Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-29 @ 4:17 AM
Study NCT ID:
NCT02238912
Status:
COMPLETED
Last Update Posted:
2014-09-12
First Post:
2014-09-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Preclinical Toxicity andTherapeutic Efficacy of Kandhaga Rasayanam in Padarthamarai
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000084002', 'term': 'Tinea Cruris'}, {'id': 'D014008', 'term': 'Tinea Pedis'}, {'id': 'C000656825', 'term': 'tinea barbae'}, {'id': 'D014005', 'term': 'Tinea'}], 'ancestors': [{'id': 'D003881', 'term': 'Dermatomycoses'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D007402', 'term': 'Intertrigo'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D005533', 'term': 'Foot Dermatoses'}, {'id': 'D005534', 'term': 'Foot Diseases'}, {'id': 'D011537', 'term': 'Pruritus'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'lastUpdateSubmitDate': '2014-09-10', 'studyFirstSubmitDate': '2014-09-10', 'studyFirstSubmitQcDate': '2014-09-10', 'lastUpdatePostDateStruct': {'date': '2014-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'burning sensation, vanishing of lesions', 'timeFrame': '45 days'}], 'primaryOutcomes': [{'measure': 'skin scrapping test', 'timeFrame': '45 days'}], 'secondaryOutcomes': [{'measure': 'itching, quality of life', 'timeFrame': '45 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['tinea'], 'conditions': ['Tinea Infections Such as Tinea Corporis, Tinea Cruris, Tinea Pedis, Tinea Mannum, Tinea Barbae, Tinea Capitis Are Studied']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'AYUSH PORTAL, GOOGLE SCHOLAR'}], 'seeAlsoLinks': [{'url': 'http://www.ctri.nic.in/', 'label': 'TRIAL REGISTERED IN CTRI'}]}, 'descriptionModule': {'briefSummary': 'this study is intended to find out the therapeutic efficacy of the siddha drug Kandhaga Rasayanam in Padarthamarai ( Ring worm infection )'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients clinically diagnosed with tinea infection.\n* direct microscopy skin scraping test positive.\n\nExclusion Criteria:\n\n* pregnant or nursing women.\n* use of other topical or oral antifungals, immunosuppressive drugs, anthelmintic drugs either currently or during 2 weeks preceeding initiation of drug trial.\n* allergy or hyperensitivity to any component of the drug.\n* clinical case of eczema, lichen planus, pityriasis versicolor, drug induced eruptions, urticaria, intertrigo, tinea ungium.\n* diabetic patients.'}, 'identificationModule': {'nctId': 'NCT02238912', 'acronym': 'KR', 'briefTitle': 'Evaluation of Preclinical Toxicity andTherapeutic Efficacy of Kandhaga Rasayanam in Padarthamarai', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National institute of Siddha'}, 'officialTitle': 'Evaluation of Preclinical Toxicity of a Siddha Formulation Kandhaga Rasayanam ( KR ) and Its Therapeutic Efficacy in Padarthamarai ( Dermatophytoses ) by an Open Clinical Trial', 'orgStudyIdInfo': {'id': 'EXII(1)/29097/2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Kandhaga Rasayanam- single arm', 'description': 'Kandhaga Rasayanam- 2grams twice a day for 45 days', 'interventionNames': ['Drug: kandhaga rasayanam']}], 'interventions': [{'name': 'kandhaga rasayanam', 'type': 'DRUG', 'otherNames': ['Siddha herbo mineral drug KR.'], 'description': 'KANDHAGA RASAYANAM is a siddha herbo mineral drug with sulphur as a sole mineral ingredient. It is chosen from the classic Siddha text Siddha Vaidhya Thirattu.', 'armGroupLabels': ['Kandhaga Rasayanam- single arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '600047', 'city': 'Chennai', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'National institute of siddha', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National institute of Siddha', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Research scholar', 'investigatorFullName': 'Dr.R.Meena', 'investigatorAffiliation': 'National institute of Siddha'}}}}