PC-300 Tea Effect on Triglyceride Levels

NCT03649269 | Completed

• 1 other identifier: 2014/02
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypertriglyceridemia

Keywords

Eryngium heterophyllum; Amphipterygium adstringens; tea

Outcome Measures

Primary Outcomes (1)

• Triglycerides serum levels.

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

  One month.

Study Arms (2)

PC-300 tea

EXPERIMENTAL

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

Dietary Supplement: PC-300 tea.

Bezafibrate

ACTIVE COMPARATOR

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

Drug: Bezafibrate

Interventions

PC-300 tea. DIETARY_SUPPLEMENT

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

Also known as: Herbal tea

PC-300 tea

Bezafibrate DRUG

Patients were prescribed 200 mg/day at night.

Also known as: Bezalip

Bezafibrate

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ciprés Grupo Médico CGM SC: lead

MeSH Terms

Conditions

Hypertriglyceridemia

Interventions

Teas, Herbal; Bezafibrate

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Benzamides; Amides; Organic Chemicals; Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Benzoates; Acids, Carbocyclic; Chlorobenzoates; Phenyl Ethers; Ethers; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Study Officials

• Hugo Mendieta Zerón, PhD.

  Ciprés Grupo Médico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 24, 2018
• First Posted: August 28, 2018
• Study Start: January 1, 2014
• Primary Completion: November 30, 2014
• Study Completion: December 31, 2014
• Last Updated: August 28, 2018

Record last verified: 2018-08