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External treatment of traditional Chinese medicine research

Zu Shi Ma plaster treatment of knee osteoarthritis random, positive drug control, multi-center clinical research

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-16008090
Enrollment
Unknown
Registered
2016-03-14
Start date
2016-03-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Osteoarthritis

Interventions

treatment group:zu shi ma plasters 24 treatment group and 24h group
treatment group:Zu Shi Ma plasters 12h treatment group
control group:Indomethacin Papua paste 24 h treatment group

Sponsors

Ethics Committee of Guang'anmen Hospital of China academy of traditional Chinese medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) comply with knee Osteoarthritis diagnostic criteria; (2) aged 40 to 75 years old; (3) Accepted the NSAID pain medications, or before (such as acetaminophen non-steroidal anti-inflammatory drug, or contains the pain of non-prescription drugs, or may contain analgesic active ingredients of traditional Chinese medicine) of the patients have been 1 week cleaning period, patients and doctors to arthritis overall assessment for the "general, poor or very poor"; Patients with arthritis pain VAS score 20 mm or higher ground to walk, and compared with the screening when pain increases at least 10 mm;Compared with the screening of the overall assessment level 1 or above;Overall assessment level 1 or above; (4) 1 week before no NSAID pain medications or, the ground walk arthritis pain VAS score 40 mm or greater, the overall assessment of the patients and doctors to arthritis for "poor or very poor"; (5) signed informed consent.

Exclusion criteria

Exclusion criteria: (1) do not conform to the knee osteoarthritis western medicine diagnostic criteria; (2) the knee is swollen; (3) the knee joint with crystalline synovial inflammation (joints), acute inflammatory arthritis, rheumatoid arthritis, psoriatic arthritis, suppurative arthritis, systemic lupus erythematosus (sle) and sjogren's syndrome, vasculitis, rheumatic diseases such as inflammatory arthritis and metabolic bone disease caused by endocrine disease; (4) injury of knee joint cartilage and ligament damage, tuberculosis, tumour, fracture, deformation osteitis (paget bone disease), severe dysplasia or congenital anomalies, browns, acromegaly, hemochromatosis disease, liver degeneration disease, primary cartilage tumour disease, etc.; (5) merge heart, brain, liver, kidney and hematopoietic system, such as serious illness;Pregnancy, ready for pregnancy or lactation women, psychiatric patients;Doubt or have alcohol and drug abuse history; (6) 2 months prior to screening received systemic hormone therapy or joint cavity or 2 months for knee arthroscopy;6 months prior to screening knee arthritis with trauma or surgery, or knee joint has a history of three or more trauma or surgery; (7) All landowners to any ingredient in the drug allergy (father of hemp, ZhangDan monk, sesame oil, yellow). (8) Today is in other clinical studies; (9) Pathological changes of pet-name ruby damaged skin or skin or skin allergies.

Design outcomes

Primary

MeasureTime frame
Pain VAS score;

Secondary

MeasureTime frame
WOMAC score;

Countries

China

Contacts

Public ContactJiang Quan

Rheumatism of hospital of China academy of traditional Chinese medicine

doctorjq@126.com+86 13901081632

Outcome results

None listed

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