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Acupuncture for Seasonal Allergic Rhinitis (ACUSAR) - A Randomised Controlled Trial

This study is currently Recruiting

January 2009 By Charite University, Berlin, Germany

First Recieved on January 28, 2008

Last Updated on January 30, 2009

Sponsor: Charite University, Berlin, Germany
Collaborators: German Research Foundation
Information provided by: Charite University, Berlin, Germany
Identifier: NCT00610584

Purpose

Acupuncture is widely use by patients with seasonal allergic rhinitis (SAR), although there is only limited evidence of its effectiveness. The aim of this three armed randomised controlled multicentre trial is to investigate the efficacy of acupuncture plus rescue medication vs. minimal (sham) acupuncture plus rescue medication vs. (b) rescue medication alone in the treatment of seasonal allergic rhinitis.

Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Eligibility

Ages Eligible for Study:16 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 - Postive 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 - Allergric asthma and/or moderate to severe atopic dermatitis - Active tuberculosis - Autoimmune 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

Investigators

  • Investigator: Stefan N Willich, MD, MBA - Principal Investigator - Epidemiology, and Health Economics, Charit? University Medical Center, 10098 Berlin, Germany

Locations

  • Charit? - Institute for Social Medicine

    Berlin, 10098 Germany

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