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The effect of mesalazine in comparison with placebo in uncomplicated diverticulosis with abdominal symptoms

Protocol summary

Summary
In a prospective study of patients who underwent colonoscopy or barium enema due to chronic abdominal pain assessment and are based on clinical symptoms and colonoscopy and radiological diagnosis of diverticulosis for them to be raised and normal abdominal ultrasound, randomly assigned to one of the therapy or placebo-treated groups. Inclusion criteria, individuals 40 to 70 years and exclusion criteria, patients with a history of abdominal surgery, musculoskeletal diseases, spinal cord injury and inflammatory bowel diseases. The number of samples in each group of 60 people and a total of 120 people. In the therapeutic group, a dose of Mesalazine 1.5 gr per day, one week per month, for 3 months and in the placebo group, the placebo for one week per month for 3 months will be used. Doctors and researchers do not know the type of drug. Effectiveness and possible side effects of the medicine is collected on a monthly follow. Patients are followed after treatment, about the relief of abdominal pain, bloating, constipation, mucus discharge(primary outcome) and relapse rate and incidence of diverticulitis and bleeding and complications of treatment (secondary outcome). The two groups will be compared with statistical analysis.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201606237080N4
Registration date: 2016-07-04, 1395/04/14
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-07-04, 1395/04/14
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
Babol University of Medical Sciences
Expected recruitment start date
2016-06-30, 1395/04/10
Expected recruitment end date
2016-07-31, 1395/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mesalazine in comparison with placebo in uncomplicated diverticulosis with abdominal symptoms
Public title
Treatment of abdominal symptoms in non-complicated
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: the patients between 40 to 70 years old that have chronic abdominal pain and colonoscopy or barium enema are done for them and based on clinical symptoms and colonoscopy and radiology; the diagnosis of diverticulosis is arisen for them. Exclusion criteria: age below 40 and above 70; patients with history of abdominal surgery; musculoskeletal disease; spinal disorders; gallbladder stone; renal stone; bowel motility disease and inflammatory bowel disease.
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Babol University of Medical Sciences, Deputy of research & technology
Street address
University of Medical Sciences, Ganjafroz Street, Babol
City
Babol
Postal code
4717641367
Approval date
2015-09-08, 1394/06/17
Ethics committee reference number
MUBABOL.REC.1394.142

Health conditions studied

1

Description of health condition studied
diverticulosis
ICD-10 code
k57.3, k57
ICD-10 code description
Diverticular disease of intestine, Diverticular disease of large intestine without perforation or abscess, Diverticular disease of both small and large intestine without perforation or abscess, Diverticular disease of intestine, part unspecified, without

Primary outcomes

1

Description
Bloat
Timepoint
At the start of intervention, 1 month later, 2 months later, 3 months later
Method of measurement
questionnaire

2

Description
Mucus discharge
Timepoint
At the start of intervention, 1 month later, 2 months later, 3 months later
Method of measurement
Number of defecation in a week

3

Description
Constipation
Timepoint
At the start of intervention, 1 month later, 2 months later, 3 months later
Method of measurement
Number of defecation in a week

4

Description
Abdominal pain
Timepoint
At the start of intervention, 1 month later, 2 months later, 3 months later
Method of measurement
VAS( score 0 to 10)

Secondary outcomes

1

Description
Diverticulitis
Timepoint
At the start of the intervention, after 2 month of treatment
Method of measurement
Clinical symptoms and signs and CT scan

2

Description
Bleeding
Timepoint
At the start of the intervention, after 2 month of treatment
Method of measurement
See bleeding

Intervention groups

1

Description
3 Pills of mesalazine 500 mg in a day (1.5 gr daily) for 1 week in each month, for 3 months.
Category
Treatment - Drugs

2

Description
3 pills of placebo, daily, for 1 week in each month, for 3 months.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Care Centers of Babol University of Medical Science
Full name of responsible person
Maede Abdinzadeh
Street address
University of Medical Sciences, Ganjafroz Street, Babol
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
Maede Abdinzade
Position
Internal Medicine Resident
Other areas of specialty/work
Street address
University of Medical Sciences, Ganjafroz Street, Babol
City
Babol
Postal code
Phone
+98 11 3219 7667
Fax
Email
abedinzadeh.ma@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Maede Abdinzade
Position
Internal Medicine Resident
Other areas of specialty/work
Street address
University of Medical Sciences, Ganjafroz Street, Babol
City
Babol
Postal code
4717641367
Phone
+98 11 3219 7667
Fax
Email
abedinzadeh.ma@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Sohrab Kazemi
Position
PhD Toxicology
Other areas of specialty/work
Street address
University of Medical Sciences, Ganjafroz Street, Babol
City
Babol
Postal code
4717641367
Phone
+98 11 3219 7667
Fax
Email
kazemi.msm@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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