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Hypoglycemic effects of aqueous extract of juglans regia in type 2 diabetic patients

Protocol summary

Summary
This study will be conducted as randomized placebo controlled clinical trial.The ethanolic extract of juglans regia (in combination with other medicinal plants has been studied for its hypoglycemic effects.We will assess the hypoglycemic effects of juglans regia leaves in type 2 diabetic patients and in comparison with placebo. Inclusion criterion is: type 2 diabetic patients on oral anti diabetic medications with FBS 140-250. Exclusion criteria are: insulin therapy, liver or kidney diseases, pregnancy and breast feeding. Patients will randomly assign in intervention and placebo groups; in intervention group, the capsules containing 250mg of the powder of aquous extract of Juglans regia leaves will be administered for three months. Capsules for placebo contain toast powder. Fasting Blood Sugar, two hr post prandial glucose and Glycosylated hemoglobin will assess before and after intervention; the results will be compare in two groups

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138803061957N1
Registration date: 2011-05-04, 1390/02/14
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-05-04, 1390/02/14
Registrant information
Name
Fataneh Hashem Dabaghian
Name of organization / entity
Research Institute for Islamic and Complementary Medicine
Country
Iran (Islamic Republic of)
Phone
+98 21 3395 0152
Email address
fatanehdabaghian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Research Institute for Islamic & Complementary Medicine
Expected recruitment start date
2011-03-31, 1390/01/11
Expected recruitment end date
2013-03-31, 1392/01/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
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Scientific title
Hypoglycemic effects of aqueous extract of juglans regia in type 2 diabetic patients
Public title
Hypoglycemic effects of aqueous extract of juglans regia in type 2 diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Type 2 diabetic patients receiving oral anti-diabetic medications with FBS 140-250 Exclusion criteria: insulin therapy, liver or kidney diseases, pregnancy, breast feeding.
Age
From 35 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
RICM ethics committee
Street address
9 pirnia alley,Lalehzar st.,Jomhury st.,Tehran, Iran
City
Tehran
Postal code
Approval date
2010-05-12, 1389/02/22
Ethics committee reference number
244

Health conditions studied

1

Description of health condition studied
Type II diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Endocrine and Metabolid Diseases

Primary outcomes

1

Description
Fasting Blood Sugar
Timepoint
Before and After intervention
Method of measurement
Biochemistry Lab test

Secondary outcomes

1

Description
2 Hr Post Prandial Glucose
Timepoint
Before and after intervention
Method of measurement
Biochemistry lab test

2

Description
HbA1c
Timepoint
Before and after intervention
Method of measurement
Blood chromatography

Intervention groups

1

Description
controle: toast powder capsule,TDS for 3 months
Category
Placebo

2

Description
Intervention group: capsules containing 250 mg powder of aquous extract of juglans regia,three times a day for 3 months.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasul Akram Hospital
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Institute For Islamic and Complementary Medicine
Full name of responsible person
Seid Ashrafoddin Gooshegir
Street address
9 pirnia alley, lalehzarno st.,jomhury avenue,Tehran ,IRAN
City
Tehran
Grant name
Grant code / Reference number
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
Research Institute for Islamic and Complementary Medicine
Full name of responsible person
Fataneh Hashem Dabaghian
Position
Research manager
Other areas of specialty/work
Street address
9 pirnia alley,Lalehzar st.,Jomhury st.,Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 3311 1619
Fax
Email
fatanehdabaghian@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Research Insstitute for Islamic and Complementary Medicine
Full name of responsible person
Fataneh Hashem Dabaghian
Position
community medicine specialist
Other areas of specialty/work
Street address
9 pirnia alley, Lalehzar st.,Jomhury st.,Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 3311 1619
Fax
Email
fatanehdabaghian@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Research Institute For Islamic &Complementary Medicine
Full name of responsible person
Fataneh Hashem Dabaghian
Position
Research expert
Other areas of specialty/work
Street address
9Pirnia,Lalehzarno st,Jomhury Av,Tehran,Iran
City
Tehran
Postal code
1145847111
Phone
+98 33111619
Fax
+98 33116726
Email
fataneh.dabaghian@yahoo.com
Web page address

Sharing plan

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