PC-300 Tea Effect on Triglyceride Levels

August 27, 2018 updated by: Ciprés Grupo Médico CGM SC

Eryngium Heterophyllum + Amphipterygium Adstringens 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ciprés Grupo Médico CGM SC

Investigators

  • Principal Investigator: Hugo Mendieta Zerón, PhD., Ciprés Grupo Médico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

November 30, 2014

Study Completion (Actual)

December 31, 2014

Study Registration Dates

First Submitted

August 24, 2018

First Submitted That Met QC Criteria

August 27, 2018

First Posted (Actual)

August 28, 2018

Study Record Updates

Last Update Posted (Actual)

August 28, 2018

Last Update Submitted That Met QC Criteria

August 27, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014/02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

With this first study researcher are not planning to share the IPD.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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