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Clinical study of Shexiang Chifeng Zhitong ointment in relieving pain of knee osteoarthritis

Clinical trial of efficacy and safety of Shexiang Chufeng Zhitong Ointment in relieving pain of knee osteoarthritis

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086462
Enrollment
Unknown
Registered
2024-07-02
Start date
2024-07-15
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

Knee Osteoarthritis

Interventions

experimental group:Diclofenac sodium sustained-release tablet 50mg orally, twice a day Ultra-short wave therapy Shexiang Chufeng pain Relief cream for external use
control group:Diclofenac sodium sustained-release tablet 50mg orally, twice a day Ultra-short wave therapy

Sponsors

Jiangsu Shengze Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Meet the Western medical diagnostic criteria for knee osteoarthritis in the Guidelines for Diagnosis and Treatment of Osteoarthritis (2021 edition); 2. Pain VAS scores of 3.0 to 7.4 (including 3.0 and 7.4); 3. The subjects give informed consent, voluntarily participate in the experiment and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Allergy, rubber allergy or known allergy to the ingredients of this product; 2. Severe cardiovascular or peripheral vascular diseases, abnormal liver and kidney function (AST, ALT > 1.5 times the upper limit of normal, blood creatinine > the upper limit of normal), bleeding diseases, coagulation dysfunction, etc.; 3. The knee joint has a serious organic injury or has undergone surgery; 4. Local skin rupture, skin damage or infection and scar skin in the knee joint; 5. Pregnant and lactating women; Or have a birth plan during the study period; 6. Any other circumstances that, in the opinion of the investigator, endanger the safety of the subject, affect the evaluation of the investigator, or have poor adherence to the protocol.

Design outcomes

Primary

MeasureTime frame
VAS;

Secondary

MeasureTime frame
Western Ontario and McMaster Universities Osteoarthritis Index;adverse reaction;

Countries

China

Contacts

Public ContactHe Chuan

Jiangsu Shengze Hospital

he-chuan@outlook.com+86 139 6210 6994

Outcome results

None listed

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