Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2026-04-16 @ 6:50 PM
Study NCT ID:
NCT01958866
Status:
COMPLETED
Last Update Posted:
2015-03-11
First Post:
2013-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Efficacy and Safety of Tinospora Crispa-extract Product Compared With the Acetaminophen
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005334', 'term': 'Fever'}], 'ancestors': [{'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-10', 'studyFirstSubmitDate': '2013-09-11', 'studyFirstSubmitQcDate': '2013-10-07', 'lastUpdatePostDateStruct': {'date': '2015-03-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body Temperature', 'timeFrame': 'Change from baseline in temperature at 1, 2, 3, 4, 6, 8, 12 and 24 hours'}], 'secondaryOutcomes': [{'measure': 'Number of adverse events: diarrhea, elevated liver enzyme and elevated creatinine', 'timeFrame': 'Participants will be followed for the duration of hospital stay (24 hours)', 'description': 'Liver and kidney function will be randomly evaluated. Number of participants with soft stool will be recorded.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Fever', 'Body temperature'], 'conditions': ['Patients With Body Temperature Between 37.8-38.5', 'No Sign of Infection', 'No Liver and Kidney Problem']}, 'descriptionModule': {'briefSummary': 'Hypothesis: Tinospora Crispa-extract Product can reduce pyretic similar to acetaminophen.\n\nThis study aims to investigate the efficacy and safety of Tinospora Crispa-extract product compared with the acetaminophen. Total of 96 patients with body temperature between 37.8-38.5 without any signs of infections will be enrolled in this study. Patients will be randomly divided into 3 groups: First group will receive acetaminophen 1000 mg every 6 hr, Second group will receive Tinospora Crispa-extract Product 2000 mg twice daily and the third group will receive placebo twice daily.', 'detailedDescription': 'Patients in each group will be monitored for body temperature at baseline (at the time of enrollment) and at 1, 2, 4, 6, 8, 24 h after receiving the tested material.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age over 18 years old\n* Body temperature between 37.8-38.5\n* Body weight not less than 40 kg but not over 100 kg\n* Liver enzymes do not exceed 2 times of normal value\n* Can comply with study protocol\n\nExclusion Criteria:\n\n* Have allergic history of any tested compounds\n* Fever from other causes, not by URI\n* Take any herbal medicines during 2 weeks before enrollment\n* Physicians decide to withdraw the subjects with any reasons'}, 'identificationModule': {'nctId': 'NCT01958866', 'briefTitle': 'Study of Efficacy and Safety of Tinospora Crispa-extract Product Compared With the Acetaminophen', 'organization': {'class': 'OTHER', 'fullName': 'Chulalongkorn University'}, 'orgStudyIdInfo': {'id': '0156'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Acetaminophen', 'description': 'Acetaminophen administer 1000 mg every 4-6 hours when fever is presented', 'interventionNames': ['Drug: Acetaminophen']}, {'type': 'EXPERIMENTAL', 'label': 'Tinospora Crispa-extract Product', 'description': 'Tinospora Crispa-extract tablet administer 500 mg every 4-6 hours when fever is presented', 'interventionNames': ['Drug: Tinospora Crispa-extract Product']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo 2 tablets will be administered every 4 hours when fever is presented', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Tinospora Crispa-extract Product', 'type': 'DRUG', 'armGroupLabels': ['Tinospora Crispa-extract Product']}, {'name': 'Acetaminophen', 'type': 'DRUG', 'armGroupLabels': ['Acetaminophen']}, {'name': 'Placebo', 'type': 'OTHER', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10330', 'city': 'Bangkok', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Pornanong Aramwit', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chulalongkorn University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Pornanong Aramwit, Pharm.D., Ph.D', 'investigatorAffiliation': 'Chulalongkorn University'}}}}