Comparison of the effect of oral zingiber officinale supplement and placebo on pre-oxidant-antioxidant balance and glycemic control in diabetic hemodialysis patients: A double blind randomized clinical trial
To determine the effect of oral zingiber officinale supplement on the Prooxidant-antioxidant balance, Glycemic varaiables and renal function indicators in hemodialysis patients with diabetes.
Design
Clinical trials have two intervention and control groups, with parallel, double blind, randomized, phase 3 on 44 patients. Eligible individuals will be randomly assigned to one of the intervention or control groups based on the blocks created by the RAS random allocation software.
Settings and conduct
The trial will be conducted at dialysis center of Imam Reza hospital affiliated to Tabriz University of Medical Sciences, Iran. All the patients will be randomly assigned to one of the two supplement or placebo groups.The boxes containing ginger and placebo capsules will be coded by the person responsible for preparing them, and the main investigators and the patients will be blinded to the type of supplement each group receives.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diabetic patients undergoing hemodialysis who have been on dialysis for at least 3 months; Two or three dialysis sessions a week; The duration of each session dialysis is 4 hours; Patients who desire to enter the study; Patients over 18 years of age
Non-Inclusion criteria: History of acute gastrointestinal disease; History of Thyroid disorders; History of gallstones; Consumption of fish oil supplement; Consumption steroid and non-steroidal anti-inflammatory drugs.
Intervention groups
Intervention group: will consume zingiber officinale, 4 capsules, daily. (placebo) control group: Take 4 capsules containing corn starch daily.
Main outcome variables
Prooxidant-antioxidant balance(PAB), Level of fasting blood sugar(FBS),Level of insulin ,HOMA-IR scores
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191109045382N2
Registration date:2020-07-06, 1399/04/16
Registration timing:registered_while_recruiting
Last update:2020-07-06, 1399/04/16
Update count:0
Registration date
2020-07-06, 1399/04/16
Registrant information
Name
Zohreh Ghoreishi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3333 1712
Email address
ghoreyshiz@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-09, 1398/11/20
Expected recruitment end date
2020-09-10, 1399/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of oral zingiber officinale supplement and placebo on pre-oxidant-antioxidant balance and glycemic control in diabetic hemodialysis patients: A double blind randomized clinical trial
Public title
The effect of oral zingiber officinale supplement in hemodialysis patients with diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetic patients undergoing hemodialysis who have been on dialysis for at least 3 months
Two or three dialysis sessions a week
The duration of each session dialysis is 4 hours
Patients who desire to enter the study
Patients over 18 years of age
Exclusion criteria:
History of acute gastrointestinal disease
History of Thyroid disorders
History of gallstones
Consumption of fish oil supplement
Consumption steroid and non-steroidal anti-inflammatory drugs
Consumption of Levothyroxine
Consumption of Warfarin
Consumption of antioxidant supplements
History of ginger allergy
Smoking
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible individuals will be randomly assigned to one of the intervention or control groups, which will be randomly assigned based on the blocks created by the RAS software.
Blinding (investigator's opinion)
Double blinded
Blinding description
In the present study, participants and researchers during the study did not know whether each individual would be in the intervention or control group. For blinding, ginger and placebo capsules will be similar in appearance, packaging and labeling. The capsules are prepared by the researcher with a capsule filling device. For this double blind study, at the start of the study, a set of bottles containing capsule is encoded A and B, by a person other than the researcher so that the researcher is not aware of the type of capsules received by each group.
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
Tabriz University of Medical Sciences, Attar Neyshabouri avenue, Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Approval date
2020-02-04, 1398/11/15
Ethics committee reference number
IR.TBZMED.REC.1398.1188
Health conditions studied
1
Description of health condition studied
Diabetic hemodialysis
ICD-10 code
E11.22
ICD-10 code description
Type 2 diabetes mellitus with diabetic chronic kidney disease
Primary outcomes
1
Description
Prooxidant-antioxidant balance (PAB)
Timepoint
At the beginning of the study and 8 weeks after intervention
Method of measurement
Measurement by biochemical method and by ELISA kit
2
Description
Level of fasting blood sugar (FBS)
Timepoint
At the beginning of the study and 8 weeks after intervention
Method of measurement
Measurement of fasting blood sugar (FBS) by enzymatic method
3
Description
Level of insulin
Timepoint
At the beginning of the study and 8 weeks after intervention
Method of measurement
Measurement of insulin by enzymatic method
4
Description
HOMA-IR scores
Timepoint
At the beginning of the study and 8 weeks after intervention
Method of measurement
Measurement of HOMA-IR score using formula
Secondary outcomes
1
Description
Serum urea levels
Timepoint
At the beginning of the study and 8 weeks after intervention
Method of measurement
Measurement of serum urea level by enzymatic method
2
Description
Serum creatinine level
Timepoint
At the beginning of the study and 8 weeks after intervention
Method of measurement
Measurement of serum creatinine level by enzymatic method
Intervention groups
1
Description
Intervention group: Patients in this group will take 4 ginger capsules 500 mg daily (prepared by the researcher or capsule filling machine) for 8 weeks.
Category
Treatment - Drugs
2
Description
Control group: In this group, patients take 4 corn starch capsules daily, which are prepared in the same shape and size as the drug capsules and will be consumed for 8 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Medical Research & Training Hospital
Full name of responsible person
Dr. Zohreh Ghoreyshi
Street address
Imam Reza Medical Research Training Center, Daneshgah street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3336 2117
Fax
Email
ghoreyshiz@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Mohammad Samiei
Street address
Vice Chancellor for Research, No 2 Central Building, Tabriz University of Medical Sciences, Daneshgah street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7581
Email
ghoreyshiz@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
Helya Rostamkhani
Position
M.Sc student of Clinical Nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Golgasht street, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3340 8619
Email
helyarostamkhani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Zohreh Ghoreyshi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Food Sciences, Golghast street, Attar Neishabouri street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3336 2117
Email
ghoreyshiz@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Zohreh Ghoreyshi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Food Sciences, Golghast street, Attar Neishabouri street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3336 2117
Email
ghoreyshiz@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
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
Title and more details about the data/document
Data collected for the primary outcomes will be shared.
When the data will become available and for how long
Accessibility to data is possible 8 months after publication.
To whom data/document is available
The data will only be available for people working in academic institutions.
Under which criteria data/document could be used
The data of the present study will only be accessible by other researchers, for conducting Meta analysis.
From where data/document is obtainable
Dr. Zohreh Ghoreyshi, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences Email: ghoreyshiz@tbzmed.ac.ir phone number: 0098 912 739 0799
What processes are involved for a request to access data/document
The applicator can send a request to the person responsible for the study by email and within 10 days the document will be sent to the requesting person.