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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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034303
Enrollment
Unknown
Registered
2020-07-01
Start date
2020-08-01
Completion date
Unknown
Last updated
2020-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Soft tissue injury

Interventions

Sponsors

Peking University Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 80 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Time for pain to disappear;

Secondary

MeasureTime frame
Pain relief rate;Changes in VAS score;The immediate onset of pain;Time for swelling to disappear;Disappearance rate of swelling;Change of swelling degree;TCM syndrome integral effective rate;Disappearance rate of single symptom in TCM ??????;Emergency medication use;

Countries

China

Contacts

Public ContactHua tian

Peking University Third Hospital

tianhua@bjmu.edu.cn+86 13511065187

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026