After approval, permission from the university ethic committee and the preparation of capsules containing extracts of medicinal plants in question, we referred to specialized clinics of Prophet Muhammad and Imam Ali of University of Medical Sciences, 80 type 2 diabetic patients after the detection, diagnoses and getting the consent were randomly assigned to 2 groups . In the both groups, patients will receive the routine medication needed to control their diabetes . In addition to these drugs, patients in the first group (control group), placebo, the second group received 3 capsules weighting 400 mg of the fruit of Berberis vulgaris extract daily and orally for 2 months in 3 meals. At baseline, one month after the start of the project and at the end of the study some blood biochemical tests and urine analysis will be done for all patients with.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016041727438N1
Registration date:2016-05-20, 1395/02/31
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-05-20, 1395/02/31
Registrant information
Name
Mohammad Rahimi Madiseh
Name of organization / entity
Shahrekord Medical University of Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 3333 5648
Email address
m_rahimi7@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University Of Medical Sciences
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2016-07-20, 1395/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Berberis Integrima on blood biochemical factors in patients with type 2 dibetes
Public title
Effects of Berberis Integrima on type 2 dibetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: diagnosis of type 2 diabetes patients; age between 30 to 60 years; fasting blood sugar ≥126mg / dl; venous plasma glucose 2 hours after ingestion of 75 g glucose ≥200mg / dl; not receiving insulin; HBA1C from 7 to 8.5 percent; duration of diabetes diagnosis be less than 10 years; only using the blood glucose lowering drugs. Exclusion criteria: age less than 30 and more than 60 years; insulin taking; smoking; chronic cardiovascular disease; chronic renal disease; triglycerides more than 500 mg / d; pregnancy; use of anticoagulant drugs (except aspirin); chronic liver disease other than fatty liver; advanced diabetic retinopathy; kidney failure; heart failure; hemorrhagic stroke; high and low work hypothyroidism.
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Shahrekord University Of Medical Sciences
Street address
Shahrekord University Of Medical Sciences, Kashani street, Shahrekord
City
Shahrekord
Postal code
8813833435
Approval date
2016-03-08, 1394/12/18
Ethics committee reference number
IR.SKUMS.REC.1394.304
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Fast blood suger
Timepoint
Baseline and after 2 months (end of the study)
Method of measurement
Blood sampling and blood glucose measurement
2
Description
HbA1C
Timepoint
Baseline and after 2 months (end of the study)
Method of measurement
Blood sampling and measurement of blood
3
Description
HDL-C
Timepoint
Baseline and after 2 months (end of the study)
Method of measurement
Blood sampling and measurement of blood
4
Description
LDL-C
Timepoint
Baseline and after 2 months (end of the study)
Method of measurement
Blood sampling and measurement of blood
5
Description
TG
Timepoint
Baseline and after 2 months (end of the study)
Method of measurement
Blood sampling and measurement of blood
6
Description
Total Chol
Timepoint
Baseline and after 2 months (end of the study)
Method of measurement
Blood sampling and measurement of blood
7
Description
VLDL
Timepoint
Baseline and after 2 months (end of the study)
Method of measurement
Calculation
8
Description
BUN
Timepoint
Baseline and after 2 months (end of the study)
Method of measurement
Blood sampling and measurement of blood
9
Description
cratinine
Timepoint
Baseline and after 2 months (end of the study)
Method of measurement
Blood sampling and measurement of blood
10
Description
AST
Timepoint
Baseline and after 2 months (end of the study)
Method of measurement
Blood sampling and measurement of blood
11
Description
ALT
Timepoint
Baseline and after 2 months (end of the study)
Method of measurement
Blood sampling and measurement of blood
12
Description
Patient weight
Timepoint
Baseline and after 2 months (end of the study)
Method of measurement
Using the scale
13
Description
length of patient
Timepoint
Baseline and after 2 months (end of the study)
Method of measurement
Using a tape measure fixed on the wall (on the scale)
14
Description
BMI
Timepoint
Baseline and after 2 months (end of the study)
Method of measurement
Calculation
Secondary outcomes
1
Description
HDL-C
Timepoint
Baseline and end of the study
Method of measurement
Blood and serum isolated from blood
2
Description
LDL-C
Timepoint
Baseline and end of the study
Method of measurement
Blood and serum isolated from blood
3
Description
Triglycerides
Timepoint
Baseline and end of the study
Method of measurement
Blood and serum isolated from blood
4
Description
Total cholesterol
Timepoint
Baseline and end of the study
Method of measurement
Blood and serum isolated from blood
5
Description
VLDL
Timepoint
Baseline and end of the study
Method of measurement
Computing
6
Description
BUN
Timepoint
Baseline and end of the study
Method of measurement
Blood and serum isolated from blood
7
Description
Cratinine
Timepoint
Baseline and end of the study
Method of measurement
Blood and serum isolated from blood
8
Description
AST
Timepoint
Baseline and end of study
Method of measurement
Blood and serum isolated from blood
9
Description
ALT
Timepoint
Baseline and end of the study
Method of measurement
Blood and serum isolated from blood
10
Description
Weight
Timepoint
Baseline and end of the study
Method of measurement
Using the same and standardized scale
11
Description
BMI
Timepoint
Baseline and end of the study
Method of measurement
Computing
Intervention groups
1
Description
Each diabetic patients in the control group, in addition to routine type 2 diabetic patients drugs, will receive daily 3 placebo capsules at 3 in the morning, noon and night .
Category
Placebo
2
Description
Each diabetes patient in the intervention group, in addition to routines medication of type 2 diabetic, will receive the daily 3 capsules of 400 mg, containing the extract of the fruit of Berberis vulgaris 3 times in the morning, noon and night for two months .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Imam Ali (AS)
Full name of responsible person
Mohammad Rahimi Madiseh
Street address
Shariati Street, Basij Square
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrekord University Of Medical Sciences
Full name of responsible person
Doctor Kamal Solati
Street address
Vice Chancellor for Research and Technology, Shahrekord University of Medical Sciences, Kashani street
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord 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
Shahrekord University Of Medical Sciences
Full name of responsible person
Mohammad Rahimi Madiseh
Position
PhD student
Other areas of specialty/work
Street address
Medical Plants Research Center, University of Medical Sciences, Rahmatiyeh
City
Shahrekord
Postal code
Phone
+98 38 3334 6722
Fax
Email
m_rahimi7@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Medical Plants Research center, Shahrekord University of Medical Sciences
Full name of responsible person
Mahmoud Rafieian-Kopaei
Position
professor
Other areas of specialty/work
Street address
Medical Plants Research center, Shahrekord University of Medical Sciences, Rahmatiyeh
City
Shahrekord
Postal code
Phone
+98 38 3334 6692
Fax
Email
rafieian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University Of Medical Sciences
Full name of responsible person
Mohammad Rahimi Madiseh
Position
ph.D student
Other areas of specialty/work
Street address
Medical Plants Research Center, University of Medical Sciences, Rahmatiyeh
City
Shahrekord
Postal code
8813833435
Phone
+98 38 3334 6722
Fax
Email
m_rahimi7@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)