Ignite Creation Date:
2025-12-24 @ 12:03 PM
Ignite Modification Date:
2025-12-27 @ 9:42 PM
Study NCT ID:
NCT01426061
Status:
COMPLETED
Last Update Posted:
2011-08-30
First Post:
2011-08-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Effect of Reflexology and Homeopathy Added to Conventional Asthma Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D006705', 'term': 'Homeopathy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-29', 'studyFirstSubmitDate': '2011-08-18', 'studyFirstSubmitQcDate': '2011-08-29', 'lastUpdatePostDateStruct': {'date': '2011-08-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change in the Asthma Quality of Life Questionnaire(AQLQ)', 'timeFrame': 'Assesment of quality of life was perfomed at baseline, at week 26 and at week 52.', 'description': 'AQLQ is self-administered questionnaire which consists of 32 questions in 4 domains (symptoms, activity limitation, emotional function and environmental stimuli). Patients responded to each question on a seven point scale (7=no impairment 1=maximal impairment) and recalled their experiences during the previous 2 weeks. The overall AQLQ score was the mean of all 32 questions. A change in score of ≥0.5 indicates the minimal important difference (MID) in AQLQ.'}], 'secondaryOutcomes': [{'measure': 'Asthma control questionnaire (ACQ)', 'timeFrame': 'At baseline, week 26 and week 52'}, {'measure': 'EuroQol(EQ-5D)', 'timeFrame': 'At baseline, week 26 and week 52'}, {'measure': 'Forced expiratory volume in 1 second', 'timeFrame': 'At baseline, week 26 and week 52'}, {'measure': 'Asthma symptoms', 'timeFrame': 'Two weeks prior to week 2, 26 and 52.', 'description': 'Daytime and nighttime symptoms were recorded in patients diaries.'}, {'measure': 'Peak expiratory flow', 'timeFrame': 'Two weeks prior to week 2, 26 and 52.', 'description': 'Morning and evening Peak expiratory flow(PEF) were performed before inhalation medication'}, {'measure': 'Rescue medication usage', 'timeFrame': 'To weeks prior to week 2, 26 and 52'}, {'measure': 'Total medication score', 'timeFrame': 'At baseline, at week 26 and week 52.', 'description': 'Total medication score was created by combaning a score given to each prescribed controller and reliever medication.'}, {'measure': 'Blood eosinophils count', 'timeFrame': 'At baseline, at week 26 and week 52'}, {'measure': 'Exhaled nitric oxide', 'timeFrame': 'At baseline, at week 26 and week 52'}, {'measure': 'Serum eosinophil cationic protein', 'timeFrame': 'At baseline, at week 26 and week 52'}, {'measure': 'PD20', 'timeFrame': 'At baseline, at week 26 and week 52', 'description': 'The provocotive dose of Methacholine causing a 20% fall in FEV1'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Complementary and alternative medicine', 'Reflexology', 'Homeopathy', 'Asthma', 'Randomized controlled trial'], 'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '14500861', 'type': 'BACKGROUND', 'citation': 'Ng TP, Wong ML, Hong CY, Koh KT, Goh LG. The use of complementary and alternative medicine by asthma patients. QJM. 2003 Oct;96(10):747-54. doi: 10.1093/qjmed/hcg121.'}, {'pmid': '12614092', 'type': 'BACKGROUND', 'citation': 'Jonas WB, Kaptchuk TJ, Linde K. A critical overview of homeopathy. Ann Intern Med. 2003 Mar 4;138(5):393-9. doi: 10.7326/0003-4819-138-5-200303040-00009.'}, {'pmid': '14973954', 'type': 'BACKGROUND', 'citation': 'McCarney RW, Linde K, Lasserson TJ. Homeopathy for chronic asthma. Cochrane Database Syst Rev. 2004;2004(1):CD000353. doi: 10.1002/14651858.CD000353.pub2.'}, {'pmid': '19740047', 'type': 'BACKGROUND', 'citation': 'Ernst E. Is reflexology an effective intervention? A systematic review of randomised controlled trials. Med J Aust. 2009 Sep 7;191(5):263-6. doi: 10.5694/j.1326-5377.2009.tb02780.x.'}, {'pmid': '11266233', 'type': 'BACKGROUND', 'citation': 'Brygge T, Heinig JH, Collins P, Ronborg S, Gehrchen PM, Hilden J, Heegaard S, Poulsen LK. Reflexology and bronchial asthma. Respir Med. 2001 Mar;95(3):173-9. doi: 10.1053/rmed.2000.0975.'}, {'pmid': '11872551', 'type': 'BACKGROUND', 'citation': 'Lewith GT, Watkins AD, Hyland ME, Shaw S, Broomfield JA, Dolan G, Holgate ST. Use of ultramolecular potencies of allergen to treat asthmatic people allergic to house dust mite: double blind randomised controlled clinical trial. BMJ. 2002 Mar 2;324(7336):520. doi: 10.1136/bmj.324.7336.520.'}, {'pmid': '12668794', 'type': 'BACKGROUND', 'citation': 'White A, Slade P, Hunt C, Hart A, Ernst E. Individualised homeopathy as an adjunct in the treatment of childhood asthma: a randomised placebo controlled trial. Thorax. 2003 Apr;58(4):317-21. doi: 10.1136/thorax.58.4.317.'}]}, 'descriptionModule': {'briefSummary': 'There is a lack of scientific evidence that homeopathy and reflexology is effective treatment of asthma. Systematic reviews have found that many clinical trials testing homeopathy and reflexology have major flaws, such as small number of participants, lack of control groups or inadequate allocation concealment.\n\nThe aim of the present study was to assess the effect of reflexology and individualised homeopathy as an adjuvant treatment in asthma. In order to address this issue, the investigators conducted an investigator-blinded, randomized, controlled parallel group study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Forced expiratory volume in 1 second (FEV1) ≥60% predicted\n* A history of bronchial asthma for minimum 6 months prior to baseline\n* An objective measure of abnormal variation in bronchial calibre(The objective measure were defined as at least one of the following)\n\n 1. a positive bronchodilator reversibility test, defined as increase in FEV1≥10% after 400 µg inhaled salbutamol;\n 2. a positive methacholine test, defined as a PD20 of \\<1000 μg;\n 3. a positive test for exercise induced asthma defined as a fall in FEV1\\>15% after a standardised 6 min exercise test; and\n 4. a positive peak expiratory flow (PEF) variability , defined by ≥3 days or 2 consecutive days with a differences between morning and evening PEF of \\>20% during a 2-week period.\n\nExclusion Criteria:\n\n* Hospitalization for asthma within 3 months,\n* Asthma exacerbation during the last month,\n* Changes in asthma medication within 30 days of screening\n* A smoking history \\> 10 pack-years and smoking within the last year.'}, 'identificationModule': {'nctId': 'NCT01426061', 'briefTitle': 'Clinical Effect of Reflexology and Homeopathy Added to Conventional Asthma Management', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Effect of Reflexology, Homeopathy and Conventional Medical Treatment in Asthma: A Randomised Controlled, Parallel Group Trial.', 'orgStudyIdInfo': {'id': '20040206'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Reflexology plus conventional treatment', 'interventionNames': ['Other: Reflexology plus conventional treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Homeopathy plus conventional treatment', 'interventionNames': ['Other: Homeopathy plus conventional treatment']}, {'type': 'NO_INTERVENTION', 'label': 'Conventional treatment', 'interventionNames': ['Other: Conventional treatment']}], 'interventions': [{'name': 'Reflexology plus conventional treatment', 'type': 'OTHER', 'description': 'Patients in the reflexology group received reflexology treatment in addition to usual care of asthma.Patients received treatments weekly for four to six weeks, followed by two treatments for one month. Treatments were then given monthly until the end of the study.', 'armGroupLabels': ['Reflexology plus conventional treatment']}, {'name': 'Homeopathy plus conventional treatment', 'type': 'OTHER', 'description': 'Patients in the homeopathy group received homeopathic treatment in addition to usual care of asthma.Homeopathic treatment was decided on an individual basis by the homeopath and prescribed as an oral treatment. Patients received homeopathic product with potency between C30 (dilution by a factor 10030 =1060) and M10 (dilution by a factor 100010 =1030). The number of homeopathy sessions attended was six to twelve during one year.', 'armGroupLabels': ['Homeopathy plus conventional treatment']}, {'name': 'Conventional treatment', 'type': 'OTHER', 'description': "Patients in the conventional treatment group received usual care of asthma. This treatment was monitored and adjusted as usual by the patient's general practitioner.", 'armGroupLabels': ['Conventional treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Department of Respiratory Diseases, University Hospital of Aarhus', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Ronald Dahl, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Respiratory Diseases, University Hospital of Aarhus, DK-8000 Aarhus C'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'GCP-unit at Aarhus University Hospital, Aarhus, Denmark', 'class': 'OTHER'}, {'name': 'Danish Classical Homeopathy Society', 'class': 'UNKNOWN'}, {'name': 'Danish Reflexologist Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Ayfer Topcu', 'investigatorAffiliation': 'University of Aarhus'}}}}