Blood PressureNCT00937196
Placebo Effects on Blood Pressure Induced by Expectancy Manipulation
A study testing Histaminum hydrochloricum globuli in people with Blood Pressure, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Histaminum hydrochloricum globuli
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2006to Mar 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- informed consent
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute of Medical Psychology, Ludwig-Maximilians-University Munich
Munich, 80336
About this study
Official title: Effects of Placebos and Verbal Suggestions on Blood Pressure - Randomized Controlled Trial
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.
- Conditions
- Blood Pressure
- Being tested
- Placebo globuli, Histaminum hydrochloricum globuli
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo globuliDrug
placebo globuli administered together with verbal suggestions of a hypotensive drug effect
Histaminum hydrochloricum globuliDrug
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Histaminum hydrochloricum globuli |
| Placebo globuli | Experimental | Not described Receives: Drug: Placebo globuli |
| No treatment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure (systolic, diastolic)
Measured: minutes 1 to 30 after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2009 (estimated)
- Study startAug 2006
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karin Meissner, Ludwig-Maximilians - University of Munich
- Investigators
- Karin Meissner, MD, Principal investigator, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00937196
- Sponsor's protocol ID
- KM-DZ-06
- Status last verified
- Aug 2013
- First submitted
- 9 Jul 2009
- Last updated
- 13 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Placebos and Verbal Suggestions on Blood Pressure - Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00937196
- Acronym / sponsor ID
- KM-DZ-06
- Conditions
- Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 10 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Histaminum hydrochloricum globuli | Active comparator | Drug: Histaminum hydrochloricum globuliTo allow double-blind administration of the placebo pills going along with verbal suggestions of a blood-pressure-lowering effect |
| Placebo globuli | Experimental | Drug: Placebo globuli |
| No treatment | No intervention | – |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- informed consent
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo globuliplacebo globuli administered together with verbal suggestions of a hypotensive drug effect | Drug | Placebo globuli |
| Histaminum hydrochloricum globuli | Drug | Histaminum hydrochloricum globuli |
Primary outcome
Blood pressure (systolic, diastolic)
Time frame: minutes 1 to 30 after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2013.
- Meissner's homepageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karin Meissner, MD principal investigator
Ludwig-Maximilians - University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Histaminum hydrochloricum globuli in people with Blood Pressure, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (systolic, diastolic) (time frame: minutes 1 to 30 after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2013.