Viewing Study NCT01527760


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Study NCT ID: NCT01527760
Status: COMPLETED
Last Update Posted: 2012-02-16
First Post: 2012-02-03
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Effectiveness of Viscum Album Mother Tincture as an Anti-hypertensive in Essential Hypertension
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D000075222', 'term': 'Essential Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-14', 'studyFirstSubmitDate': '2012-02-03', 'studyFirstSubmitQcDate': '2012-02-03', 'lastUpdatePostDateStruct': {'date': '2012-02-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Systolic and Diastolic blood pressure.', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in Serum Cholesterol', 'timeFrame': '12 weeks'}, {'measure': 'Change in Serum Triglycerides', 'timeFrame': '12 weeks'}, {'measure': 'Change in Serum LDH', 'timeFrame': '12 weeks'}, {'measure': 'Change in Serum Urea', 'timeFrame': '12 weeks'}, {'measure': 'change in Serum CKMB', 'timeFrame': '12 weeks and 16 weeks', 'description': 'The blood sample was collected at the end of 12 weeks of medication followed by a drug free period of 4 weeks.The blood sample was collected again at the end of 4 weeks of drug free period to ascertain serum CKMB.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Essential Hypertension', 'Viscum album mother tincture', 'one group pretest post-test study'], 'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '24647376', 'type': 'DERIVED', 'citation': 'Poruthukaren KJ, Palatty PL, Baliga MS, Suresh S. Clinical evaluation of Viscum album mother tincture as an antihypertensive: a pilot study. J Evid Based Complementary Altern Med. 2014 Jan;19(1):31-5. doi: 10.1177/2156587213507726. Epub 2013 Nov 5.'}]}, 'descriptionModule': {'briefSummary': 'To estimate the effectiveness of Viscum album Homoeopathic mother tincture in Essential Hypertension by conducting clinical trial in moderate hypertensive patients for a period of six weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hypertension at the range 180-120 mm of Hg for Systole \\&\n* 110-80 mm of Hg for Diastole\n\nExclusion Criteria:\n\n* Patients who are on ACEI / ARB for Hypertension\n* Diseases in which life expectancy is less than six months\n* Secondary hypertension\n* CHD\n* Family History of Mental Illness like Anxiety or depression.\n* Nasal Congestion'}, 'identificationModule': {'nctId': 'NCT01527760', 'briefTitle': 'Effectiveness of Viscum Album Mother Tincture as an Anti-hypertensive in Essential Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'Fr Muller Homoeopathic Medical College'}, 'officialTitle': 'Effectiveness of Viscum Album Mother Tincture as an Anti-hypertensive in Essential Hypertension. One Group Pretest Posttest Design', 'orgStudyIdInfo': {'id': 'RGUHS2010'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Viscum album ethanolic extract manufactured according to Homoeopathic pharmacopoeia of India (H.P.I.)', 'type': 'DRUG', 'description': 'Ten drops of Drug in 30 ml of distilled water with a frequency of three times a day for a duration of 12 weeks'}]}, 'contactsLocationsModule': {'locations': [{'zip': '575018', 'city': 'Mangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Fr Muller Homoeopathic Medical College Hospital', 'geoPoint': {'lat': 12.91723, 'lon': 74.85603}}], 'overallOfficials': [{'name': 'Dr Kurian P John, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fr Muller Homoeopathic Medical College'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fr Muller Homoeopathic Medical College', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rajiv Gandhi University of Health Sciences', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Dr Kurian P J', 'investigatorAffiliation': 'Fr Muller Homoeopathic Medical College'}}}}