NCT02286453CompletedPhase 2
Clinical Efficacy and Safety of Benjakul Recipe in Treating Primary Osteoarthritis of Knee Compared With Diclofenac (Clinical Trial Phase II)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Thammasat University
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- Pain score
Study Overview
Brief Summary
Efficacy and adverse effects of Benjakul recipe in Treating Primary Osteoarthritis of Knee Compared with Diclofenac. This study was designed as double blind, randomized controlled trial. Approval from the ethical committee of Human Research Ethics Committee of Thammasat University (No: 1 Faculty of Medicine)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 45 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with primary osteoarthritis of knee with grade I-III of Kellgren & Lawrence criteria
- •Not during breast feeding
- •Not during pregnancy with a good contraception
- •Volunteer have a normal Complete Blood Count laboratory, lipid profiles,liver function tests and renal funtion tests
- •Do not abuse drugs
- •Good cooperation
Exclusion Criteria
- •History of peptic ulcer, Gastroesophageal reflux disease (GERD), heart disease, liver disease or kidney disease
- •History of allergy diclofenac or allergy herbal medicine
Arms & Interventions
1
Experimental
Benjakul
Intervention: Benjakul recipe (Drug)
2
Active Comparator
diclofenac
Intervention: diclofenac (Drug)
Outcomes
Primary Outcomes
Pain score
Time Frame: 28 days
Pain score from Visual analog scale
Secondary Outcomes
- Pain score(28 days)
Investigators
Patamaporn Rachawat
Piya Pinsornsak
Thammasat University
Study Sites (1)
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