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CompletedNCT05398874Updated Sep 2, 2022

Clinical Efficacy of Ginkgo Biloba Extract in the Treatment of Knee Osteoarthritis

An interventional study of Ginkgo biloba extract + standard treatment( paracetamol+Diclofenac100mg SR) and placebo in addition to the standard treatment in Knee Osteoarthritis, sponsored by Kufa University. Completed at 1 site in Iraq. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-09-02.

Sponsored by Kufa University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Nov 2021, registered May 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
All
01

Study summary

To assess the efficacy and safety of the Ginkgo biloba extract in patients with Knee OA.

02

Conditions studied

  • Knee Osteoarthritis
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 60 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Kufa University is the lead sponsor of 14 studies on the registry; 3 are open to participants now.

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

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients 40-75 years old with knee OA.
  • Grade II and Grade III according to the Kellgrenn-Lawrence (KL) grading system of radiographic OA.

Exclusion criteria

Exclusion Criteria:

  • Pregnancy, breastfeeding
  • Liver or renal problems
  • Patient taking any drug that might interact with Ginkgo extract (eg. warfarin, etc.)
  • patient with cardiovascular or cerebral vascular disorders, uncontrolled diabetes, allergic to ginkgo, recent surgery or hospital admission, >75 years old.
  • Allergic or contraindicated to using NSAIDs
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Ginkgo + standard

    the patients received Ginkgo biloba extract in addition to standard treatment

    Combination Product: Ginkgo biloba extract + standard treatment( paracetamol+Diclofenac100mg SR)

  • Placebo comparator
    placebo + standard

    the patients received a placebo in addition to the standard treatment

    Combination Product: placebo in addition to the standard treatment

Interventions

  • Combination productGinkgo biloba extract + standard treatment( paracetamol+Diclofenac100mg SR)

    120 mg leaf extract , twice daily in addition to Diclofenac 100 mg Once daily + paracetamol 1g Twice daily

    Also known as: Ginko Natrol company + Dolipran+Olfen 100 SR

  • Combination productplacebo in addition to the standard treatment

    placebo in addition to the standard treatment

06

What researchers measure

Primary outcomes

  1. KOOS score

    42 item questionnaire to assess pain, other symptoms, activities of daily living (ADL), sport and recreation function (Sport/Rec) and knee-related quality of life (QOL).

    Time frame: Changes occured : baseline , 2 weeks , 4 weeks ,and 8 weeks

Secondary outcomes

  1. IL-6

    Serum level of interleukin 6

    Time frame: Changes occured: baseline , 4 weeks,and 8 weeks

  2. TNF-alpha

    Serum level of tumour necrosis factor - alpha

    Time frame: Changes occured: baseline , 4 weeks,and 8 weeks

  3. urinary CTX-II

    C-terminal telopeptide of type II collagen from urine samples

    Time frame: Changes occured :baseline , 4 weeks,and 8 weeks

07

Study locations

1 site
  • Private Clinic
    Najaf, N/A (Outside Of US) 00964, Iraq
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05398874
Lead sponsor
Kufa University
Responsible party
Maryam Al-Haddad (Researcher, Kufa University) — Principal investigator
First posted
Jun 1, 2022
Start date
Nov 1, 2021
Primary completion
Jun 1, 2022
Completion
Aug 1, 2022
Last update
Sep 2, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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