Evaluation of the efficacy of the Montelukast as adjunctive therapy to Mebeverine in patients with Irritable bowel syndrome (IBS)
Design
Two arm parallel group randomized trial with blinded postoperative care and outcome assessment.
Settings and conduct
Patients attending the gastroenterology clinic at Rasoul Akram Hospital and other centers, based on the Rome IV criteria.Patients will be randomly assigned to two groups. In one group, a 10 mg Montelukast tablet will be added to the standard treatment (Mebeverine, 200 mg twice a day) in the evening for 8 weeks, and in the control group, a placebo tablet will be added to the standard treatment for 8 weeks. Both medications will be packaged in unidentifiable packaging to prevent recognition by the patient and the doctor. The evaluation of the study will be through a questionnaire.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients with diarrhea-predominant irritable bowel syndrome (IBS-D) based on the Rome IV criteria.
Age between 18-65 years old
Informed consent
Exclusion criteria:
Patients with psychiatric disorders, kidney failure, celiac disease, and inflammatory bowel disease (IBD).
People who suffer from depression.
Pregnancy and lactation
History of drug allergy
Intervention groups
Intervention group: receiving Montelukast and Mebeverine.
Control group: receiving a placebo and Mebeverine.
Main outcome variables
Abdominal Pain
Abdominal distension
Satisfaction with fecal excretion
The impact of the IBS on the Patient's Quality of Life
Irritable Bowel Syndrome Severity Score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160813029327N27
Registration date:2025-03-15, 1403/12/25
Registration timing:registered_while_recruiting
Last update:2025-03-15, 1403/12/25
Update count:0
Registration date
2025-03-15, 1403/12/25
Registrant information
Name
Ramin Abrishami
Name of organization / entity
Islamic Azad University, Pharamceutical sciences branch
Country
Iran (Islamic Republic of)
Phone
+98 21 2264 1889
Email address
r_abrishami@iaups.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-03-08, 1403/12/18
Expected recruitment end date
2025-08-09, 1404/05/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of Montelukast in combination with Mebeverine and Mebeverine with placebo in patients with Irritable Bowel Syndrome
Public title
Studying the effect of Montelukast on patients with Irritable Bowel Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with diarrhea-predominant irritable bowel syndrome (IBS-D) based on the Rome IV criteria
Age between 18-65 years old
Informed consent
Exclusion criteria:
Patients with psychiatric disorders, kidney failure, celiac disease, and inflammatory bowel disease (IBD).
People who suffer from depression.
Pregnancy and lactation
History of drug allergy
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random number table: Two groups of 30 patients were made using simple randomization method, based on Random Sequence Generator via www.random.org website. For Random Allocation concealment, the method of opaque sealed envelopes with random sequence was used. Patients were allocated in one of two groups based on their entry sequence.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study both clinical caregiver and patients are not aware which medication the patient is using. Drugs will be dispensed by researcher in uniform packages with codes. Placebo tablets are quite similar in color and shape to the drug.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad university of pharmaceutical sciences
Street address
No. 99, Yakhchal Ave., Gholhak, Shariati St., Tehran
City
Tehran
Province
Tehran
Postal code
19356466
Approval date
2025-01-25, 1403/11/06
Ethics committee reference number
IR.IAU.PS.REC.1403.594
Health conditions studied
1
Description of health condition studied
Irritable bowel syndrome
ICD-10 code
K58.0
ICD-10 code description
Irritable bowel syndrome with diarrhea
Primary outcomes
1
Description
Abdominal Pain (Severity of pain and Duration of pain)
Timepoint
Before intervention and 4 weeks after intervention and 8 weeks after intervention
Method of measurement
Irritable Bowel Severity Scale (IBSS)
2
Description
Abdominal distension (Bloating, Swollen or Tight tummy)
Timepoint
Before intervention and 4 weeks after intervention and 8 weeks after intervention
Method of measurement
Irritable Bowel Severity Scale (IBSS)
3
Description
Satisfaction with fecal excretion
Timepoint
Before intervention and 4 weeks after intervention and 8 weeks after intervention
Method of measurement
Irritable Bowel Severity Scale (IBSS)
4
Description
The impact of the IBS on the Patient's Quality of Life
Timepoint
Before intervention and 4 weeks after intervention and 8 weeks after intervention
Method of measurement
Irritable Bowel Severity Scale (IBSS)
5
Description
Irritable Bowel Syndrome Severity Score
Timepoint
Before intervention and 4 weeks after intervention and 8 weeks after intervention
Method of measurement
Irritable Bowel Severity Scale (IBSS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, patients will receive Montelukast 10 mg tablets produced by Abidi Pharmaceutical Company once a day for 4 weeks plus their standard treatment, which is Mebeverine 200 mg capsules produced by Actover Pharmaceutical Company once a day.
Category
Treatment - Drugs
2
Description
Control group: In this group, patients will receive Placebo tablets once a day for 4 weeks plus their standard treatment, which is Mebeverine 200 mg capsules produced by Actover Pharmaceutical Company once a day.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Rasoul Akram hospital complex
Full name of responsible person
Mobina Hashemi
Street address
Sattar Khan St, Niayesh St., ShahrAra
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 933 688 6433
Email
Rasoolhospital@iums.ac.ir
Web page address
https://hrmc.iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masoud Parsania
Street address
Yakhchal St, Shariati st.
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2200 4355
Fax
+98 21 2260 2059
Email
mobinahashemi1999@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Amirpasha Tabaeian
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Sattar Khan St, Niayesh St., ShahrAra
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 933 688 6433
Email
aptabaeian@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ramin Abrishami
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
No. 99, the first of Yakhchal Ave., Gholhak, Shariati St.
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
021-226400515
Fax
+98 21 2260 2059
Email
r_abrishami@iaups.ac.ir
Web page address
https://tms.iau.ir/iaups/fa
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mobina Hashemi
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
No. 99, The first of Yakhchal Ave., Gholhak, Shariati St
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
021-226400515
Fax
+98 21 2260 2059
Email
mobinahashemi1999@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Information about the primary outcome will be shared after De identification of Individual Participant Data
When the data will become available and for how long
After publication of paper,for two years
To whom data/document is available
Academic persons
Under which criteria data/document could be used
Academic or clinical use. users should cite the primary document
From where data/document is obtainable
By sending an email to the corresponding author(Mobina Hashemi)
Corresponding author email: mobinahashemi1999@gmail.com
What processes are involved for a request to access data/document
Submition of valid and formal documentation of affiliation to the Academic Center, Explanation about how to use the information and the purpose of request and receiving it within one business day.