Evaluating a Chinese herbal treatment for Colles' fracture
Evaluation of the Efficacy of Ru-Yi-Jin-Huang-Saan on Colles' Fracture ---a Randomized, Double-blind, Placebo-controlled Trial
This study is testing a traditional Chinese herbal paste to see if it helps older adults heal better after surgery for Colles' fractures compared to a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 20 Years to 80 Years |
| Sex | All |
| Sponsor | Changhua Christian Hospital Academic / other |
| Locations | 1 site (Changhua, Changhua) |
| Trial ID | NCT05638360 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the efficacy and safety of Ru-Yi-Jin-Huang-Saan, a traditional Chinese herbal paste, for treating Colles' fractures. It focuses on older adults who are at higher risk for fractures due to osteoporosis. The study will involve patients who have undergone surgical fixation for their fractures and will compare the herbal treatment to a placebo. The goal is to gather clinical evidence on the effectiveness of this traditional approach in promoting fracture healing.
Who should consider this trial
Good fit: Ideal candidates are individuals over 20 years old with a Colles' fracture who have undergone surgical fixation.
Not a fit: Patients with severe systemic diseases, allergies to traditional Chinese medicine, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel, effective option for enhancing recovery from Colles' fractures in older adults.
How similar studies have performed: While traditional Chinese medicine has shown promise in laboratory settings, this specific approach in clinical settings is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Changhua, Changhua
- Changhua Christian Hospital — Changhua, Changhua, Taiwan (Recruiting)
Study contacts
- Study coordinator: LienCheng Lin, Master
- Email: shoklin@gmail.com
- Phone: 886-917603152
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.