Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-03-04 @ 8:46 PM
Study NCT ID:
NCT02187757
Status:
COMPLETED
Last Update Posted:
2015-05-15
First Post:
2014-06-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate Efficacy and Safety of PreLipid® on Subjects With Higher Than Normal Blood Lipid Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D006937', 'term': 'Hypercholesterolemia'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-14', 'studyFirstSubmitDate': '2014-06-30', 'studyFirstSubmitQcDate': '2014-07-10', 'lastUpdatePostDateStruct': {'date': '2015-05-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety of Dietary Supplement PreLipid 600 mg twice-daily with Kidney Function', 'timeFrame': 'Baseline (Day 1) to End of Study (Day 90)', 'description': 'Measure changes in Renal Function Tests: Blood Urea Nitrogen (BUN) from baseline (Day 1) to End of Study (Day 90); Serum Creatinine from baseline (Day 1) to End of Study (Day 90)'}], 'primaryOutcomes': [{'measure': 'Efficacy of Dietary Supplement PreLipid 600 mg twice-daily in lowering LDL-C levels', 'timeFrame': 'Day 1 (Baseline) to Day 90 (End of Study)', 'description': 'Change in LDL-C % from baseline (Day 1) to the end of supplementation/treatment after 90 days'}, {'measure': 'Safety of Dietary Supplement PreLipid 600 mg twice-daily', 'timeFrame': 'Day 1(Baseline) to Day 90 (End of Study)', 'description': 'Measure changes in Liver Function Tests: Aspartate Aminotransferase (AST) from baseline (Day 1) to End of Study (Day 90); Alanine Aminotransferase (ALT) from baseline (Day 1) to End of Study (Day 90) and Alkaline Phosphatase (ALP) from baseline (Day 1) to End of Study (Day 90)'}], 'secondaryOutcomes': [{'measure': 'Changes in Glycemic Status', 'timeFrame': 'Day 1 (Baseline) to Day 90 (End of Study)', 'description': 'To assess percentage changes in Blood Sugar profile (HbA1c) from baseline to at the end of supplementation after 03 months.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dyslipidemia', 'High cholesterol', 'High LDL', 'Triglycerides'], 'conditions': ['Hyperlipidemia']}, 'descriptionModule': {'briefSummary': 'Study to evaluate Efficacy and Safety of PreLipid® on subjects with higher than normal blood lipid levels', 'detailedDescription': 'A Prospective, Double Blind, Placebo-Controlled, Randomized, Multicentric, study to evaluate the safety, efficacy and tolerability of PreLipid®, a twice-daily nutritional supplement in subjects with higher than normal blood lipid levels'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nNewly diagnosed Male or Female participants with higher than normal cholesterol levels defined by the American Heart Association, National Cholesterol Education Program (NCEP) and ATP-III goals for LDL cholesterol and cut off points for therapeutic lifestyle changes (TLCs) and drug therapy in different risk categories:\n\n1. Age ≥ 18 years to ≤ 65 years\n2. LDL cholesterol levels \\>120mg/dl\n3. Ability to understand and willingness to sign and date a written Informed Consent Document at the screening visit before any protocol- specific procedures are performed and willing to adhere to the protocol and entire trial procedures -\n\nExclusion Criteria:\n\n1. Stroke, myocardial infarction, coronary artery bypass graft (CABG) percutaneous transluminal coronary angioplasty (PTCA) or angina pectoris in the past.\n2. Cardiac status New York Heart Association class III-IV\n3. Uncotrolled blood pressure \\> 150 mmhg systolic and \\> 100 mmhg diastolic\n4. Impaired renal function as shown by but not limited to serum creatinine ≥ 1.5 mg/dl for males and ≥ 1.4 mg/dl for female\n5. Clinically significant peripheral edema\n6. Clinical evidence of active liver disease or serum alenine aminotransferase (ALT) or aspartate amino transferase (AST) 2.5 times the upper limit of the normal range (2.5 X ULN)\n7. Participants on steroid\n8. Pregnancy or lactating women\n9. Known hypersensitivity to any of the study drugs\n10. Any malignancy within the last 5 years, with exception of adequately treated basal or squamous cell carcinoma of the skin or adequately treated carcinoma insitu.\n11. Current addiction or current alcohol abuse or history of substance or alcohol abuse within the last 2 years\n12. Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol\n13. Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study.\n14. Subject unlikely to comply with protocol e.g. uncooperative attitude, inability to return for follow up visits and unlikelihood completing of the study\n15. Any disease or condition that in the opinion of the investigator and/or sponsor may interfere with the completion of the studyevaluation.\n\n \\-'}, 'identificationModule': {'nctId': 'NCT02187757', 'acronym': 'Prelip', 'briefTitle': 'Study to Evaluate Efficacy and Safety of PreLipid® on Subjects With Higher Than Normal Blood Lipid Levels', 'organization': {'class': 'INDUSTRY', 'fullName': 'PreEmptive Meds, Pvt. Ltd'}, 'officialTitle': 'A Prospective, Double Blind, Placebo-Controlled, Randomized, Multicentric, Study to Evaluate the Safety, Efficacy and Tolerability of PreLipid®, a Twice-daily Nutritional Supplement in Subjects With Higher Than Normal Blood Lipid Levels', 'orgStudyIdInfo': {'id': 'Prelip/Nutra001/PMI13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PreLipid', 'description': 'Study Dietary Supplement (PreLipid 600 mg capsules) will be given to subjects twice daily 30 mins before food for 90days along with lifestyle modification.', 'interventionNames': ['Dietary Supplement: Study Dietary Supplement (Prelipid 500 mg capsules)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo 600 mg capsules', 'description': 'Placebo was given to patients twice daily 30 mins before food for 90 days along with lifestyle modification program.', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Study Dietary Supplement (Prelipid 500 mg capsules)', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['PreLipid, Natural Cholesterol Supplement, Predisease'], 'description': 'Study Dietary Supplement (PreLipid 600 mg capsules) will be given to subjects twice daily 30 mins before food for 90 days along with lifestyle modification.', 'armGroupLabels': ['PreLipid']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Placebo 600 mg capsules'], 'armGroupLabels': ['Placebo 600 mg capsules']}]}, 'contactsLocationsModule': {'locations': [{'zip': '380014', 'city': 'Ahmedabad', 'state': 'Gujarat', 'country': 'India', 'facility': 'Life Care Institute of Medical Science & Research', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'zip': '400007', 'city': 'Mumbai', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Bhatia Hospital Medical Research Society', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '411005', 'city': 'Pune', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Dr. Vikas Govind Pai Clinical Research Foundation', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'zip': '122001', 'city': 'Gurgaon', 'state': 'National Capital Territory of Delhi', 'country': 'India', 'facility': 'Division of Clinical & Preventive Cardiology, Heart Institute'}, {'zip': '302017', 'city': 'Jaipur', 'state': 'Rajasthan', 'country': 'India', 'facility': 'Fortis Escorts Hospital', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}, {'zip': '560043', 'city': 'Bangalore', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'Pace Clinical Research Center'}, {'zip': '600079', 'city': 'Chennai', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'Singvi Health Centre', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'zip': '606003', 'city': 'Tiruvannamalai', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'Rangammal Hospital', 'geoPoint': {'lat': 12.22662, 'lon': 79.07461}}], 'overallOfficials': [{'name': 'Ravi Kasliwal, MD, DM, FIMSA', 'role': 'STUDY_CHAIR', 'affiliation': 'Medanta, The Medicity, India'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PreEmptive Meds, Pvt. Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Abbott', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chairman, Department of Clinical & Preventive Cardiology', 'investigatorFullName': 'Joe Fenn', 'investigatorAffiliation': 'Medanta, The Medicity, India'}}}}