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Trial record 31 of 238 for:    essential oil

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

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ClinicalTrials.gov Identifier: NCT01794260
Recruitment Status : Unknown
Verified December 2012 by Mahidol University.
Recruitment status was:  Recruiting
First Posted : February 18, 2013
Last Update Posted : February 18, 2013
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: Cream from Zingiber cassumunar Roxb. extract Drug: Placebo cream Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Topical Preparation of Essential Oil Extracted From Zingiber Cassumunar Rokb in Patients With Osteoarthritis
Study Start Date : December 2012
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Placebo Comparator: Placebo cream
Placebo cream
Drug: Placebo cream
Experimental: Plai cream
Cream from Zingiber cassumunar Roxb. extract
Drug: Cream from Zingiber cassumunar Roxb. extract



Primary Outcome Measures :
  1. Change from baseline of The WOMAC (Western Ontario and McMaster Universities) index [ Time Frame: week 8 ]

Secondary Outcome Measures :
  1. Change from baseline of Pain visual analog scale (PVAS) [ Time Frame: week 8 ]
  2. Change from baseline of Global assessment of disease status (GADS) [ Time Frame: week 8 ]
  3. Clinical global impression of change (CGIC) [ Time Frame: Week 8 ]
  4. Patient global impression of change (PGIC) [ Time Frame: Week 8 ]
  5. Adverse events [ Time Frame: Week 8 ]


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01794260


Contacts
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Contact: Chuthamanee Suthisisang, Ph.D. 662-644-8700 pycst@mahidol.ac.th
Contact: Suwimon Yeephu, M.Sc. 6686-9836644 suwimony@swu.ac.th

Locations
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Thailand
Faculty of Medicine, Srinakharinwirot University Recruiting
Ongkarak, Nakhonnayok, Thailand, 26120
Contact: Chuthamanee Suthisisang, Ph.D    662-644-8700    pycst@mahidol.ac.th   
Contact: Suwimon Yeephu, M.Sc.    6686-9836644    suwimony@swu.ac.th   
Principal Investigator: Suwimon Yeephu, M.Sc.         
Sponsors and Collaborators
Mahidol University
Investigators
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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

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Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT01794260     History of Changes
Other Study ID Numbers: AFTA-01
First Posted: February 18, 2013    Key Record Dates
Last Update Posted: February 18, 2013
Last Verified: December 2012
Keywords provided by Mahidol University:
Osteoarthritis
Moderate ot severe pain
ZINGIBER CASSUMUNAR ROXB
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases