Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2026-03-02 @ 3:43 PM
Study NCT ID:
NCT01794260
Status:
UNKNOWN
Last Update Posted:
2013-02-18
First Post:
2012-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Topical Essential Oil Extracted From Zingiber Cassumunar Rokb in Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-02-14', 'studyFirstSubmitDate': '2012-12-11', 'studyFirstSubmitQcDate': '2013-02-14', 'lastUpdatePostDateStruct': {'date': '2013-02-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline of The WOMAC (Western Ontario and McMaster Universities) index', 'timeFrame': 'week 8'}], 'secondaryOutcomes': [{'measure': 'Change from baseline of Pain visual analog scale (PVAS)', 'timeFrame': 'week 8'}, {'measure': 'Change from baseline of Global assessment of disease status (GADS)', 'timeFrame': 'week 8'}, {'measure': 'Clinical global impression of change (CGIC)', 'timeFrame': 'Week 8'}, {'measure': 'Patient global impression of change (PGIC)', 'timeFrame': 'Week 8'}, {'measure': 'Adverse events', 'timeFrame': 'Week 8'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Osteoarthritis', 'Moderate ot severe pain', 'ZINGIBER CASSUMUNAR ROXB'], 'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis: osteoarthritis of the knee at least on side with standard radiologic method within 6 weeks (Kellgren-Lawrence radiographic grading scale at least 1)\n* Pain visual analog scale at rest at least 40 mm\n* 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.\n* Agree to attain non-pharmacologic treatment as prior to participate the study\n\nExclusion Criteria:\n\n* having an open wound or abnormal skin at site of application\n* having diagnose with other chronic arthritis such as rheumatoid arthritis\n* history of allergy to the extraction of Zingiber cassumunar Roxb\n* pregnancy or breastfeeding'}, 'identificationModule': {'nctId': 'NCT01794260', 'briefTitle': 'Efficacy and Safety of Topical Essential Oil Extracted From Zingiber Cassumunar Rokb in Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Efficacy and Safety of Topical Preparation of Essential Oil Extracted From Zingiber Cassumunar Rokb in Patients With Osteoarthritis', 'orgStudyIdInfo': {'id': 'AFTA-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo cream', 'description': 'Placebo cream', 'interventionNames': ['Drug: Placebo cream']}, {'type': 'EXPERIMENTAL', 'label': 'Plai cream', 'description': 'Cream from Zingiber cassumunar Roxb. extract', 'interventionNames': ['Drug: Cream from Zingiber cassumunar Roxb. extract']}], 'interventions': [{'name': 'Cream from Zingiber cassumunar Roxb. extract', 'type': 'DRUG', 'armGroupLabels': ['Plai cream']}, {'name': 'Placebo cream', 'type': 'DRUG', 'armGroupLabels': ['Placebo cream']}]}, 'contactsLocationsModule': {'locations': [{'zip': '26120', 'city': 'Ongkarak', 'state': 'Changwat Nakhon Nayok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Chuthamanee Suthisisang, Ph.D', 'role': 'CONTACT', 'email': 'pycst@mahidol.ac.th', 'phone': '662-644-8700'}, {'name': 'Suwimon Yeephu, M.Sc.', 'role': 'CONTACT', 'email': 'suwimony@swu.ac.th', 'phone': '6686-9836644'}, {'name': 'Suwimon Yeephu, M.Sc.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Faculty of Medicine, Srinakharinwirot University'}], 'centralContacts': [{'name': 'Chuthamanee Suthisisang, Ph.D.', 'role': 'CONTACT', 'email': 'pycst@mahidol.ac.th', 'phone': '662-644-8700'}, {'name': 'Suwimon Yeephu, M.Sc.', 'role': 'CONTACT', 'email': 'suwimony@swu.ac.th', 'phone': '6686-9836644'}], 'overallOfficials': [{'name': 'Chuthamanee Suthisisang, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Pharmacology, Faculty of Pharmacy, Mahidol University 447 Sri-Ayudhya Rd., Rajthevee, Bangkok 10400, Thailand'}, {'name': 'Suwimon Yeephu, M.Sc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Pharmacy, Srinakharinwirot University'}, {'name': 'Chuthamanee Suthisisant, Ph.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Mahidol University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}