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

RYJHS

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

2023-05-01

2024-05-31

2024-06-30

Recruiting

Early phase I

100

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

2023-06-06