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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02286453
Recruitment Status : Completed
First Posted : November 7, 2014
Last Update Posted : September 29, 2015
Sponsor:
Collaborator:
Thai Traditional Medical Knowledge Fund
Information provided by (Responsible Party):
Patamaporn Rachawat, 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)

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: Benjakul recipe Drug: diclofenac Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Efficacy and Safety of Benjakul Recipe in Treating Primary Osteoarthritis of Knee Compared With Diclofenac (Clinical Trial Phase II)
Study Start Date : September 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: 1
Benjakul
Drug: Benjakul recipe
Benjakul recipe capsule at dose of 100 mg three times a day after meal daily for 28 days

Active Comparator: 2
diclofenac
Drug: diclofenac
diclofenac capsule at dose of 25 mg three times a day after meal daily for 28 days




Primary Outcome Measures :
  1. Pain score [ Time Frame: 28 days ]
    Pain score from Visual analog scale


Secondary Outcome Measures :
  1. Pain score [ Time Frame: 28 days ]
    Pain score from Modified WOMAC score (from Modified Thai WOMAC index)



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02286453


Locations
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Thailand
Thammasat University (Ruangsit campus)
Khlong Luang, Pathum Thani, Thailand, 10120
Sponsors and Collaborators
Thammasat University
Thai Traditional Medical Knowledge Fund

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Responsible Party: Patamaporn Rachawat, Piya Pinsornsak, Thammasat University
ClinicalTrials.gov Identifier: NCT02286453     History of Changes
Other Study ID Numbers: MTU-EC-ES-6-152/56
TCTR20140816001 ( Registry Identifier: Thai Clinical Trials Registry )
First Posted: November 7, 2014    Key Record Dates
Last Update Posted: September 29, 2015
Last Verified: September 2015

Keywords provided by Patamaporn Rachawat, Thammasat University:
Osteoarthritis of The knee
Benjakul
Alternative Medicine

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action