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

NCT05638360 | Recruiting Phase 2

• 1 other identifier: RYJHS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colles' Fracture

Outcome Measures

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)

  Baseline and Day 6

Secondary Outcomes (2)

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

  Baseline and Day 6

• Change from Baseline with ultrasound at Day 6

  Baseline and Day 6

Study Arms (2)

Ru-Yi-Jin-Huang-Saan

EXPERIMENTAL

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

Drug: Ru Yi Jin Huang Powder

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Ru Yi Jin Huang Powder DRUG

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

Also known as: golden patch

Ru-Yi-Jin-Huang-Saan

Placebo DRUG

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

Also known as: starch

Placebo

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients with Colles' fracture receive surgical fixation(ORIF).

You may not qualify if:

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

Sponsors & Collaborators

• Changhua Christian Hospital: lead

Study Sites (1)

Changhua Christian Hospital

Changhua, Changhua, 50006, Taiwan

RECRUITING

Related Publications (9)

• 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.

  PMID: 32186156 BACKGROUND

• 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.

  PMID: 20600749 BACKGROUND

• 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.

  PMID: 32469881 BACKGROUND

• 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.

  PMID: 16473730 BACKGROUND

• Neumaier M, Braun KF, Sandmann G, Siebenlist S. C-Reactive Protein in Orthopaedic Surgery. Acta Chir Orthop Traumatol Cech. 2015;82(5):327-31.

  PMID: 26516948 BACKGROUND

• 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.

  PMID: 22554658 BACKGROUND

• 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.

  PMID: 21288468 BACKGROUND

• 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.

  PMID: 35628978 BACKGROUND

• Lin LC, Wang WH, Chang WK, Gao JL, Yang RC, Hsu PC, Lo LC. Evaluation of the Efficacy of the Traditional Chinese Medicine Formulation Ru-Yi-Jin-Huang-Saan on Colles Fracture After Surgery: Protocol for a Randomized, Double-Blind, Placebo-Controlled Trial. JMIR Res Protoc. 2025 Mar 5;14:e56849. doi: 10.2196/56849.

  PMID: 40053806 DERIVED

MeSH Terms

Conditions

Colles' Fracture

Interventions

Starch

Condition Hierarchy (Ancestors)

Fracture Dislocation; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Radius Fractures; Fractures, Bone

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Study Officials

• LienCheng Lin, Master

  Changhua Christian Hospital

  STUDY CHAIR

Central Study Contacts

LienCheng Lin, Master

CONTACT

886-917603152; shoklin@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of Department of Traditional Chinese Medicine

Study Record Dates

• First Submitted: November 26, 2022
• First Posted: December 6, 2022
• Study Start: May 1, 2023
• Primary Completion: June 30, 2025
• Study Completion: September 30, 2025
• Last Updated: March 19, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)