Ignite Creation Date:
2025-12-24 @ 1:28 PM
Ignite Modification Date:
2025-12-27 @ 1:13 AM
Study NCT ID:
NCT04591795
Status:
UNKNOWN
Last Update Posted:
2020-10-19
First Post:
2019-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sahastara Remedy Extract Capsule in Primary Osteoarthritis of Clinical Trial Phase II
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2020-11-09', 'releaseDate': '2020-10-17'}], 'estimatedResultsFirstSubmitDate': '2020-10-17'}}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004008', 'term': 'Diclofenac'}], 'ancestors': [{'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-10-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-12', 'studyFirstSubmitDate': '2019-05-30', 'studyFirstSubmitQcDate': '2020-10-12', 'lastUpdatePostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain score 1', 'timeFrame': '28 day', 'description': 'Pain score from Visual analog scale'}], 'secondaryOutcomes': [{'measure': 'Pain score 2', 'timeFrame': '28 day', 'description': 'Pain score from Modified WOMAC score (from Modified Thai WOMAC index)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sahastara', 'Osteoarthritis', 'Herbal Medicine'], 'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'To study efficacy and safety of Sahastara 95% ethanolic extract capsules compared to treatment Primary osteoarthritis for primary osteoarthritis, it was compared with diclofenac (Phase II).', 'detailedDescription': 'Sample size 66 volunteers\n\nThe patients were divided randomly into 2 treatment groups. The patients in group 1 received the SHT extract 300 mg/day (1 capsule of 100 mg SHT extract three times daily before meals). The patients in group 2 received diclofenac sodium 75 mg/day (1 capsule of 25 mg diclofenac three times daily after meals). In addition, the patients in both groups received 20 mg of omeprazole, 1 capsule before breakfast for protects of Gastrointestinal adverse effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No pregnancy\n* No Serious Medical Condition evaluated by Physical Examination and Laboratory results in 1 month before study\n* No Supplementary food and/or Vitamin during the study Able to follow suggestion during the study\n\nExclusion Criteria:\n\n* Uncontrolled Hypertension (BP\\>140/90 mm.Hg.) BMI \\> 30\n* Have serious medical condition including Severe peptic ulcer, congestive heart disease, Liver and Renal dysfunction.\n* On during use medicine including Rifampicin, Phenytoin, Propranolol, Theophylline'}, 'identificationModule': {'nctId': 'NCT04591795', 'briefTitle': 'Sahastara Remedy Extract Capsule in Primary Osteoarthritis of Clinical Trial Phase II', 'organization': {'class': 'OTHER', 'fullName': 'Thammasat University'}, 'officialTitle': 'Efficacy and Safety of Sahastara Remedy Extract Capsules in Treating Primary Osteoarthritis of the Knee Compared With Diclofenac (Clinical Trial Phase II)', 'orgStudyIdInfo': {'id': 'MTU-EC-TM-2-116_2/59'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '100 mg SHT extract', 'description': 'Drug: Sahastara remedy alcoholic extract comparison with diclofenac', 'interventionNames': ['Drug: Diclofenac']}, {'type': 'EXPERIMENTAL', 'label': '25 mg dicolfenac', 'description': 'Drug: diclofenac comparison with diclofenac', 'interventionNames': ['Drug: Sahastara remedy extract']}], 'interventions': [{'name': 'Sahastara remedy extract', 'type': 'DRUG', 'otherNames': ['SHT extract'], 'description': 'The concentration of SHT extract is 100 mg per capsule', 'armGroupLabels': ['25 mg dicolfenac']}, {'name': 'Diclofenac', 'type': 'DRUG', 'description': 'Diclofenac sodium, 25 mg enteric-coated tablets', 'armGroupLabels': ['100 mg SHT extract']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11130', 'city': 'Bangkok', 'state': 'BKK', 'status': 'RECRUITING', 'country': 'Thailand', 'facility': 'Mr. NARIN KAKATUM', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'centralContacts': [{'name': 'Mr.NARIN KAKATUM', 'role': 'CONTACT', 'email': 'narin.ka@ssru.ac.th', 'phone': '0667867161'}, {'name': 'Associate Professor Arunporn Itharat', 'role': 'CONTACT', 'email': 'iarunporn@yahoo.com', 'phone': '0667867161'}], 'overallOfficials': [{'name': 'Associate Professor Arunporn Itharat, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'faculty of Medicine, Thammasat University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mr NARIN KAKATUM', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Faculty of Medicine', 'investigatorFullName': 'Mr NARIN KAKATUM', 'investigatorAffiliation': 'Thammasat University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2020-10-17', 'type': 'RELEASE'}, {'date': '2020-11-09', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Mr NARIN KAKATUM, Faculty of Medicine, Thammasat University'}}}}