Chinese topical herbal medicine gives additive effect on pharmaceutical agent on fracture healing.
Wing Sum Siu, Hoi Ting Shiu, Wai Ting Shum...
https://pubmed.ncbi.nlm.nih.gov/32186156Actively Recruiting
Phase 2
Age: 20Years - 80Years
All Genders
ID05638360
Evaluation of the Efficacy of Ru-Yi-Jin-Huang-Saan on Colles' Fracture A Randomized, Double-blind, Placebo-controlled Trial
Led by Changhua Christian Hospital · Updated on 2025-03-19
100
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and effectiveness of Ru-Yi-Jin-Huang-Saan for treating Colles' fracture. The study focuses on adults aged 20 to 80 who have undergone surgical fixation for this wrist fracture. Given the aging population and increased fracture risks, traditional Chinese medicine is being studied for its potential role in aiding bone healing and reducing complications. Participants are randomly assigned to receive either the Ru-Yi-Jin-Huang-Saan patch or a placebo patch containing starch. Both patches are applied topically twice daily for six days. This randomized, double-blind trial compares these two groups to assess the effect of the herbal treatment on wrist recovery. During the study, participants will have their wrist function and pain evaluated using the Patient-Rated Wrist Evaluation (PRWE) scale at the start and on day six. Additional assessments include blood tests measuring C-reactive protein and ultrasound imaging to monitor healing progress. The trial is designed to carefully monitor safety and treatment effects over the six-day period, providing detailed insights into the herbal patch's impact on fracture recovery.
CONDITIONS
Brief Title
Evaluation of the Curative Effect of Ru-Yi-Jin-Huang-Saan
Who Can Participate
Age: 20Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 20 years or older
- Ability to understand the study and willing to participate
- Diagnosed with Colles' fracture and received surgical fixation (ORIF)
You will not qualify if you...
- Unable to cooperate with the study or complete questionnaires
- Presence of wounds on the back of the wrist
- Allergic to traditional Chinese medicine for external use or recent use of other external traditional Chinese medicines
- Having cancer, stroke, or serious systemic diseases such as severe anemia, thyroid disease, or uncontrolled diabetes
- Pregnant women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 6 days
Participants receive Ru-Yi-Jin-Huang-Saan or placebo patches applied topically twice daily.
Daily visits or check-ins for 6 days
Trial Site Locations
Total: 1 location
1
Changhua Christian Hospital
Changhua, Changhua, Taiwan, 50006
Actively Recruiting
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Research Team
L
LienCheng Lin, Master
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
In vitro & in vivo assessment of a herbal formula used topically for bone fracture treatment.
Li Hua Peng, Chun Hay Ko, Sum Wing Siu...
https://pubmed.ncbi.nlm.nih.gov/20600749Two casting methods compared in patients with Colles' fracture: A pragmatic, randomized controlled trial.
Lauri Raittio, Antti P Launonen, Teemu Hevonkorpi...
https://pubmed.ncbi.nlm.nih.gov/32469881Construct validity of the Chinese version of the Patient-rated Wrist Evaluation Questionnaire (PRWE-Hong Kong Version).
Josephine Wong Man Wah, Mike Kwan Wing Wang, Cecilia Li-Tsang Wai Ping
https://pubmed.ncbi.nlm.nih.gov/16473730C-Reactive Protein in Orthopaedic Surgery.
M Neumaier, K F Braun, G Sandmann...
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Nan-Ping Yang, Chien-Lung Chan, I-Liang Yu...
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Leena Raudasoja, Samuli Aspinen, Heidi Vastamäki...
https://pubmed.ncbi.nlm.nih.gov/35628978Evaluation 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.
Lien-Cheng Lin, Wei-Hsun Wang, Wei-Kai Chang...
https://pubmed.ncbi.nlm.nih.gov/40053806