Irritable bowel syndrome is one of the most common gastrointestinal disorders which is characterized by abdominal pain and change in bowel habit without structural problem. IBS is more common is western countries. In this study we use Boswellia carterii Birdw which has anti acid, anti-inflammation, analgesic effects; Achillea millefolium which has anti spasmodic and anti-inflammatory effect on gastrointestinal system and Zingiber officinale which has anti-oxidant effect. Each MemoGut capsule contains 300mg powder of Boswellia carterii Birdw, 50 mg powder of Zingiber officinale and Ethanolic extract of 50 gr powder of Achillea millefolium. We randomly divide patients in to case (MemoGut) and control (Starch as placebo) group. Patients underwent medication three times a day. We evaluate patients after one month of medication and after the first month we stop our medication and evaluate their symptoms once again (three months after starting medication) and we fulfill our Farsi valid questionnaire (Based on ROME III criteria) in each step. We also check side effect. We will get an informed concept from all participants.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201402089256N3
Registration date:2014-05-14, 1393/02/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-05-14, 1393/02/24
Registrant information
Name
Ali Toghiani
Name of organization / entity
Islamic Azad University, Najafabad Branch, Isfahan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 939 532 8865
Email address
toghiani@smd.iaun.ac.ir
Recruitment status
Recruitment complete
Funding source
Researchers
Expected recruitment start date
2014-02-20, 1392/12/01
Expected recruitment end date
2014-08-22, 1393/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the efficacy of Boswellia carterii, Zingiber officinale and Achillea millefolium on severity of symptoms of irritable bowel syndrome
Public title
MemoGut effect on IBS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with IBS; age older than 18 years old.
Exclusion criteria: using other medications; pregnancy; incomplete medication; participants tend to exit from study.
Age
From 18 years old to 100 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of isfahan university of medical sciences
Street address
Isfahan, Isfahan university of medical sciences
City
Isfahan
Postal code
Approval date
2014-03-10, 1392/12/19
Ethics committee reference number
493009
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
Severity of symptoms
Timepoint
Baseline, 1 and 3 months after baseline
Method of measurement
Farsi and valid IBS-SSS questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
in case group patients use Memogut capsule three times per day for a month.
Category
Treatment - Drugs
2
Description
in control group patients use starch as placebo 3 times a day for one month
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariaaty Hospital
Full name of responsible person
Ali Toghiani
Street address
102, Gole Nastaran, Golha Alley, Barazande St,
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Peyman Adibi
Street address
isfahan univercity of medical sciences, hezarjarib St, Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Ali Toghiani
Position
Medical Student
Other areas of specialty/work
Street address
102, Gole Nastaran, Golha Alley, Barazande St,
City
Isfahan
Postal code
Phone
+98 31 1450 1568
Fax
Email
Alitoghiani@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Hamid Afshar
Position
associated professor
Other areas of specialty/work
Street address
Sepahan MRI department, Mohtasham Kashani St,
City
Isfahan
Postal code
Phone
+98 31 1625 5531
Fax
Email
afshar@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan Universty of medical sciences
Full name of responsible person
Ali Toghiani
Position
Medical student
Other areas of specialty/work
Street address
102, Gole Nastaran, Golha Alley, Barazande St,
City
Postal code
Phone
+98 31 1450 1568
Fax
Email
alitoghiani@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)