Clinical Trial Protocol
Iranian Registry of Clinical Trials
06 Nov 2022
Comparing the Efficacy of Cumin Powder with Mebeverin on Severity Score and Quality of Life of the Patients Involved IBS, a Double Blind Randomized Clinical Trial
Protocol summary
Study aim
Determining the efficacy of Cumin powder on Irritable Bowel Syndrome Severity Score and quality of life compared with Mebeverin.
Design
In this double blind RCT, 100 patient that fulfill IBS Rome 4 criteria without any red flags of organic diseases that has referred from GI clinic of firoozgar hospital will enrolled according to inclusion and exclusion criteria and after filling consent form. Patient will be divided in two group randomly according to stratified randomization generated by computer. Before and after intervention questioner of IBS-SS(severity score) and IBS-QOL(quality of life)(has been translated in Persian and validated) and stool consistency according to "Bristole Stool Scale"
would be fullfilled.
Settings and conduct
This study would be performed at clinic of
gastrointestinal diseases in Firoozgar hospital. After visiting by gastroenterologist, patients with IBS symptoms that has inclusion criteria and has fulfilled consent form would be divided in two groups. Patients and researchers would be blind up to end of analysis.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 16-65 years old IBS patients according to ROME 4 criteria without red flags (such as anemia, weight loss, OB positive, night pin, recent changes in bowel habit especially in patient more than 50 years old) with moderate to severe symptoms according to IBS severity score (score >24-100) that fulfill the consent form and have ability to understand and give response exactly and be accessible and resident of this city could be enrolled in this study. They should not have metabolic disorder such as untreated hypothyroidism and
neurologic diseases or congenital neuromuscular disease, kidney and liver failure or tumors or other end organ failures. Exclusion criteria: Patients with history of
acute or chronic mental or psychological disorders or mental retardation, pregnant or breast feeding pateints, patients with history of allergic reaction to Apiaceae family or to any part of this herbal drug, and patients with addiction to alcohol or opium in recent 6 months could not enter to study. In-addition History of abdominal surgery (except non complicated appendectomy, cesarean section, laparoscopic surgery or repair of hernia and pregnancy and breast feeding or use of medication that has effect on bowel movement, and recent antibiotic consumption are another criteria for excluding.
Intervention groups
Patients are divided in two groups. 1- Mebeverin capsule and placebo powder 2-Cumin powder and placebo capsule
Main outcome variables
Evaluating the changes in severity of symptoms of irritable bowel syndrome according to IBS - Severity Score that measure abdominal pain severity and frequency and degree of bloating and degree of
satisfaction with defecation and degree of disturbance in quality of life. Each variable will measured according
"visual analog scale" from 0-100 (in sum will be 0-500).
Changes in each each symptom before and after treatment will be measured.
General information
Reason for update Acronym
IRCT registration information
IRCT registration number: IRCT20171127037640N1 Registration date: 2018-03-23, 1397/01/03
Registration timing: prospective
Last update: 2018-03-23, 1397/01/03 Update count: 0
Registration date
2018-03-23, 1397/01/03 Registrant information
Name
Khadijeh Hatami
Name of organization / entity Country
Iran (Islamic Republic of) Phone
+98 21 5530 0569 Email address
kh-hatami@razi.tums.ac.ir Recruitment status
Recruitment complete Funding source
Expected recruitment start date 2018-04-04, 1397/01/15
Expected recruitment end date 2018-07-22, 1397/04/31 Actual recruitment start date
empty
Actual recruitment end date empty
Trial completion date empty
Scientific title
Comparing the Efficacy of Cumin Powder with Mebeverin on Severity Score and Quality of Life of the Patients Involved IBS, a Double Blind Randomized Clinical Trial Public title
Comparing the Efficacy of Cumin Powder with Mebeverin on Severity Score and Quality of Life of the Patients Involved IBS, a Double Blind Randomized Clinical Trial Purpose
Treatment
Inclusion/Exclusion criteria Inclusion criteria:
Age:16-65 years old IBS patients according to ROME 4 criteria, without red flags of organic diseases such as anemia, weight loss, night pin, OB positive, recent changes in bowel habit especially in patient more than 50 years old Moderate to severe symptoms according to IBS severity score (Visual analogue scale score >24-100) Fulfill the consent form Ability to understand and give response exactly Accessible and resident in Tehran Do not have metabolic or endocrine disorders such as untreated hypothyroidism and neurologic diseases, congenital neuromuscular diseases, end organ (kidney and liver) failures, tumors and other organ failures Exclusion criteria:
Acute or chronic mental or psychological disorders such as bipolar disorder, major depression, schizophrenia, dementia and mental retardation Pregnancy and breast feeding History of allergic reaction to Apiaceae family or to any part of the drug History of addiction to alcohol or opiates in recent 6 months History of abdominal surgery (except non complicated appendectomy), C/S,
laparoscopic surgery or repair of hernia Use of medication that has effect on bowel movement, long
term use of antibiotics, anti diarrhea, laxatives, anticholinergics, opium containing drugs, resins(they could be enrolled after 1 week abstinence if they could stop their medication) Antibiotic consumption in recent month
Age
From 16 years old to 65 years old Gender
Both Phase
3
Groups that have been masked Participant
Care provider Investigator Outcome assessor Data analyser Sample size
Target sample size: 100
Randomization (investigator's opinion) Randomized
Randomization description
One hundred patients will be randomly divided in two groups according to stratified randomization generated with computer. They receive Mebeverin with Comoon placebo or Comoon powder with Mebeverin placebo.
Blinding (investigator's opinion) Double blinded
Blinding description
Drugs are packaged to two groups (A and B) by a person that won't participate in study. Patients and physicians and all persons that participate in collecting data would be blinded. After analysis the packege contents will announced.
Placebo Used Assignment
Parallel
Other design features
Secondary Ids empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of tehran university of medical Sciences
Street address
Central building of Tehran University of Medical sciences Ghods street, Keshavars Blvd,Tehran, Tehran province
City tehran Province Tehran
Postal code 1417653761 Approval date
2017-10-20, 1396/07/28
Ethics committee reference number IR.TUMS.VCR.REC.1396.3756
Health conditions studied
1
Description of health condition studied Iritable bowel syndrom
ICD-10 code K58
ICD-10 code description Irritable bowel syndrome
Primary outcomes
1
Description
Changes in symptoms of irritable bowel syndrome according to IBS-SS questioner (irritable bowel syndrome severity score) that measure abdominal pain severity and frequency and degree of bloating and degree of satisfaction with defecation and degree of disturbance in quality of life. each variable will be measured according
"visual analog scale" from 0-100 (in sum will be 0-500).
changes in each symptom before and after treatment will be measured.ٍ Equal or more than 50% improvement in IBS-SS will be considered response to treatment.
Timepoint
Before intervention and after 1 month treatment Method of measurement
IBS-SS questioner (irritable bowel syndrome severity score)
Secondary outcomes
1
Description
IBS Quality Of Life score Timepoint
Before intervention nd 1 month after beginning of treatment
Method of measurement
IBS-QOL questioner that measure changes in quality of life in ptients with irritable bowel syndrome. ( By means of it's Persian translated version that it's validity and reliability has been tested.)
Intervention groups
1
Description
Intervention group 1: First group receive Cumin powder and Mebeverin placebo capsule. Herbal powder in
determined ratio consists of Cuminum cyminum L., Trachyspemum ammi (L.) Sprague, Foeniculum vulgare Miller (fennel), Pimpinella anisum L. powder that will packaged in 3 gram sachet will be consumed 3 times a day after meal. Placebo capsule as 200 mg capsule contains Avicel will be taken two times a day before meal.
Category
Treatment - Drugs
2
Description
Intervention group 2: Second group receive Mebeverin 200 mg capsule made in IR. Iran ("loghman"
pharmaceutical company) two times a day before meal and placebo as sachet that contains 90 % avicel and 10% Cumin powder and some amount of brown color essence that is used in food industry (Iran Essence Co - CODE: FC5220 ) for mimicking color and smell. This powder will be taken 3 times a day with meal or after meal.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar Hospital and Gastrointestinal and Liver Diseases Research Center
Full name of responsible person Khadijeh Hatami
Street address
Beh Afarin Street, Vali Asr Square, Firoozgar Hospital City
Tehran Province
Tehran Postal code
1593748711 Phone
+98 21 8214 1600 Email
kh-hatami@razi.tums.ac.ir Web page address
Sponsors / Funding sources
1 Sponsor
Name of organization / entity
Tehran University of Medical Sciences Full name of responsible person
Mohammad Ali Sahraian Street address
Central building of Tehran University of Medical sciences Ghods street, Keshavars Blvd,Tehran, Tehran province
City Tehran Province
Tehran Postal code
1417653761 Phone
+98 21 8163 3379 Email
kh-hatami@razi.tums.ac.ir Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences 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 Tehran University of Medical Sciences Full name of responsible person
Khadijeh Hatami Position
Gastrointerologist Latest degree
Subspecialist
Other areas of specialty/work Traditional Medicine
Street address
Beh Afarin Street, Vali Asr Square, Firoozgar Hospital City
Tehran Province
Tehran Postal code
1593748711 Phone
+98 21 8214 1600 Email
kh-hatami@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity Tehran University of Medical Sciences Full name of responsible person
Khadijeh hatami Position
Gastrointerologist Latest degree
Subspecialist
Other areas of specialty/work Traditional Medicine
Street address
Beh Afarin Street, Vali Asr Square, Firoozgar Hospital City
Tehran Province
Tehran Postal code
1593748711 Phone
+98 21 8214 1600 Email
kh-hatami@razi.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences Full name of responsible person
Khadijeh Hatami Position
Gastrointerologist Latest degree
Subspecialist
Other areas of specialty/work Traditional Medicine
Street address
Beh Afarin Street, Vali Asr Square, Firoozgar Hospital City
Tehran Province
Tehran Postal code
1593748711 Phone
+98 21 8214 1600 Email
kh-hatami@razi.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD) Undecided - It is not yet known if there will be 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
No - There is not 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
