PC-300 Tea Effect on Triglyceride Levels

NCT ID: NCT03649269

Last Updated: 2018-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-01
• Study Completion Date: 2014-12-31

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.

Conditions

Hypertriglyceridemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PC-300 tea

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

Group Type: EXPERIMENTAL

PC-300 tea.

Intervention Type: DIETARY_SUPPLEMENT

Patients had to drink one cup of the tea half an hour before breakfast, main meal and dinner.

Bezafibrate

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

Group Type: ACTIVE_COMPARATOR

Bezafibrate

Intervention Type: DRUG

Patients were prescribed 200 mg/day at night.

Interventions

PC-300 tea.

Patients had to drink one cup of the tea half an hour before breakfast, main meal and dinner.

Intervention Type: DIETARY_SUPPLEMENT

Bezafibrate

Patients were prescribed 200 mg/day at night.

Intervention Type: DRUG

Other Intervention Names

Herbal tea; Bezalip

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ciprés Grupo Médico CGM SC

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hugo Mendieta Zerón, PhD.

Role: PRINCIPAL_INVESTIGATOR

Ciprés Grupo Médico

Other Identifiers

2014/02

Identifier Type: -

Identifier Source: org_study_id