Patients who suffer from chronic constipation and resistant to common treatments are chosen. Patients were between 18 - 75 years old and from both gender. in spite of the current treatments for at least six months,they do not cure. exclusion criteria were: any underlying disease affecting gastrointestinal motility, gastrointestinal motility drugs and patients who had a history of abdominal surgery. the present study is a clinical trial among 70 patients with chronic constipation randomly were divided in two groups of 35. VAS score is recorded during bowel movements or constipation and satisfaction of patients before medication is also recorded . based on random number allocation the patient were divided into two groups. group 1 is treated with Bisacodyl 5mg every 8 hour for 4 weeks and group 2 is treated with Prydostigmine 60mg every 8 hour for 4 weeks. To avoid any systematic error study is double blinded. All drugs are encapsulated and encoded by pharmacologists So that neither patients nor physicians are not aware of the type and method of administration. Periodically every two weeks after the initial treatment , VAS score, defecate score and satisfaction is obtained from all patients . Finally all the data are analyzed using appropriate statistical tests.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201405227080N2
Registration date:2014-12-05, 1393/09/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-12-05, 1393/09/14
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
Research Babol University of Medical Sciences
Expected recruitment start date
2012-06-01, 1391/03/12
Expected recruitment end date
2014-08-03, 1393/05/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effects of pyridostigmine and bisacodyl in Refractory constipation.
Public title
Treatment of chronic and resistant conventional therapy constipation .
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients who have constipation for more than a year and have not responded to conventional treatments . Exclusion criteria: age below 18 and above 75, the underlying disease affecting gastrointestinal motility (eg, hypothyroidism, diabetes and neurological diseases), the use of drugs affecting gastrointestinal motility (eg calcium channel blockers), history of abdominal surgery
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Babol University of Medical Sciences
Street address
University Sq, Ganje Afrooze Ave
City
Babol
Postal code
4717641367
Approval date
2014-04-22, 1393/02/02
Ethics committee reference number
4026
Health conditions studied
1
Description of health condition studied
Constipation
ICD-10 code
K90,K91,K9
ICD-10 code description
Other diseases of the digestive system
Primary outcomes
1
Description
The shape of stool
Timepoint
At the start of the intervention, Two weeks later, Four weeks later
Method of measurement
Based on image measurement
2
Description
The number of stools per week
Timepoint
At the start of the intervention, Two weeks later, Four weeks later
Method of measurement
Questionnaire
3
Description
Feeling of incomplete defecation
Timepoint
At the start of the intervention, Two weeks later, Four weeks later
Method of measurement
Questionnaire
4
Description
Duration of Defecation per time
Timepoint
At the start of the intervention, Two weeks later, Four weeks later
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: 4 weeks use of pyridostigmine( 60mg, Every 8 hours )
Category
Treatment - Drugs
2
Description
Intervention group 2: 4 weeks use of bisacodyl (5mg, Every 8 hours )
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatolah Rohani Hospital
Full name of responsible person
Dr Javad Shokri Shirvani
Street address
Interior section, Ayatolah Rohani Hospital, University Sq, Ganjafroz Street
City
Babol
2
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Dr Javad Shokri Shirvani
Street address
Interior section, shahid Beheshti Hospital , University Sq, Ganjafroz 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
Dr. Ali Akbar Moghadamnia
Street address
University Sq, Ganje Afrooze Ave
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
Dr Javad Shokri Shirvani
Position
Gastroenterologist
Other areas of specialty/work
Street address
University Sq, Ganje Afrooze Ave
City
Babol
Postal code
4717641367
Phone
+98 11 3223 8284
Fax
Email
javadshokri@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Javad Shokri Shirvani
Position
Gastroenterologist
Other areas of specialty/work
Street address
University Sq, Ganje Afrooze Ave
City
Babol
Postal code
4717641367
Phone
+98 11 3223 8284
Fax
Email
javadshokri@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Javad Shokri Shirvani
Position
Gastroenterologist
Other areas of specialty/work
Street address
University Sq, Ganje Afrooze Ave
City
Babol
Postal code
4717641367
Phone
+98 11 3223 8284
Fax
Email
javadshokri@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)