Protocol summary

Summary
The purpose of present study was to evaluate the effects of garlic on hyperglycemia, dislipidemia and hypertension in patients with type 2 diabetes mellitus. This 3 months randomized, double blind clinical trial was conducted on type 2 diabetic patients with newly diagnosed hyperglycemia (N = 60). Patients were selected from Kashan Diabetic Center, and were divided into two groups of 30 patients, they were given garlic tablet 400mg two tablets 3 times every day (six tablets daily). Each tablet contains of 1000μg Allicin or equal to 2gr fresh garlic. So that they were given 6μg Allicin or 2.4gr dry garlic powder equal to four raw garlic clove per day. The second group (30 persons)were given placebo tablets. Both groups were given diet and exercise plan.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138706091106N2
Registration date: 2008-10-12, 1387/07/21
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2008-10-12, 1387/07/21
Registrant information
Name
Zohreh Azarbad
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 2999
Email address
azarbad_zo@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
KASHAN UNIVERSITY OF MEDICAL SCIENCES
Expected recruitment start date
2005-05-22, 1384/03/01
Expected recruitment end date
2006-08-22, 1385/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Garlic in blood sugar of diabetetis patients type II
Public title
The effect of Garlic in blood sugar of diabetetis patients type II
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : The type 2 diabetic patients in range of 20-60 years old with FBS≥126 twice a day who never used blood suger lowering medicine.
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
kashan university of medical sciences
Street address
KASHAN UNIVERSITY OF MEDICAL SCIENCES,DEPUTY OF RESEARCH
City
KASHAN
Postal code
87155/111
Approval date
empty
Ethics committee reference number
8432

Health conditions studied

1

Description of health condition studied
Diabetes Mellitus type II
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
reduction in fasting blood sugar
Timepoint
baseline-2 week- 2 month - 3 month after intervention
Method of measurement
FBS test

Secondary outcomes

1

Description
hypoglysemia
Timepoint
baseline-2 weeks-2 months - 3 months after intervention
Method of measurement
blood test

2

Description
reduction in diastolic blood pressure
Timepoint
baseline-2 weeks-2 months - 3 months after intervention
Method of measurement
vital sgin(BP monitoring)

3

Description
reduction of LDL cholesterol
Timepoint
baseline-2 weeks-2 months - 3 months after intervention
Method of measurement
blood test

4

Description
reduction serum Triglyceride
Timepoint
baseline-2 weeks-2 months - 3 months after intervention
Method of measurement
blood test

Intervention groups

1

Description
Intervention group:garlic tablet
Category
empty

2

Description
Control group:placebo
Category
empty

Recruitment centers

1

Recruitment center
Name of recruitment center
Kashan Diabetic Center (Golabchi Clinic_
Full name of responsible person
Mohsen karimi dana MD
Street address
kashan-Emam street
City
kashan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Golam Ali Hamidi (Phd)
Street address
Kashan-Kashan University of Medical Sciences- Deputy of research
City
kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Ali Reza Ebadi MD
Position
Aassisstant Professor
Other areas of specialty/work
Street address
kashan-Beheshti Hospital
City
kashan
Postal code
87159/81151
Phone
+98 361555002125
Fax
+98 36 1555 8900
Email
sd ebadi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Ali Reza Ebadi MD
Position
Asistant Professor
Other areas of specialty/work
Street address
Kashan- Beheshti Hospital
City
kashan
Postal code
87159/81151
Phone
+98 36 1555 0021
Fax
+98 361558900
Email
sd Ebadi@yahoo.com
Web page address
kaums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zohreh Azarbad
Position
Midwifery MS. /Manager of Research Affairs
Other areas of specialty/work
Street address
kashan- Kashan University of Medical Sciences-Deputy of research
City
Kashan
Postal code
87155/111
Phone
+98 36 1555 2999
Fax
+98 36 1557 5057
Email
azarbad_zo@kaums.ac.ir
Web page address
kaums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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