Clinical Efficacy and Safety of Benjakul Recipe in Treati... | NCT02286453

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

NCT02286453

Sponsor

Thammasat University

Status

Completed

Last Update Posted

Sep 29, 2015Estimated

Enrollment

84Actual

Phase

Phase 2

Conditions

Osteoarthritis, Knee

Interventions

Benjakul recipe
diclofenac

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
TCTR20140816001	Registry Identifier	Thai Clinical Trials Registry

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2014

Primary Completion Date

Sep 2015Actual

Completion Date

Sep 2015Actual

First Submitted Date

Nov 5, 2014

First Submission Date that Met QC Criteria

Nov 6, 2014

First Posted Date

Nov 7, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 26, 2015

Last Update Posted Date

Sep 29, 2015Estimated

Name	Class
Thai Traditional Medical Knowledge Fund	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

84Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Benjakul	Drug: Benjakul recipe
2	Active Comparator	diclofenac	Drug: diclofenac

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Benjakul recipe	Drug	Benjakul recipe capsule at dose of 100 mg three times a day after meal daily for 28 days	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain score	Pain score from Visual analog scale	28 days

Secondary Outcomes

Measure	Description	Time Frame
Pain score	Pain score from Modified WOMAC score (from Modified Thai WOMAC index)	28 days

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Thammasat University (Ruangsit campus)		Khlong Luang	Changwat Pathum Thani	10120	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D020370	Osteoarthritis, Knee

Ancestor Terms

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004008	Diclofenac

Ancestor Terms

ID	Term
D010648	Phenylacetates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided