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PC-300 Tea Effect on Triglyceride Levels

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03649269
Recruitment Status : Completed
First Posted : August 28, 2018
Last Update Posted : August 28, 2018
Information provided by (Responsible Party):
Ciprés Grupo Médico CGM SC

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Hypertriglyceridemia Dietary Supplement: PC-300 tea. Drug: Bezafibrate Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Eryngium Heterophyllum + Amphipterygium Adstringens Tea Effect on Triglyceride Levels
Actual Study Start Date : January 1, 2014
Actual Primary Completion Date : November 30, 2014
Actual Study Completion Date : December 31, 2014

Resource links provided by the National Library of Medicine

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 Name: Herbal tea

Active Comparator: Bezafibrate
Patients that received fibrate (bezafibrate) 200 mg/day.
Drug: Bezafibrate
Patients were prescribed 200 mg/day at night.
Other Name: Bezalip

Primary Outcome Measures :
  1. Triglycerides serum levels. [ Time Frame: One month. ]
    The triglycerides serum levels were measured at the recruiting moment and after one month..

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03649269

Sponsors and Collaborators
Ciprés Grupo Médico CGM SC
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Principal Investigator: Hugo Mendieta Zerón, PhD. Ciprés Grupo Médico
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Responsible Party: Ciprés Grupo Médico CGM SC Identifier: NCT03649269    
Other Study ID Numbers: 2014/02
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: With this first study researcher are not planning to share the IPD.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ciprés Grupo Médico CGM SC:
Eryngium heterophyllum
Amphipterygium adstringens
Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents