Efficacy and Safety of Benjakul Remedy Extract Capsule in Primary Osteoarthritis versus Naproxen (Clinical Trial Phase III)
- Conditions
- Patients with knee osteoarthritis
- Registration Number
- TCTR20200827001
- Lead Sponsor
- Faculty of Medicine, Thammasat University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 350
1. Diagnosis of idiopathic OA knee according to clinical criteria of American College of Rheumatology
Knee pain + at least 3 of 6:
o Age > 50 years
o morning stiffness< 30 minutes
o crepitus
o bony tenderness
o bony enlargement
o no palpable warmth
2. Pain score according to numerical rating scale (while standing) not less than 3
3. Willing to participate
1 History of hypesensitivity herbal and naproxen
2 History of lower extremity surgery within 6 months prior to screening
3 Treatment with other drugs potentially affecting bone or cartilage metabolism such as
o Chronic systematic corticosteroids
o Glucosamine or chondroitin sulphate within 15 day prior to screening
o Hyaluronate injection into the index knee within 6 months prior to screening
o Diacerin treatment within 12 months prior to screening
4 Chronic kidney disease eGFR < 60 ml min 1 73 m2
5 History of drug or alcohol abuse
6 history of peptic ulcer disease, hepatic or renal impairment AST or ALT above normal range GFR below 30 ml min 1 73 m2
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total WOMAC of The modified Thai WOMAC scores Baseline, 2, 4 weeks between-group mean difference from baseline
- Secondary Outcome Measures
Name Time Method Short Form Health Survey Version 2 Baseline, 2, 4 weeks between-group mean difference from baseline,4x10m fast-paced walk test Baseline, 2, 4 weeks between-group time mean difference from baseline,Time up and go test Baseline, 2, 4 weeks between-group time mean difference from baseline