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Clinical trial of Zhongtongning plaster and Zhongtongning Babu plaster in the treatment of knee Osteoarthritis with placebo as control

Clinical trial of Zhongtongning plaster and Zhongtongning Babu plaster in the treatment of knee Osteoarthritis with placebo as control - Clinical trial of Zhongtongning plaster and Zhongtongning Babu plaster in the treatment of knee Osteoarthritis with placebo as control

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075041
Enrollment
Unknown
Registered
2023-08-23
Start date
2023-08-31
Completion date
Unknown
Last updated
2023-08-28

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

Conditions

osteoarthritis

Interventions

Experimental group 1, experimental group 2, control group:Experimental group 1: After routine disinfection, external application of Zhongtongning ointment was used for treatment, with each application
experimental group 2:Test group 2: After routine disinfection, external application of Zhongtongning Babu plaster was used for treatment, with each application lasting for 12 hours and treatment once
control group:Control group: After routine disinfection, Zhongtongning plaster and placebo were applied externally for 12 hours each time, with a daily treatment period of 14 days.

Sponsors

Shaanxi Provincial Traditional Chinese Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 75 Years

Inclusion criteria

Inclusion criteria: ? It conforms to the diagnostic criteria of western medicine for knee Osteoarthritis and the diagnostic criteria of TCM syndromes of dampness heat arthralgia; ? Between the ages of 40 and 75, regardless of gender; ? The VAS score is between 3-8 points (including the critical value); ? The patient or their guardian has signed an informed consent form before participating in the screening.

Exclusion criteria

Exclusion criteria: ? Knee Osteoarthritis requiring surgical treatment; ? Knee joint tuberculosis, bone tumor or other diseases that affect the knee joint, such as rheumatoid arthritis, Rheumatoid arthritis, psoriasis, metabolic bone disease, syphilitic neuropathy, brown yellow disease, and acute trauma of knee joint; ? Those who have skin lesions or acute skin infections at the knee joints and are not suitable for using patches; ? Suffering from other life-threatening serious diseases (such as malignant tumors, serious diseases of the blood, digestive or other systems), with an expected survival time of no more than 6 months; ? Patients with severe liver and kidney dysfunction: alanine Transaminase (ALT) or Aspartic acid Transaminase (AST)>2.0 × Upper limit of normal value (ULN), and/or other known liver diseases such as acute and chronic hepatitis, cirrhosis, etc; Serum creatinine>2.0 × ULN, and/or known severe renal insufficiency diseases; ? Patients who are unable to cooperate or unwilling to cooperate due to the merger of other mental illnesses; ? Pregnant, planned pregnant or lactating women (women of childbearing age need to complete the Pregnancy test); ? Those who are allergic to the known ingredients of the patch, or have a history of severe allergy, or have used Drug allergy of the patch in the past; ? Suspect or have a history of alcohol or drug abuse; ? Those who have participated in other clinical trials within three months or are currently participating in other clinical trials; ? Other situations that the researcher deems unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Joint pain VAS score;

Secondary

MeasureTime frame
Joint function score;Joint swelling degree;pain relief;Traditional Chinese Medicine Syndrome Curative Effect;Single symptom efficacy of the main symptom;Relying on the number of times used by Kaoxi;

Countries

China

Contacts

Public ContactWu Hui

Shaanxi Provincial Traditional Chinese Medicine Hospital

wuhui2000@163.com+86 151 2900 0658

Outcome results

None listed

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