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The efficacy of chicoridin in improvement of ulcerative colitis symptoms and patients' self-reported well-being

Protocol summary

Study aim
Effect of chicoridin on ulcerative colitis
Design
randomized case-control clinical trial with two arms parallel study design on 54 patient
Settings and conduct
This is a randomized case-control clinical trial to compare the effects of chicoridin on clinical features of ulcerative colitis of patient referred to the gastroenterology clinic of Rasoul-e-Akram Hospital in the years 2019 and 2020. Patients will be randomized into two groups of chicoridin (three capsules of curcumin plus three grams of mesalamine daily for 8 weeks) and control group (three grams of mesalamine daily for 8weeks). At the ends of 4 and 8 weeks of treatment, the clinical responses -based upon the same criteria- will be evaluated and compared as needed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients 18-80 years old with mild to moderate ulcerative colitis based on Simple Clinical Colitis Activity Index Exclusion criteria: hospital admission; significant comorbidities including liver or kidney diseases; pregnancy; lactating women
Intervention groups
Oral chicoridin, three capsules per day in three divided doses before meals for 8 weeks plus standard treatment for each patient as needed which at least includes oral mesalamine tablets 500 mg, six tablets per day in three divided doses for 8 weeks.
Main outcome variables
The severity of ulcerative colitis

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190712044182N2
Registration date: 2019-12-30, 1398/10/09
Registration timing: registered_while_recruiting

Last update: 2019-12-30, 1398/10/09
Update count: 0
Registration date
2019-12-30, 1398/10/09
Registrant information
Name
Mohsen Masoodi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6655 4790
Email address
masoodi.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-21, 1398/09/30
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of chicoridin in improvement of ulcerative colitis symptoms and patients' self-reported well-being
Public title
Effect of chicoridin on ulcerative colitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients 18-80 years old with mild to moderate ulcerative colitis based on Simple Clinical Colitis Activity Index
Exclusion criteria:
hospital admission significant comorbidities including liver or kidney diseases pregnancy lactating women
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 54
Randomization (investigator's opinion)
Randomized
Randomization description
One of the randomization methods is using Excel's RANDBETWEEN function. This function allows us to generate random numbers. To produce a random number in this study with sample size 54, between two numbers 1 and 54 use the = Randbetween function (1,54). This function creates a column of random numbers between 1 and 54. The rand () function selects numbers with equal probability in this interval, so the chance of choosing any number in this interval is equal to the other numbers. This means that each patient is assigned to one of two treatments, respectively. These data are 54 patients randomly assigned to two treatments, 1 and 2 (27 patients each). The sample numbers in the first and second groups are as follows: (15, 6,37,41, 23, 43, 13,35,10, 12,51,28,4,17, 26,38,20,33,11, 48, 36, 39.49, 47.8 34.22) (30, 52,27,19,42,18,9,24,40,53,1, 44, 2, 50, 45, 46,3,7,32,25, 31,54,21, 14,29 16, 5)
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, next to Milad Tower, Hemat highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2019-02-23, 1397/12/04
Ethics committee reference number
IR.IUMS.REC.1397.1188

Health conditions studied

1

Description of health condition studied
Ulcerative colitis
ICD-10 code
K51
ICD-10 code description
Ulcerative colitis

Primary outcomes

1

Description
The efficacy of chicoridin in improvement of ulcerative colitis symptoms and patients' self-reported well-being according to the “Simple Clinical Colitis Activity Index” (SCCAI)
Timepoint
4weeks and 8 weeks after the intervention onset
Method of measurement
Interviews with patients and complete table of “Simple Clinical Colitis Activity Index” (SCCAI)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Oral chicoridin, three capsules per day in three divided doses before meals for 8 weeks plus standard treatment for each patient as needed which at least includes oral mesalamine tablets.
Category
Treatment - Drugs

2

Description
Control group: Standard treatment for each patient including at least oral mesalamine tablets.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Colorectal Research Center
Full name of responsible person
Mohsen Masoodi
Street address
Rasoul-e-Akram Hospital, Maziar Mansouri Ave., Sattarkhan Street
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳1
Phone
+98 21 6655 3582
Email
crrc.iums@gmail.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Seedabas Motavalian
Street address
Iran University of Medical Sciences, Next to Milad Tower, Hemat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
motevalian.a@ iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Mohsen Masoodi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Colorectal Research Center, Rasoul-e-Akram Hospital, Maziar Mansouri St., Sattarkhan
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 6655 3582
Email
masoodi.m@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohsen Masoodi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Colorectal Research Center, Rasoul-e-Akram Hospital, Maziar Mansouri St., Sattarkhan St.
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 6655 3582
Email
masoodi.m@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohsen Masoodi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Colorectal Research Center, Rasoul-e-Akram Hospital, Maziar Mansouri St., Sattarkhan St.
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 6655 3582
Email
masoodi.m@iums.ac.ir

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
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Information about the main consequences will be shared.
When the data will become available and for how long
Start the access period, 6 months after publication of results
To whom data/document is available
Physicians , patients with ulcerative colitis
Under which criteria data/document could be used
Published as an article
From where data/document is obtainable
mohsen masoodi masoodi47@yahoo.com
What processes are involved for a request to access data/document
mail will be sent to the main author or co-response, and in less than 2 week, the available data will send to the individual.
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