The effect of combination of Descurainia Sophia and Deracocephalum syrup on clinical symptoms and quality of life in patients with irritable bowel syndrome with predominant constipation
evaluation of effect of Dracocephalum and Descurainia sophia syrup on clinical symptoms and quality of life in patients with irritable bowel syndrome with constipation
Design
This study is a randomized, double-blind clinical trial with parallel groups and a control group that will be performed with the participation of 90 patients ; Patients will be divided into intervention and control groups by block randomization
Settings and conduct
The samples will be selected from gastroenterology clinics of Emam Reza hospital of Tabriz.patients will be placed in one of the two groups. Patients in intervention group will take 10cc of Dracocephalum and Descurainia sophia syrup daily for 1month and control group will receive 10cc of placebo syrup daily for 1month.patients symptom will be assessed by Patient Assessment of Constipation–Symptom (PAC-SYM) questionnaire and Quality of life will be assessed by the quality of life questionnaire.researchers and patients and data analyzer will be blind in this study.
Participants/Inclusion and exclusion criteria
patients will be selected from the person referred to Gastroenterology clinics whom diagnosed as IBS patients according to ROME IV citeria with constipation.Inclusion criteria include: Age at 18-75 year, and willingness to participate and having normal colonoscopy.exclusion criteria include:history of drug reaction;pregnancy and lactation, having ulcerative colitis or crohn disease ,pathologic findings in colonoscopy
Intervention groups
This study will be a randomized, double -blind clinical trial with parallel groups; 90people will be randomly divided into two groups. Patients in the intervention group will take combination of Dracocephalum and Descurainia sophia syrup and control group will receive placebo syrup.
Main outcome variables
Quality of life of IBS patients
;stool stiffness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220104053626N5
Registration date:2023-01-24, 1401/11/04
Registration timing:prospective
Last update:2023-01-24, 1401/11/04
Update count:0
Registration date
2023-01-24, 1401/11/04
Registrant information
Name
Masood Dinevari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 7054
Email address
dinvarim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-05-21, 1402/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of combination of Descurainia Sophia and Deracocephalum syrup on clinical symptoms and quality of life in patients with irritable bowel syndrome with predominant constipation
Public title
The effect of combination of Descurainia Sophia and Deracocephalum syrup on patients with irritable bowel syndrome with constipation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
having IBS according to ROME IV criteria
age above 18
having normal colonoscopy within 5 years
willing to participate
Exclusion criteria:
pregnancy and lactation
any history of drug reaction
celiac disease
recent use of probiotics,laxatives,antibiotics and anti inflammatory drugs such as NSAID and corticosteroides.
history of inflammatory bowel disease( ulcerative colitis and crohn disease)
any pathologic findings in colonoscopy
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
From the patients who volunteered to participate in the study, 90 persons will be selected by simple random sampling.
Randomization method:block
Randomization unit : Individual
Randomization layers: In each block, people will be matched based on age and gender.
Random Allocation software: Random Allocation software
How to create a random sequence: Using Random Allocation software
Hide: The random sequence created is kept in a safe place and is done by an independent person who is not involved in the experiment during the study. Random allocation of hidden individuals, patients and researchers will not be aware of it.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double-blind study in which the researcher of this study and the patients participating in the study will be unaware of the type of syrup received. Syrups will be provided to patients by another person who has no role in completing the questionnaire and following patients. Patients will also be informed of the existence of two types of syrups (placebo syrup and combination of Descurainia Sophia and Deracocephalum syrup ) when obtaining consent, but will be unaware of which study groups they will be included in. Descurainia Sophia and Deracocephalum syrups are similar in appearance color, and size to placebo syrups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Ethics committee,vice chancellor for research,Faculty of medicine,Tabriz Univarsity of Medical Sciences,Golgasht st,Tabriz,Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5163996889
Approval date
2022-12-26, 1401/10/05
Ethics committee reference number
IR.TBZMED.REC.1401.901
Health conditions studied
1
Description of health condition studied
irritable bowel syndrome
ICD-10 code
K58.9
ICD-10 code description
Irritable bowel syndrome without diarrhea
Primary outcomes
1
Description
Patients quality of life
Timepoint
Before and after the intervention
Method of measurement
The quality of life questionnaire for patients with irritable bowel syndrome
2
Description
Stool stiffness
Timepoint
before and after intervention
Method of measurement
Patient Assessment of Constipation–Symptom(PAC-SYM) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in the intervention group will take 10cc of Descurainia sophia and Dracocephalum syrup(manufactured by Tabriz Traditional Medicine Center) daily for one month.
Category
Treatment - Drugs
2
Description
Control group: patients in the control group will take 10cc of placebo syrup (manufactured by Tabriz Traditional Medicine Center)daily for one month.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Masood Faghih Dinevari
Street address
Emam reza hospital, Golgast st,Tabriz.
City
Tabriz
Province
East Azarbaijan
Postal code
566614766
Phone
+98 41 3334 4918
Email
masood.dinevari@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
Vice chancellor for Research,Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5164886994
Phone
+98 41 3337 2084
Email
Shahabi_p@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
50
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
Tabriz University of Medical Sciences
Full name of responsible person
Masood faghih Dinevari
Position
Assisstant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Internal medicine department,Emam reza hospital,golgasht avenue,Daneshgah street
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Email
dinvarim@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Masood Faghih Dinevari
Position
Assisstant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Internal medicine department,Emam reza hospital,golgasht avenue,Daneshgah street
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Email
dinvarim@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Masood Faghih Dinevari
Position
assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Internal medicine department,Emam reza hospital,golgasht avenue,Daneshgah street
City
Tabriz
Province
East Azarbaijan
Postal code
5174666994
Phone
+98 41 3337 2084
Email
masood.dinevari@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD