Evaluation of curcumin effevtiveness in prophylaxis of cisplatin induced renal toxicity
Design
Control-controlled clinical trial with parallel, double-blind, randomized, phase 3 groups on 34 patients used the Excel software rand function for randomization.
Settings and conduct
This project has been carried out at Shahid Sadoughi Hospital in Yazd and Shahid Ramezanzadeh Radiation Center in Yazd. Patients in two groups of 17 receive curcumin or placebo every 12 hours.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients 18 to 80 years old to get started chemotherapy with Cisplatin
The patient satisfaction
Exclusion criteria: GFR less than 45ml / min
Evaluation of Curcumin effevtiveness in prophylaxis of Cisplatin induced renal toxicity
Public title
Evaluation of Curcumin effevtiveness in prophylaxis of renal toxicity
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients 18 to 80 years old to get started chemotherapy with Cisplatin
The patient satisfaction
Exclusion criteria:
Active infection
Heart failure
Liver failure
Taking other nephrotoxic drugs
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 34 patients are randomly divided into two treatment groups (A and B). Block random allocation method will be used for random allocation. In this study, 7 blocks of 5 are considered. The generated permutations include repeated letters A and B (eg ABAAB). These permutations are generated with the help of Random allocation software version 1. For this purpose, the list prepared by the software is from 1 to 34, which are arranged in 7 blocks of five regularly. To run this software output, we give the first qualified person number 1 and the last person will receive number 34. In order to be blind, the random allocation of this list is given to another person outside the study, and by sending a text message before assigning the type of treatment, the eligible person is asked according to the number, and thus the people enter the study. Also in the software output, both numbers 1 to 34 and permutations of the letters A and B can be seen.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study patients, clinical caregivers and outcome assessors were unaware of the type of medication patients were receiving. Patients in both groups received the medication in the same package
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yazd University of Medical Sciences
Street address
Shahid Sadoughi University of Medical Science,Shohadaye Gomnam Blvd,Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173143
Approval date
2019-03-10, 1397/12/19
Ethics committee reference number
IR.SSU.MEDICINE.REC.1398.081
Health conditions studied
1
Description of health condition studied
Nephrotoxicity caused by cisplatin injection
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Measurement of urinary protein NGAL (Neutrophil gelatinase-associated lipocalin) . In acute kidney damage, the protein is released from the damaged kidney cells after 2 hours and enters the urine.
Timepoint
Measurement of urinary NGAL two days before and two days after cisplatin injection
Method of measurement
Based on the ELISA diagnostic kit
2
Description
Measurement Mg Urinary Random
Timepoint
Two days before and two days after Cisplatin injection
Method of measurement
Laboratory data
3
Description
Measurement Ca Urinary Random
Timepoint
two Days before and two Days after Cisplatin injection
Method of measurement
Laboratory data
4
Description
Measurement Na Urinary Random
Timepoint
two Days before and two Days after Cisplatin injection
Method of measurement
Laboratory data
5
Description
Measurement K Urinary Random
Timepoint
two Days before and two Days after Cisplatin injection
Method of measurement
Laboratory data
Secondary outcomes
empty
Intervention groups
1
Description
Patients start taking curcumin capsules (500mg, Karen company) orally twice daily from two days before cisplatin injection and continue for 4 days.
Category
Prevention
2
Description
Control group:Patients start taking placebo capsules(Karen company) orally twice daily from two days before cisplatin injection and continue for 4 days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadughi hospital Yazd,Shahid Ramezanzadeh Radiotherapy Center, Yazd
Full name of responsible person
Hasanali vahedian. Masuod shabani .Mohammad ali broomand
Street address
Yazd, Safaieh, Shahid Ghandi Boulevard, Ibn Sina Street,Yazd Azadi Sq Shahid Mottahari Street
City
Yazd
Province
Yazd
Postal code
8917657961
Phone
+98 35 3725 1171
Email
shabanimasood@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Mirzaei
Street address
Shahid Sadoughi University of Medical Sciences Shohadaye Gomnan Blvd Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3820 3410
Email
b.heydari@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Behrooz Heydari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Sadoughi university of Medical Sciences,Shohadaye Gomnam Blvd,Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173143
Phone
+98 35 3820 3410
Email
b.heydari@ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Behrooz Heydari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Sadoughi University of Medical Sciences,Shohadaye Gomnam Blvd,Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173143
Phone
+98 35 3820 3410
Email
b.heydari@ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Behrooz Heydari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Sadoughi University of Medical sciences,Shohadaye Gomnam Blvd,Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173143
Phone
+98 35 3820 3410
Email
b.heydari@ssu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After nonrecognition, all data can be share
When the data will become available and for how long
6 months after publication
To whom data/document is available
All of researchers
Under which criteria data/document could be used
Nothing
From where data/document is obtainable
Behrooz Heydari email: b.heydari@ssu.ac.ir
What processes are involved for a request to access data/document
Request your information by email. The data will be sent after a week.