Ignite Creation Date:
2025-12-24 @ 2:25 PM
Ignite Modification Date:
2025-12-28 @ 1:09 AM
Study NCT ID:
NCT02568059
Status:
COMPLETED
Last Update Posted:
2016-10-18
First Post:
2015-09-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Clinical Safety of Alcoholic Extract Sahastara Remedy of Extract Capsule in Healthy Volunteers
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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-17', 'studyFirstSubmitDate': '2015-09-30', 'studyFirstSubmitQcDate': '2015-10-02', 'lastUpdatePostDateStruct': {'date': '2016-10-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical safety evaluated by History taking, Patient diary note, Physical Examination and Laboratory test including Complete Blood Count (CBC), Renal functions, Liver functions, Lipid profile, Fasting Blood Sugar (FBS), and Urinary analysis', 'timeFrame': '14 days while using intervention', 'description': 'Clinical safety was evaluated changing from baseline by History taking, Patient diary note, Physical Examination and Laboratory test including Complete Blood Count (CBC), Renal functions, Liver functions, Lipid profile, Fasting Blood Sugar (FBS), and Urinary analysis'}, {'measure': 'Clinical safety evaluated by History taking, Patient diary note, Physical Examination and Laboratory test including Complete Blood Count (CBC), Renal functions, Liver functions, Lipid profile, Fasting Blood Sugar (FBS), and Urinary analysis', 'timeFrame': '28 days while using intervention', 'description': 'Clinical safety was evaluated changing from baseline and 14 days while using intervention by History taking, Patient diary note, Physical Examination and Laboratory test including Complete Blood Count (CBC), Renal functions, Liver functions, Lipid profile, Fasting Blood Sugar (FBS), and Urinary analysis'}, {'measure': 'Clinical safety evaluated by History taking, Patient diary note, Physical Examination and Laboratory test including Complete Blood Count (CBC), Renal functions, Liver functions, Lipid profile, Fasting Blood Sugar (FBS), and Urinary analysis', 'timeFrame': '14 days after stop intervention', 'description': 'Clinical safety was evaluated changing from baseline,14 days and 28 days while using intervention by History taking, Patient diary note, Physical Examination and Laboratory test including Complete Blood Count (CBC), Renal functions, Liver functions, Lipid profile, Fasting Blood Sugar (FBS), and Urinary analysis'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The clinical safety of Sahastara remedy alcoholic extract in healthy volunteers. Investigators will investigate safety of 100 and 200 mg of Sahastara remedy extract capsule in healthy volunteers. This is Clinical trial Phase I.', 'detailedDescription': 'The sahastara remedy (SHT) is a Thai traditional medicine that is use to relieve pain of musculoskeletal problem. There is study shown that SHT extract was not found acute and chronic toxicity in rat. However, there is no study regarding safety in human. Thus, this study is a clinical trial Phase I that investigate clinical safety of SHT alcoholic extract in healthy volunteers. The clinical safety will monitor for 28 days in continuously use of 100 and 200 mg SHT extraction 3 time a day and after stop intervention for 14 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 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\n* Able to follow suggestion during the study\n\nExclusion Criteria:\n\n* Uncontrolled Hypertension (BP\\>140/90 mm.Hg.)\n* 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': 'NCT02568059', 'briefTitle': 'The Clinical Safety of Alcoholic Extract Sahastara Remedy of Extract Capsule in Healthy Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'Thammasat University'}, 'officialTitle': 'The Clinical Safety of Alcoholic Extract Sahastara Remedy of Extract Capsule in Healthy Volunteers (Clinical Trial Phase I)', 'orgStudyIdInfo': {'id': 'MTU-EC-TM-1-179/57'}, 'secondaryIdInfos': [{'id': 'TCTR20150917001', 'type': 'REGISTRY', 'domain': 'Thai Clinical Trials Registry(TCTR)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '100 mg SHT extract', 'description': 'The Sahastara remedy alcoholic extract capsule dose 100 mg.', 'interventionNames': ['Drug: Sahastara remedy alcoholic extract']}, {'type': 'EXPERIMENTAL', 'label': '200 mg SHT extract', 'description': 'The Sahastara remedy alcoholic extract capsule dose 200 mg.', 'interventionNames': ['Drug: Sahastara remedy alcoholic extract']}], 'interventions': [{'name': 'Sahastara remedy alcoholic extract', 'type': 'DRUG', 'description': 'comparison of different dose of drug', 'armGroupLabels': ['100 mg SHT extract', '200 mg SHT extract']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12120', 'city': 'Klongnueng', 'state': 'Changwat Pathum Thani', 'country': 'Thailand', 'facility': 'Faculty of Medicine, Thammasat University'}], 'overallOfficials': [{'name': 'Puritat Kanokkangsadal, M.Sc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Applied Thai Traditional Medicine, Faculty of Medicine, Thammasat University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thammasat University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Applied Thai Traditional Medicine, Faculty of Medicine', 'investigatorFullName': 'Puritat Kanokkangsadal', 'investigatorAffiliation': 'Thammasat University'}}}}