Protocol summary

Summary
Target study: Hypoglycemic and hypolipidemic effect of Berberis vulgaris hydroalcoholic Root extract in patients with Type2 Diabetes. Our study was double-blind, Randomized and placebo controlled. Inclusion criteria: Age 20-65 years; HbA1C <8.5%; Fasting Blood Sugar <200; diagnosis of Diabetes less than 1 years; Only use oral blood glucose lowering drugs. Exclusion criteria: triglyceride More Than 500; pregnancy; Consumers of anticoagulants drugs (except Aspirin); chronic liver disease except fatty liver disease; Renal Failure; Heart failure; Hemorrhagic strokes; hypothyroidism and hyperthyroidism. In this study 84 patients divided into Block - random quaternary two groups ( in forty-two patients in addition to their prescibed drugs treated with Berberis vulgaris capsules 500 mg twice per day every twelve hours and in forty-two other patients in addition to their prescibed drugs received placebo capsules 500 mg twice per day every twelve hours for six weeks). at baseline of study Blood pressure, Body mass index, waist-to-hip ratio was measured and blood samples for laboratory tests include: fasting Blood Sugar,2hour post prandial, fructosamine, lipid profile, fasting blood insulin, Blood Urea Nitrogen, Creatinine, and liver enzymes tests were taken, then the indexes HOMA-IR and HOMA-β% was calculated. After sixth week all tests were performed again, and Hypoglycemic and hypolipidemic effect of Berberis vulgaris hydroalcoholic Root extract discussed

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201504264610N3
Registration date: 2015-05-03, 1394/02/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-05-03, 1394/02/13
Registrant information
Name
Foroogh Namjoyan
Name of organization / entity
School of pharmacy
Country
Iran (Islamic Republic of)
Phone
+98 61 1373 8380
Email address
f.namjooyan@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2014-03-06, 1392/12/15
Expected recruitment end date
2014-08-11, 1393/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The randomized.placebo controlled clinical trial of Berberis vulgaris hydroalcoholic root extract capsules on glycaemic and lipid parameters in type 2 diabetes mellitus patients
Public title
Effect of hydroalcoholic root extract of berberis vulgaris in patients with Type2 Diabetes.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 20-65 years; HbA1C <8.5; Fasting Blood Sugar <200; diagnosis of Diabetes less than 1 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; Renal Failure; Heart failure; Hemorrhagic strokes; hypothyroidism and hyperthyroidism
Age
From 20 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
Jundishapur University of Medical Sciences, Golestan Blvd
City
ahvaz
Postal code
Approval date
2014-01-11, 1392/10/21
Ethics committee reference number
ajums.REC.1392.285

Health conditions studied

1

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

Primary outcomes

1

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

2

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

3

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

Secondary outcomes

1

Description
Lipid profile
Timepoint
baseline, after six weeks
Method of measurement
Blood samples from patients, mg /dl

2

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

3

Description
Body Mass Index
Timepoint
baseline, after six weeks
Method of measurement
calculated as weight (kg)/height (m2)

Intervention groups

1

Description
Forty-two Patients in addition to previous medications, Berberis vulgaris root extract Capsule 500 mg twice per day, every twelve hours for six weeks.
Category
Treatment - Drugs

2

Description
Forty-two Patients in addition to previous medications, placebo Capsule 500 mg twice per day, every twelve hours for six weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes Clinic Department ,Golestan Hospital
Full name of responsible person
Dr.mehrnoosh zakerkish
Street address
Golestan Hospital Farvardin St,Golestan Blvd,
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz JundishapurUniversity of Medical Sciences
Full name of responsible person
Dr.Nader saki
Street address
Deputy of Research, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz JundishapurUniversity 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
Dr. Foroogh Namjooyan
Position
Ph.D, Assistant professor
Other areas of specialty/work
Street address
Pharmacognosy Department, School of Pharmacy, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Phone
+98 61 3373 8381
Fax
Email
namjoyan@yahoo.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
Dr. Foroogh Namjooyan
Position
Ph.D of pharmacognosy, pharmacognosy department, school of pharmacy
Other areas of specialty/work
Street address
Pharmacognosy Department, School of Pharmacy, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Phone
+98 61 3373 8381
Fax
Email
namjoyan@yahoo.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
Dr. Foroogh Namjooyan
Position
Ph.D
Other areas of specialty/work
Street address
Pharmacognosy Department, School of Pharmacy, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
00986133738381
Phone
+98 61 3373 8381
Fax
Email
namjoyan@yahoo.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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