Comparison of the effectiveness of a mixture of plant extracts and placebo on the severity of symptoms in patients with irritable bowel syndrom: A randomized double blind clinical trial
Evaluation of the clinical effect of Echinophora platyloba, Trachyspermum copticum and Zataria multiflora combination extracts on
irritable bowel syndrome
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 80 patients
Settings and conduct
Study place: Gastroenterology Department of Bouali Hospital in Tehran.
Type of blinding: Double blind.
How to do blinding: To hide the diagnosis of the type of drug or placebo, we try to use the simulation of syrup forms (similar in taste and color) for drugs and placebo and install codes extracted from the table of random blocks on them and to keep participating patients, clinical researcher, health personnel (Nurses, etc.) who are responsible for caring for patients, data collectors and those evaluating outcomes completely blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
People in the age range of 18 to 65 years; Having written consent; People who have a definite diagnosis of IBS based on the Rome Criteria.
Non-inclusion criteria:
Any concomitant disease other than IBS; People who are allergic to thyme or thyme or aloe vera or other herbal medicines; people who have a history of taking herbal medicines during the last 3 months; pregnant and lactating woman
Intervention groups
Intervention group: Syrup containing Echinophora platyloba, Trachyspermum copticum and Zataria multiflora combination extracts in combination with routine medications for irritable bowel syndrome.
Control group: placebo syrup without mixed extracts in combination with routine medications for irritable bowel syndrome
Main outcome variables
IBS severity score; severity of abdominal pain; severity of bloating
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210404050833N1
Registration date:2021-07-21, 1400/04/30
Registration timing:registered_while_recruiting
Last update:2021-07-21, 1400/04/30
Update count:0
Registration date
2021-07-21, 1400/04/30
Registrant information
Name
Zeinab sadat Tabaee Fazli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2255 6336
Email address
zeinabfazli96@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-16, 1400/04/25
Expected recruitment end date
2021-09-29, 1400/07/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of a mixture of plant extracts and placebo on the severity of symptoms in patients with irritable bowel syndrom: A randomized double blind clinical trial
Public title
Effectiveness of herbal mixture in IBS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People in the age range of 18 to 65 years
Written informed consent
People with a definitive diagnosis of IBS based on the Rome Criteria
Exclusion criteria:
Any concomitant illness other than IBS
People who are allergic to Echinophora platyloba, Trachyspermum copticum and Zataria multiflora or other herbal medicines
People who have had a history of taking herbal medicines during the last 3 months
Pregnant and lactating lady
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Based on simple randomization, two series of numbers are obtained with the help of Random.org. Accordingly, patients who meet the conditions for entering the plan will be assigned to one of the two groups of treatment or placebo, respectively.
Blinding (investigator's opinion)
Double blinded
Blinding description
Using exactly the same forms of syrup for medicine and placebo and installing the codes extracted from the random block table on them, the participants, the main researcher, the health care personnel (doctors, nurses, etc.) who are responsible for caring for the patients, Data collectors and those evaluating the outcome are completely blinded.
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 , at the beginning of Yakhchal Ave, Gholhak, Shariati Ave
City
Tehran
Province
Tehran
Postal code
19395-6466
Approval date
2021-05-31, 1400/03/10
Ethics committee reference number
IR.IAU.PS.REC.1399.311
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
Abdominal pain
Timepoint
Before starting the intervention and one month after that
Method of measurement
Paitient severity score questionnaire
2
Description
IBS severity score
Timepoint
Before starting the intervention and one month after that
Method of measurement
Paitient severity score questionnaire
Secondary outcomes
1
Description
Blowing
Timepoint
Before starting the intervention and one month after that
Method of measurement
Paitient severity score questionnaire
Intervention groups
1
Description
Intervention group: Individuals who met the inclusion criteria will take a drug formulated with a mixture of Echinophora platyloba, Trachyspermum copticum and Zataria multiflora extracts, prepared in Yas Drug Pharmacy, at a dose of 5 ml, 3 times a day for a month.
Category
Treatment - Drugs
2
Description
Control group: Individuals who met the inclusion criteria will take a placebo formulated without a mixture of plant extracts prepared in Yas Drug Pharmacy, at a dose of 5 ml, 3 times a day for a month.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bouali hospital
Full name of responsible person
Zeinab sadat Tabaee Fazli
Street address
Damavand Ave; Emam Hosein square
City
Tehran
Province
Tehran
Postal code
17117
Phone
+98 21 3334 8036
Fax
Email
Bouali.hospital96@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zeinab sadat Tabaee Fazli
Street address
No.99 , Yakhchal Ave, Gholhak , Shariati Ave
City
Tehran
Province
Tehran
Postal code
19395-6466
Phone
+98 21 2264 0051
Email
zeinabfazli96@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Yas Daru Knowledge base Pharmaceutical Company
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ramin Abrishami
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No 99, Yakhchal Ave , Gholhak , Shariati Ave
City
Tehran
Province
Tehran
Postal code
19395-6466
Phone
+98 21 2264 0051
Email
r_abrishami@iaups.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zeinab sadat Tabaee Fazli
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Unit 1, No.13, Shifte alley, after Hedayat square, Darus
City
Tehran
Province
Tehran
Postal code
1943894471
Phone
+98 21 2255 6336
Email
zeinabfazli96@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zeinab sadat Tabaee Fazli
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Unit 1, No.13, Shifte alley, after Hedayat square, Darus
City
Tehran
Province
Tehran
Postal code
1943894471
Phone
+98 21 2255 6336
Fax
Email
zeinabfazli96@yahoo.com
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
There is no more information
When the data will become available and for how long
There is no more information
To whom data/document is available
There is no more information
Under which criteria data/document could be used
There is no more information
From where data/document is obtainable
There is no more information
What processes are involved for a request to access data/document