Ignite Creation Date:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2026-03-03 @ 2:48 AM
Study NCT ID:
NCT02515006
Status:
COMPLETED
Last Update Posted:
2015-08-04
First Post:
2015-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Homeopathy for Persistent Insomnia in Patients With Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D009369', 'term': 'Neoplasms'}], '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-02', 'studyFirstSubmitDate': '2015-07-30', 'studyFirstSubmitQcDate': '2015-08-02', 'lastUpdatePostDateStruct': {'date': '2015-08-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in sleep efficiency on the Insomnia Severity Index', 'timeFrame': 'From baseline to 6 Months'}], 'secondaryOutcomes': [{'measure': 'Change in Anxiety and Depression on Hospital Anxiety Depression Scale', 'timeFrame': 'From Baseline to 6 Months'}, {'measure': 'Change in Quality of Life on Short Form-36 Scale', 'timeFrame': 'From Baseline to 6 Months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Chronic Insomnia', 'Cancer']}, 'descriptionModule': {'briefSummary': 'Persistent insomnia is highly prevalent complaint in cancer survivors, but is seldom satisfactorily addressed. The adaptation to cancer care of a validated, cost-effective intervention may offer a practicable solution. The aim of this study was to investigate the clinical effectiveness of homeopathy for insomnia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* scheduled to begin chemotherapy or radiotherapy\n* chemotherapy or radiotherapy\n* meet diagnostic criteria for chronic insomnia (i.e., lasting for at least one month)\n* Chronic insomnia has been defined in previous research:as the presence of (1) three or more episodes of insomnia (i.e., ≥ 30minuteSOL, ≥ 60minute wake after sleep onset (WASO), or ≤ 6.5 hour total sleep time (TST) per night) of per week and (2) daytime effects of insomnia, such as irritability, difficulty concentrating, or fatigue for at least one month.\n* have the permission of their oncologists to participate.\n\nExclusion Criteria:\n\n* untreated alcohol or substance abuse or dependence,\n* bipolar, or psychotic disordermedical conditions such as seizure disorder, restless leg disorder, or Parkinson's disease\n* untreated sleep disorders such as sleep apnea\n* Taking other alternative medicines"}, 'identificationModule': {'nctId': 'NCT02515006', 'briefTitle': 'Impact of Homeopathy for Persistent Insomnia in Patients With Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Adwin Life Care'}, 'officialTitle': 'Randomized Controlled Trial of Homeopathy Compared With Treatment As Usual for Persistent Insomnia in Patients With Cancer', 'orgStudyIdInfo': {'id': 'Adwin/chr/1121'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Homeopathy', 'description': 'Individualized homeopathy treatment as a supportive care', 'interventionNames': ['Other: Homeopathy Medicine']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Usual Care'}], 'interventions': [{'name': 'Homeopathy Medicine', 'type': 'OTHER', 'description': "Homeopathy, or homeopathic medicine, is a holistic system of treatment. Individualized homeopathy remedy was based on the most characteristic and clear mental symptoms. Secondly, general symptoms were taken into account.C-potencies were provided and manufactured according to the Homeopathic Pharmacopoeia and Hahnemann's methodology. Each individualized homeopathic remedy were be prescribed in C-potencies", 'armGroupLabels': ['Homeopathy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ahmedabad', 'state': 'Gujarat', 'country': 'India', 'facility': 'Center for Homeopathy Research', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'zip': '302019', 'city': 'Jaipur', 'state': 'Rajasthan', 'country': 'India', 'facility': 'Center for Homeopathy Research', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}], 'overallOfficials': [{'name': 'Tejendra H Patel, BBA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Center for Homeopathy Research'}, {'name': 'Neha Sharma, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NMP Medical Research Institute'}, {'name': 'Govind Sharma, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Adwin Life Care'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adwin Life Care', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Center For Homeopathy Research, India', 'class': 'UNKNOWN'}, {'name': 'Sonal Foundation, India', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}