Development of Green Mei Products for the Prevention of Metabolic Syndrome

September 2, 2021 updated by: Chung Shan Medical University
The aim of this study is to investigate the antihypertensive effects of Mei-Gin formula-4 (MGF-4) and Mei-Gin formula-7.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • South
      • Taichung, South, Taiwan, 402
        • Chung Shan Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MGF-4
Take two MGF-4 capsules twice a day for 8 weeks. A 250 mg capsule contents 243 mg MGF-4 and other excipients.
Dietary supplement: MGF-4
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.
Experimental: MGF-7
Take two MGF-7 capsules twice a day for 8 weeks. A 250 mg capsule contents 243 mg MGF-7 and other excipients.
Dietary supplement: MGF-7
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Week 0, 4 and 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Week 0 and 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chung Shan Medical University

Investigators

  • Principal Investigator: Han-Hui Chang, MS student, Chung Shan Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2019

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

August 12, 2021

First Submitted That Met QC Criteria

September 2, 2021

First Posted (Actual)

September 9, 2021

Study Record Updates

Last Update Posted (Actual)

September 9, 2021

Last Update Submitted That Met QC Criteria

September 2, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS2-19033

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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