Purpose: Effect of garlic tables on glucose, lipid profile. visfatin and leptin in patients with diabetes type . Design: randomized, double-blind, placebo-controlled Inclusion Criteria for Control and Intervention group: 1. the age should be between 20 to 60 years 2. Have diabetes and their disease have been diagnosed since 5 years ago. Exclusion Criteria for Control and Intervention group: 1.Individuals who did not consume less than 80 percent of the garlic tablets 2.Individuals who did changed the dosage of the drug intake .The sample size for study is 50 patients. Duration of intervention: 12 weeks. Intervention: Garlic pills in the intervention group and the placebo in the control group. Outcome of current study: Effect of garlic tablet on FBS, HbA1C, lipid profile, Leptin and Visfatin
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014070813160N4
Registration date:2014-11-22, 1393/09/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-11-22, 1393/09/01
Registrant information
Name
Shima Dehghan
Name of organization / entity
Yazd Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1624 5453
Email address
sh.dehghan@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
University of Medical Sciences, Yazd
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2014-08-30, 1393/06/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of garlic tables on glucose,lipid profile . visfatin and leptin inpatients with diabetes type 2
Public title
Effect of garlic tables on with diabetes type 2
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria for Control and Intervention group : age between 20 to 60 years ; have diabetes and their diabetes have been diagnosed for 5 years.
Exclusion Criteria for Control and Intervention group : Disorders and diseases of the kidney, liver, heart - cardiovascular, blood pressure, thyroid and cancer ; Taking vitamin supplements or antioxidant in recent months ; Pregnancy and lactation ; insulin injections ; Smoking during the last 5 to 6 years ; Participation in another research project ; less than 80 percent of people who took garlic tablets ; People who have a change in the type and dose of your medication
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Random allocation
software
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee Yazd University of Medical Sciences
Street address
Emam Hossein square . Yazd
City
Yazd
Postal code
Approval date
2013-04-21, 1392/02/01
Ethics committee reference number
34128/1/17/ت
Health conditions studied
1
Description of health condition studied
Diabetes mellitus type 2
ICD-10 code
E10, E11,
ICD-10 code description
Diabetes mellitus
Primary outcomes
1
Description
HbA1c
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
Enzymatic colorimetric( GOD-PAP)Photometric method for single point measurements
Secondary outcomes
1
Description
HDL
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
Enzymatic colorimetric( GOD-PAP)Photometric method for single point measurements
2
Description
LDL
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
Enzymatic colorimetric( GOD-PAP)Photometric method for single point measurements
3
Description
CHO
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
Enzymatic colorimetric( GOD-PAP)Photometric method for single point measurements
4
Description
TG
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
Enzymatic colorimetric( GOD-PAP)Photometric method for single point measurements
5
Description
Waist
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
Meter
6
Description
Blood pressure
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
Sphygmomanometer
7
Description
Leptin hormon
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
ELISA method
8
Description
Visfatin hormon
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
ELISA method
9
Description
Fasting blood glucose
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
Enzymatic colorimetric( GOD-PAP)Photometric method for single point measurements
Intervention groups
1
Description
Intervention group:Taking 3 tablets of 400 mg of garlic, for 12 weeks
Category
Treatment - Drugs
2
Description
Control group: Taking 3 placebo tablets at doses of 400 mg for 12 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital Endocrinology Center
Full name of responsible person
Dr Alireza Esteghamati
Street address
After Doctor Gharib St , at the end of the keshavarz Av. Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor Yazd University of Medical Sciences
Full name of responsible person
Dr Ehrampush
Street address
Emam Hossein Square ,Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
University of Medical Sciences, Yazd
Full name of responsible person
Mozafari doctor
Position
Supervisor
Other areas of specialty/work
Street address
Emam Hossein Square , Yazd
City
Yazd
Postal code
Phone
+98 35 1624 0691
Fax
Email
mozaffari.kh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Valiasr Hospital Indocrinology Center
Full name of responsible person
Dr Esteghamati
Position
Endocrinologist
Other areas of specialty/work
Street address
After Doctor Gharib St , at the end of the keshavarz Av. Tehran
City
Tehran
Postal code
Phone
+98 21 8841 7918
Fax
Email
mozaffari.kh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
University of Medical Sciences, Yazd
Full name of responsible person
Razieh Khademian Ravandi
Position
Student of Master Science
Other areas of specialty/work
Street address
22 Number , Eighteen alley, Nilufar St , Apadana St , sohrsvardi St , Tehran
City
Tehran
Postal code
Phone
+98 21 8876 8384
Fax
Email
KHADEMIANRAZIEH@YAHOO.COM
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)