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

NCT ID: NCT02286453

Last Updated: 2015-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-09-30

Brief Summary

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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

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Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Benjakul

Group Type EXPERIMENTAL

Benjakul recipe

Intervention Type DRUG

Benjakul recipe capsule at dose of 100 mg three times a day after meal daily for 28 days

2

diclofenac

Group Type ACTIVE_COMPARATOR

diclofenac

Intervention Type DRUG

diclofenac capsule at dose of 25 mg three times a day after meal daily for 28 days

Interventions

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Benjakul recipe

Benjakul recipe capsule at dose of 100 mg three times a day after meal daily for 28 days

Intervention Type DRUG

diclofenac

diclofenac capsule at dose of 25 mg three times a day after meal daily for 28 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Thai Traditional Medical Knowledge Fund

OTHER_GOV

Sponsor Role collaborator

Thammasat University

OTHER

Sponsor Role lead

Responsible Party

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Patamaporn Rachawat

Piya Pinsornsak

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Thammasat University (Ruangsit campus)

Khlong Luang, Changwat Pathum Thani, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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TCTR20140816001

Identifier Type: REGISTRY

Identifier Source: secondary_id

MTU-EC-ES-6-152/56

Identifier Type: -

Identifier Source: org_study_id

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