Placebo Effects on Blood Pressure Induced by Expectancy Manipulation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Karin Meissner, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT00937196
First received: July 9, 2009
Last updated: August 9, 2013
Last verified: August 2013
  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 Blind (Subject, 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 Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:
  • Blood pressure (systolic, diastolic) [ Time Frame: minutes 1 to 30 after intervention ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

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
Study First Received: July 9, 2009
Last Updated: August 9, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on April 17, 2014