Clinical Efficacy and Safety of Benjakul Recipe in Treating Primary Osteoarthritis of Knee Compared With Diclofenac
Information source: Thammasat University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoarthritis, Knee
Intervention: Benjakul recipe (Drug); diclofenac (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Thammasat University Overall contact: Patamaporn Rachawat, B.ATM, Phone: +66 89 9229386, Email: akobanah@hotmail.com
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)
Clinical Details
Official title: Clinical Efficacy and Safety of Benjakul Recipe in Treating Primary Osteoarthritis of Knee Compared With Diclofenac (Clinical Trial Phase II)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Pain score
Secondary outcome: Pain score
Eligibility
Minimum age: 45 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Patients with primary osteoarthritis of knee with grade I-III of Kellgren & Lawrence
criteria
2. Not during breast feeding
3. Not during pregnancy with a good contraception
4. Volunteer have a normal Complete Blood Count laboratory, lipid profiles,liver
function tests and renal funtion tests
5. Do not abuse drugs
6. Good cooperation
Exclusion Criteria:
1. BMI > 32
2. History of peptic ulcer, Gastroesophageal reflux disease (GERD), heart disease, liver
disease or kidney disease
3. History of allergy diclofenac or allergy herbal medicine
Locations and Contacts
Patamaporn Rachawat, B.ATM, Phone: +66 89 9229386, Email: akobanah@hotmail.com
Thammasat University (Ruangsit campus), Khlong Luang, Pathum Thani 10120, Thailand; Recruiting Patamaporn Rachawat, bachelor, Phone: +66 89 9229386, Email: akobanah@hotmail.com Piya Pinsornsak, MD FRCOST, Phone: +66 84 6392078, Email: pinpiya2003@yahoo.com
Additional Information
Starting date: September 2014
Last updated: November 6, 2014
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