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Study on the efficacy and safety of 'YiCeng' plaster on pain relief in people with knee osteoarthritis

Not Applicable
Recruiting
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
Inclusion Criteria

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.

Exclusion Criteria

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
NameTimeMethod
visual analog scale (VAS);Western Ontario and McMaster Universities Arthritis Index scores (WOMAC);
Secondary Outcome Measures
NameTimeMethod
erve growth factor;Knee pain sensitivity threshold;Skin irritation;Safety;Knee circumference;
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