Study of the therapeutic effect of pomegranate seed in reducing fasting blood glucose, glycosylated hemoglobin, triglyceride and blood cholesterol in patients with type 2 diabetes
Determining the therapeutic effect of pomegranate seed in reducing fasting blood glucose, glycosylated hemoglobin, triglyceride and cholesterol levels in patients with type 2 diabetes
Design
Clinical trial with control group, with parallel groups,doubleا blind, randomized
Settings and conduct
This study was performed to control the patients' blood sugar in Yazd Diabetes Research Center by double-blind and randomized study by handing over the envelopes containing the sample or control sample to patients and selecting one of the envelopes by them and blinding the patient and the investigator.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of type 2 diabetes for one to ten years; Use of metformin and glibenclamide pills; Age of 30-60 years.
Exclusion criteria: Cardiovascular disease; Renal, liver, pulmonary disorder; inflammatory and chronic gastrointestinal diseases; thyroid dysfunction; lactose intolerance; insulin injection; body mass index (BMI)> 35 kg / m2; breastfeeding and pregnancy
Intervention groups
The subjects were type 2 diabetic patients who referred to the Yazd center of diabetes research . To select the samples, the records of diabetic patients in the research center were examined, patients who had inclusion criteria of the research Invited to participate in the study.
Main outcome variables
fasting blood glucose, glycosylatedhemoglobin, triglyceride and cholesterol.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170125032171N2
Registration date:2018-05-01, 1397/02/11
Registration timing:retrospective
Last update:2018-05-01, 1397/02/11
Update count:0
Registration date
2018-05-01, 1397/02/11
Registrant information
Name
Monire Seyed Hashemi
Name of organization / entity
Yazd University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 3223 8915
Email address
m.seiedhashemi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-07, 1396/06/16
Expected recruitment end date
2018-04-19, 1397/01/30
Actual recruitment start date
2017-09-07, 1396/06/16
Actual recruitment end date
2018-01-21, 1396/11/01
Trial completion date
empty
Scientific title
Study of the therapeutic effect of pomegranate seed in reducing fasting blood glucose, glycosylated hemoglobin, triglyceride and blood cholesterol in patients with type 2 diabetes
Public title
Study of the effect of pomegranate seed in diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of type 2 diabetes for between one and ten years
Taking metformin and glibenclamide tablets
Exclusion criteria:
Heart disease
Insulin injection
Body mass index (BMI) above 35 kg / m2
Breastfeeding
kidney problems
thyroid dysfunction
pregnancy
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The two envelopes, in which they are written as sample or control, are delivered to patients and person chooses one.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients and the investigator's individual and the analyst are not aware of the contents of the drug package used in each group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Yazd University of Medical Sciences
Street address
Bahonar field, Shahid Sadoughi University of Medical Sciences, Yazd
City
Yazd
Province
Yazd
Postal code
8951737915
Approval date
2016-09-05, 1395/06/15
Ethics committee reference number
IR.SSU.REC.1395.106
Health conditions studied
1
Description of health condition studied
Diabetes type 2
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Blood glucose
Timepoint
Before the intervention and 8 weeks after starting
Method of measurement
Measuring blood sugar level in the laboratory
2
Description
Glycosylated hemoglobin
Timepoint
Before the intervention and 8 weeks after starting
Method of measurement
Measuring blood sugar level in the laboratory
3
Description
Triglyceride
Timepoint
Before the intervention and 8 weeks after starting
Method of measurement
Measuring blood sugar level in the laboratory
4
Description
cholestrol
Timepoint
Before the intervention and 8 weeks after starting
Method of measurement
Measuring blood sugar level in the laboratory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group receives tea bags of 5 grams of pomegranate seed powder twice a day for 8 weeks.
Category
Treatment - Drugs
2
Description
Control group: This group receives tea bags of 5 grams of poly ethylene glycol twice a day for 8 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Diabetes Research Center
Full name of responsible person
Monire Seyed Hashemi
Street address
Bahonar Square
City
Yazd
Province
Yazd
Postal code
8951737915
Phone
+98 35 3728 0226
Email
diabet_center@yahoo.com
Web page address
http://ssu.ac.ir/cms/index.php?id=1287
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Monire Seyed Hashemi
Street address
Bahonar Square
City
Yazd
Province
Yazd
Postal code
8951737915
Phone
+98 35 3728 0226
Email
diabet_center@yahoo.com
Web page address
http://ssu.ac.ir/cms/index.php?id=1287
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
Monire Seyed Hashemi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Bahonar Square
City
Yazd
Province
Yazd
Postal code
8951737915
Phone
+98 35 3728 0226
Email
m.seiedhashemi@yahoo.com
Web page address
http://ssu.ac.ir/cms/index.php?id=1287
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Majid Emtiazy
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Diabetes Center; Bahonar Square
City
Yazd
Province
Yazd
Postal code
8951737915
Phone
+98 35 3728 0226
Email
MajidEmtiazi@rocketmail.com
Web page address
http://ssu.ac.ir/cms/index.php?id=1287
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Monire Seyed Hashemi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Bahonar Square
City
Yazd
Province
Yazd
Postal code
8951737915
Phone
+93 53 720 5711
Email
m.seiedhashemi@yahoo.com
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
The total potential data can be shared after unidentifiable people
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Data will only be available to researchers in academia and academia
Under which criteria data/document could be used
By observing ethical principles for scientific use
From where data/document is obtainable
Address: Yazd Bahonar Square, Diabetes Research Center
Phone: 00983537280226
Fax: 00983537280216
email : diabet_center@yahoo.com
What processes are involved for a request to access data/document