Investigation of the effect of quercetin and berberine on laboratory and functional indices of the heart and pulmonary vessels in patients with pulmonary arterial hypertension

Investigation of the effect of quercetin and berberine on laboratory and functional indices of the heart and pulmonary vessels in patients with pulmonary arterial hypertension

140 patients with pulmonary arterial hypertension (PAH) were randomly divided into 7 groups including PAH, PAH + Placebo, PAH + Quercetin (QS) 250, PAH+QS500, PAH+ Berberin (BBR) 500, PAH+BBR1000 and PAH+QS+BBR. And the phase 3 clinical trial is being investigated.

The study is conducted in Afzalipur Hospital, Kerman, and double blinding including the researcher and the patient is done by coding the drugs.

In this study, based on the information contained in the checklists, 140 patients with pulmonary artery hypertension and over 10 years of age were selected from among the patients who referred to the heart or lung department of Afzalipur Hospital by the colleagues of the heart or lung specialist. Randomly, they are placed in 7 groups of 20 people who are homogenized in terms of age, gender and BMI. How to calculate the sample size is explained below. Exclusion criteria include liver, kidney, diabetes, specific diseases such as cancer and known vascular diseases except pulmonary artery hypertension (such as valvular diseases and left heart failure).

In this study, daily doses of 250 and 500 mg of quercetin and 500 and 1000 mg of berberine are given to patients with PAH.

Right ventricular systolic pressure ,Right ventricular diastolic pressure ، Partial pressure of oxygen ، Creatinine, Serum glutamic-pyruvic transaminase , serum glutamic – oxaloacetic transaminase, Alkaline Phosphatase, Triglyceride, High Density Lipoprotein, Cholesterol, Low Density Lipoprotein ،Superoxide dismutase, Glutathione Peroxidase, Malondialdehyde, Tumor necrosis factor alpha, Interleukin (IL) -8, IL-6

The patients are divided into seven groups of 20 people according to the order of referral and after meeting the entry criteria and after obtaining the consent form according to balanced blocked randomization. Block randomization is a commonly used technique in clinical trial design to reduce bias and achieve balance in the allocation of participants to treatment arms, especially when the sample size is small.

The main drug and the placebo are coded by a person who is not aware of the study. The specialist doctor introduces the patient to receive the medicine. The distributor (nurse), who is unaware of the codes, randomly gives the medicines to the patients. After taking the medicine, the patient goes to the doctor and is examined. The doctor gives the results to a researcher who is not aware of the codes for analysis.

At the time of publication of the article and after that based on the reasonable request and the needs of other researchers, study variables and statistical tests used to compare the studied groups, as well as information about the participants and the study protocol and other information, will be provided to the requester.

Unlimited after publication of articles

Other researchers in the studied field

Data sharing will be done in the form of a joint proposal

By email to the corresponding author

The applicant contacts the corresponding author via e-mail and submits his request, and the corresponding author provides them after consulting with other colleagues.