Diabetes is a common metabolic disease in the world that has many adverse effects. One of the best criteria for controlling this disease is HbA1c that shows the average of blood glucose in 2-3 past months. Gum Olibanum (from trees of the genus Boswellia) has been traditionally used in the treatment of various diseases such as diabetes. The goal of this study is the comparison of gum olibanum resin extract effect with placebo on the treatment of type 2 diabetes.Inclusion criteria is diabetic patients with FBS=140-200 mg/dl.Exclusion criteria are pregnant and nursing women; People under 18 years old and above 65 years old; cases of intensive diabetic; Using drugs which affect blood glucose like edible and positional Steroid; Diuretics drugs.This study has been designed as double-blined clinical trial on 86 patients with type 2 diabetes.The patients randomly will be divided to interventional and placebo groups.The groups will be treated with Gum olibanum (400 mg cap) and placebo tow times per day for 12 weeks,respectively. At the end of 12 weeks the FBS and HbA1c will be measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112078318N1
Registration date:2012-03-08, 1390/12/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-03-08, 1390/12/18
Registrant information
Name
Dr. Amir Ziaee
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 1336 0084
Email address
aazadmehr@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Qazvin University of Medical Sciences
Expected recruitment start date
2011-11-03, 1390/08/12
Expected recruitment end date
2012-08-02, 1391/05/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Gum Olibanum on FBS and Glycosilated Hemoglobine(HbA1c) in Type II Diabetic Patient
Public title
The Effect of Gum Olibanum on blood glucose
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Suffering from type II diabetic with fasting blood glucose 140-200 Exclusion criteria: Pregnant and nursing women; People under 18 years old and above 65 years old; In case of intensive diabetic; Using drugs which affect blood glucose like edible and positional Steroid; Diuretics drugs
Age
From 25 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
86
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
Qazvin University of Medical Sciences
Street address
Vice chancellor for research, Qazvin University of Medical Sciences, Shahid Bahonar blvd.
City
Qazvin
Postal code
Approval date
2011-04-27, 1390/02/07
Ethics committee reference number
د/20/2741
Health conditions studied
1
Description of health condition studied
Type II Diabetic
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
FBS level
Timepoint
After 12 Weeks of taking drug
Method of measurement
glucometer
2
Description
HbA1c level
Timepoint
After 12 Weeks of taking drug
Method of measurement
Laboratory kit
Secondary outcomes
empty
Intervention groups
1
Description
Gum Olibanum (400 mg cap) two times per day for 12 weeks
Category
Treatment - Drugs
2
Description
Placebo two times per day for 12 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
hospitals in Qazvin
Full name of responsible person
Dr.Amir Ziaee, ِِDr.Abbas Azadmehr
Street address
Metabolic Disease Research Center, Booali-Sina University Hospital
City
Qazvin
2
Recruitment center
Name of recruitment center
Metabolic Disease Research Center
Full name of responsible person
Street address
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Saeed Assefzadeh
Street address
Vice chancellor for research, Qazvin University of Medical Sciences, Shahid Bahonar blvd.
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Dr.Amir ziaee
Position
Associate Professor of Endocrinology, Immunology PhD, Assistant Professor of Immunology
Other areas of specialty/work
Street address
Qazvin Metabolic Disease Research Center, Boo-Ali Hospital, Boo-Ali St., Qazvin, Iran
City
Qazvin
Postal code
Phone
+98 28 1336 0084
Fax
+98 28 1332 6033
Email
aazadmehr@qums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Metabolic Diseases Research Center, Qazvin University of Medical Sciences
Full name of responsible person
Dr.Amir Ziaee, Dr.Abbas Azadmehr
Position
Associate Professor of Endocrinology, Assistant Professor of Immunology, PhD Immunology
Other areas of specialty/work
Street address
Qazvin Metabolic Disease Research Center, Boo-Ali Hospital, Boo-Ali St., Qazvin, Iran
City
Qazvin
Postal code
Phone
+98 28 1336 0084
Fax
+98 28 1332 6033
Email
aazadmehr@qums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Metabolic Diseases Research Center, Qazvin University of Medical Sciences
Full name of responsible person
Dr.Amir Ziaee, Dr.Abbas Azadmehr
Position
Associate Professor of Endocrinology, Immunology PhD, Assistant Professor of Immunology
Other areas of specialty/work
Street address
Qazvin Metabolic Disease Research Center, Boo-Ali Hospital, Boo-Ali St., Qazvin, Iran
City
Qazvin
Postal code
Phone
+98 28 1336 0084
Fax
+98 13326033
Email
aazadmehr@qums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)