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A multicenter, prospective real-world study of Shangkeling Spray in the treatment of acute ankle sprain

A multicenter, prospective real-world study of Shangkeling Spray in the treatment of acute ankle sprain

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500103995
Enrollment
Unknown
Registered
2025-06-10
Start date
2025-06-15
Completion date
Unknown
Last updated
2025-06-16

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

Conditions

Acute ankle sprain

Interventions

Experimental group:On the basis of physical therapy, the experimental group was treated with Shangkeling spray. Usage and Dosage: For the experimental group, apply Shangkeling Spray externally. Aim th
Control group:On the basis of physical therapy, the control group was treated with Yunnan Baiyao aerosol. Dosage and Administration: For the control group, apply Yunnan Baiyao Aerosol externally. Aim

Sponsors

The First Affiliated Hospital of Jinan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Age>=18 years old, gender not limited; 2) Acute ankle sprain of grade I and II that meets the diagnostic criteria; 3) The disease course before enrollment was <=72 hours; 4) Voluntarily sign the written informed consent form.

Exclusion criteria

Exclusion criteria: 1) Those with fractures at the site of ankle sprain; 2) Those who need surgical treatment due to severe ligament damage at the sprain site (such as complete rupture of the anterior talofibular ligament); 3) Those with local swelling and pain in the ankle joint caused by infection (including specific and non-specific); 4) Those with sensory disorders caused by nervous system disorders in the legs during sprains; 5) Those with musculoskeletal diseases and other severe lower extremity sprains (excluding ankle sprains); 6) Those who are allergic to the known components of the therapeutic drug used in this study (such as alcohol, foxtail, white clover, verbena, crane grass, and bean root, etc.).

Design outcomes

Primary

MeasureTime frame
Main effectiveness indicators;

Secondary

MeasureTime frame
VAS score;AOFAS score of the ankle joint;Swelling circumference;Dorsiflexion range of motion of the ankle joint;The types and quantities of emergency medications used to relieve ankle pain during the treatment period;

Countries

China

Contacts

Public ContactHou Huige

The First Affiliated Hospital of Jinan University

18620085802@126.com+86 186 2008 5802

Outcome results

None listed

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