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Zhenggu Lotion for Chronic Lateral Ankle Ligament Injuries: A Randomized Controlled Trial on Efficacy and Standardized Protocol Development

Zhenggu Lotion for Chronic Lateral Ankle Ligament Injuries: A Randomized Controlled Trial on Efficacy and Standardized Protocol Development

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001668
Enrollment
Unknown
Registered
2026-07-06
Start date
2026-09-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Chronic lateral ankle ligament injury

Interventions

Experimental group:Zhenggu Lotion fumigation plus functional exercise
Control group:Warm-water fumigation plus functional exercise

Sponsors

?Capital Medical University Affiliated Beijing Jishuitan Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Aged 18–65 years old, no gender restriction; 2) Confirmed history of ankle inversion sprain with a disease course of = 3 months; 3) Mild to moderate injury of the anterior talofibular ligament (ATFL) and/or calcaneofibular ligament (CFL); 4) No prior surgical treatment, and no other external Chinese medicinal therapies administered within the past month; 5) Patients provide informed consent, exhibit good compliance, and are able to complete follow-up visits

Exclusion criteria

Exclusion criteria: 1) Combined injury of medial deltoid ligament, tibiofibular syndesmosis injury, or ankle fracture (including avulsion fracture); 2) Previous history of ankle surgery or severe ankle trauma; 3) Acute ankle sprain (disease course 10 mmol/L), peripheral vascular disease or peripheral neuropathy; 7) Pregnant or lactating women; 8) Participants enrolled in other clinical trials; 9) Severe muscular atrophy or nerve injury

Design outcomes

Primary

MeasureTime frame
High-frequency ultrasonographic assessment of lateral ankle ligament healing;Cumberland Ankle Instability Tool score;

Secondary

MeasureTime frame
Visual Analogue Scale score;American Orthopaedic Foot and Ankle Society ankle-hindfoot score;Traditional Chinese Medicine syndrome score;Ankle range of motion;English Ankle swelling score;Anterior drawer test;Single-leg balance test;36-Item Short Form Health Survey (SF-36);Patient satisfaction score;Adverse events;

Countries

China

Contacts

Public ContactQi Qingxue

?Capital Medical University Affiliated Beijing Jishuitan Hospital

81557061@qq.com13811717240

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Aug 10, 2026