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A randomized controlled trial on the efficacy and safety of Zhishang Ointment in the treatment of acute closed soft tissue injuries (ankle)

A randomized controlled trial on the efficacy and safety of Zhishang Ointment in the treatment of acute closed soft tissue injuries (ankle)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000218
Enrollment
Unknown
Registered
2025-02-08
Start date
2024-08-25
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Acute closed soft tissue injury (ankle)

Interventions

Experimental group:Basic treatment + zhishang ointment
Control group:Basic treatment + diclofenac diethylamine emulgel

Sponsors

Wang Jing Hospital of CACMS
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Meet the Western medical diagnostic criteria for acute closed soft tissue injury (ankle); 2.72 hours have a clear history of unilateral ankle joint trauma resulting in local ankle swelling pain and joint mobility disorders; 3. Age 18-70 years old gender unlimited; 4. Voluntarily sign informed consent and agree to participate in all visits as required by the study protocol.

Exclusion criteria

Exclusion criteria: 1. There is skin damage in the affected area; 2. Long-term use of NSAIDS; 3. Patients with ankle joint fracture and complete ligament tear; 4. People who are allergic to any of the ingredients in the test drug or who have had contact dermatitis due to the use of the ointment multiple times (more than three times); 5. Pregnant or lactating women; 6. Participants who have participated or are participating in other clinical trials within three months; 7. Other situations considered inappropriate by the investigator for participation in this study.

Design outcomes

Primary

MeasureTime frame
AOFAS ankle-hind foot score;

Secondary

MeasureTime frame
Pain relief time (50% pain relief time);Pain visual analogue scale (VAS);Incidence of contact dermatitis;Time to pain relief (time to 100% pain relief);European Five-dimensional Health Scale (EQ-5D-5L) score;Swelling rate;Swelling resolution time;

Countries

China

Contacts

Public ContactYong Zhao

Wang Jing Hospital of CACMS

huliangjun@shivictory.com15827639709

Outcome results

None listed

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