Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:55 PM
Study NCT ID:
NCT00606658
Status:
COMPLETED
Last Update Posted:
2012-09-20
First Post:
2008-01-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Usefulness of Shirodhara for Insomnia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-18', 'studyFirstSubmitDate': '2008-01-21', 'studyFirstSubmitQcDate': '2008-01-21', 'lastUpdatePostDateStruct': {'date': '2012-09-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insomnia Severity Index', 'timeFrame': 'Baseline, end of five days and end of 14 days'}], 'secondaryOutcomes': [{'measure': 'HD-16 Quality of Life Scale', 'timeFrame': 'Baseline, end of 5 days and 14 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Insomnia', 'Ayurveda', 'Shirodhara', 'Quality of Life'], 'conditions': ['Insomnia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.scuhs.edu', 'label': 'Visit Southern California University of Health Sciences Website'}]}, 'descriptionModule': {'briefSummary': 'This pilot study will attempt to test the effects of this non-invasive procedure on a small sample of insomnia patients and also determine the feasibility of recruiting and retaining participants during the trial for such treatments in the United States.', 'detailedDescription': 'A prospective case series design will be adopted. Due to the small sample size and the preliminary nature of the study, a single case study or case series are classified under Observational Descriptive Studies. The investigators will seek local Institutional Review Board (IRB) approval. Ten volunteers who respond to the recruitment efforts will be enrolled into the study. Successful enrollment is based on strict inclusion and exclusion criteria. Brahmi oil (sesame oil processed with Bacopa monieri and other herbs) will be used to perform Shirodhara. Each participant will be treated for 40 minutes for five consecutive days. Outcome measures data will be collected at baseline, third day and fifth day and a week after the treatment is over. Additionally, demographic data will be collected at baseline as well. Participants will be asked to record any adverse events or side effects they observe during the study period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18-75 of either sex\n* Duration of insomnia at least one year\n* Willing to sign an informed consent\n* A score of minimum 14 on the Insomnia severity index\n\nExclusion Criteria:\n\n* Comorbidities such as Depression or any other psychological conditions that require medications\n* Currently on prescription medication for insomnia\n* Serious medical conditions such as uncontrolled hypertension, uncontrolled diabetes, or any other acute condition that disturbs sleep and requires waking up in the middle of the night\n* Participants unwilling to comply with the protocol\n* Anyone who is in litigation or receiving disability, workers' compensation benefits"}, 'identificationModule': {'nctId': 'NCT00606658', 'briefTitle': 'Usefulness of Shirodhara for Insomnia', 'organization': {'class': 'OTHER', 'fullName': 'Southern California University of Health Sciences'}, 'officialTitle': 'Usefulness of Shirodhara (Oil Dripping Treatment in Ayurveda) for Insomnia - A Case Series', 'orgStudyIdInfo': {'id': 'SCU-07-VINJ002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Oil dripping therapy', 'description': 'Single Arm', 'interventionNames': ['Procedure: Shirodhara Oil Treatment']}], 'interventions': [{'name': 'Shirodhara Oil Treatment', 'type': 'PROCEDURE', 'description': 'Oil dripping on the forehead in a constant stream for about 40 minutes for five consecutive days.', 'armGroupLabels': ['Oil dripping therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90604', 'city': 'Whittier', 'state': 'California', 'country': 'United States', 'facility': 'Southern California University of Health Sciences', 'geoPoint': {'lat': 33.97918, 'lon': -118.03284}}], 'overallOfficials': [{'name': 'Sivarama P Vinjamury, MAOM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Southern California University of Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southern California University of Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Sivarama Vinjamury', 'investigatorAffiliation': 'Southern California University of Health Sciences'}}}}