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AUTO-ACUSAR - Effects of Acupuncture on the Autonomic Nervous System in Seasonal Allergic Rhinitis Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Charite University, Berlin, Germany.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01271595
First received: December 23, 2010
Last updated: January 6, 2011
Last verified: December 2010
  Purpose

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.


Condition Intervention
Seasonal Allergic Rhinitis
Other: sham acupuncture

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Acupuncture in Seasonal Allergic Rhinitis- Effects on the Autonomic Nervous System (AUTO-ACUSAR)- an Explorative Substudy of ACUSAR

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Heart Rate Variability [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    RMSSD, LF, HF, HR, blood pressure


Secondary Outcome Measures:
  • Salivary Amylase and Cortisol, Cortisol Awakening Response (CAR) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Measurements were taken during the experimental setting 3 times , CAR by the patients the day before first and last acupuncture


Enrollment: 60
Study Start Date: August 2009
Estimated Study Completion Date: May 2011
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: acupuncture
12 sessions of acupuncture according to TCM
Other: sham acupuncture
12 sessions of sham acupuncture over 8 weeks
Other Name: acupuncture
Sham Comparator: sham acupuncture
superficial acupuncture at non acupuncture sites
Other: sham acupuncture
12 sessions of sham acupuncture over 8 weeks
Other Name: acupuncture

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   16 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • Patients with >2 years of moderate to severe SAR
  • Positive skin-prick test and/or RAST (at least class 2) results
  • Visual analogue scale >40mm and <80 mm for SAR symptoms during the past year
  • Patients must be able to complete a diary for self-evaluation of symptoms and recording use of anti-symptomatic medication
  • Use of, or indication for, oral antihistamines as anti-allergic medication
  • Written informed consent

Exclusion Criteria:

  • Perennial SAR or other types of chronic rhinitis
  • Allergic asthma and/or moderate to severe atopic dermatitis
  • Active tuberculosis
  • Auto-immune disorders
  • Severe chronic inflammatory diseases
  • History of anaphylactic reactions
  • Hypersensitivity to Rescue medication or related drugs used in study related drugs
  • Specific immunotherapy >3 years
  • Simultaneous participation in other clinical trials
  • Serious acute or chronic organic disease or mental disorder
  • Pregnancy or breast feeding
  • Allergy desensitisation therapy (current, during the past two years, or planned in the next two years)
  • Blood coagulation disorder and/or current use of anticoagulants
  • Previous acupuncture treatment for SAR
  • Any Complementary and alternative medicine treatment at the moment, in the last three months or planned in the next two years

    • intake of Beta-Blocker Medication
    • use of pacemaker
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01271595

Locations
Germany
Institute for Socialmedicine, Epidemiology and Health Economics, Charité University Medical Center
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Benno Brinkhaus, Prof. Dr. Institute for Socialmedicine, Epidemiology and Health Economics, Charité University Medical Center
  More Information

No publications provided

Responsible Party: Dr. Miriam Ortiz, Institute for Socialmedicine, Epidemiology an Health Economics Charité University Medical Center
ClinicalTrials.gov Identifier: NCT01271595     History of Changes
Other Study ID Numbers: EA1/214/07a
Study First Received: December 23, 2010
Last Updated: January 6, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
acupuncture
autonomic nervous system
seasonal allergic rhinitis

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Rhinitis, Allergic, Seasonal
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on November 25, 2014