Development of Green Mei Products for the Prevention of Metabolic Syndrome

Hypertension Clinical Trial

Official title:

Development of Green Mei Products for the Prevention of Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05039437
• Other study ID #: CS2-19033
• Status: Completed
• Phase: N/A
• Start date: June 15, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: September 2021
• Source: Chung Shan Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Metabolic Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
Taiwan	Chung Shan Medical University	Taichung	South

Sponsors (1)

Lead Sponsor	Collaborator
Chung Shan Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change the blood pressure after intervention	Compare the difference of own SBP and DBP between the week 0, 4 and 8 in each groups	Week 0, 4 and 8
Secondary	Change from baseline serum MDA and TEAC at Week 8	Compare the difference of serum MDA and TEAC between week 0 and 8	Week 0 and 8