Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-02-25 @ 11:03 PM
Study NCT ID:
NCT03658369
Status:
COMPLETED
Last Update Posted:
2019-09-10
First Post:
2018-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of LANCONONE in Weight-bearing Joint Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-09', 'studyFirstSubmitDate': '2018-09-01', 'studyFirstSubmitQcDate': '2018-09-01', 'lastUpdatePostDateStruct': {'date': '2019-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'WOMAC (Western Ontario and McMaster universities Osteoarthritis Index) pain score', 'timeFrame': '56 days', 'description': 'Change in pain score.The score ranges from 0-5, wherein 0 indicates no pain and 5 indicates extreme pain.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteo Arthritis Knee']}, 'descriptionModule': {'briefSummary': 'The current study has been designed to primarily assess the effect of Lanconone® in comparison to placebo on pain in weight bearing joints.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. BMI ≥ 25 and ≤ 29.9 kg/m2.\n2. With unilateral or bilateral OA of the knee for at least greater than 3 months, as presented by pain in the knee at least for last 3 months.\n3. Post-menopausal females (LMP at least 12 months prior to the screening).\n\nExclusion Criteria:\n\n1. History of osteoarthritis for more than 3 years.\n2. Systolic Blood Pressure ≥140 mm Hg and Diastolic Blood Pressure ≥ 90 mm Hg\n3. FBS\\>140 mg/dl.\n4. Smokers or chronic alcoholics.\n5. Participants planning to travel in the next 56 days or engage in any non-routine activity that is likely to strain the knees.'}, 'identificationModule': {'nctId': 'NCT03658369', 'briefTitle': 'Effect of LANCONONE in Weight-bearing Joint Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vedic Lifesciences Pvt. Ltd.'}, 'officialTitle': 'To Assess the Lanconone® (E-OA-07) Efficacy in Weight-bearing Joint Pain', 'orgStudyIdInfo': {'id': 'EB/180601/LANCONONE/PAIN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lanconone®', 'description': 'Lanconone®: 2 Capsules once a day after breakfast', 'interventionNames': ['Dietary Supplement: Lanconone®']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Methyl Crystalline Cellulose', 'description': '2 Capsules once a day after breakfast', 'interventionNames': ['Dietary Supplement: Methyl crystalline cellulose']}], 'interventions': [{'name': 'Lanconone®', 'type': 'DIETARY_SUPPLEMENT', 'description': '2 capsules', 'armGroupLabels': ['Lanconone®']}, {'name': 'Methyl crystalline cellulose', 'type': 'DIETARY_SUPPLEMENT', 'description': '2 Capsules', 'armGroupLabels': ['Methyl Crystalline Cellulose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400067', 'city': 'Mumbai', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Ayush Nursing Home', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '400067', 'city': 'Mumbai', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Dinanath Nursing Home', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '400068', 'city': 'Mumbai', 'state': 'Maharashtra', 'country': 'India', 'facility': 'K.K Medical Centre', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '400076', 'city': 'Mumbai', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Siddhant Clinic', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}], 'overallOfficials': [{'name': 'Shalini Srivastava, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Vedic Lifesciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vedic Lifesciences Pvt. Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}