A multicenter phase II randomized, double-blind, placebo-controlled trial for efficacy and safety of injuries ointment in the treatment of ankle joint sprain (qi and blood stasis zhen)
- Conditions
- Ankle sprain
- Registration Number
- ITMCTR1900002854
- Lead Sponsor
- Beijing hospital of traditional Chinese medicine affiliated to capital medical university
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1. Meet the diagnostic criteria for ankle sprain;
2. Syndrome differentiation of qi stagnation and blood stasis;
3. Pain VAS score 4 to 7;
4. Only one injured site can be evaluated;
5. The injure occurred within 48 hours;
6. Aged between 18 and 65 years;
7. Informed consent and signed informed consent voluntarily.
1. The target site is accompanied by severe sprain or strain, resulting in rupture of muscles, tendons and other soft tissues, open trauma, or joint dislocation, fracture, nerve injury and viscera injury;
2. The same target has been damaged within 3 months;
3. Non-steroidal anti-inflammatory drugs and other drugs with anti-inflammatory and analgesic effects or traditional Chinese medicine therapy with the effect of activating blood circulation and removing stasis and swelling and relieving pain were used within 12 hours before enrollment;
4. Those who had used non-drug therapy (such as massage, physiotherapy, acupuncture, etc.) other than rest and cold compress before joining the group;
5. Have used steroid drugs within 30 days;
6. For patients with severe primary diseases and mental disorders, such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system, liver function (ALT and AST) was 1.5 times higher than the upper limit of normal value, and SCr was higher than the upper limit of normal value;
7. Allergic constitution (allergic to two or more substances) or matrix components such as experimental drug ingredients and alcohol;
8. Participants in other clinical trials within the past 1 month;
9. Women who are nursing or pregnant, or who are planning to become pregnant;
10. Other patients judged inappropriate to participate in this study by the researcher.
Note: external force caused the rupture of muscles, tendons and other soft tissues, clinical manifestations of local pain, emptiness or depression, tenderness, loss or loss of muscle or tendon function. Ultrasound is helpful in diagnosis.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in VAS score on day 14 from baseline;
- Secondary Outcome Measures
Name Time Method