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A randomized double-blind placebo-controlled clinical trial was conducted to evaluate the efficacy and safety of Huiyang Zhitong plaster in the treatment of knee osteoarthritis with synovitis

Clinical efficacy and safety evaluation of Huiyang Zhitong plaster on knee osteoarthritis complicated with synovitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000548
Enrollment
Unknown
Registered
2025-03-18
Start date
2024-10-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Knee Osteoarthritis with Synovitis.

Interventions

Placebo Group:Apply two pieces of placebo plasters externally to the medial and lateral edges of the patella, for 8 hours each time, once daily, continuously for 2 weeks.
Huaiyang Zhitong Plaster Group:Apply two pieces of Huaiyang Zhitong Plaster externally to the medial and lateral edges of the patella for 8 hours each time once daily continuously for 2 weeks.

Sponsors

The Affiliated Traditional Chinese Medicine Hospital Southwest Medical Universit.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Meets the diagnostic criteria for knee osteoarthritis knee synovitis and Traditional Chinese 2) Medicine syndromes of cold and damp obstruction. 3) Kellgren & Lawrence grading for knee osteoarthritis is = Grade II. 4) No treatment for knee osteoarthritis has been administered in the past month. 5) Age between 30 and 70 years regardless of gender.

Exclusion criteria

Exclusion criteria: 1) Patients with secondary knee osteoarthritis caused by other conditions such as those resulting from joint trauma congenital or hereditary diseases etc. 2) Patients with allergies to the study drug or those with skin ulcerations rashes infections or other issues in the knee joint area. 3)Pregnant or breastfeeding women or those planning to conceive use sperm donation or egg donation within the month. 4) Patients who have participated in any other clinical trials in the past three months. 5) Patients unwilling to accept study measures or unable to cooperate due to mental illness or other conditions. 6) Patients with severe primary diseases of the heart brain liver kidneys or hematopoietic system. 7) Patients who have received medication for knee osteoarthritis or knee synovitis within the past week which may affect the evaluation of efficacy and safety endpoints. 8) Any other factors deemed by the investigator to render the patient unsuitable for participation in the trial.

Design outcomes

Primary

MeasureTime frame
WOMAC Score;Visual Analog Scale (VAS) Score;Clinical effective rate;

Secondary

MeasureTime frame
Changes of fluid accumulation in knee joint under color ultrasound;Security assessment;

Countries

China

Contacts

Public ContactHouyin Shi

The Affiliated Traditional Chinese Medicine Hospital Southwest Medical Universit.

623340767@qq.com+86 136 7967 9283

Outcome results

None listed

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