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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02823912
Other study ID # Capdis
Secondary ID
Status Not yet recruiting
Phase Phase 2/Phase 3
First received July 1, 2016
Last updated July 15, 2016
Start date October 2016
Est. completion date October 2017

Study information

Verified date July 2016
Source University of Guadalajara
Contact Leonel Garcia Benavides, PhD
Phone 10585200
Email drleonelgb@hotmail.com
Is FDA regulated No
Health authority México: Secretaria de Salud
Study type Interventional

Clinical Trial Summary

The increased mortality from cardiovascular disease has a significant impact on the population, and the prevalence of these diseases it become one of the major problems, since it is the leading cause of mortality and 1 in 3 Mexicans suffer from cardiovascular disease according ENSANUT; the above is attributed to the increase of diseases associated with an inflammatory process accelerated as obesity, dyslipidemia, hypertension (SAH) and diabetes mellitus (DM).

The cholesterol is a major risk factor in the development of cardiovascular disease, and in turn increases the chances of death; however, the treatment of choice is based on changes in lifestyle, which for most people are difficult to maintain long-term. As for the drug therapy treated with drugs many people do not achieve their therapeutic goals, and therefore the inflammatory condition that underlies this disease remains.

Recent studies have focused on the possible role of capsaicin in the inflammatory state through the agonistic effect it has on TRPV1. It has demonstrated the antiinflammatory activity of capsaicin to enhance inflammation by free fatty acids (FFA) and reducing the expression of certain genes involved in this process induced. Capsaicin is a natural choice and well tolerated with few side effects limited to the gastrointestinal tract such as dyspepsia and intestinal irregularity, for the above is of interest to evaluate the effect of capsaicin on the profile of inflammatory cytokines in individuals with dyslipidemia.


Description:

It will conduct a clinicala trial, double - blind, randomized and placebo control group. Female and male patients, with dyslipidemia. Two groups will be formed with 17 patients each (capsaicin 150 mg per day or Magnesia calcinada). At the beginning and end of the intervention clinical and laboratory determination. The data obteined were analyzed using SPSS statistical software version 22. It was considered statistically significant at p <0.05


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 17
Est. completion date October 2017
Est. primary completion date April 2017
Accepts healthy volunteers No
Gender Both
Age group 25 Years to 45 Years
Eligibility Inclusion Criteria:

- diagnosis of dyslipidemia at the time of screening

- BMI of 25 kg /m2 to 34.9 kg / m2

- Without drug treatment in the last three months

- Signature of consent information in writing

Exclusion Criteria:

- Pregnant or lactating

- Total cholesterol = 239 mg / dL, =400 TG, LDL-C =139

- Other inflammatory diseases

- consumption of some type of supplement

- Diagnosis or history of kidney or liver disease 8 History of hypersensitivity to the compounds used in the study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Intervention

Drug:
Capsaicin

Magnesia calcinada


Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
University of Guadalajara LN. Jessica Lucia Barajas Vega, PhD. Teresa Arcelia Garcia Cobian

Outcome

Type Measure Description Time frame Safety issue
Primary Inflammatory cytokines profile TNFa 90 days No
Primary Inflammatory cytokines profile IL-1ß 90 days No
Primary Inflammatory cytokines profile IL-6 90 days No
Primary Inflammatory cytokines profile IL-8 90 days No
Primary Inflammatory cytokines profile MIP-1ß 90 days No
Secondary Lipids profile total cholesterol 90 days No
Secondary Lipids profile triglycerides 90 days No
Secondary Lipids profile C-HDL 90 days No
Secondary Lipids profile C-LDL 90 days No
Secondary Lipids profile C-VLDL 90 days No
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