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

Primary Purpose

Osteoarthritis

Status

Unknown status

Phase

Phase 2

Locations

Thailand

Study Type

Interventional

Intervention

Cream from Zingiber cassumunar Roxb. extract

Placebo cream

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Osteoarthritis, Moderate ot severe pain, ZINGIBER CASSUMUNAR ROXB

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Faculty of Medicine, Srinakharinwirot UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo cream

Plai cream

Arm Description

Placebo cream

Cream from Zingiber cassumunar Roxb. extract

Outcomes

Primary Outcome Measures

Change from baseline of The WOMAC (Western Ontario and McMaster Universities) index

Secondary Outcome Measures

Change from baseline of Pain visual analog scale (PVAS)

Change from baseline of Global assessment of disease status (GADS)

Clinical global impression of change (CGIC)

Patient global impression of change (PGIC)

Adverse events

Full Information

NCT ID

NCT01794260

First Posted

December 11, 2012

Last Updated

February 14, 2013

Sponsor

Mahidol University

1. Study Identification

Unique Protocol Identification Number

NCT01794260

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Unknown status

Study Start Date

December 2012 (undefined)

Primary Completion Date

December 2013 (Anticipated)

Study Completion Date

December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mahidol University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis

Keywords

Osteoarthritis, Moderate ot severe pain, ZINGIBER CASSUMUNAR ROXB

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo cream

Arm Type

Placebo Comparator

Arm Description

Placebo cream

Arm Title

Plai cream

Arm Type

Experimental

Arm Description

Cream from Zingiber cassumunar Roxb. extract

Intervention Type

Drug

Intervention Name(s)

Cream from Zingiber cassumunar Roxb. extract

Intervention Type

Drug

Intervention Name(s)

Placebo cream

Primary Outcome Measure Information:

Title

Change from baseline of The WOMAC (Western Ontario and McMaster Universities) index

Time Frame

week 8

Secondary Outcome Measure Information:

Title

Change from baseline of Pain visual analog scale (PVAS)

Time Frame

week 8

Title

Change from baseline of Global assessment of disease status (GADS)

Time Frame

week 8

Title

Clinical global impression of change (CGIC)

Time Frame

Week 8

Title

Patient global impression of change (PGIC)

Time Frame

Week 8

Title

Adverse events

Time Frame

Week 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chuthamanee Suthisisang, Ph.D.

Phone

662-644-8700

pycst@mahidol.ac.th

First Name & Middle Initial & Last Name or Official Title & Degree

Suwimon Yeephu, M.Sc.

Phone

6686-9836644

suwimony@swu.ac.th

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chuthamanee Suthisisang, Ph.D.

Organizational Affiliation

Department of Pharmacology, Faculty of Pharmacy, Mahidol University 447 Sri-Ayudhya Rd., Rajthevee, Bangkok 10400, Thailand

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Suwimon Yeephu, M.Sc.

Organizational Affiliation

Faculty of Pharmacy, Srinakharinwirot University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Chuthamanee Suthisisant, Ph.D

Organizational Affiliation

Mahidol University

Official's Role

Study Chair

Facility Information:

Facility Name

Faculty of Medicine, Srinakharinwirot University

City

Ongkarak

State/Province

Nakhonnayok

ZIP/Postal Code

26120

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chuthamanee Suthisisang, Ph.D

Phone

662-644-8700

pycst@mahidol.ac.th

First Name & Middle Initial & Last Name & Degree

Suwimon Yeephu, M.Sc.

Phone

6686-9836644

suwimony@swu.ac.th

First Name & Middle Initial & Last Name & Degree

Suwimon Yeephu, M.Sc.

12. IPD Sharing Statement

Learn more about this trial

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

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