Thirty diabetic Patients diagnosed by endocrinologist will be included in this study. Exclusion criteria are: co-existing other diseases, using special drugs and not being cooperative during research. Intervention group will take 5 gr of barberry fruit (3-4 teaspoon dissolved in 250 ml of water) two times a day for 2 month. Control group will take placebo. Glucose and insulin level will determine every month. Change of serum glucose and insulin level will compare before and after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138902063808N1
Registration date:2010-09-22, 1389/06/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-09-22, 1389/06/31
Registrant information
Name
Durdi Qujeq
Name of organization / entity
Department of Biochemistry, Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1222 9591
Email address
d.qujeq@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol University of Medical Sciences
Expected recruitment start date
2010-07-10, 1389/04/19
Expected recruitment end date
2012-07-10, 1391/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Barberry fruit in patients with diabetes type 2
Public title
Effect of barberry fruit in patients with diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with diabetes type 2. Exclusion criteria: co-existing other diseases, using special drugs and not being cooperative during research.
Age
To 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Babol Uinversity of Medical Sciences
Street address
Babol Uinversity of Medical Sciences, Ganj-afrooz Avenue
City
Babol
Postal code
4774547176
Approval date
2010-04-25, 1389/02/05
Ethics committee reference number
112
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E10-E14
ICD-10 code description
Diabetes mellitus
Primary outcomes
1
Description
Glucose
Timepoint
3 Months
Method of measurement
Biochemical lab Method
2
Description
HbA1c
Timepoint
3 months
Method of measurement
Biochemical lab Method
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 5 gr of barberry fruit (3-4 teaspoons dissolved in 250 ml of water) two times a day for 2 month
Category
Treatment - Drugs
2
Description
Control group: placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Babol University of Medical Sciences
Full name of responsible person
Dr. Zolykha Moazezy
Street address
Babol University of Medical Sciences
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol Uinversity of Medical Sciences
Full name of responsible person
Dr Mostefasadeh
Street address
Babol Uinversity of Medical Sciences
City
Babol
Grant name
دانشگاه علوم پزشکی بابل
Grant code / Reference number
112/30
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol Uinversity 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
Babol University of Medical Sciences
Full name of responsible person
Dr.Zolykha Moazezy
Position
MD
Other areas of specialty/work
Street address
Babol University of Medical Sciences
City
Babol
Postal code
4717647745
Phone
+98 11 1222 9591
Fax
+98 111226109
Email
z.moazzezi@mubabol.ac.ir
Web page address
www.mubabol.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol Uinversity of Medical Sciences
Full name of responsible person
Dr. Durdi Qujeq
Position
Associate Professor, PhD
Other areas of specialty/work
Street address
Babol Uinversity of Medical Sciences
City
Babol
Postal code
4774547176
Phone
+98 11 1222 9591
Fax
+98 11 1222 6109
Email
d.qujeq@mubabol.ac.ir
Web page address
www.mubabol.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Babol Uinversity of Medical Sciences
Full name of responsible person
Dr. Durdi Qujeq
Position
PhD
Other areas of specialty/work
Street address
Babol Uinversity of Medical Sciences
City
Babol
Postal code
4774547176
Phone
+98 11 1222 9591
Fax
+98 11 1222 6109
Email
d.qujeq@mubabol.ac.ir
Web page address
www.mubabol.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)