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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo cream

Group Type PLACEBO_COMPARATOR

Placebo cream

Intervention Type DRUG

Plai cream

Cream from Zingiber cassumunar Roxb. extract

Group Type EXPERIMENTAL

Cream from Zingiber cassumunar Roxb. extract

Intervention Type DRUG

Interventions

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Cream from Zingiber cassumunar Roxb. extract

Intervention Type DRUG

Placebo cream

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No