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
About this trial
This is an interventional treatment trial for Hypertriglyceridemia focused on measuring Eryngium heterophyllum, Amphipterygium adstringens, tea
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.
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
NCT ID
NCT03649269
First Posted
August 24, 2018
Last Updated
August 27, 2018
Sponsor
Ciprés Grupo Médico CGM SC
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.
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PC-300 Tea Effect on Triglyceride Levels
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