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The effect of silymarin on inflammatory factors TNF-α and IL-1β and it’s probable relationship with cognitive function of Alzheimer’s patients.

Protocol summary

Study aim
Determine the effectiveness of silymarin in improving Alzheimer's patients and using it as an adjunct
Design
(There is only one group with 20 members in the study and all participants receive one kind of intervention) Given that silymarin is currently available as a natural treatment for liver problems in the market, the study is in Phase 4.
Settings and conduct
In the Neurology Clinic of Imam Reza Hospital in Kermanshah, according to criteria of Alzheimer's patients are selected, The study compared the status of patients before receiving silymarin and after receiving silymarin. Patients' drug regimens do not change at the time of entry, and only silymarin is added to their drug regimen.The diet is supposed to give them three tablets of 140 mg of silymarin daily for three months. Before and after receiving silymarin, the measurement of inflammatory factors IL-1β and TNF-α , is performed by ELISA kit and the MMSE test for evaluation of cognitive function in patients.
Participants/Inclusion and exclusion criteria
Patients who diagnosed with brain imaging and biochemical tests, Alzheimer's by a neurologist. inclusion criteria: Patients diagnosed with brain imaging and biochemical tests, Alzheimer's have been approved by a neurologist. Non-entry criteria: Epilepsy, heart failure, kidney failure, dialysis, hypothyroidism, vitamin B12 deficiency, mental illness, stroke, brain tumor, hydrocephaly, brain infections, pregnancy, excerbation of symptoms when patiants want to start silymarin
Intervention groups
Because the study is for the first time, 20 patients with Alzheimer's disease are included in a pilot study, and the study is evaluated before receiving silymarin and after receiving silymarin.
Main outcome variables
Score of cognitive function in Mini Mental State Examination; Serum levels of TNF-α inflammatory factor; Serum levels of IL-1β inflammatory factor

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20131219015870N3
Registration date: 2018-06-10, 1397/03/20
Registration timing: retrospective

Last update: 2018-06-10, 1397/03/20
Update count: 0
Registration date
2018-06-10, 1397/03/20
Registrant information
Name
Amir Kiani
Name of organization / entity
Kermanshah University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 83 3427 6482
Email address
akiani@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-24, 1396/12/05
Expected recruitment end date
2018-05-26, 1397/03/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of silymarin on inflammatory factors TNF-α and IL-1β and it’s probable relationship with cognitive function of Alzheimer’s patients.
Public title
The effect of silymarin on Alzheimer’s diseases
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who diagnosed with brain imaging and biochemical tests, Alzheimer's by a neurologist
Exclusion criteria:
epilepsy heart failure CKD hypothyroidism vitamon b 12 deficiency psychiatric desease stroke brain tumor hydrocephaly encephalitis pragnancy excerbation of symptoms when patiants want to start silymarin
Age
No age limit
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size: 22
Actual sample size reached: 20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Patients' drug regimens do not change at the time of entry, and only silymarin is added to their medication regimen.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee in the research of Pharmaceutical Sciences Branch of Islamic Azad University
Street address
Pharmaceutical Sciences Branch of Islamic Azad University, Yakhchal ave,Gholhak
City
tehran
Province
Tehran
Postal code
193956466
Approval date
2017-02-01, 1395/11/13
Ethics committee reference number
IR.IAU.PS.REC.1395.56

Health conditions studied

1

Description of health condition studied
Alzheimer disease
ICD-10 code
G30
ICD-10 code description
Alzheimer's disease

Primary outcomes

1

Description
Score of cognitive function in Mini Mental State Examination
Timepoint
At the beginning of the study (before the intervention) and 3 months later
Method of measurement
Mini Mental State Examination

2

Description
Serum levels of TNF-α inflammatory factor
Timepoint
At the beginning of the study (before the intervention) and 3 months later
Method of measurement
ELISA

3

Description
Serum levels of IL-1β inflammatory factor
Timepoint
At the beginning of the study (before the intervention) and 3 months later
Method of measurement
ELISA

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: daily 3 tablets of 140 mg silymarin for 3 months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam reza hospital
Full name of responsible person
Dr.Amir Kiani
Street address
Parastar Blvd, Imam reza hospital
City
kermanshah
Province
Kermanshah
Postal code
6714415333
Phone
+98 83 3427 6301
Email
k2004heidary@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Faculty of Pharmaceutical Sciences, Islamic Azad University of Medical Sciences, Tehran
Full name of responsible person
Dr gholamreza amin
Street address
Faculty of Pharmaceutical Sciences Islamic Azad University of Medical Sciences, Yakhchal Ave, Gholhak
City
Tehran
Province
Tehran
Postal code
193956466
Phone
+98 21 2264 0051
Email
gh_amin@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Faculty of Pharmaceutical Sciences, Islamic Azad University of Medical Sciences, Tehran
Proportion provided by this source
50
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
Persons

2

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr daryoush afshari
Street address
Parastar Blvd, Imam reza hospital
City
Kermanshah
Province
Kermanshah
Postal code
6714415333
Phone
+98 83 3427 6301
Email
afshari_d@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kermanshah university of Medical Science
Proportion provided by this source
50
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
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr amir kiani
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Toxicology
Street address
Parastar blvd, Kermanshah University Medical Science
City
Kermanshah
Province
Kermanshah
Postal code
6734667149
Phone
+98 83 3427 6493
Email
akiani@kums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr amir kiani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Toxicology
Street address
Parastar Blvd, Kermanshah University of Medical Science
City
Kermanshah
Province
Kermanshah
Postal code
6734667149
Phone
+98 83 3427 6493
Email
akiani@kums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Pharmaceutical Sciences, Islamic Azad University, Tehran Medical Branch
Full name of responsible person
Kiana Heydari
Position
Student of pharmacy
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmaceutical Sciences, Islamic Azad University, Yakhchal Ave, Gholhak
City
Tehran
Province
Tehran
Postal code
193956466
Phone
+98 21 2264 0051
Email
k2004heidary@gmail.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
The total potential data can be shared after unidentifiable people
When the data will become available and for how long
Start the access period one year after the print results
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
if The disclosure of requested information does not disturb other research related to this research
From where data/document is obtainable
By Dr. Amir Kiani's email Kermanshah University of Medical Sciences: akiani@kums.ac.ir
What processes are involved for a request to access data/document
The publisher send email to the principal responsible person, And the principal will respond to the publisher after checking, then this response will be passed from the publisher to the requesting person
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