Ignite Creation Date:
2025-12-24 @ 12:40 PM
Ignite Modification Date:
2026-02-04 @ 2:52 PM
Study NCT ID:
NCT02155361
Status:
COMPLETED
Last Update Posted:
2014-11-17
First Post:
2014-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Topical Citrullus Colocynthis Fruit Oil Efficacy in Treatment of Painful Peripheral Diabetic Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003929', 'term': 'Diabetic Neuropathies'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-14', 'studyFirstSubmitDate': '2014-05-31', 'studyFirstSubmitQcDate': '2014-06-02', 'lastUpdatePostDateStruct': {'date': '2014-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Scores on the Neuropathic Pain Scale (NPS)', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'WHOQOL-BREF Score', 'timeFrame': '12 weeks'}, {'measure': 'Number of Participants with Adverse Events', 'timeFrame': '12 weeks'}, {'measure': 'Nerve Conduction Velocity (NCV) (m/sec) of common peroneal nerve (CPN)', 'timeFrame': '12 weeks'}, {'measure': 'NCV (m/sec) of tibial nerve', 'timeFrame': '12 weeks'}, {'measure': 'Distal latency (millisecond) of superficial peroneal nerve (SPN)', 'timeFrame': '12 weeks'}, {'measure': 'Distal latency (millisecond) of sural nerve', 'timeFrame': '12 weeks'}, {'measure': 'Sensory amplitude (microvolt) of SPN', 'timeFrame': '12 weeks'}, {'measure': 'Sensory amplitude (microvolt) of sural nerve', 'timeFrame': '12 weeks'}, {'measure': 'Motor amplitude (microvolt) of CPN', 'timeFrame': '12 weeks'}, {'measure': 'Motor amplitude (microvolt) of tibial nerve', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diabetes mellitus', 'Diabetes complications', 'Pain'], 'conditions': ['Diabetic Neuropathies']}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate the topical Citrullus colocynthis fruit oil efficacy in treatment of painful peripheral diabetic neuropathy (PDN) in a randomized double blind placebo-controlled clinical trial design. This study includes 60 patients from SUMS endocrinology and diabetes clinic. Patients with painful conditions other than PDN such as radiculopathies will be excluded. After giving the Informed consent the patients will be underwent NCS (Nerve Conduction Study) for confirming the diagnosis before recruitment. They will be followed for 12 weeks and after 12 weeks the outcome measures including Neuropathic Pain Scale (NPS), WHOQOL-BREF (World Health Organisation Quality of Life Brief) questionnaire and electrodiagnostic criteria will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Controlled type 1 or 2 diabetes mellitus\n* Painful Peripheral diabetic neuropathy for more than 3 months\n* Age more than 18 years old\n* Patients consent on enrolling study and admitting study protocol\n\nExclusion criteria:\n\n* Other causes of pain in lower extremities like lumbar disk herniation\n* Ulcerative lesions in lower extremities\n* Dermatitis\n* Pregnancy\n* Lactation\n* Citrullus colocynthis allergy\n* Unstable cardiac, neurological or renal disease\n* Diagnosed other types of neuropathy'}, 'identificationModule': {'nctId': 'NCT02155361', 'briefTitle': 'Evaluation of Topical Citrullus Colocynthis Fruit Oil Efficacy in Treatment of Painful Peripheral Diabetic Neuropathy', 'organization': {'class': 'OTHER', 'fullName': 'Shiraz University of Medical Sciences'}, 'officialTitle': 'Evaluation of Topical Citrullus Colocynthis Fruit Oil Efficacy in Treatment of Painful Peripheral Diabetic Neuropathy', 'orgStudyIdInfo': {'id': 'CT-9377-7007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Topical Citrullus colocynthis fruit oil', 'description': 'Topical Citrullus colocynthis fruit oil (1%) 1 cc twice daily', 'interventionNames': ['Drug: Topical Citrullus colocynthis fruit oil (1%)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (Vehicle)', 'description': 'Topical vehicle oil 1 cc twice daily', 'interventionNames': ['Drug: Topical vehicle oil']}], 'interventions': [{'name': 'Topical Citrullus colocynthis fruit oil (1%)', 'type': 'DRUG', 'armGroupLabels': ['Topical Citrullus colocynthis fruit oil']}, {'name': 'Topical vehicle oil', 'type': 'DRUG', 'armGroupLabels': ['Placebo (Vehicle)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shiraz', 'state': 'Fars', 'country': 'Iran', 'facility': 'Department of Physical Medicine and Rehabilitation - Shiraz University of Medical Sciences', 'geoPoint': {'lat': 29.61031, 'lon': 52.53113}}, {'city': 'Shiraz', 'state': 'Fars', 'country': 'Iran', 'facility': 'Research Center for Traditional Medicine and History of Medicine-Shiraz University of Medical Sciences', 'geoPoint': {'lat': 29.61031, 'lon': 52.53113}}], 'overallOfficials': [{'name': 'Mesbah Shams, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Research Center for Traditional Medicine & History of Medicine - Shiraz University of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shiraz University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Mesbah Shams', 'investigatorFullName': 'Mesbah Shams, MD', 'investigatorAffiliation': 'Shiraz University of Medical Sciences'}}}}