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IRCT20191218045798N1 IRCT 2020-06-07 Tabriz University of Medical Sciences Effects of Iranian propolis supplementation on chronic kidney disease Effects of Iranian propolis supplementation on proteinuria, 24 hour urine, serum creatinine, prooxidant-antioxidant Balance, Glycemic indices, quality of life and blood pressure in patients with chronic kidney disease: a randomized, double-blind, placebo-controlled trial 2020-07-22 anticipated 44 Complete https://irct.ir/trial/48603 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study is a randomized, double-blinded, placebo-controlled clinical trial. Among patients with chronic kidney disease (CKD) referred to specialized clinics of Tabriz, 44 patients who met the inclusion criteria were selected by simple sampling. These patients were randomly allocated to intervention or control groups (each with 22 patients), and matching between groups was done based on age and whether or not they had diabetes, Blinding description: Randomization is performed by a person who has no involvement in the process of caring for or following up on patients. After random allocation, by using double-blind method patients are unaware of the type of intervention performed for each group. For blindness, at the beginning of the study, a set of cans containing propolis or placebo capsules are encoded by someone other than the researcher as A or B. Patients are followed up for three months, after which the blindness is broken. 3 chronic kidney disease (CKD). Intervention 1: Intervention group: Subjects in the intervention group received daily 250 mg Propolis extract containing 72 mg total amount of phenolic compounds (2 capsules containing 125 mg Propolis extract, 1 capsule before breakfast and 1 capsule before dinner) for 90 days. Propolis capsules are produced by Asal Shahdineh Golha Company in Isfahan and propolis extract is alcoholic. Intervention 2: Control group: whom in the control group received 1000 mg of placebo daily (Because the final weight of each propolis capsule is 500 mg) for 90 days. Placebo capsules are produced by Asal Shahdineh Golha Company in Isfahan. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Paniz Anvari fard
No.44, 6 meter bahar., mokhaberat street., 35 meter sina.,elgoli., Tabriz town
Tabriz Iran (Islamic Republic of) 5167717998 +98 41 3381 3665 panizanvari@yahoo.com Tabriz University of Medical Sciences scientific Paniz Anvari fard
No.44, 6 meter bahar., mokhaberat street., 35 meter sina.,elgoli., Tabriz town
Tabriz Iran (Islamic Republic of) 5167717998 +98 41 3381 3665 panizanvari@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) The tendency to participate in the study Having stage 2 or 3 CKD according to eGFR of 30-89 ml/min per 1.73 m2 Aged 20-80 years old 20 years 80 years Both BMI less than 18.5 or more than 35 kg/ m2 Kidney transplant recipients Pregnancy or breastfeeding Having any kind of allergy or asthma Receiving steroids or other immune system suppressors Taking herbals in the last 3 months Smoking, Being addicted, consuming alcohol or opioids Professional athletes Having chronic inflammatory disease (rheumatoid arthritis, IBD), severe depression, schizophrenia, severe liver failure, liver cirrhosis, cancers, severe infection Treatment - Drugs Placebo Intervention group: Subjects in the intervention group received daily 250 mg Propolis extract containing 72 mg total amount of phenolic compounds (2 capsules containing 125 mg Propolis extract, 1 capsule before breakfast and 1 capsule before dinner) for 90 days. Propolis capsules are produced by Asal Shahdineh Golha Company in Isfahan and propolis extract is alcoholic. Control group: whom in the control group received 1000 mg of placebo daily (Because the final weight of each propolis capsule is 500 mg) for 90 days. Placebo capsules are produced by Asal Shahdineh Golha Company in Isfahan Improvement in kidney function ( proteinuria, 24 hour urine, serum creatinine ). Timepoint: at the beginning and end of the study. Method of measurement: 24-hour urine collection to measure 24-hour urine volume and proteinuria, Jaffe's method for measuring serum creatinine. Prooxidant-antioxidant Balance. Timepoint: at the beginning and end of the study. Method of measurement: prooxidant-antioxidant Balance method. Glycemic indices ( FBS, HbA1c, insulin ) and HOMA-IR index. Timepoint: at the beginning and end of the study. Method of measurement: biochemical assessment. Quality of life. Timepoint: at the beginning and end of the study. Method of measurement: questionnaire. Blood pressure. Timepoint: at the beginning and end of the study. Method of measurement: Mercury sphygmomanometer. Tabriz University of Medical Sciences Approved 2020-05-18 ethics committee of tabriz university of medical sciences No.44, 6 meter bahar., mokhaberat street., 35 meter sina.,elgoli., Tabriz town Tabriz East Azarbaijan Iran (Islamic Republic of)