The aim of this study is evaluation of the curcumin effect on chronic kidney (CKD) and diabetes mellitus (DM) patients.
Design
The study will be done on the CKD and DM patients. Forty eligible patients will be divided two groups (A & B) (20 patients in each group) and received curcumin and placebo respectively for 8 weeks. The level of auditory threshold, latency and intervals of I, III and V waves at the beginning and end of the study are measured and examined by the auditory brainstem response test.
Settings and conduct
The study will be performed in clinics of Shiraz University of Medical Sciences. Using the randomization method of 4 permutation blocks with a ratio of 1: 1, all possible blocks are arranged. We give these blocks a random number. Using R software, a random number is selected and sampling is performed, and finally group A and B receive curcumin and placebo respectively for 8 weeks. The characteristics of the type and dose of drugs remain constant throughout the study. Each patient will receive an order number and the medication in pre-packaged bottles. All of curcumin and placebo capsules are the same color, weight, shape and size. Patients are followed up each week by two researchers by telephone to avoid side effects. The treatment process is kept secret from clinic researchers, laboratory staff and patients.
Participants/Inclusion and exclusion criteria
The study will be done on the CKD and DM patients. Exclusion criteria are mental illness, complementary medicine methods, use of antioxidants, aspirin and warfarin, pregnancy, breast feeding and gallstone.
Intervention groups
Group A: Patients will receive one 500 mg capsule (500 mg of turmeric extract with 475 mg of curcuminoid, Karen Company) and group B: Patients will receive one placebo capsule (containing starch) daily for 8 weeks.
Main outcome variables
Auditory threshold, Glomerular filtration rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210620051629N1
Registration date:2021-08-18, 1400/05/27
Registration timing:prospective
Last update:2021-08-18, 1400/05/27
Update count:0
Registration date
2021-08-18, 1400/05/27
Registrant information
Name
Aida Doostkam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3628 1528
Email address
doostkam@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The assessment of curcumin in comparison with placebo on the auditory neuropathy in chronic kidney disease and diabetes mellitus patients
Public title
The assessment of curcumin in comparison with placebo on the auditory neuropathy in chronic kidney disease and diabetes mellitus patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All chronic kidney and diabetic patients with definitive diagnosis of nephrologist and endocrinologist who have been ill for more than 6 months
All patients with chronic renal disease and diabetes with definitive diagnosis who have hearing impairment in the initial evaluation
All chronic renal and diabetic patients with definitive diagnosis with glomerular filtration rate less than 60
Exclusion criteria:
Use of aspirin and warfarin
Mental diseases
Usage of other complementary medicine methods
Pregnancy
lactation
Usage of other antioxidant drugs except Nephrovit pills
Having gallstones
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The method of permutation bloc randomization with quadri-bloces
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the investigator and the participant are not aware of the drug. Each patient in the experimental group receives a 500 mg capsule of curcumin daily for 8 weeks, and in the control group, each patient receives starch-containing capsules for 8 weeks. Each patient receives the medication in pre-packaged bottles. All placebo drugs and tablets are the same color, weight, shape, and size.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
ZAND street, Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2021-07-11, 1400/04/20
Ethics committee reference number
IR.SUMS.REC.1400.337
Health conditions studied
1
Description of health condition studied
Chronic kidney disease
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease (CKD)
Primary outcomes
1
Description
Hearing threshold based on auditory brain stem responses (ABR)
Timepoint
Before intervention, After intervention
Method of measurement
Minimum hearing threshold based on auditory brain stem responses (ABR)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Daily consumption of one capsule of 500 mg of turmeric extract (containing 475 mg of curcuminoid, Karen Company) for 8 weeks
Category
Treatment - Drugs
2
Description
Control group: Daily consumption of one starch capsule for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Nemazi hospital, Khalili hospital
Full name of responsible person
Aida Doostkam
Street address
ZAND Ave, Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3235 7282
Email
doostkam@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Abbas Rezaeianzadeh
Street address
ZAND Ave, Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Aida Doostkam
Position
MD. PhD. , Health Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
ZAND Ave, Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3235 7282
Email
doostkam@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Aida Doostkam
Position
MD. PhD. , Health Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
ZAND Ave, Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3235 7282
Email
doostkam@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Aida Doostkam
Position
MD. PhD., Health Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
ZAND street, Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3235 7282
Email
doostkam@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is 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
Title and more details about the data/document
Part of the data can be shared after unidentified
When the data will become available and for how long
6 months after publication
To whom data/document is available
Interested researchers in this field
Under which criteria data/document could be used
Using for research works
From where data/document is obtainable
Research and technology deputy
What processes are involved for a request to access data/document
Sending an Email to research and technology deputy.