Efficacy and Safety of Topical Essential Oil Extracted From Zingiber Cassumunar Rokb in Osteoarthritis

February 14, 2013 updated by: Mahidol University

Efficacy and Safety of Topical Preparation of Essential Oil Extracted From Zingiber Cassumunar Rokb in Patients With Osteoarthritis

The objectives of this study are to assess short term efficacy and safety of of topical preparation of essential oil extracted from ZINGIBER CASSUMUNAR ROXB in patients suffering from osteoarthritic pain

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Nakhonnayok
      • Ongkarak, Nakhonnayok, Thailand, 26120
        • Recruiting
        • Faculty of Medicine, Srinakharinwirot University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Suwimon Yeephu, M.Sc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis: osteoarthritis of the knee at least on side with standard radiologic method within 6 weeks (Kellgren-Lawrence radiographic grading scale at least 1)
  • Pain visual analog scale at rest at least 40 mm
  • No previous analgesic treatment or receiving stable dose of analgesic drugs at least 2 weeks. If previously treated with antidepressants, glucosamine, chondroitin or diacerein, dosage should be stable for at least 3 months.
  • Agree to attain non-pharmacologic treatment as prior to participate the study

Exclusion Criteria:

  • having an open wound or abnormal skin at site of application
  • having diagnose with other chronic arthritis such as rheumatoid arthritis
  • history of allergy to the extraction of Zingiber cassumunar Roxb
  • pregnancy or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo cream
Drug: Placebo cream
Experimental: Plai cream
Cream from Zingiber cassumunar Roxb. extract
Drug: Cream from Zingiber cassumunar Roxb. extract

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline of The WOMAC (Western Ontario and McMaster Universities) index
Time Frame: week 8
week 8

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: Week 8
Week 8
Change from baseline of Pain visual analog scale (PVAS)
Time Frame: week 8
week 8
Change from baseline of Global assessment of disease status (GADS)
Time Frame: week 8
week 8
Clinical global impression of change (CGIC)
Time Frame: Week 8
Week 8
Patient global impression of change (PGIC)
Time Frame: Week 8
Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Study Director: Chuthamanee Suthisisang, Ph.D., Department of Pharmacology, Faculty of Pharmacy, Mahidol University 447 Sri-Ayudhya Rd., Rajthevee, Bangkok 10400, Thailand
  • Principal Investigator: Suwimon Yeephu, M.Sc., Faculty of Pharmacy, Srinakharinwirot University
  • Study Chair: Chuthamanee Suthisisant, Ph.D, Mahidol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

December 11, 2012

First Submitted That Met QC Criteria

February 14, 2013

First Posted (Estimate)

February 18, 2013

Study Record Updates

Last Update Posted (Estimate)

February 18, 2013

Last Update Submitted That Met QC Criteria

February 14, 2013

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AFTA-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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