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Completed

NCT Number: NCT05039437

Development of Green Mei Products for the Prevention of Metabolic Syndrome

The aim of this study is to investigate the antihypertensive effects of Mei-Gin formula-4 (MGF-4) and Mei-Gin formula-7.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chung Shan Medical University

Taichung, South, 402, Taiwan

About this study

It's a randomized, and single-blind trial and was designed to evaluate the effects of MGFs (MGF-4 and MGF-4) on blood pressure. 50 participants with hypertension (systolic blood pressure between 130-179 mmHg or diastolic blood pressure between 85-109 mmHg) who did not accept any hypertension medication were randomized allocated to either MGF-4 or MGF-7 group. Participants were instructed to take 4 capsules of MGF-4 or MGF-7 daily throughout the duration of the 8 weeks intervention study. After treatment, the change of the blood pressure and relative mechanism were analyzed.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The age of the subject is 20 to 70 years old.
  • The subject is a patient with hypertension (SBP is between 130-179 mmHg, DBP is between 85-109mmHg, one of the two can be diagnosed), and there are no serious illnesses requiring hospitalization during the study period treatment.
  • No hypertension medication.
  • The subject can understand the test process described in the consent form and the possible potential risks and benefits, and able to sign the consent form.
  • The subjects shall observe diet control during the trial period.

Exclusion criteria

  • Subjects diagnosed with cancer and still under active treatment.
  • Subjects diagnosed with heart disease and still under active treatment.
  • Other drugs are used, whose pharmacological effects may affect blood pressure or may aggravate the effects of drugs.
  • Subjects who have systemic infection and need systemic antibiotics.

Treatment and study plan

MGF-4

Dietary Supplement

Participants were instructed to take 2 capsules of MGF-4 twice a day, and measure own blood pressure at morning everyday throughout the duration of the study.

MGF-7

Dietary Supplement

Participants were instructed to take 2 capsules of MGF-7 twice a day, and measure own blood pressure at morning everyday throughout the duration of the study.

Primary outcomes

  1. Change the blood pressure after intervention

    Time frame: Week 0, 4 and 8

    Compare the difference of own SBP and DBP between the week 0, 4 and 8 in each groups

Secondary outcomes

  1. Change from baseline serum MDA and TEAC at Week 8

    Time frame: Week 0 and 8

    Compare the difference of serum MDA and TEAC between week 0 and 8

Sponsors and collaborators

Lead sponsor

Chung Shan Medical University

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 9, 2021
Registry last updated
Sep 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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