Evaluation of the effect of silymarin on cholesterol triglyceride and BMI in patients with type 2 diabetes mellitus referring to endocrine clinic of Imam khomeini hospital Urmia
Evaluation of the effect of silymarin on cholesterol triglyceride and BMI in patients with type 2 diabetes mellitus referring to endocrine clinic of Imam khomeini hospital Urmia
Design
In this study ,50 eligible patients with type 2 diabetes mellitus refferd in the endocrinology clinic of Imam khomeini Hospital of Urmia are chosen.Patients will be randomly assigned into two groups of control and intervention ,each patient will have a special code.
Settings and conduct
Patients will be randomly assigned to either intervention or control group after obtaining informed consent. The control group will receive routine oral antidiabetic drugs and placebo and the intervention group will receive common oral antidiabetic drugs and 140 mg silymarin twice a day for 12 days. The researcher and the patients will not be informed about the allocation of patients to the intervention or control groups (double blind). Patients will be evaluated at the start of the study and the second month for LDL ,HDL, triglyceride ,total cholestrol and BMI, and the results will be recorded on the relevant chart.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
age between 30_65; diabetes diagnosis according to WHO standards (FBS>126 or 2hpp>200 or HbA1c>9%); having fasting blood sugar less than 250 mg/dl; history of diabetes mellitus more than one year; having informed consent. Exclusion criteria: insulin therapy, pregnancy and lactation; autoimmune and malignant diseases, taking medications that interfere with plasma levels of blood sugar; smoking; undergoing surgery
Intervention groups
The study will be conducted with the participation of two groups of patients with type 2 diabetes mellitus. The intervention group who will receive the routine anti diabetic treatment with silymarin and the control group who will receive routine anti diabetic treatment with placebo.
Main outcome variables
BMI and Lipid profile
General information
Reason for update
Acronym
ULS
IRCT registration information
IRCT registration number:IRCT20170814035697N4
Registration date:2019-10-06, 1398/07/14
Registration timing:retrospective
Last update:2019-10-06, 1398/07/14
Update count:0
Registration date
2019-10-06, 1398/07/14
Registrant information
Name
Hamdolah Sharifi
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3275 4992
Email address
sharifi.h@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2019-08-21, 1398/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of silymarin on cholesterol triglyceride and BMI in patients with type 2 diabetes mellitus referring to endocrine clinic of Imam khomeini hospital Urmia
Public title
Evaluation of the effect of silymarin on cholesterol triglyceride and BMI in patients with type 2 diabetes mellitus referring to endocrine clinic of Imam khomeini hospital Urmia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 30_65
Diagnose of diabetics according of WHO criteria FBS >126 mg/dl or 2hpp>200 mg/dl or HbA1c>9%
A history of DM is more than 1 year old
FBS<250
Conscious informed consent to participate in the study
Exclusion criteria:
Insulin therapy
for autoimmune diseases and cancer
Taking drugs that interfere with the level of plasma glucosesmoking
Smoking
Pregnancy and lactationcatching
Hospitalized or undergoing surgery
Age
From 30 years old to 65 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is that 46 letters A and 46 B characters are poured into a bag, and if a sample is chosen, a number is randomly taken out of the bag. If the letter A is the group receiving the silymarin, and if the letter B The control group was identified
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the patient, the person who performed the project, the relevant guidance teachers, and the patient's blind physician were kept so that none of them is aware of the type of drug (silymarin or placebo) by the patient.
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Street address
Urmia University of Medical Sciences;Resalat Ave;Jahad Blvd;Urmia;West Azerbijan Provine;Iran
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2018-12-04, 1397/09/13
Ethics committee reference number
332.Ir.umsu.rec.1397
2
Ethics committee
Name of ethics committee
Uremia University of Medical Sciences
Street address
Orjhans Alley ، Resalat Blvd,Urmia,Iran
City
Urmia
Province
West Azarbaijan
Postal code
571483734
Approval date
2018-12-04, 1397/09/13
Ethics committee reference number
Ir.umsu.rec.1397.
Health conditions studied
1
Description of health condition studied
BMI and Lipid profile in type 2 DM
ICD-10 code
ICD-10 code description
R4
Primary outcomes
1
Description
Lipid profile
Timepoint
Before and after of treatment
Method of measurement
Lab data
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: routin treatment +livergol tablets with a dose of 40 mg ,BID ,daily for patients with type 2 DM
Category
Treatment - Drugs
2
Description
Control group:routin anti diabetes treatment with placebo