Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-03-01 @ 12:18 AM
Study NCT ID:
NCT02100202
Status:
UNKNOWN
Last Update Posted:
2014-03-31
First Post:
2014-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study of Dietary Supplements in Chronic Smokers Having Mild to Moderate Hyperlipidemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006949', 'term': 'Hyperlipidemias'}], 'ancestors': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2014-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-03-26', 'studyFirstSubmitDate': '2014-03-22', 'studyFirstSubmitQcDate': '2014-03-26', 'lastUpdatePostDateStruct': {'date': '2014-03-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety and tolerability (composite measure)', 'timeFrame': 'Baseline and on day 30', 'description': 'Physical and clinical laboratory evaluations - Electrocardiogram (ECG), haematology \\[complete blood count (CBC)\\], biochemical tests (serum urea, serum creatinine), liver function test and urine analysis'}], 'primaryOutcomes': [{'measure': 'Change in urine cotinine and serum oxidative stress marker levels', 'timeFrame': 'Baseline and on day 30', 'description': 'nicotine metabolite (cotinine) and serum oxidative stress marker (malondialdehyde) levels'}], 'secondaryOutcomes': [{'measure': 'Change in serum lipid profile', 'timeFrame': 'Baseline and on day 30', 'description': 'Low density lipoprotein-cholesterol (LDL-C), very low density lipoprotein-cholesterol (VLDL-C), high density lipoprotein-cholesterol (HDL-C), total cholesterol (TC)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dietary supplements', 'Cotinine level', 'Malondialdehyde', 'Chronic smokers', 'Hyperlipidemia'], 'conditions': ['Chronic Smokers', 'Hyperlipidemia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.nlm.nih.gov/medlineplus/dietarysupplements.html', 'label': 'Dietary supplements'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the efficacy and safety of dietary supplements (BioTurmin, BioTurmin-WD and MaQxan) on cotinine level and oxidative stress marker in chronic smokers having mild to moderate hyperlipidemia after 30 days of intervention.', 'detailedDescription': 'In a randomized, double-blind, placebo control trial, the efficacy and safety of dietary supplements (BioTurmin, BioTurmin-WD and MaQxan) will be investigated in chronic smokers having mild to moderate hyperlipidemia. Sixty subjects will be randomly assigned to receive the dietary supplements and placebo for 30 days. The efficacy of the supplements will be measured by estimating cotinine and malondialdehyde level.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMen \\> 20 years\n\nChronic cigarette/ beedi smoker (2-3 packets/day since last 3 years or more) with mild to moderate hyperlipidemia (LDL ranging 160-189 mg/dL, TC \\>200 mg/dL and/or HDL-C \\<40 mg/dL)\n\nBeing mentally competent and able to understand all study requirements and sign the informed consent form.\n\nExclusion Criteria:\n\nPatients with Chronic obstructive pulmonary disease (COPD)\n\nWomen\n\nPatients with severe liver, renal, cardiac or brain diseases.\n\nUnable to complete follow up.\n\nSubjects on any medication like diuretics.\n\nAllergic to any medication.\n\nWith a history of alcohol and/or drug abuse.'}, 'identificationModule': {'nctId': 'NCT02100202', 'briefTitle': 'Efficacy and Safety Study of Dietary Supplements in Chronic Smokers Having Mild to Moderate Hyperlipidemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Olive Lifesciences Pvt Ltd'}, 'officialTitle': 'Efficacy and Safety Study of Dietary Supplements (BioTurmin, BioTurmin-WD and MaQxan) on Cotinine Level and Oxidative Stress Marker in Chronic Smokers Having Mild to Moderate Hyperlipidemia', 'orgStudyIdInfo': {'id': 'OLS-SH/02-14 Ver 01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Capsules containing 250 mg of placebo, two times a day', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'BioTurmin', 'description': 'Capsules containing 250 mg of BioTurmin (Curcuma longa rhizomes extract), two times a day', 'interventionNames': ['Dietary Supplement: BioTurmin (Curcuma longa rhizomes extract)']}, {'type': 'EXPERIMENTAL', 'label': 'BioTurmin-WD', 'description': 'Capsules containing 250 mg of BioTurmin-WD (water dispersible curcuminoids), two times a day', 'interventionNames': ['Dietary Supplement: BioTurmin-WD (Water dispersible curcuminoids)']}, {'type': 'EXPERIMENTAL', 'label': 'MaQxan', 'description': 'Capsules containing 10 mg of MaQxan (Tagetes erecta flower extract), two times a day', 'interventionNames': ['Dietary Supplement: MaQxan (Tagetes erecta flower extract)']}], 'interventions': [{'name': 'Placebo', 'type': 'OTHER', 'armGroupLabels': ['Placebo']}, {'name': 'BioTurmin (Curcuma longa rhizomes extract)', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['BioTurmin']}, {'name': 'BioTurmin-WD (Water dispersible curcuminoids)', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['BioTurmin-WD']}, {'name': 'MaQxan (Tagetes erecta flower extract)', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['MaQxan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '560050', 'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'contacts': [{'name': 'Venkateshwarlu K, MD (Ayur)', 'role': 'CONTACT', 'email': 'drvenkatesh64@gmail.com', 'phone': '919945232107'}, {'name': 'Raveendra K R, MD', 'role': 'CONTACT', 'email': 'drkrraveendra@gmail.com', 'phone': '919448134587'}, {'name': 'Raveendra K R, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Venkateshwarlu K, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sreenivasa Clinic Diabetic Research Center', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}], 'centralContacts': [{'name': 'Shivaprasad H N, M Pharma, Ph.D', 'role': 'CONTACT', 'email': 'shiv@olivelifesciences.com', 'phone': '918971489704'}, {'name': 'Bhanumathy M, M Pharma', 'role': 'CONTACT', 'email': 'bhanumathy@olivelifesciences.com', 'phone': '919986411152'}], 'overallOfficials': [{'name': 'Venkateshwarlu K, MD (Ayur)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sreenivasa Clinic Diabetic Research Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Olive Lifesciences Pvt Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}