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

NCT ID: NCT05638360

Last Updated: 2025-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2025-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Colles' Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ru-Yi-Jin-Huang-Saan

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

Group Type EXPERIMENTAL

Ru Yi Jin Huang Powder

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Ru Yi Jin Huang Powder

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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golden patch starch

Eligibility Criteria

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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

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Changhua Christian Hospital

OTHER

Sponsor Role lead

Responsible Party

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LienCheng Lin

Deputy Director of Department of Traditional Chinese Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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LienCheng Lin, Master

Role: STUDY_CHAIR

Changhua Christian Hospital

Locations

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Changhua Christian Hospital

Changhua, Changhua, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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LienCheng Lin, Master

Role: CONTACT

886-917603152

Facility Contacts

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Lien-Cheng Lin, Master

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 32186156 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20600749 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32469881 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16473730 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 26516948 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22554658 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21288468 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35628978 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40053806 (View on PubMed)

Other Identifiers

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RYJHS

Identifier Type: -

Identifier Source: org_study_id

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