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临床试验/NCT03649269
NCT03649269已完成不适用

Eryngium Heterophyllum + Amphipterygium Adstringens Tea Effect on Triglyceride Levels

Ciprés Grupo Médico CGM SC0 个研究点目标入组 34 人开始时间: 2014年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
34
主要终点
Triglycerides serum levels.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with hypertriglyceridemia, aged >18 years and with an educational level at least of primary school.

排除标准

  • Patients with hepatic disease and those missing an appointment during the study.

研究组 & 干预措施

PC-300 tea

Experimental

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

干预措施: PC-300 tea. (Dietary Supplement)

Bezafibrate

Active Comparator

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

干预措施: Bezafibrate (Drug)

结局指标

主要结局

Triglycerides serum levels.

时间窗: One month.

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

次要结局

未报告次要终点

研究者

发起方
Ciprés Grupo Médico CGM SC
申办方类型
Other
责任方
Sponsor

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