Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00012303

Trial Description

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Title

Open label placebos in allergic rhinitis: a pilot randomized controlled trial

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Trial Acronym

OPALL

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URL of the Trial

http://n.a.

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Brief Summary in Lay Language

This study investigates the impact of placebos on allergic rhinitis. Placebo effects in allergic rhinitis are well-known. In the traditional view placebos require deception. But recent research has demonstrated that placebos may work even without concealment. This study aims to examine the effect of placebos without deception in patients with allergic rhinitis.

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Brief Summary in Scientific Language

It is well-known that placebos have an impact on allergic rhinitis. Recent research demonstrated that even placebos without deception may have an effect, for example in patients with chronic lower back pain. The current study aims to examine if there is an an analogue effect for patients with allergic rhinitis. Furthermore, the study wants to investigate the conditions of this effect, for example conditioning or expectancy effects.

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Organizational Data

  •   DRKS00012303
  •   2017/04/24
  •   [---]*
  •   yes
  •   Approved
  •   MS052016, Ethikkommission der Deutschen Gesellschaft für Psychologie
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Allergic rhinitis
  •   J30 -  Vasomotor and allergic rhinitis
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Interventions/Observational Groups

  •   Group 1: Patients will be informed that although placebos contain no medication, placebo effects may still be powerful. For example, the body may automatically respond to taking placebo pills, like Pavlov's dogs that salivated when they heard the bell. These information are given in order to enhance expectancy effects.
    Patients in group 1 receive placebos without deception (pill, p.o.), for 2 weeks, 2 per day.
    Patients of all groups will be asked to maintain their regular medication. Patient-experimenter interaction shall be similar for all groups.
  •   Group 2: Patients will be informed that although placebos contain no medication, placebo effects may still be powerful. For example, the body may automatically respond to taking placebo pills, like Pavlov's dogs that salivated when they heard the bell. These information are given in order to enhance expectancy effects.
    Patients in group 2 will then be told to be in the control group that receives no placebos.
  •   Group 3: Patients will only be informed that placebos contain no medication.
    Patients in group 3 receive placebos without deception (pill, p.o.), for 2 weeks, 2 per day.
  •   Group 4: Patients will only be informed that placebos contain no medication.
    Patients in group 4 will then be told to be in the control group that receives no placebos.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   data analyst
  •   Active control (effective treament of control group)
  •   Basic research/physiological study
  •   Factorial
  •   N/A
  •   N/A
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Primary Outcome

allergic symptoms, self-developed questionnaire (after 2 weeks)

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Secondary Outcome

Quality of life, SF-36 (after 2 weeks)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2016/05/13
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   60   Years
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Additional Inclusion Criteria

allergic rhinitis diagnosed by a physician, taking drugs against allergic rhinitis

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Exclusion Criteria

diabetes, pregnancy, psychiatric or neurological diseases

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Medical School Berlin
    • Mr.  Prof. Dr.  Michael  Schaefer 
    • Calandrellistr.1-9
    • 12247  Berlin
    • Germany
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    • Medical School Berlin
    • Mr.  Prof. Dr.  Michael  Schaefer 
    • Calandrellistr. 1-9
    • 12247  Berlin
    • Germany
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    end of 1:1-Block address contact scientific-contact
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    • Medical School Berlin
    • Mr.  Prof. Dr.  Michael  Schaefer 
    • Calandrelistr. 1-9
    • 12247  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Medical School Berlin
    • Mr.  Prof. Dr.  Michael  Schaefer 
    • Calandrellistr. 1-9
    • 12247  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/07/01
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Trial Publications, Results and other Documents

  • [---]*
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* This entry means the parameter is not applicable or has not been set.