PC-300 Tea Effect on Triglyceride Levels

Ciprés Grupo Médico CGM SC

Status: Completed

Conditions: Hypertriglyceridemia

Treatments: Drug: Bezafibrate; Dietary Supplement: PC-300 tea.

Study type: Interventional

Funder types: Other

Identifiers

NCT03649269

2014/02

Details and patient eligibility

About

Herbal medicine represents an alternative for treating dyslipidemia. The aim of this project was to evaluate the PC-300 tea (Eryngium heterophyllum egelm + Amphipterygium adstringens) against hypertriglyceridemia.

Baseline samples of serum total cholesterol and triglycerides were obtained and measured again after 1 month of treatment with the following two alternatives: 1) PC-300, one cup half an hour before eating, and 2) bezafibrate 200 mg/d.

Full description

It was a descriptive, prospective, longitudinal, and comparative clinical study developed at Ciprés Grupo Médico S.C. (CGM), Toluca, Mexico, from January 2014 to December 2014.

Patients with hypertriglyceridemia were invited to participate in the study. Voluntary subjects were assigned sequentially into two treatment groups: 1) fibrate (bezafibrate) 200 mg/day, and 2) PC-300 tea, one cup half an hour before eating.

Patients were measured (m) and weighed (kg) (Obi, México). Body mass index (BMI) was calculated as weight (kg) divided by height (m) squared. Blood pressure was measured with a calibrated sphygmomanometer (Welch Allyn, USA) after 5 min of rest.

All of the patients were given a low lipid diet. Calculated kcal were based on ideal weight minus 200 kcal/day if overweight.

Results were expressed as mean ± Standard deviation (SD). Differences between initial vs. final values were compared with the Mann-Whitney U test. The normality hypothesis was tested using the Kolmogorov-Smirnov test. A p value of <0.05 was considered significant. All tests were performed with the SPSS ver. 23 statistical software program.

Enrollment: 34 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with hypertriglyceridemia, aged >18 years and with an educational level at least of primary school.

Exclusion criteria

• Patients with hepatic disease and those missing an appointment during the study.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

PC-300 tea

Experimental group

Description:

Patients that received the Eryngium heterophyllum + Amphipterygium adstringens tea, one cup half an hour before eating.

Treatment:

Dietary Supplement: PC-300 tea.

Bezafibrate

Active Comparator group

Description:

Patients that received fibrate (bezafibrate) 200 mg/day.

Treatment:

Drug: Bezafibrate