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Development of Green Mei Products for the Prevention of Metabolic Syndrome

Primary Purpose

Hypertension

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
MGF-4
MGF-7
Sponsored by
Chung Shan Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Chung Shan Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

MGF-4

MGF-7

Arm Description

Take two MGF-4 capsules twice a day for 8 weeks. A 250 mg capsule contents 243 mg MGF-4 and other excipients.

Take two MGF-7 capsules twice a day for 8 weeks. A 250 mg capsule contents 243 mg MGF-7 and other excipients.

Outcomes

Primary Outcome Measures

Change the blood pressure after intervention
Compare the difference of own SBP and DBP between the week 0, 4 and 8 in each groups

Secondary Outcome Measures

Change from baseline serum MDA and TEAC at Week 8
Compare the difference of serum MDA and TEAC between week 0 and 8

Full Information

First Posted
August 12, 2021
Last Updated
September 2, 2021
Sponsor
Chung Shan Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05039437
Brief Title
Development of Green Mei Products for the Prevention of Metabolic Syndrome
Official Title
Development of Green Mei Products for the Prevention of Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
June 15, 2019 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chung Shan Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MGF-4
Arm Type
Experimental
Arm Description
Take two MGF-4 capsules twice a day for 8 weeks. A 250 mg capsule contents 243 mg MGF-4 and other excipients.
Arm Title
MGF-7
Arm Type
Experimental
Arm Description
Take two MGF-7 capsules twice a day for 8 weeks. A 250 mg capsule contents 243 mg MGF-7 and other excipients.
Intervention Type
Dietary Supplement
Intervention Name(s)
MGF-4
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
MGF-7
Intervention Description
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 Outcome Measure Information:
Title
Change the blood pressure after intervention
Description
Compare the difference of own SBP and DBP between the week 0, 4 and 8 in each groups
Time Frame
Week 0, 4 and 8
Secondary Outcome Measure Information:
Title
Change from baseline serum MDA and TEAC at Week 8
Description
Compare the difference of serum MDA and TEAC between week 0 and 8
Time Frame
Week 0 and 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Han-Hui Chang, MS student
Organizational Affiliation
Chung Shan Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chung Shan Medical University
City
Taichung
State/Province
South
ZIP/Postal Code
402
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

Development of Green Mei Products for the Prevention of Metabolic Syndrome

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