Determining the effect of curcumin-piperine supplementation on malondialdehyde levels in diabetic nephropathy patients
Determining the effect of curcumin-piperine supplementation on superoxide dismutase level in diabetic nephropathy patients
Determining changes in serum concentration of interleukin 6 in diabetic nephropathy patients receiving curcumin-piperine supplement compared to placebo
Design
Randomized, double-blind, placebo-controlled
Settings and conduct
randomized controlled trial that will be conducted in the clinic of Valiasr Hospital in Zanjan.60 patients will be selected who have type 2 diabetes and use oral antidiabetic drugs or insulin.
Participants/Inclusion and exclusion criteria
This study will be a randomized controlled trial that will be conducted in the clinic of Hazrat Waliasr Hospital in Zanjan. According to the previous study in this field, 60 patients will be selected who have type 2 diabetes and use oral antidiabetic drugs or insulin. The criteria for entering the study will be as follows:
• Age ≥18 years
• Type 2 diabetes and nephropathy
• Estimated glomerular filtration rate (eGFR) ≥60 ml/min per 1.73 square meters
• Controlled HTN (systolic). blood pressure [BP] <140 and diastolic blood pressure <90).
Exit criteria
History of gallstones, biliary obstruction (due to the adverse effect of curcumin on these cases), drug intolerance, or the patient's lack of cooperation and the use of chemotherapy drugs (such as methotrexate, paclitaxel, etc.), NSAIDs, antibiotics ( such as vancomycin) and herbal medicines that interfere with kidney function within two weeks before sampling.
Investigating the effect of curcumin-piperine supplementation on interleukin 6 and oxidative stress index in diabetic nephropathy patients
Public title
Investigating the effect of curcumin-piperine supplementation on interleukin 6 and oxidative stress index in diabetic nephropathy patients
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Age ≥18 years
Type 2 diabetes and nephropathy
Estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2
Controlled HTN (systolic). blood pressure [BP] <140 and diastolic blood pressure <90)
Exclusion criteria:
History of gallstones and biliary obstruction
Kidney transplant treatment
Autoimmune disease or malignancy
pregnancy
liver damage
History of organ transplantation
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random Allocation software was used to randomize the sample into two treatment and placebo groups. Output of mentioned software includes a table that shows the number of each patient is located in each group (intervention or placebo)
Blinding (investigator's opinion)
Double blinded
Blinding description
This study has been designed as double-blind and persons including participants, and investigators, were kept unaware of the treatment administered. Drug and placebo vials have similar packaging and labeling and all recorded data will be encoded in the questionnaires and software.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Zanjan University Of Medical Sciences
Street address
Valiasr hospital
City
zanjan
Province
Zanjan
Postal code
98
Approval date
2023-11-21, 1402/08/30
Ethics committee reference number
IR.ZUMS.REC.1402.162
Health conditions studied
1
Description of health condition studied
Type 2 diabetic patients with nephropathy
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
fasting blood suger
Timepoint
From the beginning of the study (before the start of the intervention) and 90 days after the start of the curcumin-piperine supplement
Method of measurement
Enzymatic method using a kit
2
Description
creatinine
Timepoint
From the beginning of the study (before the start of the intervention) and 90 days after the start of the curcumin-piperine supplement
Method of measurement
Enzymatic method using a kit
3
Description
urine albumine
Timepoint
From the beginning of the study (before the start of the intervention) and 90 days after the start of the curcumin-piperine supplement
Method of measurement
Turbidometry
4
Description
Malondialdehyde
Timepoint
From the beginning of the study (before the start of the intervention) and 90 days after the start of the curcumin-piperine supplement
Method of measurement
Eliza
5
Description
Superoxide dismutase
Timepoint
From the beginning of the study (before the start of the intervention) and 90 days after the start of the curcumin-piperine supplement
Method of measurement
eliza
6
Description
interleukin 6
Timepoint
From the beginning of the study (before the start of the intervention) and 90 days after the start of the curcumin-piperine supplement
Method of measurement
eliza
7
Description
HbA1C
Timepoint
From the beginning of the study (before the start of the intervention) and 90 days after the start of the curcumin-piperine supplement
Method of measurement
Enzymatic method using a kit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 500m/gram curcumin per day for 3 months
Category
Treatment - Other
2
Description
Control group: Placebo (500 mg of lactose) to be consumed daily for 3 months
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Negin Parsamanesh
Street address
Valiasr square
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 912 441 8600
Email
neginparsa.684@gmail.com
2
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Ayoub pezeshki
Street address
Valiasr square
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 912 141 7187
Email
dr.a.pezeshki@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Ayoub Pezeshki
Street address
Valiasr hospital
City
Zanjan
Province
Zanjan
Postal code
98
Phone
+98 912 141 7187
Email
dr.a.pezeshki@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
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
Mashhad University of Medical Sciences
Full name of responsible person
Amirhossein Sahebkar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
The end of Shahid Fakuri Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 915 122 1496
Email
amir_saheb2000@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Kamyar Mansouri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biostatistics
Street address
Mahdavi
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 912 441 8600
Email
kamyarmansori@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Negin Parsamanesh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Laboratory Medicine
Street address
Valiasr hospital
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 912 441 8600
Fax
Email
neginparsa.684@gmail.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
ecause the participant’s informations should remain confidental.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available