Efficacy and Safety of Topical Essential Oil Extracted From Zingiber Cassumunar Rokb in Osteoarthritis
1 other identifier
interventional
100
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2012
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 11, 2012
CompletedFirst Posted
Study publicly available on registry
February 18, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedFebruary 18, 2013
December 1, 2012
1 year
December 11, 2012
February 14, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline of The WOMAC (Western Ontario and McMaster Universities) index
week 8
Secondary Outcomes (5)
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
Study Arms (2)
Placebo cream
PLACEBO COMPARATORPlacebo cream
Plai cream
EXPERIMENTALCream from Zingiber cassumunar Roxb. extract
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicine, Srinakharinwirot University
Ongkarak, Changwat Nakhon Nayok, 26120, Thailand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Chuthamanee Suthisisang, Ph.D.
Department of Pharmacology, Faculty of Pharmacy, Mahidol University 447 Sri-Ayudhya Rd., Rajthevee, Bangkok 10400, Thailand
- PRINCIPAL INVESTIGATOR
Suwimon Yeephu, M.Sc.
Faculty of Pharmacy, Srinakharinwirot University
- STUDY CHAIR
Chuthamanee Suthisisant, Ph.D
Mahidol University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 11, 2012
First Posted
February 18, 2013
Study Start
December 1, 2012
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
February 18, 2013
Record last verified: 2012-12