Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2026-03-01 @ 8:54 PM
Study NCT ID:
NCT04146558
Status:
COMPLETED
Last Update Posted:
2025-06-15
First Post:
2019-10-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ayurvedic Treatment Package in Plaque Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-11', 'studyFirstSubmitDate': '2019-10-29', 'studyFirstSubmitQcDate': '2019-10-29', 'lastUpdatePostDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Psoriasis-specific quality of life', 'timeFrame': '6 months', 'description': 'Psoriasis specific DLQI scores'}], 'secondaryOutcomes': [{'measure': 'Psoriasis Severity', 'timeFrame': '3 months', 'description': 'Psoriasis Area Severity Index (PASI) score'}, {'measure': 'Psoriasis Severity', 'timeFrame': '6 months', 'description': 'Psoriasis Area Severity Index (PASI) score'}, {'measure': 'Psoriasis Severity', 'timeFrame': '12 months', 'description': 'Psoriasis Area Severity Index (PASI) score'}, {'measure': 'Psoriasis-specific quality of life', 'timeFrame': '3 months', 'description': 'Psoriasis specific DLQI scores'}, {'measure': 'Psoriasis-specific quality of life', 'timeFrame': '12 months', 'description': 'Psoriasis specific DLQI scores'}, {'measure': 'Adverse events', 'timeFrame': '3 months'}, {'measure': 'Adverse events', 'timeFrame': '6 months'}, {'measure': 'Adverse events', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psoriasis']}, 'descriptionModule': {'briefSummary': 'Psoriasis is a chronic, immune-mediated inflammatory skin disease that is associated with substantial impairment of physical and psychological quality of life. The conventional treatment protocols manages the condition but with remissions and relapses which create anxiety in patients. Many of the patients withdraw from active social life as the disease attains chronicity. Several studies are pointing towards a conjoint management strategy incorporating the traditional and alternate medical systems. In this regard, Ayurveda is commonly used by psoriatic patients in India. Considering this fact it is high time to conduct a study to scientifically evaluate the efficacy of Ayurvedic treatment protocol in managing psoriasis as well as its potential to improve the quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with psoriasis having age 18 years or more\n* Patients with moderate-to-severe plaque psoriasis with a PASI score of 12 or higher\n* Psoriasis diagnosed 6 months or more before study entry\n* Those who are poorly controlled based on physicians assessment with topical treatments, phototherapy, systemic therapy, or a combination of these therapies.\n* Participants who have given informed consent.\n\nExclusion Criteria:\n\n* Participants with other systemic illnesses\n* Lactating and pregnant mothers.\n* Alcohol dependence/Narcotic dependence /Steroid dependence\n* In the judgment of the investigator, unable or unwilling to follow the protocol and instructions'}, 'identificationModule': {'nctId': 'NCT04146558', 'briefTitle': 'Ayurvedic Treatment Package in Plaque Psoriasis', 'organization': {'class': 'OTHER', 'fullName': 'Universität Duisburg-Essen'}, 'officialTitle': 'A Randomized Open Label Clinical Trial on the Efficacy of an Ayurvedic Treatment Package on Symptom Severity and Quality of Life in Plaque Psoriasis', 'orgStudyIdInfo': {'id': 'GI012019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Internal ayurvedic treatment', 'description': 'All possible internal preparations will be administered for a period of 12 months.\n\nAll administered preparations with its dosage and duration will be documented All preparations will be subjected to lab test for clearing heavy metal and pesticide content before the administration', 'interventionNames': ['Drug: Individualized internal ayurvedic treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'External ayurvedic treatment', 'description': 'Application of warm external oil (Ayyapala kera tailam) on affected parts twice daily', 'interventionNames': ['Other: External ayurvedic treatment']}], 'interventions': [{'name': 'Individualized internal ayurvedic treatment', 'type': 'DRUG', 'description': 'All possible internal preparations will be administered for a period of 12 months.\n\nAll administered preparations with its dosage and duration will be documented All preparations will be subjected to lab test for clearing heavy metal and pesticide content before the administration', 'armGroupLabels': ['Internal ayurvedic treatment']}, {'name': 'External ayurvedic treatment', 'type': 'OTHER', 'description': 'Application of warm external oil (Ayyapala kera tailam) on affected parts twice daily', 'armGroupLabels': ['External ayurvedic treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '679 531', 'city': 'Shōranūr', 'state': 'Kerala', 'country': 'India', 'facility': 'PNNM Ayurveda College', 'geoPoint': {'lat': 10.76181, 'lon': 76.27078}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universität Duisburg-Essen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Poomulli Neelakandan Namboodiripad Memorial Ayurveda Medical College', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Holger Cramer', 'investigatorAffiliation': 'Universität Duisburg-Essen'}}}}