Cerebral Circulatory DisorderPhase 2CCPANCT05543837
Capsaicin for Cerebral Perfusion Augmentation
A Phase 2 study testing Capsaicin in people with Cerebral Circulatory Disorder, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
Trial summary
To determine the effect of capsaicin upon serial transcranial Doppler (TCD) markers of cerebral blood flow (CBF). Methods Serial TCD testing in 30 participants with cerebrovascular risk factors. Capsaicin doses .66 and .99 μMol. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Circulatory Disorder
- What is being tested?
- Capsaicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteMexico
- Study dates
- 20 Sep 2022to 28 Feb 2023
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent Form
- Previous diagnosis and stable condition of one of the following:
- Diabetes Mellitus Hypertension Dyslipidemia Chronic Obstructive Pulmonary Disease
Who cannot join
- History of alergy or hypersensibility to dietary capsaicin
- Previous diagnosis of stroke
- Chronic use of cholinergic/anticholinergic drugs
- Chronic use of sympathomimetic drugs
- Chronic use of serotonergic drugs
- Chronic use of dopaminergic drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Capsaicin on the Augmentation of Cerebral Perfusion. A Phase II Study.
To determine the effect of capsaicin upon serial transcranial Doppler (TCD) markers of cerebral blood flow (CBF). Methods Serial TCD testing in 30 participants with cerebrovascular risk factors. Capsaicin doses .66 and .99 μMol. Outcomes: peak systolic and end-diastolic velocities in the middle cerebral artery (MCA), mean velocity (MV), pulsatility index (PI), CBF index, arterial pressure, and perceived pungency (PP) in five minutes intervals up to 20 minutes.
Read the detailed description
Subjects The study is expected to enroll 30 participants who will be recruited from the Internal Medicine outpatient clinic. Those willing to participate will be asked to sign the informed consent form (ICF) and will received the assigned dose of capsaicin. Half of the participants in each dose group will receive stimulation on either left or right side of the palate, but TCD measurements will be bilateral. Chemical stimuli From an initial 0.1% capsaicin (Sigma-Aldrich, St. Louis, MO) stock solution in 95% ethanol; solutions with 66 and 99 μMol/ml solutions will be obtained by diluting the stock solution with distilled water. One milliliter of each dilution was pipetted on to 2 cm filter paper squares. Then, the filter papers will be let dry. Immediately before application, filter papers will be rehydrated with 1 milliliter of distilled water. The rehydrated filter paper will be applied and will remain stationary on the subject's hemi palate's posterior surface during TCD measurements. Participants will be instructed not to swallow and to avoid touching the paper filter with their tongue for the 20 minutes of the experiment.
TCD testing With a TCD device (Philips Sonos 7500®) will include: peak systolic velocity (PSV) and end-diastolic velocity (EDV) in the middle cerebral artery (MCA) through the temporal window of the stimulated side. After a basal recording post stimulation recordings will initiate immediately after stimulation, and will be followed by serial recordings every five minutes and up to 20 minutes. At each time point the systolic pressure (SP), diastolic pressure (DP), and perceived pungency (PP) on a visual analog scale will be recorded. TCD markers of cerebral blood flow From the initial measurements the Mean velocity (MV) = EDV + [(PSVEDV) / 3], pulsatility index (PI) = PSV - EDV / MV, mean arterial pressure (MAP) = ((2 * DP) + SP) / 3 and, the CBF index (CBFi), CBFi = (MAP * 10) / 1.47^PI, will be calculated.
Statistical analysis Shapiro Wilkins W-Test for normality. The results of the continuous variables will be described as median (max-min) or mean+/- SD according to distribuition. The categorical variables will be described as tables of absolute and relative frequencies, and the comparisons between the groups of subjects (according to the dose of capsaicin) will be carried out with chi-square tests. To compare the variables studied between the groups of subjects (according to the different doses of capsaicin), Mann-Whitney U-Test/independent samples Student´s T-Test will be used appropriately. For comparisons of the baseline state with the changes recorded over time, various Wilcoxon signed-rank tests will be performed.The relationship between pungency ratings and MV response will be evaluated by Spearman's rho test. The level of statistical significance will be set at 0.05.
- Conditions
- Cerebral Circulatory Disorder
- Being tested
- Capsaicin
- Keywords
- capsaicin, cerebal perfusion
- Medical subject headings
- Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapsaicinDrug
Also called 8-Methyl-N-vanillyl-trans-6-nonenamide
Patients will receive a fixed dose of capsaicin
| Study group | Role | What they receive |
|---|---|---|
| Capsaicin .66μMol/ml | Experimental | Group receiving .66μMol/ml Receives: Drug: Capsaicin |
| Capsaicin .99μMol/ml | Experimental | Group receiving .99μMol/ml Receives: Drug: Capsaicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean velocity
The Mean velocity in the Middle Cerebral Artery
Measured: 20 minutes
Pulsatility Index
A calculated flow parameter in ultrasound, derived from the maximum, minimum, and mean Doppler frequency shifts during a defined cardiac cycle.
Measured: 20 minutes
Secondary outcomes (2)
Mean arterial pressure (MAP)
The average arterial pressure throughout one cardiac cycle, systole, and diastole.
Measured: 20 minutes
Cerebral Blood Flow index
The result of the following formula: CBFi = (MAP * 10) / 1.47^Pulsatility Index.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start20 Sep 2022
- Primary completion30 Sep 2022
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Circulatory DisorderStudies 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 2
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Collaborators
- Centenario Hospital Miguel Hidalgo
- Responsible party
- Principal investigator, Juan Manuel Marquez Romero, Instituto Mexicano del Seguro Social
- Investigators
- Juan M Marquez-Romero, MD, MSc, Principal investigator, Unidad de Medicina de Alta Especialidad, Torre Medica CMQ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05543837
- Sponsor's protocol ID
- 2022-E-20
- Acronym
- CCPA
- Status last verified
- Mar 2023
- First submitted
- 13 Sep 2022
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared with any qualified investigator upon request to the PI after signing a data use agreement.
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Capsaicin on the Augmentation of Cerebral Perfusion. A Phase II Study.
- ClinicalTrials.gov ID
- NCT05543837
- Acronym / sponsor ID
- CCPA / 2022-E-20
- Conditions
- Cerebral Circulatory Disorder
- Keywords
- capsaicin, cerebal perfusion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Collaborators
- Centenario Hospital Miguel Hidalgo
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 16 Sep 2022 (actual)
- 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.
To determine the effect of capsaicin upon serial transcranial Doppler (TCD) markers of cerebral blood flow (CBF). Methods Serial TCD testing in 30 participants with cerebrovascular risk factors. Capsaicin doses .66 and .99 μMol. Outcomes: peak systolic and end-diastolic velocities in the middle cerebral artery (MCA), mean velocity (MV), pulsatility index (PI), CBF index, arterial pressure, and perceived pungency (PP) in five minutes intervals up to 20 minutes.
Detailed description
Subjects The study is expected to enroll 30 participants who will be recruited from the Internal Medicine outpatient clinic. Those willing to participate will be asked to sign the informed consent form (ICF) and will received the assigned dose of capsaicin. Half of the participants in each dose group will receive stimulation on either left or right side of the palate, but TCD measurements will be bilateral. Chemical stimuli From an initial 0.1% capsaicin (Sigma-Aldrich, St. Louis, MO) stock solution in 95% ethanol; solutions with 66 and 99 μMol/ml solutions will be obtained by diluting the stock solution with distilled water. One milliliter of each dilution was pipetted on to 2 cm filter paper squares. Then, the filter papers will be let dry. Immediately before application, filter papers will be rehydrated with 1 milliliter of distilled water. The rehydrated filter paper will be applied and will remain stationary on the subject's hemi palate's posterior surface during TCD measurements. Participants will be instructed not to swallow and to avoid touching the paper filter with their tongue for the 20 minutes of the experiment.
TCD testing With a TCD device (Philips Sonos 7500®) will include: peak systolic velocity (PSV) and end-diastolic velocity (EDV) in the middle cerebral artery (MCA) through the temporal window of the stimulated side. After a basal recording post stimulation recordings will initiate immediately after stimulation, and will be followed by serial recordings every five minutes and up to 20 minutes. At each time point the systolic pressure (SP), diastolic pressure (DP), and perceived pungency (PP) on a visual analog scale will be recorded. TCD markers of cerebral blood flow From the initial measurements the Mean velocity (MV) = EDV + [(PSVEDV) / 3], pulsatility index (PI) = PSV - EDV / MV, mean arterial pressure (MAP) = ((2 * DP) + SP) / 3 and, the CBF index (CBFi), CBFi = (MAP * 10) / 1.47^PI, will be calculated.
Statistical analysis Shapiro Wilkins W-Test for normality. The results of the continuous variables will be described as median (max-min) or mean+/- SD according to distribuition. The categorical variables will be described as tables of absolute and relative frequencies, and the comparisons between the groups of subjects (according to the dose of capsaicin) will be carried out with chi-square tests. To compare the variables studied between the groups of subjects (according to the different doses of capsaicin), Mann-Whitney U-Test/independent samples Student´s T-Test will be used appropriately. For comparisons of the baseline state with the changes recorded over time, various Wilcoxon signed-rank tests will be performed.The relationship between pungency ratings and MV response will be evaluated by Spearman's rho test. The level of statistical significance will be set at 0.05.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capsaicin .66μMol/ml | Experimental | Drug: CapsaicinGroup receiving .66μMol/ml |
| Capsaicin .99μMol/ml | Experimental | Drug: CapsaicinGroup receiving .99μMol/ml |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed Informed Consent Form
- Previous diagnosis and stable condition of one of the following:
- Diabetes Mellitus Hypertension Dyslipidemia Chronic Obstructive Pulmonary Disease
Key exclusion criteria (6 listed)
- History of alergy or hypersensibility to dietary capsaicin
- Previous diagnosis of stroke
- Chronic use of cholinergic/anticholinergic drugs
- Chronic use of sympathomimetic drugs
- Chronic use of serotonergic drugs
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 |
|---|---|---|
| CapsaicinAlso: 8-Methyl-N-vanillyl-trans-6-nonenamidePatients will receive a fixed dose of capsaicin | Drug | Capsaicin .66μMol/ml, Capsaicin .99μMol/ml |
Primary outcome
Mean velocity
Time frame: 20 minutes
The Mean velocity in the Middle Cerebral Artery
Pulsatility Index
Time frame: 20 minutes
A calculated flow parameter in ultrasound, derived from the maximum, minimum, and mean Doppler frequency shifts during a defined cardiac cycle.
2 secondary outcomes
Mean arterial pressure (MAP)
Time frame: 20 minutes
Cerebral Blood Flow index
Time frame: 20 minutes
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 14 Mar 2023.
- Individual participant dataSharing planned: Yes. Data will be shared with any qualified investigator upon request to the PI after signing a data use agreement.
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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.
Juan M Marquez-Romero, MD, MSc principal investigator
Unidad de Medicina de Alta Especialidad, Torre Medica CMQ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capsaicin in people with Cerebral Circulatory Disorder, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
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 3 inclusion and 6 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 14 Mar 2023. 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 Mexico. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Mean velocity (time frame: 20 minutes). The study lists 2 primary outcomes in all. 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 14 Mar 2023.