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IRCT20210926052600N1 IRCT 2021-12-22 Gorgan University of Medical Sciences Comparison of the effect of Hibiscus sabdariffa L. extract and thiazide on treatment of hypertension in patients with mild chronic kidney disease : A randomized controlled clinical trial: double blinded Comparison of the effect of Hibiscus sabdariffa L. extract and thiazide on treatment of hypertension in patients with mild chronic kidney disease 2021-03-21 anticipated 64 Complete https://irct.ir/trial/60320 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be assigned to experimental and control groups using the random block method. To perform randomization using quadruple blocks, first by throwing 16 regular hexagons 16 times, a random sequence of 16 quadruple blocks will be generated from the following blocks: AABB-ABAB-ABBA-BAAB-BABA-BBAA In the sequence, there will be 32 of each letter A and B. According to the above block, 64 envelopes will be prepared and in each envelope, the letter A or B will be placed and will be numbered from 1 to 64. The person delivering the envelopes to the patients does not know the letters inside. Randomization is done by a statistics and methodology consultant who does not have access to patients and only he knows what is in each envelope. Patients who received the letter A will be in the intervention group and patients who received the letter B will be in the control group, Blinding description: The study is double-blind, so that all patients and physicians evaluating the interventions designed in the study or the consequences after the intervention (assistant of internal medicine and nephrology and hypertension) will not be aware of the patient grouping. The drugs used will be available in similar form and packaging so that it is not possible for anyone to identify the study group during the study process. 3 Patients with hypertension with mild renal failer. Intervention 1: In the first group, 25 mg of hydrochlorothiazide tablets and 40 mg of valsartan tablets daily every 12 hours for 3 months. Intervention 2: Control group: Control group: Group 2: 420 mg hibiscus tablets every 12 hours and 40 mg valsartan every 12 hours for 3 months. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Behdad Dehkhoda
Sayad Shirazi Hospital, Sayad Shirazi Boulevard, Bahonar Square, Gorgan
gorgan Iran (Islamic Republic of) 74394917867 +98 17 3220 2154 forwar.b1367@gmail.com Gorgan University of Medical Sciences scientific Dr. Saeid Amirkhanloo
Sayad Shirazi Hospital, Sayad Shirazi Boulevard, Bahonar Square, Gorgan
gorgan Iran (Islamic Republic of) 74394917867 +98 17 3220 2173 drsam74ir@ymail.com Gorgan University of Medical Sciences Iran (Islamic Republic of) 1. Non-pregnant man or woman 18 to 70 years old 2. Consent to participate in the study 3. A patient with confirmed clinical signs of hypertension with mild renal failure 4. Abnormal blood pressure (=> 130/80 according to AHA criteria) 5. Patient follow-up 18 years 70 years Both 1- Allergy to the plant 2- Normal blood pressure (mm HgSBP ≤ 120; DBP ≤ 80 mm Hg) / blood pressure below 100 and blood pressure => 160/100 3- Patients with diabetes mellitus, severe renal failure, coronary artery disease, heart failure, malignant hypertension [BP ≥ 180/110], etc.) 4- Study of changing antihypertensive drugs in patients 5- Systolic blood pressure below 100 during the study 6- Pregnancy 7. Any metabolic or malabsorption disease that may interfere with the absorption of hibiscus (such as celiac disease, chronic pancreatitis, etc.). 8- Use of psychiatric drugs (mood stabilizer, anti-depressant, anti-anxiety or anti-psychotic I12 Hypertensive chronic kidney disease Treatment - Drugs Treatment - Drugs In the first group, 25 mg of hydrochlorothiazide tablets and 40 mg of valsartan tablets daily every 12 hours for 3 months Control group: Control group: Group 2: 420 mg hibiscus tablets every 12 hours and 40 mg valsartan every 12 hours for 3 months. Patients' blood pressure changes,, albuminuria and proteinuria. Timepoint: Blood pressure at the beginning and 3 months after the intervention. Method of measurement: Based on laboratory Examination. Electrolytes. Timepoint: Electrolytes at the beginning and 3 months after the start of the intervention. Method of measurement: Based on laboratory Examination. Albuminuria and proteinuria. Timepoint: albuminuria, proteinuria, GFR according to MDRD formula. Method of measurement: Based on laboratory Examination. Gorgan University of Medical Sciences Approved 2021-08-15 Ethics committee of Golestan University of Medical Sciences Vice Chancellor for Research and Technology, Golestan University of Medical Sciences, at the beginning of Shast Kola Road, Hyrkan Street Gorgan Golestan Iran (Islamic Republic of)