Viewing Study NCT02532699



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Last Modification Date: 2024-10-26 @ 11:48 AM
Study NCT ID: NCT02532699
Status: COMPLETED
Last Update Posted: 2015-08-26
First Post: 2015-08-14

Brief Title: Anti-hypertensive Effect of Mycelia of Antrodia Cinnamomea
Sponsor: Chung Shan Medical University
Organization: Chung Shan Medical University

Study Overview

Official Title: Anti-hypertensive Effect of Fermented Mycelia of Antrodia Cinnamomea Among Mild Hypertensive Subjects in a Double-blinded Randomized Trial
Status: COMPLETED
Status Verified Date: 2015-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This the first report undertaken to assess the effect of supplementation with oral gamma-aminobutyric acid GABA adenosine and antrosterol-containing AC mycelia on blood pressure among people with mild hypertension Overall AC mycelia consumption for 8 weeks could successfully reduce mean diastolic and systolic BP through the suppression of PRA that is linked to downstream suppresion of angiotensin II formation which further decreases the sympathetic outflow that leads to hypertension In addition to blood pressure lowering properties AC mycelia also has beneficial effect in reducing oxidative stress significantly No adverse events were noted suggesting that AC mycelia deserve its consideration as a candidate for safe alternative treatment to conventional anti-hypertensive medications
Detailed Description: This the first report undertaken to assess the effect of supplementation with oral gamma-aminobutyric acid GABA adenosine and antrosterol-containing AC mycelia on blood pressure among people with mild hypertension Forty-one subjects with systolic blood pressure SBP between 130 and 179 mm Hg andor diastolic blood pressure DBP between 85 and 109 mm Hg were randomized to receive either AC mycelia or starch placebo for 8 weeks and had follow-up observation for an additional 2 weeks SBP in the subjects given GABA adenosine and antrosterol-rich AC mycelia significantly decreased compared to those who received the placebo p005 DBP also decreased after the intake of AC mycelia Compared to the placebo AC mycelia significantly reduced plasma renin activity by a maximum of 25 and 36 on week 8 This suppression suggested that AC mycelia is a potent inhibitor of renin and its bioavailability is sufficient to produce BP reduction after a short term of oral administration Neither adverse events nor abnormal laboratory findings were noted throughout the study period suggesting that GABA adenosine and antrosterol-rich AC mycelia significantly decreased borderline hypertension which may support its consideration as a safe alternative treatment compared to conventional anti-hypertensive medications

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
E099N0115-MY2 OTHER_GRANT Grape King Bio Ltd None