1- Objectives: Offering treatments with better performance and fewer side effects in patients with ulcerative proctitis.
2- Design: This is a clinical trial that will be performed in Health Centers of the Babol University of Medical Science. All of the patients will be selected based on both inclusion and exclusion criterias.
3- Setting and conduct: Before starting the study of each case a complete historical and physical examination as well as laboratory tests such as CBC, Cr, LFT and U/A will be done. The patients are randomly divided to two groups with 30 patients in each.
4- Participants including major eligibility criteria: Inclusion criteria:pateints older than 15 years old that have ulcerative colitis upon endoscopic and histologic criteria; severity of disease should be at least 3 of 12. Exclusion criteria:hypersensitivity to salicilate ; active PUD; important liver,renal or heart disease; patients not respond to 5-ASA and on maintenance therapy with 5-ASA .
5- Intervention: The patients of the intervention group are treated by 1 g Mesalasine suppository daily while the control group will be treated by both 3 g oral Mesalasine and 1 g Mesalasine suppository each day. The patients will be visited after four weeks of staring the study. Then, the screening will be continued every 3 mounts until 1 year.
6- Main outcome variables:clinical, endoscopic, and histopathologic response to each treatment strategies.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201604307080N3
Registration date:2016-10-25, 1395/08/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-10-25, 1395/08/04
Registrant information
Name
Javad Shokri Shirvani
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1223 8284
Email address
drshokrij@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
university funding sources
Expected recruitment start date
2014-12-21, 1393/09/30
Expected recruitment end date
2016-09-20, 1395/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Combined oral and topical 5-ASA versus topical 5-ASA for the treatment of ulcerative proctitis.
Public title
Effect of mesalasine in treatment of distal inflammation of intestine.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Pateints older than 15 years old that have ulcerative colitis upon endoscopic and histologic criteria; severity of disease should be at least 3 of 12.
Exclusion criteria: Hypersensitivity to salicilate ; Active PUD; Important liver,renal or heart disease; Patients not respond to 5-ASA and on maintenance therapy with 5-ASA.
Age
From 15 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
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
Ethic committee of Babol University of Medical Sciences
Street address
Vice president of research, University of Medical Sciences , Ganjafrooz Street
City
Babol
Postal code
47176-41367
Approval date
2016-01-31, 1394/11/11
Ethics committee reference number
MUBABOL.REC.1394.307
Health conditions studied
1
Description of health condition studied
Ulcerative Colitis
ICD-10 code
K51
ICD-10 code description
Crohn disease of large intestine
Primary outcomes
1
Description
Clinical response to each therapy groups
Timepoint
4 weaks after startin study then every 3 month until 1 year
Method of measurement
Disease Activity Index, Simple Clinical Colitis Activity Index Questianaire
2
Description
Endoscopic response to each therapy groups
Timepoint
4 weaks after startin study then every 3 month until 1 year
Method of measurement
Disease Activity Index, Simple Clinical Colitis Activity Inde Questianaire
3
Description
Histopathologic response to each therapy groups
Timepoint
4 weaks after startin study then every 3 month until 1 year
Method of measurement
Disease Activity Index, Simple Clinical Colitis Activity Index Questianaire
Secondary outcomes
1
Description
Drug adverse reaction
Timepoint
4 weaks after starting of study then every 3 month until one yesr
Method of measurement
Questionnaire
2
Description
Compliance to each treatment strategy
Timepoint
4 weaks after starting of study then every 3 month until one yesr
Method of measurement
Questionare
Intervention groups
1
Description
Intervention group will be treated with mesalazine suppository500mg twice daily for one year.
Category
Treatment - Drugs
2
Description
Control group will be treated with oral mesalasin 500 mg two tablets three times daily and mesalasin suppositiry 500mg two times daily for one year.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Rouhani Hospital
Full name of responsible person
Aida Ghasempour
Street address
Internal Medicine Department, Ayatollah Rohani Hospital, Ganjafrooz street
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Babol University of Medical Sciences
Full name of responsible person
Ali Bijani
Street address
University of Medical Sciences, Ganjafroz Street, Babol
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Aida Ghasempour
Position
Internal Medicine Resident
Other areas of specialty/work
Street address
Internal Medicine Department, Ayatollah Rohani Hospital, Ganjafrooz street
City
Babol
Postal code
47176-47745
Phone
+98 11 3199 5926
Fax
+98 11 3219 0181
Email
Aida_gh1985@yahoo.com
Web page address
http://rohani.mubabol.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Aida Ghasempour
Position
Internal Medicine Resident
Other areas of specialty/work
Street address
Internal Medicine Mepartment, Ayatollah Rohani Hospital, Ganjafrooz street
City
Babol
Postal code
47176-47745
Phone
+98 11321995926
Fax
+98 11 3219 0181
Email
Aida_gh1985@yahoo.com
Web page address
http://rohani.mubabol.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Aida Ghasempour
Position
Internal Medicine Resident
Other areas of specialty/work
Street address
Internal Medicine Department, Ayatollah Rouhani Hospital, Ganjafrooz street
City
Babol
Postal code
47176-47745
Phone
+98 11321995926
Fax
+98 11 3219 0181
Email
aida_gh1985@yahoo.com
Web page address
http://rohani.mubabol.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)