Evaluation of the effect of Berberis integerrima fruit extract on the indicators of glycemic control in type 2 diabetic patients: A Randomized Controlled Clinical Trial
To evaluate the efficacy of Barberry extract on blood glucose control indices in patients with type 2 diabetes
Design
A Randomized controlled clinical trial. All 60 people who meet the inclusion criteria of present Randomized Controlled Clinical Trial will be randomly divided into intervention and control groups. Block Randomization will be used for randomization.
Before entering the study, the study procedure will be fully explained to the individual and a consent form will be provided.
Settings and conduct
In present study, patients will be selected from those referring to Endocrinology and Metabolism Research Center of Isfahan University of Medical Sciences (Sedigheh Tahereh Research Center).
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Age between 18 and 80 years; Diagnosis of type 2 diabetes according to ADA criteria with disease duration of at least 2 years; Taking metformin; Glycosylated hemoglobin between 6.5% and 9%.
Non-inclusion criteria: Use of alcohol or other substances could be abused: Hepatic or renal disorder; Use of oral antidiabetic drugs increasing insulin secretion (sulfonylureas and repaglinide) and insulin products; pregnancy and lactation.
Intervention groups
Intervention group: Barberry syrup, 5 CC, twice daily for 2 months in addition to self medication.
Control group: Patient control for 2 months and following the patient's previous medication regimen.
Evaluation of the effect of Berberis integerrima fruit extract on the indicators of glycemic control in type 2 diabetic patients: A Randomized Controlled Clinical Trial
Public title
The effects of Berberis integerrima fruit extract on blood glucose
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 80 years old
Diagnosis of type 2 diabetes according to ADA criteria with disease duration of at least 2 years
Treatment with Metformin
Glycosylated hemoglobin (HbA1c) between 6.5 and 11%
Exclusion criteria:
Using alcohol and other substances which cab be abused
Hepatic or renal disorder
Use of oral antidiabetic drugs increasing insulin secretion (sulfonylureas and repaglinide) and insulin products
Pregnancy and lactation
Age
From 18 years old to 80 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
Block randomization: blocks of size 4 will be used, so that patients will be assigned to drug and control groups based on the determined sequence by the blocks.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib street, Azadi square
City
Esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-05-14, 1398/02/24
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.104
Health conditions studied
1
Description of health condition studied
Type 2 diabet melitus
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Fasting Blood Glucose
Timepoint
Before and After Intervention
Method of measurement
Laboratory Test
2
Description
Serum Insulin
Timepoint
Before and After Intervention
Method of measurement
Laboratory Test
3
Description
HbA1C
Timepoint
Before and After Intervention
Method of measurement
HPLC test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Berberis oral solution, 5 ml twice daily, for 8 weeks
Category
Treatment - Drugs
2
Description
Control group: without use of Berberis oral solution, monitoring will be done for 8 weeks.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences
Full name of responsible person
Rasool Soltani
Street address
Khorram street , Jomhouri Eslami square
City
Esfahan
Province
Isfehan
Postal code
8187698191
Phone
+98 31 3792 7067
Email
soltani@pharm.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Rasool Soltani
Street address
Isfahan University of Medical Sciences, Hezar Jarib street, Azadi square
City
Esfahan
Province
Isfehan
Postal code
81746-83461
Phone
+98 31 3786 5537
Email
soltani@pharm.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Rasool Soltani
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
No 20, Baqe Daryache street
City
Esfahan
Province
Isfehan
Postal code
8176776161
Phone
+98 31 3786 5537
Email
soltani@pharm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Rasool Soltani
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
No 20, Baqe Daryache street
City
Esfahan
Province
Isfehan
Postal code
8176776161
Phone
+98 31 3786 5537
Email
soltani@pharm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Rasool Slotani
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
No 20, Baqe Daryache street
City
Esfahan
Province
Isfehan
Postal code
8176776161
Phone
+98 31 3792 7067
Email
soltani@pharm.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD