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IRCT20200516047465N1 IRCT 2020-08-09 Mazandaran University of Medical Sciences The effect of sweet almond on chronic renal failure Evaluation of the effect of sweet almond capsule on function of kidney and quality of life in patients with chronic renal failure 2020-08-05 anticipated 60 Complete https://irct.ir/trial/48318 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomization, a quadruple block randomization method is used. In this method, all permutations obtained from 2 groups are calculated as follows: 1) AABB 2) ABAB 3) ABBA 4) BABA 5) BAAB 6) BBAA Among them, using random number table, we will select samples in the following order. The selected permutation: 3, 1, 4, 5, 2, 6, 3, 1, 2, 5, 6, 4, 1, 6, 3 A is the intervention group and B is the control group. The advantage of this method is that the groups are equal, Blinding description: For blinding, the patient and attending physician responsible for evaluating patients and also the researcher will be unaware of the type of treatment for each group (drug or placebo). For this purpose, after randomization and division of patients into two groups, the drug and placebo are separated by code A or B, and then they are labled by the statistical consultant. In this way, the patient, the attending physician, and the researcher will not be aware of the type of treatment. Drug and placebo are similar in appearance, color and smell. 3 Condition 1: Chronic kidney disease, stage 2. Condition 2: Chronic kidney disease, stage 3. Intervention 1: The drug is made in faculty of pharmacy, Shahid Beheshti University of Medical Sciences. Intervention group will receive capsules, containing 350 mg of almond, twice a day; 30minutes before breakfast and 30 minutes before dinner. Both groups are treated for 8 weeks. Intervention 2: The placebo is made in faculty of pharmacy, Shahid Beheshti University of Medical Sciences. Control group will receive placebo capsules exactly according to the original medication, twice a day; 30minutes before breakfast and 30 minutes before dinner. Both groups are treated for 8 weeks. Yes - There is a plan to make this available What will be shared: Laboratory information When: Four months after printing the results To whom: Researchers working in academic and scientific institutions Conditions: Researchers working in academic and scientific institutions Where to obtain: s.meghdadi@mazums.ac.ir How to obtain: Email to the researcher Comments:
public Sedighe Meghdadi
Faculty of Iranian Medicine, next to Baghban Special Clinic, Khazar Boulevard
Sari Iran (Islamic Republic of) 4816895475 +98 11 3325 5545 sedighe.meghdadi@yahoo.com Mazandaran University of Medical Sciences scientific Mohammad Yousofpour
Faculty of Iranian Medicine, next to Baghban Clinic, Khazar Boulevard
Sari Iran (Islamic Republic of) 4816895475 +98 11 3324 3117 m.yousofpoor@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients with chronic kidney disease stage 2 and 3 Age range 18 to 75 years 18 years 75 years Both Clinically unstable Malignancy Heart Failure Previous diagnosis of primary hyperoxaluria History of calcium oxalate kidney stone Known allergy to almond Liver failure Pregnancy Inability to communicate Polycystic kidney disease Acute infectious disease N18.2 N18.3 Chronic kidney disease, stage 2 Chronic kidney disease, stage 3 Treatment - Drugs Placebo The drug is made in faculty of pharmacy, Shahid Beheshti University of Medical Sciences. Intervention group will receive capsules, containing 350 mg of almond, twice a day; 30minutes before breakfast and 30 minutes before dinner. Both groups are treated for 8 weeks. The placebo is made in faculty of pharmacy, Shahid Beheshti University of Medical Sciences. Control group will receive placebo capsules exactly according to the original medication, twice a day; 30minutes before breakfast and 30 minutes before dinner. Both groups are treated for 8 weeks. Glomerular filtration rate. Timepoint: Before and after the intervention. Method of measurement: Modification of Diet in Renal Disease (MDRD) formula. Serum creatinine. Timepoint: before and after the intervention. Method of measurement: Laboratory blood test. Blood Urea Nitrogen. Timepoint: before and after the intervention. Method of measurement: Laboratory blood test. 24-hour urine protein. Timepoint: before and after the intervention. Method of measurement: 24-hour urine evaluation. Serum Albumin. Timepoint: before and after the intervention. Method of measurement: Laboratory blood test. Serum uric acid. Timepoint: before and after the intervention. Method of measurement: Laboratory blood test. Serum potassium. Timepoint: before and after the intervention. Method of measurement: Laboratory blood test. Blood pressure. Timepoint: before and after the intervention. Method of measurement: Sphygmomanometer. Hemoglobin. Timepoint: before and after the intervention. Method of measurement: Laboratory blood test. Serum C-Reactive Protein (CRP). Timepoint: before and after the intervention. Method of measurement: Laboratory blood test. Lipid profile. Timepoint: before and after the intervention. Method of measurement: Laboratory blood test. Fasting blood sugar. Timepoint: before and after the intervention. Method of measurement: Laboratory blood test. Quality of Life. Timepoint: before and after the intervention. Method of measurement: The Short Form (36) Health Survey (SF-36). Mazandaran University of Medical Sciences Approved 2020-04-27 Ethics committee of Mazandaran University of Medical Sciences Faculty of Iranian Medicine, next to Baghban Special Clinic, Khazar Boulevard Sari Mazandaran Iran (Islamic Republic of)