Randomized, double-blind, placebo-controlled clinical study of Zhongyi Ointment in the treatment of K-L Grade II knee osteoarthritis

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200065268

Enrollment

Unknown

Registered

2022-11-01

Start date

2022-11-01

Completion date

Unknown

Last updated

2023-05-15

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

Conditions

Knee osteoarthritis

Interventions

Kidney asthenia and marrow deficiency group-treatment group:Zhongyi Ointment

Kidney deficiency and marrow deficiency group - control group:placebo

Yang deficiency and cold coagulation group - treatment group:Zhongyi Ointment

Yang deficiency and cold coagulation group - control group:placebo

Congestion block group - treatment group:Zhongyi Ointment

Congestion block group - control group:placebo

Eligibility

Sex/Gender

All

Age

50 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Volunteer to participate in this clinical study, agree to be randomly assigned, understand and be willing to sign the informed consent form. 2. The age is between 50 and 80 years old. 3. Class II patients who meet the radiologic diagnostic criteria of Kellgren Lawrecne. 4. Those who meet the diagnostic criteria of knee osteoarthritis in traditional Chinese medicine and western medicine. 5. Those who do not take other relevant treatment drugs or adopt relevant treatment methods within one week (those who take drugs for a long time should stop taking drugs for one week before being included in the observation).

Exclusion criteria

Exclusion criteria: 1. Those with anxiety, depression or poor compliance with mental illness. 2. Previous trauma to the knee joint. 3. Patients with primary bone metabolism related diseases. 4. Those who are allergic to the components of the drug or have incomplete skin on the knee joint. 5. Those who have participated in clinical trials of other drugs within 3 months. 6. Patients who dropped out of the study. 7. Refuse to treat patients with traditional Chinese medicine or traditional Chinese medicine. Note: Patients who meet any of the above conditions cannot be included in this study.

Design outcomes

Primary

Measure	Time frame
visual analogue scale;WOMAC scale;	—

Secondary

Measure	Time frame
Skin temperature of knee joint;	—

Countries

China

Contacts

Public ContactKexiao Yu

Chongqing Traditional Chinese Medicine Hospital

csyxk@126.com+86 18223279491

Outcome results

None listed

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