Capsaicin for Cerebral Perfusion Augmentation

NCT05543837 | Completed Phase 2 DMC

• 1 other identifier: 2022-E-20
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cerebral Circulatory Disorder

Keywords

capsaicin; cerebal perfusion

Outcome Measures

Primary Outcomes (2)

• Mean velocity

  The Mean velocity in the Middle Cerebral Artery

  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.

  20 minutes

Secondary Outcomes (2)

• Mean arterial pressure (MAP)

  20 minutes

• Cerebral Blood Flow index

  20 minutes

Study Arms (2)

Capsaicin .66μMol/ml

EXPERIMENTAL

Group receiving .66μMol/ml

Drug: Capsaicin

Capsaicin .99μMol/ml

EXPERIMENTAL

Group receiving .99μMol/ml

Drug: Capsaicin

Interventions

Capsaicin DRUG

Patients will receive a fixed dose of capsaicin

Also known as: 8-Methyl-N-vanillyl-trans-6-nonenamide

Capsaicin .66μMol/ml; Capsaicin .99μMol/ml

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent Form
• Previous diagnosis and stable condition of one of the following:
• Diabetes Mellitus Hypertension Dyslipidemia Chronic Obstructive Pulmonary Disease

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead
• Centenario Hospital Miguel Hidalgo: collaborator

Study Sites (1)

Centenario Hospital Miguel Hidalgo

Aguascalientes, 20259, Mexico

Location

MeSH Terms

Conditions

Cerebrovascular Disorders

Interventions

Capsaicin

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Study Officials

• Juan M Marquez-Romero, MD, MSc

  Unidad de Medicina de Alta Especialidad, Torre Medica CMQ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 16, 2022
• Study Start: September 20, 2022
• Primary Completion: September 30, 2022
• Study Completion: February 28, 2023
• Last Updated: March 14, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 6 months
• Access Criteria: Any qualified investigator in the field

Locations

ME (1)