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Placebo Effects on Blood Pressure Induced by Expectancy Manipulation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00937196
First Posted: July 10, 2009
Last Update Posted: August 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Karin Meissner, Ludwig-Maximilians - University of Munich
  Purpose
The objective of the present study was to examine the effects of a single placebo intervention on blood pressure and to investigate autonomic and psychological mediating mechanisms.

Condition Intervention
Blood Pressure Drug: Placebo globuli Drug: Histaminum hydrochloricum globuli

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Effects of Placebos and Verbal Suggestions on Blood Pressure - Randomized Controlled Trial

Further study details as provided by Karin Meissner, Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:
  • Blood pressure (systolic, diastolic) [ Time Frame: minutes 1 to 30 after intervention ]

Enrollment: 45
Study Start Date: August 2006
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Histaminum hydrochloricum globuli
To allow double-blind administration of the placebo pills going along with verbal suggestions of a blood-pressure-lowering effect
Drug: Histaminum hydrochloricum globuli
Experimental: Placebo globuli Drug: Placebo globuli
placebo globuli administered together with verbal suggestions of a hypotensive drug effect
No Intervention: No treatment

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • informed consent

Exclusion Criteria:

  • not meeting inclusion criteria
  • hypotension or hypertension
  • treated or untreated hypertension or hypotension
  • Severe systemic disorders (tumors, tbc, diabetes, asthma etc)
  • diseases that influence the cardiovascular or gastrointestinal system
  • intake of drugs affecting blood pressure and/or autonomic nervous system
  • pregnancy and lactation phase
  • body mass index >= 32
  • cardiovascular risk factors (diabetes, smoking)
  • drug or alcohol abuse
  • insufficient compliance
  • participation in another trial within the last three months
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00937196


Locations
Germany
Institute of Medical Psychology, Ludwig-Maximilians-University Munich
Munich, Germany, 80336
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Investigators
Principal Investigator: Karin Meissner, MD Ludwig-Maximilians - University of Munich
  More Information

Additional Information:
Responsible Party: Karin Meissner, PD Dr. med., Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT00937196     History of Changes
Other Study ID Numbers: KM-DZ-06
First Submitted: July 9, 2009
First Posted: July 10, 2009
Last Update Posted: August 13, 2013
Last Verified: August 2013