The present study was conducted to assess the effect of addition of a herbal drug; silymarine (livergol) to treatment regimen of diabetic patients with aim of better control of the disease.
Design
In the present study, patients with diabetes type II who attend in OPD clinic of Buali hospital, Qazvin, Iran will be included. They will be randomly divided into two groups and treated for 4 months. The first group will receive silymarine (livergol 70) 140 mg PO Bid. The second group will receive placebo with the same order.
Settings and conduct
The current study will be performed in OPD specialty clinic of Buali hospital, Qazvin, Iran. The participants will be sent to a predetermined pharmacy to receive their drugs randomly without knowing of its content.
Participants/Inclusion and exclusion criteria
Patients with diagnosis of diabetes type II, if provided informed consent for participation in the study and met inclusion criteria
Intervention groups
The control group: will receive basic medical management included instructions for proper diet and avoiding sedentary lifestyle, administration of insulin and oral hypoglycemic if clinically indicated+ placebo.
The study group: will receive basic medical management included instructions for proper diet and avoiding sedentary lifestyle, administration of insulin and oral hypoglycemic if clinically indicated+ silymarine.
Main outcome variables
FBS; HbA1C; lipid profile; BMI;
General information
Reason for update
Acronym
DM
IRCT registration information
IRCT registration number:IRCT20150204020951N4
Registration date:2018-01-21, 1396/11/01
Registration timing:prospective
Last update:2018-01-21, 1396/11/01
Update count:0
Registration date
2018-01-21, 1396/11/01
Registrant information
Name
Amir Mohammad Kazemifar
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3335 6696
Email address
amkazemifar@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Role of silymarine (livergol) in improving control indices of diabetes type II
Public title
Silymarine in control of diabetes type II
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
suffering from diabetes mellitus according to WHO criteria
at least 1 year duration of the disease
Exclusion criteria:
Presence of acute complications of DM (such as DKA)
presence of vascular complications of DM
presence of diabetic foot
Other major renal, hepatic, and heart diseases
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization using random numbers table
Blinding (investigator's opinion)
Double blinded
Blinding description
In the present study, patients who participate in the study will be blinded through administration of placebo. The researcher who will assess the out comes after complete of the study will be also blinded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of ًQazvin University of Medical Sciences
Street address
Research Deputy; Faculty of Medicine; Qazvin University of Medical Sciences; Bahonar Blvd.
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Approval date
2017-07-26, 1396/05/04
Ethics committee reference number
IR.QUMS.REC. 1396.204
Health conditions studied
1
Description of health condition studied
Diabetes Mellitus
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Fasting Blood Sugar
Timepoint
Before the study; two and four months later
Method of measurement
As reported by laboratory
2
Description
Lipid profile
Timepoint
Before the study; two and four months later
Method of measurement
As reported by laboratory
3
Description
HbA1c
Timepoint
Before the study; four months later
Method of measurement
As reported by laboratory
4
Description
Body Mass Index
Timepoint
Before the study; four months later
Method of measurement
By one of the researchers after measuring body weight and height
Secondary outcomes
empty
Intervention groups
1
Description
The control group: will receive basic medical management included instructions for proper diet and avoiding sedentary lifestyle, administration of insulin and oral hypoglycemic if clinically indicated+ placebo. The study group: will receive basic medical management included instructions for proper diet and avoiding sedentary lifestyle, administration of insulin and oral hypoglycemic if clinically indicated+ silymarine.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
OPD clinic of internal medicine, Buali hospital
Full name of responsible person
Bahram Mehrtash
Street address
Buali St.
City
Qazvin
Province
Qazvin
Postal code
3413786165
Phone
+98 28 3333 2930
Fax
+98 28 3335 6696
Email
dr.houshmand@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mahnaz Abbasi
Street address
Bahonar Blvd.
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3323 9253
Email
dr.mabbasi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Bahram Mehrtash
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Buali St.
City
Qazvin
Province
Qazvin
Postal code
3413786165
Phone
+98 28 3333 2930
Email
dr.houshmand@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Bahram Mehrtash
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Buali St.
City
Qazvin
Province
Qazvin
Postal code
3413786165
Phone
+98 28 3333 2930
Email
dr.houshmand@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Amir Mohammad Kazemifar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Forensic Medicine
Street address
Buali St.
City
Qazvin
Province
Qazvin
Postal code
3413786165
Phone
+98 28 3333 2930
Email
am.kazemifar@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data can be shared after removing the personal identifications.
When the data will become available and for how long
For six months after publication of results of the study
To whom data/document is available
Academic researchers in the field of medicine
Under which criteria data/document could be used
For design of the future related study or meta-analysis
From where data/document is obtainable
Via email of the corresponding author of the related article
What processes are involved for a request to access data/document
Within 30 days after the request and validation of the requesting person