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

Colles' Fracture Clinical Trial

Official title:

Evaluation of the Efficacy of Ru-Yi-Jin-Huang-Saan on Colles' Fracture ---a Randomized, Double-blind, Placebo-controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05638360
• Other study ID #: RYJHS
• Status: Recruiting
• Phase: Phase 2
• Start date: May 1, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: June 2023
• Source: Changhua Christian Hospital
• Contact: LienCheng Lin, Master
• Phone: 886-917603152
• Email: shoklin[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colles' Fracture

Intervention

Drug:
• Ru Yi Jin Huang Powder
Each patch contains 13g Ru Yi Jin Huang Powder and 10c.c. water.
• Placebo
Each patch contains 13g starch and 10c.c. water.

Locations

Country	Name	City	State
Taiwan	Changhua Christian Hospital	Changhua

Sponsors (1)

Lead Sponsor	Collaborator
Changhua Christian Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (8)

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

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.j — View Citation

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/jo — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.; 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.; 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	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)	Baseline and Day 6
Secondary	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)	Baseline and Day 6