Objective: Study on efficacy of Vaccinium arctostaphylos L. fruits extract in treatment of type 2 diabetic patients. Study population: type 2 diabetic patients attending the Karaj diabetes clinic. Inclusion criteria: type 2 diabetic patients, patients aged 40 to 60 years, patients with fasting glucose serum levels between 200 and 250 mg/dl, patients with glycosylated hemoglobin blood levels between 6.5 and 8 percents, patients whose blood glucose levels are not within the normal range despite using a combination of oral synthetic antidiabetic drugs. Exclusion criteria: patients with cardiac, renal or hepatic diseases, concomitant infections, pregnant women, women planning pregnancy, breast-feeding women. The intervention: The Caucasian whortleberry fruits extract is administered to a group of about 30 patients at the dose of one 500 mg capsule every 8 hours in addition to the oral synthetic antidiabetic drugs for 2 months and placebo is administered to another group of about 30 patients every 8 hours in addition to the oral synthetic antidiabetic drugs for 2 months. At the end of the study, the fasting glucose, 2 hours postprandial glucose and glycosylated hemoglobin blood levels in the drug group and the placebo group are determined and compared with each other.
General information
Acronym
SEVAFETDP
IRCT registration information
IRCT registration number:IRCT138902292288N3
Registration date:2010-06-12, 1389/03/22
Registration timing:prospective
Last update:
Update count:0
Registration date
2010-06-12, 1389/03/22
Registrant information
Name
Saeed Kianbakht
Name of organization / entity
Iranian Academic Center for Education, Culture and Research Institute of Medicinal Plants
Country
Iran (Islamic Republic of)
Phone
+98 26147640109
Email address
kianbakht@imp.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Institute for Islamic and Complementary Medicine
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2011-09-23, 1390/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study on efficacy of Vaccinium arctostaphylos (L.) fruits extract in treatment of type 2 diabetic patients
Public title
Study on efficacy of Caucasian whortleberry in treatment of type 2 diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: type 2 diabetic patients, patients aged 40 to 60 years, patients with fasting glucose serum levels between 200 and 250 mg/dl, patients with glycosylated hemoglobin blood levels between 6.5 to 8 percent, patients whose blood glucose levels are not within the normal range despite using a combination of oral synthetic antidiabetic drugs. Exclusion criteria: patients with cardiac, renal or hepatic diseases, concomitant infections, pregnant women, women planning pregnancy, breast-feeding women.
Age
From 40 years old to 60 years old
Gender
Both
Phase
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
Research Institute for Islamic and Complementary Medicine
Street address
Number 9, Pirnia Alley, Lalehzar Shomali Street, Jomhoori Eslami Avenue
City
Tehran
Postal code
1145847111
Approval date
2010-12-05, 1389/09/14
Ethics committee reference number
238/tm/p26
Health conditions studied
1
Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus type 2
Primary outcomes
1
Description
Fasting glucose serum level
Timepoint
2 months
Method of measurement
Medical laboratory (kit)
2
Description
Glycosylated hemoglobin blood level
Timepoint
2 months
Method of measurement
Medical laboratory (kit)
Secondary outcomes
1
Description
2 hours postprandial glucose serum level
Timepoint
2 months
Method of measurement
Medical laboratory (kit)
Intervention groups
1
Description
Caucasian whortleberry fruits extract, one 500 mg capsule every 8 hours in addition to the oral synthetic antidiabetic drugs for 2 months
Category
Treatment - Drugs
2
Description
One placebo capsule every 8 hours in addition to the oral synthetic antidiabetic drugs for 2 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of diabetes
Full name of responsible person
Dr. Behrouz Abasi Alaee
Street address
Number 448, Street Bareghan, Square Azadegan
City
Karaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Institute for Islamic and Complementary Medicine
Full name of responsible person
Dr. Dabaghian
Street address
Number 9, Pirnia Alley, Lalehzar Shomali Street, Jomhoori Eslami Avenue
City
Tehran
Grant name
238
Grant code / Reference number
238
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Institute for Islamic and Complementary Medicine
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
Institute of Medicinal Plants affiliated with the ACECR
Full name of responsible person
Dr. Saeed Kianbakht
Position
Ph.D. in pharmacology, assistant professor of the department of pharmacology and applied medicine in
Other areas of specialty/work
Street address
Institute of Medicinal Plants, Research Complex of the ACECR, End of Kavosh Boulevard, Kavosh Research Town, 55th Kilometer of Tehran-Gazvin Freeway
City
Karaj
Postal code
2378965473
Phone
+98 26 1476 4010
Fax
+98 26 1476 4021
Email
kianbakht@imp.ac.ir, skianbakht@gmail.com
Web page address
www.imp.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Institute of Medicinal Plants affiliated with the ACECR
Full name of responsible person
Dr. Saeed Kianbakht
Position
Ph.D. in pharmacology, assistant professor of the department of pharmacology and applied medicine in
Other areas of specialty/work
Street address
Institute of Medicinal Plants, Research Complex of the ACECR, End of Kavosh Boulevard, Kavosh Research Town, 55th Kilometer of Tehran-Gazvin Freeway
City
Karaj
Postal code
2378965473
Phone
+98 26 1476 4010
Fax
+98 26 1476 4021
Email
kianbakht@imp.ac.ir, skianbakht@gmail.com
Web page address
www.imp.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Institute of Medicinal Plants affiliated with the ACECR
Full name of responsible person
Dr. Saeed Kianbakht
Position
Ph.D. in pharmacology, assistant professor of the department of pharmacology and applied medicine in
Other areas of specialty/work
Street address
Institute of Medicinal Plants, Research Complex of the ACECR, End of Kavosh Boulevard, Kavosh Research Town, 55th Kilometer of Tehran-Gazvin Freeway
City
Karaj
Postal code
2378965473
Phone
+98 26 1476 4010
Fax
+98 26 1476 4021
Email
kianbakht@imp.ac.ir, skianbakht@gmail.com
Web page address
www.imp.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)