Development of Green Mei Products for the Prevention of M... | NCT05039437

Studies
Development of Green Mei Products for the Prevention of Metabolic Syndrome

NCT05039437

Sponsor

Chung Shan Medical University

Status

Completed

Last Update Posted

Sep 9, 2021Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

Hypertension

Interventions

MGF-4
MGF-7

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 15, 2019Actual

Primary Completion Date

Dec 1, 2019Actual

Completion Date

Dec 31, 2019Actual

First Submitted Date

Aug 12, 2021

First Submission Date that Met QC Criteria

Sep 2, 2021

First Posted Date

Sep 9, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 2, 2021

Last Update Posted Date

Sep 9, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MGF-4	Experimental	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
MGF-7	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MGF-4	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Han-Hui Chang, MS student	Chung Shan Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chung Shan Medical University		Taichung	South	402	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided