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NCT04790942

Effect of Berberine Hydrochloride on Blood Pressure and Vascular Endothelial Function in Patients With Hypertension

Status unknown Phase 4 Last updated 10 March 2021
What this trial tests

Phase 4 trial testing berberine hydrochloride in Hypertension in 30 participants. Status unknown.

Timeline
22 October 2020
Primary endpoint
22 February 2022
22 May 2022

Quick facts

Lead sponsorJun Tao
PhasePhase 4
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment30
Start date22 October 2020
Primary completion22 February 2022
Estimated completion22 May 2022
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Jun Tao

Who can join

Adults 18 to 75, any sex, with Hypertension or Endothelial Dysfunction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Hypertension is a progressive cardiovascular syndrome caused by multiple causes, which can lead to changes in the function and structure of the heart and blood vessels. It is the leading risk factor of cardiovascular disease. Berberine (BBR) hydrochloride is an isoquinoline alkaloid (chemical formula: C20H18NO4) extracted from traditional Chinese herb Coptis chinensis. It has been widely used to treat diarrhea and enteritis for hundreds of years in China. BBR has extremely high clinical application value. It is an over-the-counter drug with low price, good safety and few adverse reactions in China. We found that Berberine (BBR) hydrochloride tablets have a hypotensive effect in clinical practice. However, there are few clinical studies on the treatment of hypertensive patients with BBR tablets. In addition, the clinical dosage of BBR tablets is not uniform, and its molecular mechanism is still unclear. In order to further evaluate the clinical efficacy of BBR in reducing blood pressure and improving vascular endothelial injury, we carried out this clinical trial of drug intervention for hypertensive population. After signed the informed consent, the subjects are assigned to the lifestyle intervention group (CON) and berberine hydrochloride group (BBR). The berberine hydrochloride group (BBR) take berberine hydrochloride tablets (0.4g, 3 times/day, 3 months) . We will follow up blood pressure and vascular endothelial function in 1 month and 3 months after taking the medicine.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Effects of Berberine on Atherosclerosis.
    Rui R, Yang H, Liu Y, Zhou Y, et al · · 2021 · cited 36× · PMID 34899318 · DOI 10.3389/fphar.2021.764175
  2. NADPH-oxidases as potential pharmacological targets for thrombosis and depression comorbidity.
    Amadio P, Sandrini L, Zarà M, Barbieri SS, et al · · 2024 · cited 16× · PMID 38310682 · DOI 10.1016/j.redox.2024.103060

Verify or expand the search:

Other recruiting trials for Hypertension

Currently open trials in the same condition.

Other Jun Tao trials

Trials by the same sponsor.

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Data sources for this page

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