search
Back to results

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

Primary Purpose

Seasonal Allergic Rhinitis

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
sham acupuncture
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Seasonal Allergic Rhinitis focused on measuring acupuncture, autonomic nervous system, seasonal allergic rhinitis

Eligibility Criteria

16 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute for Socialmedicine, Epidemiology and Health Economics, Charité University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

acupuncture

sham acupuncture

Arm Description

12 sessions of acupuncture according to TCM

superficial acupuncture at non acupuncture sites

Outcomes

Primary Outcome Measures

Heart Rate Variability
RMSSD, LF, HF, HR, blood pressure

Secondary Outcome Measures

Salivary Amylase and Cortisol, Cortisol Awakening Response (CAR)
Measurements were taken during the experimental setting 3 times , CAR by the patients the day before first and last acupuncture

Full Information

First Posted
December 23, 2010
Last Updated
November 19, 2018
Sponsor
Charite University, Berlin, Germany
search

1. Study Identification

Unique Protocol Identification Number
NCT01271595
Brief Title
AUTO-ACUSAR - Effects of Acupuncture on the Autonomic Nervous System in Seasonal Allergic Rhinitis Patients
Acronym
AUTO-ACUSAR
Official Title
Acupuncture in Seasonal Allergic Rhinitis- Effects on the Autonomic Nervous System (AUTO-ACUSAR)- an Explorative Substudy of ACUSAR
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis
Keywords
acupuncture, autonomic nervous system, seasonal allergic rhinitis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
acupuncture
Arm Type
Active Comparator
Arm Description
12 sessions of acupuncture according to TCM
Arm Title
sham acupuncture
Arm Type
Sham Comparator
Arm Description
superficial acupuncture at non acupuncture sites
Intervention Type
Other
Intervention Name(s)
sham acupuncture
Other Intervention Name(s)
acupuncture
Intervention Description
12 sessions of sham acupuncture over 8 weeks
Primary Outcome Measure Information:
Title
Heart Rate Variability
Description
RMSSD, LF, HF, HR, blood pressure
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Salivary Amylase and Cortisol, Cortisol Awakening Response (CAR)
Description
Measurements were taken during the experimental setting 3 times , CAR by the patients the day before first and last acupuncture
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benno Brinkhaus, Prof. Dr.
Organizational Affiliation
Institute for Socialmedicine, Epidemiology and Health Economics, Charité University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Socialmedicine, Epidemiology and Health Economics, Charité University Medical Center
City
Berlin
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs