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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01794260
• Other study ID #: AFTA-01
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: December 11, 2012
• Last updated: February 14, 2013
• Start date: December 2012
• Est. completion date: December 2013

Study information

• Verified date: December 2012
• Source: Mahidol University
• Contact: Chuthamanee Suthisisang, Ph.D.
• Phone: 662-644-8700
• Email: pycst[@]mahidol.ac.th
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Drug:
• Cream from Zingiber cassumunar Roxb. extract

• Placebo cream

Locations

Country	Name	City	State
Thailand	Faculty of Medicine, Srinakharinwirot University	Ongkarak	Nakhonnayok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline of The WOMAC (Western Ontario and McMaster Universities) index		week 8	No
Secondary	Change from baseline of Pain visual analog scale (PVAS)		week 8	No
Secondary	Change from baseline of Global assessment of disease status (GADS)		week 8	No
Secondary	Clinical global impression of change (CGIC)		Week 8	No
Secondary	Patient global impression of change (PGIC)		Week 8	No
Secondary	Adverse events		Week 8	Yes