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The effect of Berberis root active component (Berberine) on blood sugar control in patients with Type2 Diabetes.

Protocol summary

Summary
Target study:Hypoglycemic effect of Berberis Root active component (Berberine) in patients with Type2 Diabetes. our study Will be double-blind, Randomized and controlled -placebo. Inclusion criteria: Age 30-65 years; HbA1C 7-8.5; Fasting Blood Sugar 126 -200; diagnosis of Diabetes less than 10 years; Only use oral blood glucose lowering drugs. Exclusion critria: triglyceride More Than 500 ;pregnancy ; Consumers of anticoagulants drugs (except Aspirin);chronic liver disease except fatty liver disease; proliferative Diabetic retinopathy; Renal Failure; Heart failure; Hemorrhagic strokes; hypothyroidism and hyperthyroidism; treatment with Insulin. in this study 84 patients divided into Block - random quaternary Two groups (forty-two patients in addition to Previous drugs and new life style, Herbal Berberine capsules 500 mg twice per day every twelve hours and forty-two other patients in addition to previous drugs and new life, style placebo capsules 500 mg twice per day every twelve hours for four weeks is given). at baseline of study Blood pressure, height and Bady mass index calculated and 2hour post prandial, fasting Blood Sugar, fructosamine, lipid profile, fasting blood insulin, Blood Urea Nitrogen, Creatinine, and liver enzymes take sampling, then the indexes HOMA-IR, HOMA-β% will calculated. And after fourth week All tests were performed again, and Hypoglycemic effect of Berberine Will be discussed .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013040712933N1
Registration date: 2013-06-12, 1392/03/22
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-06-12, 1392/03/22
Registrant information
Name
Zahra Mehraban
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1320 9667
Email address
mehraban.z@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences.
Expected recruitment start date
2013-05-07, 1392/02/17
Expected recruitment end date
2013-06-07, 1392/03/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Berberis root active component (Berberine) on blood sugar control in patients with Type2 Diabetes.
Public title
Effect of Berberis root active component (Berberine) in patients with Type2 Diabetes.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 30-65 years; HbA1C 7-8.5; Fasting Blood Sugar 126 -200; diagnosis of Diabetes less than 10 years; Only use oral blood glucose lowering drugs . Exclusion critria: Fasting Blood Sugar More Than 200; HbA1C More Than 8.5 ;triglyceride More Than 500; pregnancy; Consumers of anticoagulants drugs (except Aspirin); chronic liver disease except fatty liver disease; proliferative Diabetic retinopathy; Renal Failure; Heart failure; Hemorrhagic strokes; hypothyroidism and hyperthyroidism; treatment with Insulin.
Age
From 30 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 84
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
Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Esfand St, Golestan Blvd .
City
Ahvaz
Postal code
6136845348
Approval date
2013-03-09, 1391/12/19
Ethics committee reference number
ETH-705

Health conditions studied

1

Description of health condition studied
Type 2 Diabet
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus

Primary outcomes

1

Description
Fasting Blood Sugar
Timepoint
baseline , after four weeks.
Method of measurement
Blood samples from patients, mg/dl

2

Description
2hpp( 2 hour post prandial)
Timepoint
baseline , after four weeks.
Method of measurement
Blood samples from patients, mg/dl

3

Description
Fructosamine
Timepoint
baseline , after four weeks.
Method of measurement
Blood samples from patients ,umol

Secondary outcomes

1

Description
Lipid profile
Timepoint
baseline , after four weeks.
Method of measurement
Blood samples from patients,Mg per deciliter

2

Description
Blood pressure
Timepoint
baseline , after four weeks.
Method of measurement
Manometer, mmHg

3

Description
Body Mass Index
Timepoint
baseline , after four weeks.
Method of measurement
Scale,Meter,Kg/m2

Intervention groups

1

Description
Intervention group: Forty-two Patients in addition to previous medications, a new lifestyle, Herbal Capsule Berberine 500 mg twice per day, every twelve hours for four weeks.
Category
Placebo

2

Description
Control group: Forty-two Patients in addition to previous medications, a new lifestyle, placebo Capsule 500 mg twice per day, every twelve hours for four weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes Clinic Department , Golestan Hospital
Full name of responsible person
Zahra Mehraban,MD
Street address
Farvardin St,Golestan Blvd, Golestan Hospital
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research Ahvaz University of Medical Sciences
Full name of responsible person
Mostafa Feghhi, MD
Street address
Esfand St, Golestan Blvd.
City
Ahvaz
Grant name
-
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research Ahvaz 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Zahra Mehraban, MD
Position
Resident of Internal Medicine
Other areas of specialty/work
Street address
Esfand St, Golestan Blvd.
City
Ahvaz
Postal code
6136845348
Phone
+98 61 1336 1984
Fax
+98 79 1555 3691
Email
Mehraban.z@ajums.ac.ir &Dr.mehraban90@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mrs Homeyra Rashidi , MD
Position
Associated Professor
Other areas of specialty/work
Street address
Esfand St, Golestan Blvd.
City
Ahvaz
Postal code
6136845348
Phone
+98 61 1336 1984
Fax
+98 79 1555 3691
Email
Mehraban.z@ajums.ac.ir &Dr.mehraban90@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Zahra Mehraban,MD
Position
Resident of Internal Medicine
Other areas of specialty/work
Street address
Golestan Boulevard , Esfand Street
City
Ahvaz
Postal code
6136845348
Phone
+98 61 1336 1984
Fax
+98 79 1555 3691
Email
Mehraban.z@ajums.ac.ir & DR.mehraban90@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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