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A clinical randomized controlled study of external application of Xibisan in treating knee osteoarthritis due to cold and damp block

A clinical randomized controlled studyof external application of Xibisan in treating knee osteoarthritis due to cold and damp block

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076147
Enrollment
Unknown
Registered
2023-09-26
Start date
2023-06-06
Completion date
Unknown
Last updated
2023-10-03

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:Take 50g of finely ground Chinese medicine powder, and make paste with 80? water and 2g Vaseline. When the temperature drops below the skin temperature, apply it directly to the aff
Control group:The control group used PE plastic film to separate the contact between the drug and the skin, and the knee Bi powder was applied externally according to the method of the experimental gr

Sponsors

Chongqing Nanchuan District Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1: 1.Primary KOA, in line with the above diagnostic criteria of Chinese medicine and Western medicine 2: 2. The X-ray grading conforms to Kellner &Lawrance X-ray grading I ~ III 3: 3. age between 45 -80, weight and gender were not limited 4: 4. Haven’t been recieved systematic treatment, including knee surgery and sodium hyaluronate injection. 5: 5.The subject is informed and signs a written informed consent.

Exclusion criteria

Exclusion criteria: 1: 1.Combined with other knee diseases, such as gouty arthritis, rheumatoid arthritis, pigmented villous nodular synovitis, traumatic arthritis, etc. 2: 2.Patients with metabolic bone disease, tumor, trauma, etc. affecting knee joint 3: 3.Patients who had taken non-steroidal anti-inflammatory drugs (NSAIDs) and/or injected drugs into the joint cavity 1 month before the current treatment 4: 4.Patients who received surgical treatment within 1 year, such as joint cleaning 5: 5.patients with severe medical disease and mental illness 6: 6.Patients with a history of gastrointestinal bleeding 7: 7.Women who are pregnant, planning to be pregnant or lactating 8: 8.There are studies of drug allergy 9: 9.Patients with long-term use of other drugs that affect safety and efficacy evaluation.

Design outcomes

Primary

MeasureTime frame
WOMAC Osteoarthritis Index;Visual Analogue Scale;Traditional Chinese Medicine Syndrome Points;

Secondary

MeasureTime frame
Magnetic resonance imaging, color Doppler ultrasound, C-reactive protein, erythrocyte sedimentation rate;The incidence of possible adverse reactions such as skin allergies, itching, or pain;

Countries

China

Contacts

Public ContactYunhua Zhang

Chongqing Nanchuan District Hospital of Traditional Chinese Medicine

yunhua_2008@163.com+86 173 5329 9009

Outcome results

None listed

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