Protocol summary

Study aim
The effect of Silymarin supplementation on lipid profile and fasting blood sugar and HbA1c in patients with type 2 diabetes
Design
A controlled, parallel-group, single-blind, randomized, phase II-III clinical trial in 48 patients. Using a block randomization approach.
Settings and conduct
The present study includes 48 adults with T2DM aged 30-68 years who referred to the Endocrinology and Metabolism Research Institute of Iran University of Medical Sciences in 2021.in intervention group three 140 mg pills per day were chosen as the supplementary dosage for Silymarin the control group were placed on a carbohydrate distribution diet for 12 weeks. The tablet was administered by an endocrinologist and the patient and the project's executor did not know that the supplement had received Silymarin, this study was a single-blind.
Participants/Inclusion and exclusion criteria
Age group 68-30 years Fasting plasma sugar more than 126 mg/dl Duration of the onset of the disease more than 2 years exclusion criteria؛ Cardiovascular disease, infectious diseases, kidney disease, thyroid disease Treatment with Silymarin 30 days before study - Taking chemical drugs and herbal supplements and nutritional supplements - Insulin therapy
Intervention groups
In diabetes, Silymarin reduces plasma glucose by reducing insulin resistance and repairing beta cells in the pancreas. Each patient in the silymarin group was given 3 capsules of 140 mg silymarin daily and a carbohydrate distribution diet also the control group for 12 weeks
Main outcome variables
in both silymarin and control groups after the study, significant reduction was seen in lipid profile and glycemic index in both. However, after adjusted for physical activity, duration of diabetic, drug use no significant difference was observed between the two groups for other investigated factors after 12 weeks of intervention.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230318057749N1
Registration date: 2024-02-24, 1402/12/05
Registration timing: retrospective

Last update: 2024-02-24, 1402/12/05
Update count: 0
Registration date
2024-02-24, 1402/12/05
Registrant information
Name
Samira Ferdowsi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3474 1908
Email address
samira.fer230@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-01, 1400/09/10
Expected recruitment end date
2022-05-22, 1401/03/01
Actual recruitment start date
2021-12-11, 1400/09/20
Actual recruitment end date
2022-07-16, 1401/04/25
Trial completion date
2022-07-16, 1401/04/25
Scientific title
The effect of Silymarin on the level of lipid profile and fasting blood sugar and HbA1c in patients with type 2 diabetes.
Public title
The effect of Silymarin in type 2 diabetes.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with type 2 diabetes referring to the clinic of the Endocrine Research Institute of Iran University of Medical Sciences Age group 30-68 years Fasting plasma sugar more than 126 mg/dl Duration of the onset of the disease more than 2 years
Exclusion criteria:
Pregnant and lactating women People less than 30 years old Following a special diet Suffering from cardiovascular disease, infectious diseases, kidney disease, thyroid disease Treatment with Sealy Marine in 30 days before the study Using chemical drugs and herbal supplements and nutritional supplements Insulin therapy
Age
From 30 years old to 68 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
Sample size
Target sample size: 60
Actual sample size reached: 48
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization: Simple randomization is one of the most popular methods used to implement the randomization process. In this method, there is a possibility of inequality in the number of people assigned to each group, especially in studies with a small sample size.
Blinding (investigator's opinion)
Single blinded
Blinding description
First, the case of diabetic patients whose ages were between 30-68 years old was examined by visiting the clinic of the Endocrine Research Institute of Iran University of Medical Sciences and coordinating with the relevant officials. Then they were selected by simple non-probability sampling (convenience sampling). The objectives of this research were fully explained to the subjects. If they are willing to cooperate, they were asked to read and fill out a written consent form and register in the project. The researcher gave the two control and intervention groups a diet plan and Silymarin tablets were prescribed by a senior endocrinologist, and the nutritionist and the project manager did not know which person received Silymarin supplements.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Faculty of Medical Sciences and Technologies, Islamic Azad University, Science a
Street address
No. 37, Shaghayegh Ave, South Shahran, Tehran
City
Tehran
Province
Tehran
Postal code
1478674871
Approval date
2021-11-30, 1400/09/09
Ethics committee reference number
IR.IAU.SRB.REC.1400.281

Health conditions studied

1

Description of health condition studied
Type 2 Diabetic
ICD-10 code
I Certain
ICD-10 code description
Chapter IV Endocrine, nutritional and metabolic diseases(E00-E90)

Primary outcomes

1

Description
lipid profile and Glycemic index
Timepoint
Measurement of lipid profile and glycemic index at the beginning of the study and after consumption of silymarin study
Method of measurement
laboratory kit

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Silymarin supplement use -control group: Diet intake-Type 2 diabetes patients took Silymarin supplement in the form of 140 mg capsules from Gol Daru company - 3 times a day for 12 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Endocrinology and Metabolism Research Institute, Iran University of Medical Sciences
Full name of responsible person
Samira Ferdowsi Sochelmaei
Street address
No. 37, Shaghayegh Ave, South Shahran, Tehran
City
Tehran
Province
Tehran
Postal code
1478674871
Phone
+98 11 3474 1908
Email
samira.fer230@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Vice President of Research and Technology, Islamic Azad University, Research Sciences Unit
Street address
At the end of Satari Highway, University Square, Hesarak Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4484 5205
Email
med@srbiau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Institute of Endocrinology and Metabolism Iran university
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Samira Ferdowsi Sochelmaei
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No. 37, Shaghayegh Ave, South Shahran., Tehran
City
Tehran
Province
Tehran
Postal code
1478674871
Phone
+98 11 3474 1908
Email
samira.fer230@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Samira Ferdowsi Sochelmaei
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No. 37, Shaghayegh., South Shahran., Tehran
City
Tehran
Province
Tehran
Postal code
1478674871
Phone
+98 11 3474 1908
Email
samira.fer230@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Samira Ferdowsi Suchelmaei
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No. 37, , Shaghayegh Ave, South Shahran Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1478674871
Phone
+98 11 3474 1908
Email
samira.fer230@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Clinical study report-Study protocol Only part of the data, such as information related to the main outcome, can be shared.
When the data will become available and for how long
The access period begins 6 months after the results are published.
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Researchers can see the main result of the study, including the results and review of the study.
From where data/document is obtainable
Phytotherapy Research Samira Ferdowsi
What processes are involved for a request to access data/document
The data will be shared after publication in the journal.
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