baseline

Time frame:
Baseline and 12 weeks
Reported as:
Median · joints
Tender Joint Count, Change From Baseline
jointsShinbaroPlacebo
Tender Joint Count, Change From Baseline-2.0 (-5.0 to 0)-1.0 (-4.0 to 0)
Statistical analysis
  • Shinbaro vs Placebo · Wilcoxon (Mann-Whitney) · p = 0.006
SecondaryTender Joint Count, Change From Baseline

Change in Tender joint count (TJC) at 16 weeks from baseline = TJC at 16 weeks - TJC at baseline.. * Negative value means improvement from baseline * Positive value means deterioration from baseline

Time frame:
Baseline and 16 weeks
Reported as:
Median · joints
Tender Joint Count, Change From Baseline
jointsShinbaroPlacebo
Tender Joint Count, Change From Baseline-2.0 (-5.0 to 1.0)-1.0 (-5.0 to 1.0)
Statistical analysis
  • Shinbaro vs Placebo · Wilcoxon (Mann-Whitney) · p = 0.186
SecondarySwollen Joint Count, Change From Baseline

Change in Swollen joint count (SJC) at 4 weeks from baseline = SJC at 4 weeks - TJC at baseline.. * Negative value means improvement from baseline * Positive value means deterioration from baseline

Time frame:
Baseline and 4 weeks
Reported as:
Median · Joints
Swollen Joint Count, Change From Baseline
JointsShinbaroPlacebo
Swollen Joint Count, Change From Baseline0 (0 to 0)0 (0 to 0)
Statistical analysis
  • Shinbaro vs Placebo · Wilcoxon (Mann-Whitney) · p = 0.493
SecondarySwollen Joint Count, Change From Baseline

Change in Swollen joint count (SJC) at 8 weeks from baseline = SJC at 8 weeks - TJC at baseline.. * Negative value means improvement from baseline * Positive value means deterioration from baseline

Time frame:
Baseline and 8 weeks
Reported as:
Median · Joints
Swollen Joint Count, Change From Baseline
JointsShinbaroPlacebo
Swollen Joint Count, Change From Baseline0 (0 to 0)0 (0 to 0)
Statistical analysis
  • Shinbaro vs Placebo · Wilcoxon (Mann-Whitney) · p = 0.062
SecondarySwollen Joint Count, Change From Baseline

Change in Swollen joint count (SJC) at 12 weeks from baseline = SJC at 12 weeks - TJC at baseline.. * Negative value means improvement from baseline * Positive value means deterioration from baseline

Time frame:
Baseline and 12 weeks
Reported as:
Median · Joints
Swollen Joint Count, Change From Baseline
JointsShinbaroPlacebo
Swollen Joint Count, Change From Baseline0 (0 to 0)0 (0 to 0)
Statistical analysis
  • Shinbaro vs Placebo · Wilcoxon (Mann-Whitney) · p = 0.604
SecondarySwollen Joint Count, Change From Baseline

Change in Swollen joint count (SJC) at 16 weeks from baseline = SJC at 16 weeks - TJC at baseline.. * Negative value means improvement from baseline * Positive value means deterioration from baseline

Time frame:
Baseline and 16 weeks
Reported as:
Median · Joints
Swollen Joint Count, Change From Baseline
JointsShinbaroPlacebo
Swollen Joint Count, Change From Baseline0 (0 to 0)0 (0 to 0)
Statistical analysis
  • Shinbaro vs Placebo · Wilcoxon (Mann-Whitney) · p = 0.252
SecondaryAcetaminophen Rescue

yes = AAP rescue use, no = no AAP rescue use

Time frame:
Baseline 4 weeks
Reported as:
Number · participants
Acetaminophen Rescue
participantsShinbaroPlacebo
yes74
no102102
Statistical analysis
  • Shinbaro vs Placebo · Chi-squared · p = 0.378
SecondaryAcetaminophen Rescue

yes = AAP rescue use, no = no AAP rescue use

Time frame:
4 weeks and 8 weeks
Reported as:
Number · participants
Acetaminophen Rescue
participantsShinbaroPlacebo
yes107
no9999
Statistical analysis
  • Shinbaro vs Placebo · Chi-squared · p = 0.485
SecondaryAcetaminophen Rescue

yes = AAP rescue use, no = no AAP rescue use

Time frame:
8 weeks and 12 weeks
Reported as:
Number · participants
Acetaminophen Rescue
participantsShinbaroPlacebo
yes44
no105102
Statistical analysis
  • Shinbaro vs Placebo · Fisher Exact · p = 1.000
SecondaryAcetaminophen Rescue

yes = AAP rescue use, no = no AAP rescue use

Time frame:
12 weeks and 16 weeks
Reported as:
Number · participants
Acetaminophen Rescue
participantsShinbaroPlacebo
yes42
no105104
Statistical analysis
  • Shinbaro vs Placebo · Fisher Exact · p = 0.683
SecondaryNumber of OMERACT-OARSI Responder

Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Number of patients who met OMERACT-OARSI criteria = significant clinical improvement in osteoarthritis symptom after treatment

Time frame:
Baseline and 4 weeks
Reported as:
Number · participants
Number of OMERACT-OARSI Responder
participantsShinbaroPlacebo
Responder4832
Nonresponder6174
Statistical analysis
  • Shinbaro vs Placebo · Chi-squared · p = 0.036
SecondaryNumber of OMERACT-OARSI Responder

Number of patients who met OMERACT-OARSI criteria = significant clinical improvement in osteoarthritis symptom after treatment

Time frame:
Baseline and 8 weeks
Reported as:
Number · participants
Number of OMERACT-OARSI Responder
participantsShinbaroPlacebo
responder5638
nonresponder5368
Statistical analysis
  • Shinbaro vs Placebo · Chi-squared · p = 0.022
SecondaryNumber of OMERACT-OARSI Responder

Number of patients who met OMERACT-OARSI criteria = significant clinical improvement in osteoarthritis symptom after treatment

Time frame:
Baseline and 12 weeks
Reported as:
Number · participants
Number of OMERACT-OARSI Responder
participantsShinbaroPlacebo
responder6243
nonresponder4763
Statistical analysis
  • Shinbaro vs Placebo · Chi-squared · p = 0.017
SecondaryNumber of OMERACT-OARSI Responder

Number of patients who met OMERACT-OARSI criteria = significant clinical improvement in osteoarthritis symptom after treatment

Time frame:
Baselie and 16 weeks
Reported as:
Number · participants
Number of OMERACT-OARSI Responder
participantsShinbaroPlacebo
Number of OMERACT-OARSI Responder5540
Statistical analysis
  • Shinbaro vs Placebo · Chi-squared · p = 0.060

Adverse events

Collected over Any event between randomization (week 0) and study end (week 16). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Shinbaro—1/109 (0.9%)55/109 (50.5%)
Placebo—4/106 (3.8%)45/106 (42.5%)
Most frequent serious events
Most frequent serious events
EventShinbaroPlacebo
FractureMusculoskeletal and connective tissue disorders0/1091/106
SurgeryGeneral disorders1/1091/106
Skin rashMusculoskeletal and connective tissue disorders0/1091/106
liver function abnormalityHepatobiliary disorders0/1091/106
Most frequent other events
Showing 10 of 17
Most frequent other events
EventShinbaroPlacebo
Abdominal discomfortGastrointestinal disorders18/10913/106
Upper respiratory infectionImmune system disorders16/1095/106
Skin rashSkin and subcutaneous tissue disorders10/10912/106
LeukopeniaBlood and lymphatic system disorders11/1098/106
NauseaGastrointestinal disorders9/10910/106
Liver function changeHepatobiliary disorders8/1098/106
ParesthesiaNervous system disorders2/1094/106
AnemiaBlood and lymphatic system disorders2/1094/106
HeadacheNervous system disorders4/1093/106
insomniaPsychiatric disorders0/1093/106

Baseline characteristics

1 patients in the Shinbaro group (n=110) and 3 in the placebo group (n=110) did not receive the allocated intervention as they withdrew immediately after randomization. Also, information on 1 patient in the placebo group was not complete leading to drop out.

Age, Continuous
Age, Continuous(years)ShinbaroPlaceboTotal
Mean60.7 ± 7.259.4 ± 8.060.1 ± 7.6
Sex: Female, Male
Sex: Female, Male(Participants)ShinbaroPlaceboTotal
Female10098198
Male9817
Weight
Weight(kg)ShinbaroPlaceboTotal
Mean58.9 ± 7.459.0 ± 8.158.9 ± 7.7
Height
Height(cm)ShinbaroPlaceboTotal
Mean156.7 ± 6.7157.0 ± 6.0156.8 ± 6.3
Body mass index
Body mass index(kg/m2)ShinbaroPlaceboTotal
Mean23.9 ± 2.523.9 ± 2.823.9 ± 2.6
Duration of OA
Duration of OA(months)ShinbaroPlaceboTotal
Mean28.6 ± 46.831.7 ± 47.230.1 ± 46.9
Family history of OA
Family history of OA(participants)ShinbaroPlaceboTotal
Yes302555
No7981160
AUSCAN pain (0-100)
AUSCAN pain (0-100)(units on a scale)ShinbaroPlaceboTotal
Mean49.7 ± 16.748.2 ± 19.948.9 ± 18.3

14 further baseline measures are reported on the registry.

08

Study locations

3 sites
  • Seoul National Univ. Bundang Hospital
    Bundang, Gyeonggi-do 463-870, Korea, Republic of
  • Seoul National University Hospital
    Seoul, 110-744, Korea, Republic of
  • SMG-SNU Boramae Medical Center
    Seoul, 156-707, Korea, Republic of
09

References and documents

Publications

  • Kloppenburg M. Hand osteoarthritis-nonpharmacological and pharmacological treatments. Nat Rev Rheumatol. 2014 Apr;10(4):242-51. doi: 10.1038/nrrheum.2013.214. Epub 2014 Jan 28. PubMed 24468932 ↗
  • Shin K, Kim JW, Moon KW, Yang JA, Lee EY, Song YW, Lee EB. The efficacy of diacerein in hand osteoarthritis: a double-blind, randomized, placebo-controlled study. Clin Ther. 2013 Apr;35(4):431-9. doi: 10.1016/j.clinthera.2013.02.009. Epub 2013 Mar 6. PubMed 23474153 ↗
  • Kim JK, Park SW, Kang JW, Kim YJ, Lee SY, Shin J, Lee S, Lee SM. Effect of GCSB-5, a Herbal Formulation, on Monosodium Iodoacetate-Induced Osteoarthritis in Rats. Evid Based Complement Alternat Med. 2012;2012:730907. doi: 10.1155/2012/730907. Epub 2012 Mar 4. PubMed 22474519 ↗
  • Pham T, van der Heijde D, Altman RD, Anderson JJ, Bellamy N, Hochberg M, Simon L, Strand V, Woodworth T, Dougados M. OMERACT-OARSI initiative: Osteoarthritis Research Society International set of responder criteria for osteoarthritis clinical trials revisited. Osteoarthritis Cartilage. 2004 May;12(5):389-99. doi: 10.1016/j.joca.2004.02.001. PubMed 15094138 ↗
  • Hochberg MC, Altman RD, April KT, Benkhalti M, Guyatt G, McGowan J, Towheed T, Welch V, Wells G, Tugwell P; American College of Rheumatology. American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee. Arthritis Care Res (Hoboken). 2012 Apr;64(4):465-74. doi: 10.1002/acr.21596. PubMed 22563589 ↗
  • Park YG, Ha CW, Han CD, Bin SI, Kim HC, Jung YB, Lim HC. A prospective, randomized, double-blind, multicenter comparative study on the safety and efficacy of Celecoxib and GCSB-5, dried extracts of six herbs, for the treatment of osteoarthritis of knee joint. J Ethnopharmacol. 2013 Oct 7;149(3):816-24. doi: 10.1016/j.jep.2013.08.008. Epub 2013 Aug 14. PubMed 23954277 ↗
  • Coxib and traditional NSAID Trialists' (CNT) Collaboration; Bhala N, Emberson J, Merhi A, Abramson S, Arber N, Baron JA, Bombardier C, Cannon C, Farkouh ME, FitzGerald GA, Goss P, Halls H, Hawk E, Hawkey C, Hennekens C, Hochberg M, Holland LE, Kearney PM, Laine L, Lanas A, Lance P, Laupacis A, Oates J, Patrono C, Schnitzer TJ, Solomon S, Tugwell P, Wilson K, Wittes J, Baigent C. Vascular and upper gastrointestinal effects of non-steroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials. Lancet. 2013 Aug 31;382(9894):769-79. doi: 10.1016/S0140-6736(13)60900-9. Epub 2013 May 30. PubMed 23726390 ↗
  • Park JK, Shin K, Kang EH, Ha YJ, Lee YJ, Lee KH, Lee EY, Song YW, Choi Y, Lee EB. Efficacy and Tolerability of GCSB-5 for Hand Osteoarthritis: A Randomized, Controlled Trial. Clin Ther. 2016 Aug;38(8):1858-1868.e2. doi: 10.1016/j.clinthera.2016.06.016. Epub 2016 Jul 21. PubMed 27449412 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01910116
Lead sponsor
Seoul National University Hospital
Collaborators
Green Cross Corporation
Responsible party
Eun Bong Lee (Professor, Seoul National University Hospital) — Principal investigator
First posted
Jul 29, 2013
Start date
Sep 2013
Primary completion
Nov 2014
Completion
Nov 2014
Results posted
Dec 17, 2015
Last update
Dec 17, 2015

Study contacts

Eun Bong Lee, MD PhD
principal investigator · Seoul National University College of Medicine
Jin Kyun Park, MD
study director · Seoul National University Hospital
Yun Jong Lee, MD PhD
study director · Seoul National Universty Bundang Hospital
Kichul Shin, MD PhD
study director · SMG-SNU Boramae Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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