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IRCT20230220057462N1 IRCT 2023-03-18 Bam University of Medical Sciences The effect of quercetin and berberine on 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 2023-04-21 anticipated 140 Complete https://irct.ir/trial/68684 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 pulmonary arterial hypertension. Intervention 1: Control group: People included in this study group have RVSP above 35 mmHg and receive their classical treatments during the study period. Intervention 2: Intervention group 1: In this group, people with pulmonary artery hypertension, in addition to receiving classic drugs, will receive a placebo capsule daily during the period of the pilot study. Intervention 3: Intervention group2: In this group, people with pulmonary artery hypertension, in addition to receiving classic drugs, during the period that is obtained in the pilot study, receive one QS oral supplement capsule at a dose of 250 mg/day. Intervention 4: Intervention group 3: In this group, people with pulmonary artery hypertension, in addition to receiving classic drugs, during the period that is obtained in the pilot study, they receive a QS oral supplement capsule at a dose of 500 mg/day. Intervention 5: Intervention group 4: In this group, people with pulmonary artery hypertension, in addition to receiving classic drugs, during the period that is obtained in the pilot study, daily receive one berberine capsule with a dose of 500 orally. Intervention 6: Intervention group 5: In this group, people with pulmonary artery hypertension, in addition to receiving classic drugs, during the period that is obtained in the pilot study, daily receive a berberine capsule with a dose of 1000 orally. Intervention 7: Intervention group 6: In this group, people with pulmonary artery hypertension, in addition to receiving classic drugs, during the period that is obtained in the pilot study, daily receive one capsule of QS with a dose of 250 mg and one capsule of berberine with a dose of 500 mg orally. Yes - There is a plan to make this available What will be shared: 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. When: Unlimited after publication of articles To whom: Other researchers in the studied field Conditions: Data sharing will be done in the form of a joint proposal Where to obtain: By email to the corresponding author How to obtain: The applicant contacts the corresponding author via e-mail and submits his request, and the corresponding author provides them after consulting with other colleagues. Comments:
public Hamid Najafipour
Bulvard 22 Bahman
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3222 4071 najafipourh@kmu.ac.ir Kerman University of Medical Sciences scientific Hamid Najafipour
Blvd 22 Bahman
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3222 4071 najafipourh@kmu.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) Patients with pulmonary artery hypertension 10 years 70 years Both Liver disease kidney Diseases diabetes Specific diseases such as cancer and known vascular diseases I27.2 Other secondary pulmonary hypertension Treatment - Drugs Placebo Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Control group: People included in this study group have RVSP above 35 mmHg and receive their classical treatments during the study period. Intervention group 1: In this group, people with pulmonary artery hypertension, in addition to receiving classic drugs, will receive a placebo capsule daily during the period of the pilot study. Intervention group2: In this group, people with pulmonary artery hypertension, in addition to receiving classic drugs, during the period that is obtained in the pilot study, receive one QS oral supplement capsule at a dose of 250 mg/day. Intervention group 3: In this group, people with pulmonary artery hypertension, in addition to receiving classic drugs, during the period that is obtained in the pilot study, they receive a QS oral supplement capsule at a dose of 500 mg/day. Intervention group 4: In this group, people with pulmonary artery hypertension, in addition to receiving classic drugs, during the period that is obtained in the pilot study, daily receive one berberine capsule with a dose of 500 orally. Intervention group 5: In this group, people with pulmonary artery hypertension, in addition to receiving classic drugs, during the period that is obtained in the pilot study, daily receive a berberine capsule with a dose of 1000 orally. Intervention group 6: In this group, people with pulmonary artery hypertension, in addition to receiving classic drugs, during the period that is obtained in the pilot study, daily receive one capsule of QS with a dose of 250 mg and one capsule of berberine with a dose of 500 mg orally. People with pulmonary artery peak systolic pressure >35 mm Hg. Timepoint: The first and last days of study. Method of measurement: Echocardiography. Arterial oxygen saturation percentage. Timepoint: The first and last days of study. Method of measurement: Pulse oximeter. High density lipoprotein. Timepoint: The first and last days of study. Method of measurement: laboratory test. Cholesterol. Timepoint: The first and last days of study. Method of measurement: laboratory test. Triglyceride. Timepoint: The first and last days of study. Method of measurement: laboratory test. Heart rate. Timepoint: The first and last days of study. Method of measurement: Pulse oximeter. The diameter of the right ventricular cavity at the end of systole (RVESd). Timepoint: The first and last days of study. Method of measurement: Echocardiography. The size of the diameter of the right ventricular cavity at the end of diastole. Timepoint: The first and last days of study. Method of measurement: Echocardiography. The percentage of the volume of blood that leaves the ventricle in each beat. Timepoint: The first and last days of study. Method of measurement: Echocardiography. Shortening Fraction. Timepoint: The first and last days of study. Method of measurement: Echocardiography. Pulmonary Velocity Acceleration time. Timepoint: The first and last days of study. Method of measurement: Echocardiography. Pulmonary vessel resistance. Timepoint: The first and last days of study. Method of measurement: Echocardiography. Tricuspid regurgitation velocity. Timepoint: The first and last days of study. Method of measurement: Echocardiography. The level of superoxide dismutase. Timepoint: The first and last days of study. Method of measurement: The relevant kit. The level of glutathione peroxidase. Timepoint: The first and last days of study. Method of measurement: The relevant kit. The amount of malondialdehyde. Timepoint: The first and last days of study. Method of measurement: The relevant kit. Interleukin 6. Timepoint: The first and last days of study. Method of measurement: Elisa kit. Tumor necrosis factor alpha. Timepoint: The first and last days of study. Method of measurement: Elisa kit. Creatinine. Timepoint: The first and last days of study. Method of measurement: laboratory test. Serum glutamic-pyruvic transaminase. Timepoint: The first and last days of study. Method of measurement: laboratory test. Alanine aminotransferease. Timepoint: The first and last days of study. Method of measurement: laboratory test. Serum glutamic oxaloacetic transaminase. Timepoint: The first and last days of study. Method of measurement: laboratory test. Kerman University of Medical Sciences Physiology research center Bam University of Medical Sciences Kerman University of Medical Sciences Physiology research center Approved 2023-02-06 Ethics Committee of Kerman University of Medical Sciences Medical Faculty, Kerman University of Medical Sciences Blvd. 22 Bahman, Kerman, Iran Kerman Kerman Iran (Islamic Republic of)