PC-300 Tea Effect on Triglyceride Levels
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|ClinicalTrials.gov Identifier: NCT03649269|
Recruitment Status : Completed
First Posted : August 28, 2018
Last Update Posted : August 28, 2018
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|
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 (Clinical Trial)|
|Actual Enrollment :||34 participants|
|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)|
|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|
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.
Patients were prescribed 200 mg/day at night.
Other Name: Bezalip
- Triglycerides serum levels. [ Time Frame: One month. ]The triglycerides serum levels were measured at the recruiting moment and after one month..
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 ClinicalTrials.gov identifier (NCT number): NCT03649269
|Principal Investigator:||Hugo Mendieta Zerón, PhD.||Ciprés Grupo Médico|