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Completed

NCT Number: NCT03649269

PC-300 Tea Effect on Triglyceride Levels

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PC-300 tea.

Dietary Supplement

Patients had to drink one cup of the tea half an hour before breakfast, main meal and dinner.

Other names: Herbal tea

Bezafibrate

Drug

Patients were prescribed 200 mg/day at night.

Other names: Bezalip

Primary outcomes

  1. Triglycerides serum levels.

    Time frame: One month.

    The triglycerides serum levels were measured at the recruiting moment and after one month..

Sponsors and collaborators

Lead sponsor

Ciprés Grupo Médico CGM SC

Other

Registry information

Official study title

Eryngium Heterophyllum + Amphipterygium Adstringens Tea Effect on Triglyceride Levels

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 28, 2018
Registry last updated
Aug 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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