Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-01-03 @ 3:04 PM
Study NCT ID:
NCT02983669
Status:
COMPLETED
Last Update Posted:
2017-10-04
First Post:
2016-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Zataria Multiflora Boiss (Shirazi's Thyme) on Nonalcoholic Fatty Liver Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-05-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-03', 'studyFirstSubmitDate': '2016-12-02', 'studyFirstSubmitQcDate': '2016-12-05', 'lastUpdatePostDateStruct': {'date': '2017-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in ALT (Alanin aminotransferase) level', 'timeFrame': '3 months'}, {'measure': 'Change in grade of fatty liver in sonography by use of Saverymuttu Scoring System', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Change in AST (Aspartate aminotransferase) level', 'timeFrame': '3 months'}, {'measure': 'Fasting blood sugar (FBS)', 'timeFrame': '3 months'}, {'measure': 'Change in Gama GT (γ-glutamyl transpeptidase) level', 'timeFrame': '3 monyhs'}, {'measure': 'Fasting insulin level', 'timeFrame': '3 months'}, {'measure': 'Body weight', 'timeFrame': '3 months'}, {'measure': 'Waist circumference', 'timeFrame': '3 months'}, {'measure': 'Hip circumference', 'timeFrame': '3 months'}, {'measure': 'Number of patients with adverse events', 'timeFrame': '4 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Thymus Plant', 'Multiflotriol [Supplementary Concept]', 'Zataria multiflora', 'Complementary Therapies', 'Herbal Medicine', 'Medicine, traditional'], 'conditions': ['Fatty Liver', 'Fatty Liver, Nonalcoholic']}, 'descriptionModule': {'briefSummary': "The aim of this study is to evaluate the effects and safety of a dietary supplement, Zataria multiflora Boiss (Shirazi's Thyme) in the treatment of non alcoholic fatty liver disease (NAFLD).", 'detailedDescription': "In a randomized double-blind placebo-controlled clinical trial Shirazi's Thyme is compared with placebo. Investigators select randomly 90 patients with NAFLD by inclusion criteria. Investigators measure anthropometric and laboratory parameters including fasting blood sugar, insulin, liver enzymes, lipid profile, and grade in sonography before intervention and 90 days later. Patients are divided into two equal groups. Intervention group in addition to diet and exercise recommendations receive capsules containing 700 mg of Shirazi thyme powder daily for 90 days. Placebo group in addition to the same recommendations for diet and exercise, receives placebo capsules twice daily."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age: 20-65 years\n* Body mass index: 18-35 kg/m2\n* Serum ALT level: \\>45 U/Lit. in Males, \\>29 U/Lit. in Females\n* Grade \\>=1 fatty liver in liver sonography\n\nExclusion Criteria:\n\n* Pregnancy and Lactation\n* Acute or chronic liver failure\n* Acute or chronic renal failure\n* Autoimmune or viral hepatitis\n* Wilson's disease\n* Diabetes mellitus\n* Alcoholism\n* Malignancy\n* Hypothyroidism or hyperthyroidism\n* Drug used in last three months: OCP, metformin, vitamin E, ursodeoxycholic acid, glucocorticoids, thiazolidenediones.\n* History of allergic reactions to Thyme"}, 'identificationModule': {'nctId': 'NCT02983669', 'acronym': 'ThymeLiv', 'briefTitle': "The Effects of Zataria Multiflora Boiss (Shirazi's Thyme) on Nonalcoholic Fatty Liver Disease", 'organization': {'class': 'OTHER', 'fullName': 'Shiraz University of Medical Sciences'}, 'officialTitle': "The Effects of Zataria Multiflora Boiss (Shirazi's Thyme) on Biochemical Markers and Imaging Studies of Patients With Nonalcoholic Fatty Liver Disease (NAFLD)", 'orgStudyIdInfo': {'id': '94-7648'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Thyme', 'description': 'Zataria multiflora Boiss powder capsule 350 mg twice daily for 3 months', 'interventionNames': ['Dietary Supplement: Thyme']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Wheat powder capsule 350 mg twice daily for 3 months', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Thyme', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ["Shirazi's Thyme"], 'description': 'Thyme capsule 350 mg twice daily', 'armGroupLabels': ['Thyme']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo capsule 350 mg twice daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shiraz', 'state': 'Fars', 'country': 'Iran', 'facility': 'Shahid Motahhari Clinic, Shiraz University of Medical Sciences', 'geoPoint': {'lat': 29.61031, 'lon': 52.53113}}], 'overallOfficials': [{'name': 'Majid Nimruzi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research Center for Traditional Medicine & History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran'}, {'name': 'Mojtaba Heydari, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research Center for Traditional Medicine & History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran'}, {'name': 'Nasrin dokht Zamani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research Center for Traditional Medicine & History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shiraz University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor of Internal medicine and Endocrinology', 'investigatorFullName': 'Mesbah Shams, MD', 'investigatorAffiliation': 'Shiraz University of Medical Sciences'}}}}