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Study on the clinical efficacy of Qifang Xibi Formula in the treatment of knee osteoarthritis

Study on the clinical efficacy of Qitao Huayu Formula in the treatment of knee osteoarthritis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001639
Enrollment
Unknown
Registered
2025-09-01
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

osteoarthritis of the knee

Interventions

Experimental group:Qifang Xibi Formula
Control group:Qifang Xibi Formula Placebo

Sponsors

Huadong Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Age 40-85 years old; 2. Meet the diagnostic criteria of osteoarthritis of the knee in Chinese and Western medicine; 3. Those who have already received other conservative treatments must undergo a washout period of more than 1 week; 4. Sign the informed consent.

Exclusion criteria

Exclusion criteria: 1) Combined with knee tumors tuberculosis osteomyelitis; 2) bilateral knee osteoarthritis patients; 3) once received knee surgery; 4) damp-heat paralysis type knee osteoarthritis; 5) allergy (allergic to more than two kinds of food medicines pollen etc.) or allergic to the test drug ingredients known or easy to allergic to the skin; 6) combined with cardio-cerebral-vascular hepatic renal oncological and hematopoietic system and other serious primary diseases People with cardiovascular cerebrovascular hepatic renal tumor and hematopoietic system and other serious primary diseases; 7) Liver function is higher than the upper limit of the normal value of two times or renal function is higher than the upper limit of the normal value of two times; 8) Combined with rheumatoid immunity diseases or acute injuries; 9) treatment of the local skin damage or skin conditions are not suitable for external treatment; 10) the researcher believes that it is not suitable for the inclusion of the test of other circumstances.

Design outcomes

Primary

MeasureTime frame
visual analogue scale;

Secondary

MeasureTime frame
Lower Limb Function Test;Western Ontario and McMaster Osteoarthritis Index;The Medical Outcomes Study 36-Item Short-Form Health Survey;

Countries

China

Contacts

Public ContactWang Wenhao

Huadong Hospital Affiliated to Fudan University

whwang88@163.com13918006027

Outcome results

None listed

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