Development of Green Mei Products for the Prevention of Metabolic Syndrome
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hypertension
Started Jun 2019
Shorter than P25 for not_applicable hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedFirst Submitted
Initial submission to the registry
August 12, 2021
CompletedFirst Posted
Study publicly available on registry
September 9, 2021
CompletedSeptember 9, 2021
September 1, 2021
6 months
August 12, 2021
September 2, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 (1)
Change from baseline serum MDA and TEAC at Week 8
Week 0 and 8
Study Arms (2)
MGF-4
EXPERIMENTALTake two MGF-4 capsules twice a day for 8 weeks. A 250 mg capsule contents 243 mg MGF-4 and other excipients.
MGF-7
EXPERIMENTALTake two MGF-7 capsules twice a day for 8 weeks. A 250 mg capsule contents 243 mg MGF-7 and other excipients.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chung Shan Medical University
Taichung, South, 402, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Han-Hui Chang, MS student
Chung Shan Medical University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2021
First Posted
September 9, 2021
Study Start
June 15, 2019
Primary Completion
December 1, 2019
Study Completion
December 31, 2019
Last Updated
September 9, 2021
Record last verified: 2021-09