the affect of saffron solution enema on Ulcerative colitis activity
Design
The clinical trial has a control group with blind and two-way groups that randomly assign patients to the two groups will be done using graph pad software. The sample size was calculated using gpower software and considering the high effect rate (0.4) and considering the power of 80% and alpha error of 0.05, 52 people (26 people in each group were calculated. 60 people (30 patients in each group) will be studied.
Settings and conduct
The practical location of the project is Tabriz Medical School. Patients in the control group are prescribed Iranian mesalazine tablets 2 grams daily and saffron dye solution enema as a placebo in the amount of 50 cc daily for 4 weeks. The intervention group is prescribed 2 grams of mesalazine tablets and a solution of saffron solution as a solution of 300 mg of saffron in 50 cc of water daily for 4 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Patients with newly diagnosed disease or with recent recurrence who can accept and tolerate enema.
Exclusion criteria: 1. Patients with controlled disease
2. Patients who do not tolerate enema.
3. Patients with comorbidities
4. Pregnant or lactating patients
Intervention groups
In this randomized, double-blind study, 60 patients with ulcerative colitis were selected by available sampling and entered the study. These patients are randomly divided into two groups. Patients in the control group are prescribed Iranian mesalazine 2 g daily and saffron dye solution as a placebo in the amount of 50 cc daily for 4 weeks. The intervention group is prescribed 2 grams of mesalazine and a solution of saffron solution as a solution of 300 mg of saffron in 50 cc of water daily for 4 weeks.
Main outcome variables
The primary outcome in this study is the severity of the disease, which will be measured using the mayo score.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190701044062N5
Registration date:2021-04-03, 1400/01/14
Registration timing:retrospective
Last update:2021-04-03, 1400/01/14
Update count:0
Registration date
2021-04-03, 1400/01/14
Registrant information
Name
manouchehr khoshbaten
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 3010
Email address
mkhoshbaten@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2021-01-20, 1399/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of saffron enema with placebo in controlling the disease of patients with ulcerative colitis based on Mayo score
Public title
Effect of saffron solution on ulcerative colitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who's disease is diagnosed recently or recent relapce
Patients who can tolerate enema
Exclusion criteria:
Patients with good controlled disease
Patients who can't tolerate enema
Patients with associated disease: Crohn, Intermediate colitis, CMV, Pseudomembrano colitis, Heart failure, Renal failure, PSC
Age
No age limit
Gender
Both
Phase
0
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of patients to two groups will be done using graph pad software. Random numbers will only be available to the head nurse until the end of the study. Patients and specialists evaluating the severity of the disease and the statistical analyst will be blind to the allocation of individuals to study groups until the end of the study. And the desired solutions are marked with A and B and will be provided by the nurse.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and specialists evaluating the severity of the disease and the statistical analyst will be blind to the allocation of individuals to study groups until the end of the study
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
The central building of Tabriz University of Medical Science,Golgasht St.,Azadi St.
City
Tabriz
Province
East Azarbaijan
Postal code
5154751637
Approval date
2020-08-01, 1399/05/11
Ethics committee reference number
IR.TBZMED.REC.1399.480
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
Disease activity based on Mayo score
Timepoint
Assessment of disease activity at the beginning of the study and 28 days after the start of saffron enema solution
Method of measurement
Mayo Score
Secondary outcomes
1
Description
Frequent defecation
Timepoint
Evaluation of stool frequency at the beginning of the study and 28 days after starting saffron enema solution
Method of measurement
Mayo Score
2
Description
Rectal bleeding
Timepoint
Evaluation of rectal bleeding at the beginning of the study and 28 days after starting saffron enema solution
Method of measurement
Mayo score
3
Description
Endoscopic findings
Timepoint
Evaluation of endoscopic findings at the beginning of the study and 28 days after starting saffron enema
Method of measurement
Mayo score
Intervention groups
1
Description
Intervention group: The intervention group is prescribed 2 grams of mesalazine tablets and saffron solution as a solution of 300 mg of saffron in 50 cc of water, daily for 4 weeks and the severity of the disease Will be evaluated by usin.g mayo score before and after the study
Category
Treatment - Drugs
2
Description
Control group: The control group is prescribed 2 grams of mesalazine tablets and saffron color's solution as a solution of 300 mg of saffron color in 50cc of water, daily for 4 weeks and the severity of the disease will be elevated by using mayo score before and after the study.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Manouchehr Khoshbaten
Street address
Imam Reza Hospital Clinic, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5154751637
Phone
+98 41 3337 2088
Email
mkhoshbaten@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ata Mahmoodpour
Street address
Imam Reza Hospital Clinic, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5154751637
Phone
+98 41 3337 2084
Email
a.mahmoodpour@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Manouchehr Khoshbaten
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Reza Hospital Clinic, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5154751637
Phone
+98 41 3337 2088
Email
mkhoshbaten@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Manouchehr Khoshbaten
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Reza Hospital Clinic ,Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5154751637
Phone
+98 41 3337 2088
Email
mkhoshbaten@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Manouchehr Khoshbaten
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Reza Hospital Clinic, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5154751637
Phone
+98 41 3337 2088
Email
mkhoshbaten@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
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