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

Phase 2

• Conditions: Osteoarthritis
• Interventions: Drug: Placebo cream; Drug: Cream from Zingiber cassumunar Roxb. extract

• Registration Number: NCT01794260
• Lead Sponsor: Mahidol University

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-12
• Study Start: 2012-12
• Study First Submitted: 2012-12-11
• Study First Submitted QC: 2013-02-14
• Last Update Submitted: 2013-02-14
• Study First Posted: 2013-02-18
• Last Update Posted: 2013-02-18
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo cream	Placebo cream	Placebo cream
Plai cream	Cream from Zingiber cassumunar Roxb. extract	Cream from Zingiber cassumunar Roxb. extract

Primary Outcome Measures

Name	Time	Method
Change from baseline of The WOMAC (Western Ontario and McMaster Universities) index	week 8

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of Medicine, Srinakharinwirot University; 🇹🇭 Ongkarak, Nakhonnayok, Thailand