Effect of Boswellia serrata on blood glucose, insulin, fasting insulin resistance index, fructose amine and lipid profile in type (II) diabetes patients
Objective: Purpose of this study, is investigation of antidiabetic and hypolipidemic effect of Boswellia serrata on type 2 diabetic patients.
Design: In this clinical trial study, sixty diabetic patients (males and females) in the age range of 30-48 years from Ahvaz Golestan hospital were investigated. The patients divided into 2 groups: 1. control group, 2. test group.
Setting and conduct: Test group received oral hypoglycemic agents and Boswellia serrata for 4 weeks (300 mg, three times, chewing and package form) administrated daily. blood samples before and after 4 weeks of it being done. control group randomized selected from Type 2 diabetic patients during trial, has been treated only with oral hypoglycaemic agents. blood samples before and after 4 weeks of it being done.
Participant including major eligibility criteria:
Including criteria to study: age range between 30-65 years; only use the oral hypoglycemic agents; type 2 diabetic patients.
Exclusion criteria to study: have Hepatic cirrhosis; pregnant and lactating women; active Proliferative Diabetic Retinopathy (PDR); Chronic Kidney Disease (CKD); Congestive Heart Failure (CHF); Myocardial Infarction (MI) in recent 6 mont.
Intervention: Boswellia serrata (300 mg, three times, chewing and package form) administrated daily and control group oral agents alone.
Main outcome measures (variables): investigation of below variables before and after treatment and comparison with control group.
1. Serum Lipid profiles
2. Serum insulin
3. Serum Fasting glucose
4. Insulin resistance (HOMA-IR)
5. Serum SGPT
6. Serum fructose Amine
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112258515N1
Registration date:2013-10-18, 1392/07/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-10-18, 1392/07/26
Registrant information
Name
Akram Ahangarpour
Name of organization / entity
Department of Physiology, Diabete Research Center and Physiology Research Center of Ahvaz Jundishapu
Country
Iran (Islamic Republic of)
Phone
+98 61 1333 0685
Email address
ahangarpur@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Diabetes Research Center, vice chancellore for research, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
Expected recruitment start date
2012-01-21, 1390/11/01
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Boswellia serrata on blood glucose, insulin, fasting insulin resistance index, fructose amine and lipid profile in type (II) diabetes patients
Public title
Effect of Boswellia serrata on diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Including criteria to study: age range between 30-65 years; only use the oral hypoglycemic agents; type 2 diabetic patients
Exclusion criteria to study: have Hepatic cirrhosis; pregnant and lactating women; active Proliferative Diabetic Retinopathy (PDR); Chronic Kidney Disease (CKD); Congestive Heart
Age
From 30 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
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 Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
Street address
45 plaque, postal code 61335189, Ethics committee of Ahvaz Jundishapur University of Medical Sciences, Department of physiology, Ahvaz, Iran.
Test group received oral hypoglycemic agents and Boswellia serrata for 4 weeks (300 mg, three times, chewing and package form) administrated daily. blood samples before and after 4 weeks of it being done.
Category
Treatment - Drugs
2
Description
control group randomized selected from Type 2 diabetic patients during trial,has been treated only with oral hypoglycaemic agents. blood samples before and after 4 weeks of it being done.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Research Center, vice chancellor for research, ahvaz jundishapur univercity of medical scie
Full name of responsible person
Hajia Shabazian
Street address
Ahvaz, Golestan Hospital, Western Esfand Street.
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Ahvaz Jundishapur University of Medical Sciences.
Full name of responsible person
Mostafa Feghhi
Street address
45 plaque, 61335189, Vice Chancellor for 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
Vice Chancellor for Research, Ahvaz Jundishapur 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
61335189, Department of Physiology, Diabetes Research Center and Physiology Research Center, Ahvaz J
Full name of responsible person
Akram Ahangarpour
Position
Associated prof
Other areas of specialty/work
Street address
45 plaque, 61335189, Department of Physiology, Diabetes Research Center and Physiology Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.
City
Ahvaz
Postal code
Phone
+98 916 608 0817
Fax
Email
akramahangarpour@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Physiology, Diabetes Research Center of Ahvaz Jundishapur University of Medical Scienc
Full name of responsible person
Akram Ahangarpour
Position
associated professor.
Other areas of specialty/work
Street address
45 plaque, 61335-189, Department of Physiology, Diabetes Research Center, Iran, Ahvaz, golestan street, Jundishapur University of Medical Sciences
61335-189, Department of Physiology, Diabetes Research Center, Iran, Ahvaz, golestan street, Jundishapur University of Medical SciencesJundishapur University of Medical Sciences