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RecruitingNCT05638360Updated Mar 19, 2025

Evaluation of the Curative Effect of Ru-Yi-Jin-Huang-Saan

A Phase 2 interventional study of Ru Yi Jin Huang Powder and Placebo in Colles' Fracture, sponsored by Changhua Christian Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-03-19.

Sponsored by Changhua Christian Hospital · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 4 months ago, but the record still lists the study as recruiting.
  • Started May 2023; still recruiting 3 years 6 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Study summary

The purpose of this study is to assess the efficacy and safety of Ru-Yi-Jin-Huang-Saan for the treatment of Colles' fracture.

Read the detailed description

According to the definition of the World Health Organization, Taiwan officially entered the aged society in 2018. The population over the age of 65 exceeds 14% of the total population. Based on this, it is estimated that we will enter a super-aged society in 2026. Because the older the age, the higher the rate of bone loss, and the higher the risk of osteoporosis, the easier it is to fracture due to falls. The incidence of bone fracture is directly proportional to the aging population. Traditional Chinese Medicine(TCM) interventional fracture treatment has a long history and experience.

Many recent studies show that TCM is benefit to reduce risk of total hip replacement and has a positive influence on the prevention of osteoporotic fracture. In drug mechanism research, some Chinese herbal medicine has been proved to promote bone fracture healing . Although most of these researches have been confirmed in the laboratory, little information is available on true patients. In clinical we observe a lot of topical Chinese medicine been used after fracture, so the purpose of this thesis is to investigate the effective of topical Chinese herbal paste. This study may lead to build the usage of guideline after fracture.

02

Conditions studied

  • Colles' Fracture

Browse trials for

03

In context

Colles' Fracture

32 studies on the registry are indexed under Colles' Fracture; 4 are open to participants now.

This study's planned enrollment of 100 is above the median of 90 across 27 interventional studies indexed under Colles' Fracture.

Browse Colles' Fracture studies →

Lead sponsor

Changhua Christian Hospital is the lead sponsor of 76 studies on the registry; 11 are open to participants now.

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

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. People who are over 20 years old and have no lack of mental ability can understand the content of the experiment and are willing to participate in it.
  2. Patients with Colles' fracture receive surgical fixation(ORIF).

Exclusion criteria

Exclusion Criteria:

  1. People are unable to cooperate with experiments and fill out questionnaires.
  2. Patients have wounds on the back of their wrists.
  3. Patients are allergic to traditional Chinese medicine for external applications or have used other traditional Chinese medicine for external applications.
  4. Patients have cancer, stroke, and systemic diseases such as severe anemia, thyroid disease, uncontrolled diabetes, etc.
  5. Pregnant woman.
05

Study design

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

Study arms

  • Experimental
    Ru-Yi-Jin-Huang-Saan

    Participants received Ru-Yi-Jin-Huang-Saan patch topically twice daily for 6 days.

    Drug: Ru Yi Jin Huang Powder

  • Placebo comparator
    Placebo

    Participants received a starch patch topically twice daily for 6 days.

    Drug: Placebo

Interventions

  • DrugRu Yi Jin Huang Powder

    Each patch contains 13g Ru Yi Jin Huang Powder and 10c.c. water.

    Also known as: golden patch

  • DrugPlacebo

    Each patch contains 13g starch and 10c.c. water.

    Also known as: starch

06

What researchers measure

Primary outcomes

  1. Change from Baseline in Patient-Rated Wrist Evaluation(PRWE) scale at Day 6

    The PRWE scale is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living. 1. Pain subscale: contains 5 items each of which is further rated from 1-10. The maximum score in this section is 50 and minimum 0. 2. Function subscale: contains total 10 items which are further divided into 2 sections i.e specific activities (having 6 items) and usual activities (having 4 items). The maximum score in this section is 50 and minimum 0. Possible scores range from 0 (best score) to 100 (worst score). Change = (Day 6 score - Baseline score)

    Time frame: Baseline and Day 6

Secondary outcomes

  1. Change from Baseline in C-reactive protein(CRP) at Day 6

    CRP is used primarily as an indicator of inflammation.The higher the value, the more severe the inflammation is. Change = (Day 6 score - Baseline score)

    Time frame: Baseline and Day 6

  2. Change from Baseline with ultrasound at Day 6

    ultrasound is used primarily as an indicator of swelling.The larger the value, the more swollen it is. Change = (Day 6 score - Baseline score)

    Time frame: Baseline and Day 6

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Siu WS, Shiu HT, Shum WT, Ko Chun H, Lau CBS, Hung Leung K, Leung Ping C. Chinese topical herbal medicine gives additive effect on pharmaceutical agent on fracture healing. J Tradit Chin Med. 2019 Dec;39(6):853-860. PubMed 32186156 ↗
  • Peng LH, Ko CH, Siu SW, Koon CM, Yue GL, Cheng WH, Lau TW, Han QB, Ng KM, Fung KP, Lau CB, Leung PC. In vitro & in vivo assessment of a herbal formula used topically for bone fracture treatment. J Ethnopharmacol. 2010 Sep 15;131(2):282-9. doi: 10.1016/j.jep.2010.06.039. Epub 2010 Jun 30. PubMed 20600749 ↗
  • Raittio L, Launonen AP, Hevonkorpi T, Luokkala T, Kukkonen J, Reito A, Laitinen MK, Mattila VM. Two casting methods compared in patients with Colles' fracture: A pragmatic, randomized controlled trial. PLoS One. 2020 May 29;15(5):e0232153. doi: 10.1371/journal.pone.0232153. eCollection 2020. PubMed 32469881 ↗
  • Wah JW, Wang MK, Ping CL. Construct validity of the Chinese version of the Patient-rated Wrist Evaluation Questionnaire (PRWE-Hong Kong Version). J Hand Ther. 2006 Jan-Mar;19(1):18-26, quiz 27. doi: 10.1197/j.jht.2005.10.003. PubMed 16473730 ↗
  • Neumaier M, Braun KF, Sandmann G, Siebenlist S. C-Reactive Protein in Orthopaedic Surgery. Acta Chir Orthop Traumatol Cech. 2015;82(5):327-31. PubMed 26516948 ↗
  • Sebastin SJ, Chung KC. An Asian perspective on the management of distal radius fractures. Hand Clin. 2012 May;28(2):151-6. doi: 10.1016/j.hcl.2012.03.007. PubMed 22554658 ↗
  • Yang NP, Chan CL, Yu IL, Lee CY, Chou P. Estimated prevalence of orthopaedic fractures in Taiwan--A cross-sectional study based on nationwide insurance data. Injury. 2010 Dec;41(12):1266-72. doi: 10.1016/j.injury.2010.05.025. Epub 2010 Jun 17. PubMed 21288468 ↗
  • Raudasoja L, Aspinen S, Vastamaki H, Ryhanen J, Hulkkonen S. Epidemiology and Treatment of Distal Radius Fractures in Finland-A Nationwide Register Study. J Clin Med. 2022 May 18;11(10):2851. doi: 10.3390/jcm11102851. PubMed 35628978 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05638360
Lead sponsor
Changhua Christian Hospital
Responsible party
LienCheng Lin (Deputy Director of Department of Traditional Chinese Medicine, Changhua Christian Hospital) — Principal investigator
First posted
Dec 6, 2022
Start date
May 1, 2023
Primary completion
Jun 30, 2025 (estimated)
Completion
Sep 30, 2025 (estimated)
Last update
Mar 19, 2025

Study contacts

LienCheng Lin, Master
Contact
shoklin@gmail.com
886-917603152
LienCheng Lin, Master
study chair · Changhua Christian Hospital

Oversight

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

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