Development of Green Mei Products for the Prevention of Metabolic Syndrome

NCT ID: NCT05039437

Last Updated: 2021-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-15
• Study Completion Date: 2019-12-31

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

MGF-4

Intervention Type: 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

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

Group Type: EXPERIMENTAL

MGF-7

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chung Shan Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Han-Hui Chang, MS student

Role: PRINCIPAL_INVESTIGATOR

Chung Shan Medical University

Locations

Chung Shan Medical University

Taichung, South, Taiwan

Countries

Taiwan

Other Identifiers

CS2-19033

Identifier Type: -

Identifier Source: org_study_id