PC-300 Tea Effect on Triglyceride Levels

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Eryngium Heterophyllum + Amphipterygium Adstringens Tea Effect on Triglyceride Levels

Conditions
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Hypertriglyceridemia

Intervention / Treatment
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* Dietary Supplement: PC-300 tea.
* Drug: Bezafibrate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PC-300 tea<br>Patients that received the Eryngium heterophyllum + Amphipterygium adstringens tea, one cup half an hour before eating. | Dietary Supplement: PC-300 tea.<br>* Patients had to drink one cup of the tea half an hour before breakfast, main meal and dinner.<br>* Other names: Herbal tea;|
| Active Comparator: Bezafibrate<br>Patients that received fibrate (bezafibrate) 200 mg/day. | Drug: Bezafibrate<br>* Patients were prescribed 200 mg/day at night.<br>* Other names: Bezalip;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triglycerides serum levels. | The triglycerides serum levels were measured at the recruiting moment and after one month.. | One month. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eryngium heterophyllum, Amphipterygium adstringens, tea