Clinical Efficacy and Safety of Benjakul Recipe in Treating Primary Osteoarthritis of Knee Compared With Diclofenac
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
Benjakul recipe
diclofenac
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Osteoarthritis of The knee, Benjakul, Alternative Medicine
Eligibility Criteria
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:
- BMI > 32
- History of peptic ulcer, Gastroesophageal reflux disease (GERD), heart disease, liver disease or kidney disease
- History of allergy diclofenac or allergy herbal medicine
Sites / Locations
- Thammasat University (Ruangsit campus)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Benjakul
diclofenac
Outcomes
Primary Outcome Measures
Pain score
Pain score from Visual analog scale
Secondary Outcome Measures
Pain score
Pain score from Modified WOMAC score (from Modified Thai WOMAC index)
Full Information
NCT ID
NCT02286453
First Posted
November 5, 2014
Last Updated
September 26, 2015
Sponsor
Thammasat University
Collaborators
Thai Traditional Medical Knowledge Fund
1. Study Identification
Unique Protocol Identification Number
NCT02286453
Brief Title
Clinical Efficacy and Safety of Benjakul Recipe in Treating Primary Osteoarthritis of Knee Compared With Diclofenac
Official Title
Clinical Efficacy and Safety of Benjakul Recipe in Treating Primary Osteoarthritis of Knee Compared With Diclofenac (Clinical Trial Phase II)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Thammasat University
Collaborators
Thai Traditional Medical Knowledge Fund
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Osteoarthritis of The knee, Benjakul, Alternative Medicine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Benjakul
Arm Title
2
Arm Type
Active Comparator
Arm Description
diclofenac
Intervention Type
Drug
Intervention Name(s)
Benjakul recipe
Intervention Description
Benjakul recipe capsule at dose of 100 mg three times a day after meal daily for 28 days
Intervention Type
Drug
Intervention Name(s)
diclofenac
Intervention Description
diclofenac capsule at dose of 25 mg three times a day after meal daily for 28 days
Primary Outcome Measure Information:
Title
Pain score
Description
Pain score from Visual analog scale
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Pain score
Description
Pain score from Modified WOMAC score (from Modified Thai WOMAC index)
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
BMI > 32
History of peptic ulcer, Gastroesophageal reflux disease (GERD), heart disease, liver disease or kidney disease
History of allergy diclofenac or allergy herbal medicine
Facility Information:
Facility Name
Thammasat University (Ruangsit campus)
City
Khlong Luang
State/Province
Pathum Thani
ZIP/Postal Code
10120
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
Clinical Efficacy and Safety of Benjakul Recipe in Treating Primary Osteoarthritis of Knee Compared With Diclofenac
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