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IRCT20200522047538N1 IRCT 2022-09-26 Gorgan University of Medical Sciences Comparison of the effect of Hibiscus sabdariffa L. extract and thiazide on albuminuria in patients with type 2 diabetes Comparison of the effect of Hibiscus sabdariffa L. extract and thiazide on albuminuria in patients with type 2 diabetes 2022-09-23 anticipated 105 Complete https://irct.ir/trial/48615 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible patients will be assigned to the experimental and control groups using the randomized block method. For random allocation using blocks of 4, first by throwing 32 regular hexagons, a random sequence of 32 blocks of 4 will be generated from among the following blocks: AABB-ABAB-ABBA-BAAB-BABA-BBAA, Blinding description: All patients and doctors evaluating the interventions designed in the study or the outcomes after the intervention (internal medicine assistant and nephrology and blood pressure subspecialist) will not know about the group in which the patient is examined. All interventions in both groups will be designed similarly and the procedure will be the same on all samples in all groups. The drugs used will also be supplied in the same form and packaging so that it is not possible to identify the study group during the study process. 3 Type 2 diabetes. Intervention 1: Intervention group: 25 mg hydrochlorothiazide tablets daily and 40 mg valsartan tablets every 12 hours. Intervention 2: Intervention group: 420 mg hibiscus tablet every 12 hours morning and night. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: Access period starts 6 months after the results are published To whom: It will be available to researchers working in academic and scientific institutions Conditions: There are no special conditions. Where to obtain: Dr. Maryam Kiani Phone number :00989113778569 Email: kiani.m94@gmail.com How to obtain: The applicant should provide his / her study file and the purpose of receiving the data in the form of an email with his / her research file (research plan), then after 3 months the file will be provided to the person Comments:
public Dr.Maryam Kiani
2nd floor, 1st apartment, 12th Sardar street, Jangal street
Kordkoy Iran (Islamic Republic of) 4881864747 +98 17 3432 3594 kiani.m94@gmail.com Gorgan University of Medical Sciences scientific Dr.Saeid Amirkhanlou
Nephrologie's Clinic Department, Ground Floor, Shahid Sayad Shirazi Hospital, Sayad Shirazi Blvd., Bahonar Square, Gorgan, Iran
Gorgan Iran (Islamic Republic of) 4915663158 +98 17 3226 1175 drsam74ir@ymail.com Gorgan University of Medical Sciences Iran (Islamic Republic of) 40 to 70 years old2 Man or Non-pregnant woman Provide conscious written and verbal consent The patient should be admitted to the clinic with a diagnosis of type 2 diabetes confirmed Blood pressure above 130/80 mm Hg The person is willing and able to follow the study instructions and go to the clinic for a visit. 40 years 70 years Both Allergic to the plant Normal blood pressure (mm HgSBP ≤ 120; DBP ≤ 80 mm Hg) Stage two and above Patients with renal failure, coronary artery disease, heart failure .Pregnancy Any metabolic or malabsorption disease that may interfere with the absorption of hibiscus (such as celiac disease, chronic pancreatitis, etc.). Taking psychiatric medications (mood stabilizer, antidepressant, anti-anxiety or antipsychotic) E08.2 Diabetes mellitus due to underlying condition with kidney complications Treatment - Drugs Treatment - Drugs Intervention group: 25 mg hydrochlorothiazide tablets daily and 40 mg valsartan tablets every 12 hours Intervention group: 420 mg hibiscus tablet every 12 hours morning and night Urinary albumin. Timepoint: Albuminuria before the intervention and 3 months later. Method of measurement: Using a 24-hour urine collection test and examining the amount of protein and albumin excretion. Blood pressure. Timepoint: Blood pressure with a sphygmomanometer before the start of the intervention and three consecutive weeks after the start of the intervention and after the end of the intervention. Method of measurement: Blood pressure measurement is performed by an experienced and trained technician who is unaware of the intervention, in a blinded manner. According to the Kaplan protocol, the blood pressure of the patients after at least 5 minutes of rest in a sitting position for three consecutive weeks at a certain hour by It is measured by an experienced and trained technician. For this measurement, Richter's Nova model desktop mercury pressure gauge is used. Gorgan University of Medical Sciences Approved 2022-08-21 Ethics committee of Golestan University of Medical Sciences Vice President of Research, Golestan University of Medical Sciences, the beginning of Shast Kala Road, Hirkan Blvd., Gorgan Gorgan Golestan Iran (Islamic Republic of)