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
Design
a randomized, double-blind, placebo-controlled trial
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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 and 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). • Aged 18-64 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 Insulin and immune system suppressors • Taking herbals in the last 3 months • Smoking, Being addicted, consuming alcohol or opioids • Professional athletes • Having chronic inflammatory disease
Intervention groups
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.
Main outcome variables
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
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191218045798N1
Registration date:2020-06-07, 1399/03/18
Registration timing:prospective
Last update:2020-06-07, 1399/03/18
Update count:1
Registration date
2020-06-07, 1399/03/18
Registrant information
Name
Paniz Anvari fard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3381 3665
Email address
panizanvari@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2020-10-21, 1399/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Effects of Iranian propolis supplementation on chronic kidney disease
Purpose
Treatment
Inclusion/Exclusion criteria
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 and 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)
Aged 18-64 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 Insulin, 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
Age
From 18 years old to 64 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
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 whether or not they had diabetes.
Blinding (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of tabriz university of medical sciences
Street address
No.44, 6 meter bahar., mokhaberat street., 35 meter sina.,elgoli., Tabriz town
City
Tabriz
Province
East Azarbaijan
Postal code
5167717998
Approval date
2020-05-18, 1399/02/29
Ethics committee reference number
IR.TBZMED.REC.1399.177
Health conditions studied
1
Description of health condition studied
chronic kidney disease (CKD)
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
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
Secondary outcomes
1
Description
prooxidant-antioxidant Balance
Timepoint
at the beginning and end of the study
Method of measurement
prooxidant-antioxidant Balance method
2
Description
Glycemic indices ( FBS, HbA1c, insulin ) and HOMA-IR index
Timepoint
at the beginning and end of the study
Method of measurement
biochemical assessment
3
Description
quality of life
Timepoint
at the beginning and end of the study
Method of measurement
questionnaire
4
Description
blood pressure
Timepoint
at the beginning and end of the study
Method of measurement
Mercury sphygmomanometer
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Specialized clinics of Tabriz University of Medical Sciences
Full name of responsible person
MohammadReza Ardalan
Street address
No.44, 6 meter bahar., mokhaberat street., 35 meter sina.,elgoli., Tabriz town
City
Tabriz
Province
East Azarbaijan
Postal code
5167717998
Phone
+98 41 3381 3665
Email
panizanvari@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
deputy of Research and Technology, Tabriz University of Medical Sciences
Street address
deputy of Research and Technology, Tabriz University of Medical Sciences, Azadi street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Paniz Anvari fard
Position
master of science student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No.44, 6 meter bahar., mokhaberat street., 35 meter sina.,elgoli., Tabriz town
City
Tabriz
Province
East Azarbaijan
Postal code
5167717998
Phone
+98 41 3381 3665
Email
panizanvari@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Paniz Anvari fard
Position
master sciences student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No.44, 6 meter bahar., mokhaberat street., 35 meter sina.,elgoli., Tabriz town
City
Tabriz
Province
East Azarbaijan
Postal code
5167717998
Phone
+98 41 3381 3665
Email
panizanvari@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Paniz Anvari fard
Position
master science student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No.44, 6 meter bahar., mokhaberat street., 35 meter sina.,elgoli., Tabriz town
City
Tabriz
Province
East Azarbaijan
Postal code
5167717998
Phone
+98 41 3381 3665
Email
panizanvari@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD