Study on the efficacy and safety of 'YiCeng' plaster on pain relief in people with knee osteoarthritis
- Conditions
- Knee osteoarthritis
- Registration Number
- ITMCTR2100004949
- Lead Sponsor
- Kunshan Third People's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Patients with symptomatic knee osteoarthritis, using the KOA diagnostic criteria in the 2007 edition of the Osteoarthritis Diagnostic and Treatment Guidelines;
2. Patients with painful knee osteoarthritis;
3. Subjects with pain score of at least 30 mm on 100 mm visual analogue scale;
4. Subjects over 40 years old;
5. Subjects who have not used easy layer application or Votalin ointment in the past;
6. Subjects who must sign the ICF before the start of the study.
1. The history of knee trauma or surgery within 6 months before this trial;
2. Arthroscopy or intra-articular injection therapy within 3 months before this trial;
3. Currently participating in other clinical trials;
4. Other concomitant knee diseases, such as rheumatoid arthritis(RA), gouty arthritis, etc.
5. Combination of mental disorders or other diseases that do not accurately describe the symptoms;
6. Combination of other serious diseases, such as severe diabetes,severe liver or kidney disease, malignancy, infectious diseases etc.;
7. History of severe skin allergies;
8. During pregnancy or lactation.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method visual analog scale (VAS);Western Ontario and McMaster Universities Arthritis Index scores (WOMAC);
- Secondary Outcome Measures
Name Time Method erve growth factor;Knee pain sensitivity threshold;Skin irritation;Safety;Knee circumference;