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

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

This study is done at Tabriz University of Medical Sciences. After simple sampling and stratified randomized allocation and being double blind, the intervention is performed.

Inclusion criteria: • 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 Exclusion criteria: • 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 immune system suppressors • Taking herbals in the last 3 months • Smoking, Being addicted, consuming alcohol or opioids • Professional athletes • Having chronic inflammatory disease

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 and 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.

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

1) Elimination of proteinuria (Protein excretion greater than 300 mg/day) with microalbuminuria (Urinary albumin to creatinine ratio greater than 30 mg/g) or macroalbuminuria (Urinary albumin to creatinine ratio greater than 300 mg / g) from Inclusion criteria. 2) Changing the age range of 18-64 to 20-80 years in the inclusion criteria; According to the age group of CKD patients observed in the sampling process. Along with the addition of matching the intervention and placebo groups in terms of age as 20-60 and 60-80 years. 3) Elimination of insulin intake from the exclusion criteria according to the opinion of Dr. Mohammad Reza Ardalan, a nephrology consultant (as stated in the proposal, the two groups of intervention and placebo will be matched in terms of diabetes). 4) Changing the expected recruitment end date to 2021/10/22 due to current Covid-19 pandemic conditions *All the mentioned changes have been approved by the ethics committee of Tabriz University of Medical Sciences and have been registered.

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.

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.

There is no further information.