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Injuries ointment treatment compared to placebo for evaluation of soft tissue contusion (qi and blood stasis) the efficacy and safety: randomized, double-blind, placebo-controlled, multicenter phase II exploratory clinical trials

Injuries ointment treatment compared to placebo for evaluation of soft tissue contusion (qi and blood stasis) the efficacy and safety: randomized, double-blind, placebo-controlled, multicenter phase II exploratory clinical trials

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900028564
Enrollment
Unknown
Registered
2019-12-27
Start date
2020-02-01
Completion date
Unknown
Last updated
2020-01-06

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

Conditions

Soft tissue contusion

Interventions

Experimental group:Test intervention
Control group:Placebo

Sponsors

Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria of western medicine for acute soft tissue contusion; 2. TCM syndrome is qi stagnation and blood stasis; 3. Pain VAS score >=4 and < 7; 4. There is only one damage site that can be evaluated; 5. The damage occurred within 48h; 6. Aged between 18 and 65 years; 7. Informed consent and voluntary informed consent.

Exclusion criteria

Exclusion criteria: 1. Diagnosis of chronic soft tissue contusion; 2. Patients with fractures or complete rupture of muscles, tendons, ligaments and other soft tissues; 3. There are skin lesions such as skin bruising and bleeding, ulcer, eczema, rash, etc.; 4. Non-steroidal anti-inflammatory drugs and other drugs with anti-inflammatory and analgesic effects or traditional Chinese medicine with the effect of activating blood circulation and removing stasis and swelling and relieving pain were used within 12 hours before enrollment; 5. 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 in patients with severe primary disease or mental illness, such as cardio-cerebrovascular disease, liver, kidney and hematopoietic system; 6. Allergic constitution (allergic to two or more substances) or matrix components such as experimental drug ingredients and alcohol; 7. Women who are nursing or preparing for pregnancy; 8. Have participated in other clinical trials within the past 1 month; 9. Other patients judged inappropriate to participate in this study by the researcher; Note: muscle, tendon, ligament and other soft tissue rupture, clinical manifestations of local pain, void or concave Depression, tenderness, loss or loss of muscle or tendon function. Ultrasound is helpful in diagnosis.

Design outcomes

Primary

MeasureTime frame
Changes in VAS score on day 14 from baseline;

Countries

China

Contacts

Public ContactLi Chungen

Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University/Beijing institute of Traditional Chinese Medicine

leechungen@126.com+86 13693199728

Outcome results

None listed

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