Development of Green Mei Products for the Prevention of Metabolic Syndrome

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Dietary Supplement: MGF-7; Dietary Supplement: MGF-4

• Registration Number: NCT05039437
• Lead Sponsor: Chung Shan Medical University

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.

Study Timeline

• Study Start: 2019-06-15
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-31
• Study First Submitted: 2021-08-12
• Status Verified: 2021-09
• Study First Submitted QC: 2021-09-02
• Last Update Submitted: 2021-09-02
• Study First Posted: 2021-09-09
• Last Update Posted: 2021-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MGF-7	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.
MGF-4	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chung Shan Medical University; 🇨🇳 Taichung, South, Taiwan