A three-arm randomized, parallel controlled, multicenter clinical trial evaluating the efficacy, safety, and economics of sprays for the treatment of soft tissue injury (qi stagnation and blood stasis syndrome) with pain relief time as the primary endpoint
- Conditions
- Soft tissue injury
- Registration Number
- ITMCTR2000003441
- Lead Sponsor
- Peking University Third Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1) Meet the diagnostic criteria of simple soft tissue injury in western medicine;
2) Conform to the standard of TCM qi stagnation and blood stasis syndrome;
3) The injured part is the limbs (including joints);
4) The injury shall not exceed 48 hours before enrollment;
5) VAS score of pain symptoms >= 4 at enrollment;
6) Aged 14-80 years;
7) Subjects understand and voluntarily participate in this study and sign the informed consent.
1) Patients needing surgical treatment.
2) Combined with fracture, joint dislocation, complete ligament fracture, infection, joint effusion, tumor, and nerve and blood vessel injury.
3) Patients with damaged skin, poor skin condition or allergic skin.
4) The same target site has been damaged within 3 months.
5) Patients with systemic collagenous connective tissue diseases, such as systemic lupus erythematosus, rheumatoid arthritis, etc.
6) Those who have received acupuncture, physiotherapy, massage and other treatments after the onset of the disease.
7) Non-steroidal anti-inflammatory drugs (except aspirin which has been taken for a long time for prevention and treatment of cardiovascular diseases, the original dose can be maintained) or other drugs with analgesic effect, or Traditional Chinese medicine for promoting blood circulation, removing blood stasis and relieving swelling and pain within 12 hours before enrollment.
8) patients with serious cardiovascular disease, liver disease (ALT, AST >= 2 times upper limit of normal), kidney disease (Scr > 1.2 times upper limit of normal), infectious disease or other serious complications.
9) Known to be allergic to alcohol, isopropanol, propanediol or other ingredients of the test drugs, and allergic constitution.
10) According to the researcher's judgment, the enrollment may affect the follow-up visits and compliance of the subjects and other situations that may cause loss of follow-up.
11) Women who are pregnant or preparing for pregnancy and breast-feeding.
12) Participants in other clinical trials within 1 month.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time for pain to disappear;
- Secondary Outcome Measures
Name Time Method Change of swelling degree;Changes in VAS score;Disappearance rate of single symptom in TCM ;The immediate onset of pain;Pain relief rate;Emergency medication use;Time for swelling to disappear;TCM syndrome integral effective rate;Disappearance rate of swelling;