Placebo Effects on Blood Pressure Induced by Expectancy Manipulation

NCT ID: NCT00937196

Last Updated: 2013-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2007-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Blood Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Histaminum hydrochloricum globuli

To allow double-blind administration of the placebo pills going along with verbal suggestions of a blood-pressure-lowering effect

Group Type ACTIVE_COMPARATOR

Histaminum hydrochloricum globuli

Intervention Type DRUG

Placebo globuli

Group Type EXPERIMENTAL

Placebo globuli

Intervention Type DRUG

placebo globuli administered together with verbal suggestions of a hypotensive drug effect

No treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Placebo globuli

placebo globuli administered together with verbal suggestions of a hypotensive drug effect

Intervention Type DRUG

Histaminum hydrochloricum globuli

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* informed consent

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Karin Meissner

PD Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karin Meissner, MD

Role: PRINCIPAL_INVESTIGATOR

Ludwig-Maximilians - University of Munich

Locations

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Institute of Medical Psychology, Ludwig-Maximilians-University Munich

Munich, , Germany

Site Status

Countries

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Germany

Related Links

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Other Identifiers

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KM-DZ-06

Identifier Type: -

Identifier Source: org_study_id