Clinical Efficacy and Safety of Benjakul Recipe in Treating Primary Osteoarthritis of Knee Compared With Diclofenac

Phase 2

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Drug: Benjakul recipe; Drug: diclofenac

• Registration Number: NCT02286453
• Lead Sponsor: Thammasat University

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-11-05
• Study First Submitted QC: 2014-11-06
• Study First Posted: 2014-11-07
• Status Verified: 2015-09
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2015-09-26
• Last Update Posted: 2015-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Benjakul recipe	Benjakul
2	diclofenac	diclofenac

Primary Outcome Measures

Name	Time	Method
Pain score	28 days	Pain score from Visual analog scale

Secondary Outcome Measures

Name	Time	Method
Pain score	28 days	Pain score from Modified WOMAC score (from Modified Thai WOMAC index)

Trial Locations

Locations (1)

Thammasat University (Ruangsit campus); 🇹🇭 Khlong Luang, Pathum Thani, Thailand