NCT00937196

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

July 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 10, 2009

Completed
Last Updated

August 13, 2013

Status Verified

August 1, 2013

Enrollment Period

7 months

First QC Date

July 9, 2009

Last Update Submit

August 9, 2013

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (1)

  • Blood pressure (systolic, diastolic)

    minutes 1 to 30 after intervention

Study Arms (3)

Histaminum hydrochloricum globuli

ACTIVE COMPARATOR

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

Drug: Histaminum hydrochloricum globuli

Placebo globuli

EXPERIMENTAL
Drug: Placebo globuli

No treatment

NO INTERVENTION

Interventions

Placebo globuliDRUG

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

Placebo globuli
Histaminum hydrochloricum globuliDRUG
Histaminum hydrochloricum globuli

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Medical Psychology, Ludwig-Maximilians-University Munich

Munich, 80336, Germany

Location

Related Links

Study Officials

  • Karin Meissner, MD

    Ludwig-Maximilians - University of Munich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. med.

Study Record Dates

First Submitted

July 9, 2009

First Posted

July 10, 2009

Study Start

August 1, 2006

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

August 13, 2013

Record last verified: 2013-08

Locations

DE(1)