Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT04504305
Status:
COMPLETED
Last Update Posted:
2021-04-08
First Post:
2020-08-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
To Assess the Efficacy of Investigational Product on the Neuropathic Pain in Individuals Suffering From Type II Diabetes Mellitus.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003929', 'term': 'Diabetic Neuropathies'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine 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': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-06', 'studyFirstSubmitDate': '2020-08-04', 'studyFirstSubmitQcDate': '2020-08-04', 'lastUpdatePostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by 11 point numeric rating scale.', 'timeFrame': '42 days', 'description': 'pain intensity will be assessed by 11 point numeric rating scale where 0 indicates no pain and 10 indicates worst possible pain'}], 'secondaryOutcomes': [{'measure': 'effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by Brief pain inventory.', 'timeFrame': '42 days'}, {'measure': 'effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by insomnia Severity index.', 'timeFrame': '42 Days'}, {'measure': 'effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by Neuropathy total symptom score - 6 .', 'timeFrame': '42 Days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Neuropathies', 'Insomnia Due to Medical Condition']}, 'descriptionModule': {'briefSummary': 'this study is to be carried out to examine the effect of Investigation product on diabetic individuals suffering from diabetic neuropathic pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and Females aged ≥ 40 and ≤ 65 years of age.\n* Participants with primary complaints of lower limb pain.\n* History of Diabetes mellitus for more than one year.\n* Participants with HbA1c ≥ 7.1 and ≤ 9.5%\n\nExclusion Criteria:\n\n* Diagnosed with severe cardiac disease\n* Uncontrolled hypertension defined as systolic blood pressure ≥ 139 and diastolic blood pressure ≥ 85.\n* Type II DM with history of foot ulcers in the last six months prior to the study\n* History of nerve damage not due to Painful Diabetic Neuropathy.'}, 'identificationModule': {'nctId': 'NCT04504305', 'briefTitle': 'To Assess the Efficacy of Investigational Product on the Neuropathic Pain in Individuals Suffering From Type II Diabetes Mellitus.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vedic Lifesciences Pvt. Ltd.'}, 'officialTitle': 'A Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy of Investigational Product Nerve Support Formula on the Neuropathic Pain in Individuals Suffering From Type II Diabetes Mellitus.', 'orgStudyIdInfo': {'id': 'VC/190403/NUEROPAWAY/PN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Neuropaway', 'interventionNames': ['Other: NeuropAWAY']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Microcystalline cellulose', 'interventionNames': ['Other: Microcystalline cellulose']}], 'interventions': [{'name': 'NeuropAWAY', 'type': 'OTHER', 'description': '2 capsules thrice daily to be taken half an hour prior to meal.', 'armGroupLabels': ['Neuropaway']}, {'name': 'Microcystalline cellulose', 'type': 'OTHER', 'description': '2 capsules thrice daily to be taken half an hour prior to meal.', 'armGroupLabels': ['Microcystalline cellulose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400047', 'city': 'Mumbai', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Stress Test Clinic', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '400067', 'city': 'Mumbai', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Shantaee', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vedic Lifesciences Pvt. Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}