Determining the effectiveness of silymarin in patients with inflammatory bowel disease
Design
Clinical trial with a control group, parallel groups, double-blind, randomized, phase 3, on 40 patients. The randomization will be done by the random number table method through the website http//www.graphpad.com/quickcalcs/index.cfm.
Settings and conduct
This study will be conducted with the aim of determining the efficacy of silymarin in children suffering from inflammatory bowel disease in Akbar Mashhad Hospital. In the intervention group, silymarin tablets (Gol Daru Company) with a dose of 5 mg per kilogram in divided doses three times a day for three months will be used daily, and in the control group, a placebo will be used, similar to the intervention group. Disease symptoms will be evaluated at the beginning and end of the intervention through a questionnaire. This study is double-blind, the patients and those who evaluate the outcome are unaware of the type of drug received.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Inflammatory bowel disease
Exclusion criteria: The patient's unwillingness to visit the gastroenterology clinic regularly for regular examinations and check-ups
Intervention groups
Intervention group: Silymarin tablets (Gol Daro Company) with a dose of 5 mg/kg in divided doses three times a day for three months on a daily basis.
Control group: Three times a day placebo for three months on a daily basis
Main outcome variables
The main outcome variable will be inflammatory bowel disease symptoms.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101107005123N3
Registration date:2023-02-18, 1401/11/29
Registration timing:prospective
Last update:2023-02-18, 1401/11/29
Update count:0
Registration date
2023-02-18, 1401/11/29
Registrant information
Name
Hamidreza Kianifar
Name of organization / entity
Mashahd University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1801 2469
Email address
kianifarhr@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of silymarin in patients with inflammatory bowel disease
Public title
Effect of silymarin in inflammatory bowel disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inflammatory bowel disease
Exclusion criteria:
The patient's unwillingness to visit the gastroenterology clinic regularly for regular examinations and check-ups
Presence of any other comorbidities
Age
From 5 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly divided into two groups receiving silymarin tablets and placebo. Random numbers table is used for randomization. In order to use random numbers table, it will be determined first to read the numbers in the table, then the numbers are considered for different groups. We put our hands on one of the numbers and move in one of the predetermined directions and assign the numbers to the desired groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients in the intervention group will use silymarin tablets and the control group will use placebo, similar to the intervention group. Patients and doctors who evaluate the outcome will be unaware of the type of drug received.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Vice chancellor for research, Mashhad University of Medical Sciences, Daneshgah Ave, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
34591375
Approval date
2022-11-15, 1401/08/24
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1401.590
Health conditions studied
1
Description of health condition studied
Inflammatory Bowel Disease
ICD-10 code
K50-K52
ICD-10 code description
Noninfective inflammatory bowel disease
Primary outcomes
1
Description
Clinical Symptoms
Timepoint
Before the start of the study, one month and three months after the start of the intervention
Method of measurement
Questionnaire including abdominal pain, frequency of defecation, mobility and endoscopy findings
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Silymarin tablets (Gol Daro Company) with a dose of 5 mg/kg in divided doses three times a day for three months on a daily basis
Category
Treatment - Drugs
2
Description
Control group: Three times a day placebo for three months on a daily basis
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbar Hospital
Full name of responsible person
Fatemeh Amani
Street address
Akbar Hospital, Kaveh Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٧٧٨٩٧١۵٧
Phone
+98 51 3871 3801
Email
fatemehamaanii@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Majid Ghayouri Mobarhan
Street address
Vice chancellor for research, Mashhad University of Medical Sciences, Daneshgah Ave, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
34591375
Phone
+98 51 3841 1538
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mashhad University of Medical Sciences
Position
Fellows in Training
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Akbar Hospital, Kaveh Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٧٧٨٩٧١۵٧
Phone
+98 51 3871 3801
Email
fatemehamaanii@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Amani
Position
Fellows in Training
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Akbar Hospital, Kaveh Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٧٧٨٩٧١۵٧
Phone
+98 51 3871 3801
Email
fatemehamaanii@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Amani
Position
Fellows in Training
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Akbar Hospital, Kaveh Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٧٧٨٩٧١۵٧
Phone
+98 51 3871 3801
Email
fatemehamaanii@gmail.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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available