NCT02286453

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

September 29, 2015

Status Verified

September 1, 2015

Enrollment Period

1 year

First QC Date

November 5, 2014

Last Update Submit

September 26, 2015

Conditions

Osteoarthritis, Knee

Keywords

Osteoarthritis of The kneeBenjakulAlternative Medicine

Outcome Measures

Primary Outcomes (1)

  • Pain score

    Pain score from Visual analog scale

    28 days

Secondary Outcomes (1)

  • Pain score

    28 days

Study Arms (2)

1

EXPERIMENTAL

Benjakul

Drug: Benjakul recipe

2

ACTIVE COMPARATOR

diclofenac

Drug: diclofenac

Interventions

Benjakul recipeDRUG

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

1
diclofenacDRUG

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

2

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thammasat University (Ruangsit campus)

Khlong Luang, Changwat Pathum Thani, 10120, Thailand

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Diclofenac

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Piya Pinsornsak

Study Record Dates

First Submitted

November 5, 2014

First Posted

November 7, 2014

Study Start

September 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

September 29, 2015

Record last verified: 2015-09

Locations

TH(1)