Evaluation of Curcumin's effect on inflammatory markers( Erythrocyte Sedimentation Rat, Interleukin-6, Ferritin, C-Reactive Protein) in End Stage Renal Disease patient under hemodialysis
Comparison of Interleukin-6, Erythrocyte Sedimentation Rate, Ferritin level and C-Reactive Protein level before and after consumption of curcumin in patients with End Stage Renal Disease under hemodialysis
Design
This study is a before and after clinical trial in which each study sample is considered as control group ( before intervention) and as case group( after intervention). Sample size is 42.
Settings and conduct
This study will be done in hemodialysis ward's Sina hospital of Tabriz medical Science university. Sampling method is convenience method.
Participants/Inclusion and exclusion criteria
Entry requirement: Patients with chronic renal failure under hemodialysis
No entry requirement: Patients with history of bleeding from fistula
Intervention groups
After selecting of samples, Interleukin 6 level, Erythrocyte Sedimentation Rate, C-Reactive Protein level and ferritin level will be analyzed.Then Curcumin tablet 47.5 mg will be prescribed daily for 4 months and at the end Interleukin 6 level, Erythrocyte Sedimentation Rate, C-Reactive Protein level and ferritin level will be analyzed again.
Main outcome variables
Interleukin 6 level, Erythrocyte Sedimentation Rate, C-Reactive Protein level and ferritin level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200613047751N1
Registration date:2020-07-05, 1399/04/15
Registration timing:prospective
Last update:2020-07-05, 1399/04/15
Update count:0
Registration date
2020-07-05, 1399/04/15
Registrant information
Name
Mohammad Ali Torabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3668 7845
Email address
torabim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Curcumin's effect on inflammatory markers( Erythrocyte Sedimentation Rat, Interleukin-6, Ferritin, C-Reactive Protein) in End Stage Renal Disease patient under hemodialysis
Public title
Evaluation of Curcumin's effect on inflammation in hemodialysis patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Interest to participate in the study
Suffering from chronic renal failure
Lack of consumption of nonsteroidal anti-inflammatory drugs
lack of consumption of Curcumin at least one month before study
Exclusion criteria:
Suffering from active cancer
History of cancer
Consumption of anti-coagulation drugs
Suffering of inflammatory and rheumatoid diseases
Suffering of active infection
History of bleeding through fistula
No consumption of 15 percent of tablets
Age
From 25 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Before intervention and 4 months after intervention
Method of measurement
ELISA test
2
Description
Erythrocyte sedimentation rate
Timepoint
Before intervention and 4 months after intervention
Method of measurement
Modified Westergren
3
Description
Serum's level c- reactive protein
Timepoint
Before intervention and 4 months after intervention
Method of measurement
Latex Agglutinasition
4
Description
Serum's level of ferritin
Timepoint
Before intervention and 4 months after intervention
Method of measurement
chemiluminescence
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Studying unites receive curcumin tablet orally once a day for 4 months. these tablets are curcuma brand of Dine company and have 475 mg curcumin.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hemodialysis ward of Sina hospital of Tabriz University of Medical Sciences
Full name of responsible person
Hamid Noshad
Street address
Sina hospital, Azadi Street
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3541 2101
Fax
+98 41 3541 2151
Email
hosp_sina@sina.tums.ac.ir
Web page address
http://www.sinahospital.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Samii
Street address
Third floor, Second building of Tabriz University of medical Sciencs, Gogasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3335 7310
Fax
+98 41 3334 4280
Email
research-vice@tbzmed.ac.ir
Web page address
https://researchvice.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
Ali BanagozarMohammadi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Toxicology
Street address
Central building of Tabriz University of Medical Science, Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3335 5921
Fax
+98 41 3335 9680
Email
alibanagozar@gmail.com
Web page address
https://www.tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Maryam Zaare Nahandi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Sina hospital, Azadi street
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3541 2101
Fax
+98 41 3541 2151
Email
dr_mzaare@yahoo.com
Web page address
https://sinahosp.tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Ali Torabi
Position
residency
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Sina hospital, Azadi street
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3541 2101
Fax
+98 41 3541 2151
Email
torabim@tbzmed.ac.ir
Web page address
https://sinahosp.tbzmed.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
All of the study variables will be shared without patient profiles
When the data will become available and for how long
From immediately after printing until a year later
To whom data/document is available
Researchers from scientific and research institutes
Under which criteria data/document could be used
Data will be usable just for checking methodology and data analysis methods without publication right
From where data/document is obtainable
Mohammad Ali Torabi
Address: central building of Tabriz university of medical science
Phone number:00989332718044
Email: torabim@tbzmed.ac.ir
What processes are involved for a request to access data/document
1.Send a Written request to Email address
2.Review the request by project partners within a week
3.Send requested information within 2 weeks from request time provided with the consent of partners