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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

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Osteoarthritis of The knee, Benjakul, Alternative Medicine

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Arm Type

Experimental

Arm Description

Benjakul

Arm Title

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

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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