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NCT00937196 Clinical Trial

Placebo Effects on Blood Pressure Induced by Expectancy Manipulation

Blood Pressure Clinical Trial

Official title:
Effects of Placebos and Verbal Suggestions on Blood Pressure - Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00937196
Other study ID # KM-DZ-06
Secondary ID
Status Completed
Phase N/A
First received July 9, 2009
Last updated August 9, 2013
Start date August 2006
Est. completion date March 2007

Study information
Verified date August 2013
Source Ludwig-Maximilians - University of Munich
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 45
Est. completion date March 2007
Est. primary completion date March 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 35 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• Placebo globuli
placebo globuli administered together with verbal suggestions of a hypotensive drug effect
• Histaminum hydrochloricum globuli

Locations
Country Name City State
Germany Institute of Medical Psychology, Ludwig-Maximilians-University Munich Munich

Sponsors (1)
Lead Sponsor Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Blood pressure (systolic, diastolic) minutes 1 to 30 after intervention No
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