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PC-300 Tea Effect on Triglyceride Levels

Primary Purpose

Hypertriglyceridemia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PC-300 tea.
Bezafibrate
Sponsored by
Ciprés Grupo Médico CGM SC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertriglyceridemia focused on measuring Eryngium heterophyllum, Amphipterygium adstringens, tea

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    PC-300 tea

    Bezafibrate

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    August 24, 2018
    Last Updated
    August 27, 2018
    Sponsor
    Ciprés Grupo Médico CGM SC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03649269
    Brief Title
    PC-300 Tea Effect on Triglyceride Levels
    Official Title
    Eryngium Heterophyllum + Amphipterygium Adstringens Tea Effect on Triglyceride Levels
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2014 (Actual)
    Primary Completion Date
    November 30, 2014 (Actual)
    Study Completion Date
    December 31, 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ciprés Grupo Médico CGM SC

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertriglyceridemia
    Keywords
    Eryngium heterophyllum, Amphipterygium adstringens, tea

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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)
    Allocation
    Non-Randomized
    Enrollment
    34 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PC-300 tea
    Arm Type
    Experimental
    Arm Description
    Patients that received the Eryngium heterophyllum + Amphipterygium adstringens tea, one cup half an hour before eating.
    Arm Title
    Bezafibrate
    Arm Type
    Active Comparator
    Arm Description
    Patients that received fibrate (bezafibrate) 200 mg/day.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    PC-300 tea.
    Other Intervention Name(s)
    Herbal tea
    Intervention Description
    Patients had to drink one cup of the tea half an hour before breakfast, main meal and dinner.
    Intervention Type
    Drug
    Intervention Name(s)
    Bezafibrate
    Other Intervention Name(s)
    Bezalip
    Intervention Description
    Patients were prescribed 200 mg/day at night.
    Primary Outcome Measure Information:
    Title
    Triglycerides serum levels.
    Description
    The triglycerides serum levels were measured at the recruiting moment and after one month..
    Time Frame
    One month.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hugo Mendieta Zerón, PhD.
    Organizational Affiliation
    Ciprés Grupo Médico
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    With this first study researcher are not planning to share the IPD.

    Learn more about this trial

    PC-300 Tea Effect on Triglyceride Levels

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