Ignite Creation Date:
2025-12-24 @ 1:53 PM
Ignite Modification Date:
2025-12-27 @ 9:28 PM
Study NCT ID:
NCT01271595
Status:
COMPLETED
Last Update Posted:
2018-11-20
First Post:
2010-12-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AUTO-ACUSAR - Effects of Acupuncture on the Autonomic Nervous System in Seasonal Allergic Rhinitis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006255', 'term': 'Rhinitis, Allergic, Seasonal'}], 'ancestors': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-19', 'studyFirstSubmitDate': '2010-12-23', 'studyFirstSubmitQcDate': '2011-01-06', 'lastUpdatePostDateStruct': {'date': '2018-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart Rate Variability', 'timeFrame': '8 weeks', 'description': 'RMSSD, LF, HF, HR, blood pressure'}], 'secondaryOutcomes': [{'measure': 'Salivary Amylase and Cortisol, Cortisol Awakening Response (CAR)', 'timeFrame': '8 weeks', 'description': 'Measurements were taken during the experimental setting 3 times , CAR by the patients the day before first and last acupuncture'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['acupuncture', 'autonomic nervous system', 'seasonal allergic rhinitis'], 'conditions': ['Seasonal Allergic Rhinitis']}, 'descriptionModule': {'briefSummary': 'There is inconclusive evidence whether acupuncture treatment is effective in the treatment of seasonal allergic rhinitis (SAR). Furthermore, the underlying mechanisms of acupuncture in SAR are only poorly understood. It was hypothesised that the therapeutic mechanism of acupuncture is related to changes in autonomic function. AUTO-ACUSAR is a sub-study of the DFG-funded three-arm randomized controlled trial ACUSAR trial investigating the efficacy of acupuncture vs. sham acupuncture vs. rescue medication in SAR. The aim of AUTO-ACUSAR was to investigate short and long-term effects of acupuncture vs. sham acupuncture on autonomic function in a sub-group of ACUSAR patients. Baseline values were compared to data from matched healthy controls.', 'detailedDescription': 'In AUTO-ACUSAR a subsample of ACUSAR patients from acupuncture or sham acupuncture groups were included. Tests of autonomic functions included measurement of heart rate variability during paced breathing, blood pressure, heart rate and salivary alpha amylase response to a cold pressure test (CPT) and cortisol awakening response before the first and the last of twelve treatment sessions. Healthy matched controls underwent the same measurement once only'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female or male patients (aged 16-45 years) with seasonal allergic rhinitis, clinically positive and test positive (skin-prick test and/or RAST) to grass and birch pollen\n* Patients with \\>2 years of moderate to severe SAR\n* Positive skin-prick test and/or RAST (at least class 2) results\n* Visual analogue scale \\>40mm and \\<80 mm for SAR symptoms during the past year\n* Patients must be able to complete a diary for self-evaluation of symptoms and recording use of anti-symptomatic medication\n* Use of, or indication for, oral antihistamines as anti-allergic medication\n* Written informed consent\n\nExclusion Criteria:\n\n* Perennial SAR or other types of chronic rhinitis\n* Allergic asthma and/or moderate to severe atopic dermatitis\n* Active tuberculosis\n* Auto-immune disorders\n* Severe chronic inflammatory diseases\n* History of anaphylactic reactions\n* Hypersensitivity to Rescue medication or related drugs used in study related drugs\n* Specific immunotherapy \\>3 years\n* Simultaneous participation in other clinical trials\n* Serious acute or chronic organic disease or mental disorder\n* Pregnancy or breast feeding\n* Allergy desensitisation therapy (current, during the past two years, or planned in the next two years)\n* Blood coagulation disorder and/or current use of anticoagulants\n* Previous acupuncture treatment for SAR\n* Any Complementary and alternative medicine treatment at the moment, in the last three months or planned in the next two years\n\n * intake of Beta-Blocker Medication\n * use of pacemaker'}, 'identificationModule': {'nctId': 'NCT01271595', 'acronym': 'AUTO-ACUSAR', 'briefTitle': 'AUTO-ACUSAR - Effects of Acupuncture on the Autonomic Nervous System in Seasonal Allergic Rhinitis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Acupuncture in Seasonal Allergic Rhinitis- Effects on the Autonomic Nervous System (AUTO-ACUSAR)- an Explorative Substudy of ACUSAR', 'orgStudyIdInfo': {'id': 'EA1/214/07a'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'acupuncture', 'description': '12 sessions of acupuncture according to TCM', 'interventionNames': ['Other: sham acupuncture']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham acupuncture', 'description': 'superficial acupuncture at non acupuncture sites', 'interventionNames': ['Other: sham acupuncture']}], 'interventions': [{'name': 'sham acupuncture', 'type': 'OTHER', 'otherNames': ['acupuncture'], 'description': '12 sessions of sham acupuncture over 8 weeks', 'armGroupLabels': ['acupuncture', 'sham acupuncture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Institute for Socialmedicine, Epidemiology and Health Economics, Charité University Medical Center', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Benno Brinkhaus, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute for Socialmedicine, Epidemiology and Health Economics, Charité University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. Benno Brinkhaus', 'investigatorFullName': 'Benno Brinkhaus', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}