Suspended

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

What is being tested

Placebo cream

+ Cream from Zingiber cassumunar Roxb. extract

Drug

Who is being recruted

Arthritis+2

+ Joint Diseases

+ Musculoskeletal Diseases

Over 50 Years

+8 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 2 & 3

Interventional

Study Start: December 2012

See protocol details

Summary

Principal SponsorMahidol University

Study ContactChuthamanee Suthisisang, Ph.D.More contacts

Last updated: February 18, 2013

Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2012

Actual date on which the first participant was enrolled.

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

NCT01794260

Principal SponsorMahidol University

Study ContactChuthamanee Suthisisang, Ph.D.More contacts

Last updated: February 18, 2013

Sourced from a government-validated database.Claim as a partner

Protocol

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

Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesOsteoarthritis

Criteria

4 inclusion criteria required to participate

Agree to attain non-pharmacologic treatment as prior to participate the study

Diagnosis: osteoarthritis of the knee at least on side with standard radiologic method within 6 weeks (Kellgren-Lawrence radiographic grading scale at least 1)

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

Pain visual analog scale at rest at least 40 mm

4 exclusion criteria prevent from participating

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

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo

Placebo cream

Group II

Experimental

Cream from Zingiber cassumunar Roxb. extract

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Faculty of Medicine, Srinakharinwirot University

Ongkarak, ThailandOpen Faculty of Medicine, Srinakharinwirot University in Google Maps

SuspendedOne Study Center