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)
Loading locations...
Similar Trials
Not yet recruiting
Phase 2
Effect of Unani compound formulation in the treatment of Knee joint osteoarthritisCTRI/2021/03/031747ATIONAL INSTITUTE OF UNANI MEDICINE
Unknown
Phase 2
Effectiveness and Safety of Sphaeralcea Angustifolia Standardized Extract as a Topical Treatment of Knee OsteoarthritisKnee OsteoarthritisNCT04511195Coordinación de Investigación en Salud, Mexico100
Completed
Phase 4
The Comparison of Knee Osteoarthritis Treatment With Bone Marrow Aspirate Concentrate , Leukocyte Rich Platelet Rich Plasma and Hyaluronic AcidKnee OsteoarthritisNCT03825133Clinical Center of Vojvodina180
Completed
Not Applicable
Health outcomes following SYNVISC-ONE in Knee OsteoarthritisACTRN12616001504404The University of Queensland130
Completed
Not Applicable
Radiofrequency Ablation of Genicular Nerves for Advanced Osteoarthrosis of the Knee Joint 1 Year Follow-up.Painful Osteoarthritis of the KneeNCT02688543Hospital General de Jerez de la Frontera25