This study is a randomized controlled trial study that will be done on 50 women and man from the 23 July 2014 to 23 Octobr 2014 at the Gastroenterology Clinic in Rasoolakram Hospital in Tehran. The patients had clinical criteria (criteria Room II) stipulated in internal medicine and gastroenterology authoritative book on IBs
.Intervention Group are consisted of 25 cases that intake one of the capsule that has 4.5 g of Plantago in two hours before lunch and two hours before dinner for 3 month. Control group are consisted of 25 cases that intake 200 mg of colofac capsule twice a day for 3 month.
These groups will be observed every week in first month and every 2 weeks in second month and the end of third month.
Study variables are: diarrhea, constipation, abdominal pain
Data using SPSS-17 software and descriptive and inferential statistical tests (chi-square, T test, ANOVA and paired comparisons) will be analyzed. In this study, P <0.05 was considered as statistically significant.
General information
Acronym
Plantago major and Colofac
IRCT registration information
IRCT registration number:IRCT2014070118313N1
Registration date:2014-07-21, 1393/04/30
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-07-21, 1393/04/30
Registrant information
Name
Mostafa Salehi Najaf Abadi
Name of organization / entity
Traditional Medicine Faculty, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5560 1274
Email address
m-salehi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Traditional Medicine Faculty, Tehran University of Medical Sciences
Expected recruitment start date
2014-07-23, 1393/05/01
Expected recruitment end date
2014-10-23, 1393/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparative survey of the effect of Plantagomajor and colofac on clinical sign of irritable bowel syndrome
Public title
comparative survey of the effect of Plantagomajor and colofac on clinical sign of irritable bowel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: patient with recognized IBS with Rome III criteria, age 15-45 years old,
Exclusion:Refusal or failure to cooperate in treatment, cirrhosis, Sensitivity to plantago, heart failure, Chronic renal failure,Bowel Cancer, pregnancy,psychosis
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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, Faculty of Traditional Medicine, Tehran University of Medical Sciences
Street address
Keshavarz Blv Ghods St Tehran
City
Tehran
Postal code
1417653761
Approval date
2013-11-11, 1392/08/20
Ethics committee reference number
1773/130/د/92
Health conditions studied
1
Description of health condition studied
Irritable bowel syndrome
ICD-10 code
K58
ICD-10 code description
Irritable bowel syndrome
Primary outcomes
1
Description
abdominal pain
Timepoint
Before the treatment and every week for tree month
Method of measurement
visual scale of pain
2
Description
frequency of bowel habit
Timepoint
Before the treatment and every week for tree month
Method of measurement
questionnaire
Secondary outcomes
1
Description
distention
Timepoint
befor intervention and every week for tree month
Method of measurement
questionnaire
Intervention groups
1
Description
This study will be done on 25 patient from the 23 July 2014 to 23 October 2014 at the Gastroenterology Clinic in Rasoolakram Hospital in Tehran. Intervention Group are consisted of 25 cases that intake one of the capsule that has 4.5 g of Plantago in two hours before lunch and two hours before dinner for 3 month
Category
Treatment - Drugs
2
Description
This study will be done on 25 patient from the 23 July 2014 to 23 October 2014 at the Gastroenterology Clinic in Rasoolakram Hospital in Tehran. Control group are consisted of 25 cases that intake 200 mg of colofac capsule twice a day for 3 month.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoolakram Hospital
Full name of responsible person
Dr Shahram Agah
Street address
Shahrara; Nyayesh Ave.; Sattarkhan Str.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research Traditional Medicine Faculty of Tehran University of Medica
Full name of responsible person
Mohamad Bagher Minaei
Street address
Behesht Street, Vahdat eslami Ave.
City
Tehran
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 Traditional Medicine Faculty of Tehran University of Medica
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
Traditional Medicine Faculty, Tehran University of Medical Sciences
Full name of responsible person
Mostafa Salehi Nagaf Abadi
Position
PhD candidate
Other areas of specialty/work
Street address
Behesht Ave, Vahdat eslami St.
City
Tehran
Postal code
4818786481
Phone
+98 14 1323 4040
Fax
Email
msalehi1586@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Shahram Agah
Position
gastroenterologist, Associated professor
Other areas of specialty/work
Street address
Tehran hemmat airway medical school educational faculty
City
Tehran
Postal code
Phone
+98 21 8860 2214
Fax
Email
shahramagah@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Traditional Medicine Faculty, Tehran University of Medical Sciences
Full name of responsible person
Mostafa Salehi Nagaf Abadi
Position
PhD candidate
Other areas of specialty/work
Street address
Behesht Ave., Vahdat eslami St.
City
Tehran
Postal code
Phone
+98 14 1323 4040
Fax
Email
msalehi1586@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)