TY  - JOUR
AU  - Lin, Lien-Cheng
AU  - Wang, Wei-Hsun
AU  - Chang, Wei-Kai
AU  - Gao, Jyun-Liang
AU  - Yang, Ru-Chang
AU  - Hsu, Po-Chi
AU  - Lo, Lun-Chien
PY  - 2025
DA  - 2025/3/5
TI  - 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
JO  - JMIR Res Protoc
SP  - e56849
VL  - 14
KW  - traditional Chinese medicine
KW  - Ru-Yi-Jin-Huang-Saan
KW  - external application
KW  - Colles fracture
KW  - Patient-Rated Wrist Evaluation
KW  - PRWE
KW  - PRWE score
KW  - surgeries
KW  - fracture
KW  - randomized controlled trial
KW  - RCT
KW  - alternative treatment
KW  - postoperative
KW  - protocol
KW  - Western medicine
KW  - wrist evaluation
KW  - pain relief medication
AB  - Background: Colles fracture, a common wrist injury, often requires surgical intervention. After surgery, patients may experience persistent pain and reduced wrist function, potentially resulting in long-term disability. In clinical practice, traditional Chinese medicine practitioners frequently use Ru-Yi-Jin-Huang-Saan (RYJHS) to treat such patients in Taiwan. RYJHS is a traditional Chinese herbal formula with a history spanning centuries, primarily used topically for the treatment of bone fractures and the promotion of healing. However, there is currently a lack of substantial clinical evidence supporting its efficacy in the management of postsurgical Colles fractures. To the best of our knowledge, there are no studies evaluating the clinical effectiveness of RYJHS. Objective: This study aims to investigate the therapeutic potential of RYJHS in postsurgical Colles fracture cases. An additional objective is to provide an alternative treatment option for postoperative patients unable to take anti-inflammatory and pain relief medications. Methods: This is a protocol for a randomized, double-blind, placebo-controlled trial. A total of 100 postoperative patients with Colles fracture, aged 20-80 years, will be recruited for this study. They will be randomly assigned to either the experimental or control group in a 1:1 allocation ratio. Both groups will receive standard postoperative Colles fracture treatment. The primary outcome measure will assess wrist functional recovery using the Patient-Rated Wrist Evaluation score. Secondary outcomes will include C-reactive protein levels and ultrasound measurements of wrist swelling. All of these examinations will be assessed at baseline, 3 days after surgery, and 6 days after surgery. In addition, the Dyshidrotic Eczema Area and Severity Index will be used to monitor for adverse skin reactions. Results: This protocol was registered at ClinicalTrials.gov on December 6, 2022. It was performed in accordance with the approved guidelines and regulations of the participating institutions. Recruitment began in May 2023, with data collection expected to conclude in May 2025. Study completion is expected in December 2025. Conclusions: This is the first protocol discussing the assessment of the therapeutic efficacy and safety of topical traditional Chinese medicine in patients after fracture surgery. The protocol will establish an integrated care model combining both traditional Chinese medicine and Western medicine for postsurgical fracture cases. Trial Registration: ClinicalTrials.gov NCT05638360; https://clinicaltrials.gov/ct2/show/NCT05638360 International Registered Report Identifier (IRRID): DERR1-10.2196/56849 
SN  - 1929-0748
UR  - https://www.researchprotocols.org/2025/1/e56849
UR  - https://doi.org/10.2196/56849
UR  - http://www.ncbi.nlm.nih.gov/pubmed/40053806
DO  - 10.2196/56849
ID  - info:doi/10.2196/56849
ER  -