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NCT02286453 Clinical Trial

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

Osteoarthritis, Knee Clinical Trial

Official title:
Clinical Efficacy and Safety of Benjakul Recipe in Treating Primary Osteoarthritis of Knee Compared With Diclofenac (Clinical Trial Phase II)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02286453
Other study ID # MTU-EC-ES-6-152/56
Secondary ID TCTR20140816001
Status Completed
Phase Phase 2
First received November 5, 2014
Last updated September 26, 2015
Start date September 2014
Est. completion date September 2015

Study information
Verified date September 2015
Source Thammasat University
Contact n/a
Is FDA regulated No
Health authority Thailand: Institutional Review Board
Study type Interventional

Clinical Trial 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)

Recruitment information / eligibility
Status Completed
Enrollment 84
Est. completion date September 2015
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender Both
Age group 45 Years to 80 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Benjakul recipe
Benjakul recipe capsule at dose of 100 mg three times a day after meal daily for 28 days
• diclofenac
diclofenac capsule at dose of 25 mg three times a day after meal daily for 28 days

Locations
Country Name City State
Thailand Thammasat University (Ruangsit campus) Khlong Luang Pathum Thani

Sponsors (2)
Lead Sponsor Collaborator
Thammasat University Thai Traditional Medical Knowledge Fund

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain score Pain score from Visual analog scale 28 days No
Secondary Pain score Pain score from Modified WOMAC score (from Modified Thai WOMAC index) 28 days No
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