Irritable bowel syndrome Explanation based on Iranian Tradition Medicine and The effectivness of Dracocephalum Kotschyi on quality of life and IBS Severity in patient (18-50 years old) with diarrhea-predominant or mixed type irritable bowel syndrome
-Irritable bowel syndrome Explanation based on Iranian Tradition Medicine and The effectiveness of Dracocephalum Kotschyi on quality of life and IBS Severity in patient 18-50 years old with diarrhea-predominant or mixed type of irritable bowel syndrome in Isfahan city .
Design
Controlled clinical trial with a parallel design, double-blind, randomized block, sample size 76, Phase III of a clinical trial
Settings and conduct
participants will be selected from patients referring to gasrtointestinal research center of Isfahan University of medical sciences. Blinding is guaranteed by using similar appearance between treatment and placebo and random allocation of patients in each group by a third party. therefore this study would be a double-blind study.
Participants/Inclusion and exclusion criteria
Definite diagnosis of irritable bowel syndrome based on Rome 3 criteria;
Patients with irritable bowel syndrome of diarrhea type or mixed type; Patients with moderate severity of irritable bowel syndrome; Within the age group of 18-50 years; Not being afflicted with psychiatric disorders;informed consent for study ; Having a normal colonoscopy and para-clinic evidences of intestinal cancer and other related differential diagnoses; Not taking any other drug in order to treat IBS disorder
Intervention groups
-Intervention group 1:capsule of Dracocephalum Kotschyi , three times a day.
-Intervention group 2: Starch-containing capsule, three times a day.
Main outcome variables
Severity of IBS
Life quality of patients afflicted with IBS
General information
Reason for update
Acronym
IBS
IRCT registration information
IRCT registration number:IRCT20180823040854N1
Registration date:2019-07-30, 1398/05/08
Registration timing:registered_while_recruiting
Last update:2019-07-30, 1398/05/08
Update count:0
Registration date
2019-07-30, 1398/05/08
Registrant information
Name
Parisaa Heydaree
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 9107
Email address
p.heydare@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-07, 1397/01/18
Expected recruitment end date
2019-11-21, 1398/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Irritable bowel syndrome Explanation based on Iranian Tradition Medicine and The effectivness of Dracocephalum Kotschyi on quality of life and IBS Severity in patient (18-50 years old) with diarrhea-predominant or mixed type irritable bowel syndrome
Public title
The effectivness of Dracocephalum Kotschyi on irritable bowel syndrome (IBS)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Definite diagnosis of irritable bowel syndrome based on Rome 3 criteria and confirmation of diagnosis by a gastrointestinal specialist
Patients with irritable bowel syndrome of diarrhea type or a mixed type
Patients with moderate severityof irritable bowel syndrome
Within the age group of 18-50 years
Not being afflicted with psychiatric disorders
Informed consent for study
Having a normal colonoscopy and para-clinic evidences of intestinal cancer and other related differential diagnosis
Not taking any other drug in order to treat IBS disorder
Exclusion criteria:
Be pregnant from the beginning
History of severe sensitivity reactions to aromatic substances
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
Making blind in the present study is carried out through full similarity between Dracocephalum Kotschyi with a placebo. Based on this, the patients are not aware of being in the intervention or control group, while giving the drug or placebo to patients is carried out by a person outside the research team who is unaware of allocation of people to the groups under study, nor is he aware of the type of drug or placebo. Therefore, the present study is conducted in a double-blind manner.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Isfahan University of Medical Sciences
Street address
No.4 Building, International College, Isfahan University of Medical Sciences, Hezar-Jerib Ave., Isfahan, IR Iran, 81746 73461
City
Isfahan
Province
Isfehan
Postal code
73461_81746
Approval date
2018-03-07, 1396/12/16
Ethics committee reference number
IR.MUI.REC.1396.3.960
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 in patient of Irritable bowel syndrome
Timepoint
-Determination of severity of irritable bowel syndrome symptoms in the beginning of the study (before the intervention begins) and one month after the beginning of taking Dracocephalum Kotschyi and one month after cutting its consumption.
Method of measurement
-The questionnaire and index of severity of irritable bowel syndrome symptoms
2
Description
Life quality of patients afflicted with irritable bowel syndrome and its areas
Timepoint
-In the beginning of the study (before the intervention begins) and one month after the beginning of taking Dracocephalum Kotschyi and one month after cutting its consumption.
Method of measurement
The questionnaire of life quality of patients afflicted with irritable bowel syndrome
Secondary outcomes
1
Description
Life quality mark in those afflicted with irritable bowel syndrome
Timepoint
In the beginning of the study (before the intervention begins) and one month after the beginning of taking Dracocephalum Kotschyi and one month after cutting its consumption
Method of measurement
The quality of life in those afflicted with irritable bowel syndrome
Intervention groups
1
Description
Intervention group :Hydro alcohol extract capsule of Dracocephalum Kotschyi manufactured in the School of Pharmacy of Isfahan University of Medical Sciences, three times a day each time one 75 mg capsule half an hour before each meal with one glass of water for one month
Category
Treatment - Drugs
2
Description
Control group:Placebo that Starch-containing capsule quite similar in appearance to the real capsule manufactured in the School of Pharmacy of Isfahan University of Medical Sciences, three times a day each time one capsule half an hour before each meal with one glass of water for one month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Center for Gastrointestinal Research
Full name of responsible person
Peyman Adibi
Street address
Soffeh Blvd., Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alzahra@mui.ac.ir
Web page address
http://alzahra.mui.ac.ir.
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Maryam Yavari
Street address
Isfahan University of Medical Sciences, Hezar Jerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Web page address
http://english.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Parisa Heydari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Hezar Jerib Ave.,Isfahan University Of Medical Sciences, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
73461-81746
Phone
+98 31 3668 8138
Email
parisaa_sooresh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Yavare
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Hezar Jerib Ave.,Isfahan University Of Medical Sciences, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
73461-81746
Phone
+98 31 3668 8138
Email
mariam.yavari@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Parisa Heydare
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Hezar Jerib Ave, Isfahan University Of Medical Sciences, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
73461-81746
Phone
+98 31 3668 8138
Email
Parisaa_sooresh@yahoo.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