Determination of the Effect of Rose Hydroalcoholic Extract on the Treatment of Chronic Idiopathic Constipation in Patients Referring to the Moftah Clinic in Yasuj
Design
1. The control group receives lactolose 20 cc twice a day
2. The test group receives the extract of the rose extract at a dose of 20 mg per kg body weight per day in divided doses
Settings and conduct
Patients referring to the internal clinic of shahid Mofattah Yasouj
Participants/Inclusion and exclusion criteria
Adults with chronic constipation according to Rome 4 criteria with informed consent and no underlying disease such as hypothyroidism-diabetes-celiac lead-poisoning, no structural disease, no constipation treatment before the initial visit
Intervention groups
In this study, lactulose is compared as one of the standard treatments for constipation and hydroalcoholic extract of roses.
Main outcome variables
Based on the results of the study, if the extract of rose flower extract is effective in the treatment of chronic constipation in adults, it can be used to treat constipation.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190124042481N1
Registration date:2019-02-07, 1397/11/18
Registration timing:registered_while_recruiting
Last update:2019-02-07, 1397/11/18
Update count:0
Registration date
2019-02-07, 1397/11/18
Registrant information
Name
Majid Alamdari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 2233 0163
Email address
jokar4132@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-05, 1397/10/15
Expected recruitment end date
2019-05-05, 1398/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Hydroalcoholic Extract of Rose in the Treatment of Chronic Idiopathic Constipation in Patients Referring to Mofateh Clinic in Yasuj
Public title
Extract of Rose and treatment of constipation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adults with chronic constipation according to Rome 4 criteria by obtaining informed consent
no underlying condition like diabetes and thyroid, celiac, lead poisoning, the absence of structural disease,
Non-constipation treatment before the first visit for inclusion (such as lactulose, etc.)
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization Tool: Use Random Number Tables,Numbers 101-175 RosesNumbers 176 to 250 for lactuloseThen these numbers are cluttered onto a page and start by placing a number in the direction above and, accordingly, the drug is assigned to people.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Yasuj University of Medical Sciences
Street address
Imam Sajjad Hospital
City
yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994579
Approval date
2018-10-13, 1397/07/21
Ethics committee reference number
IR.YUMS.REC.1397.113
Health conditions studied
1
Description of health condition studied
Chronic Idiopathic Constipation
ICD-10 code
K59.09
ICD-10 code description
Other constipation
Primary outcomes
1
Description
People with chronic idiopathic constipation who have 2 or more grade according to Rome 4 criteria
Timepoint
All of the above groups meet weekly on a weekly basis: initial visit and diagnosis of days 7, 14, 21 and 28 after the initial visit
Method of measurement
Interview and examination of the number and consistency of fecal excretion in week
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with chronic idiopathic constipation treated with hydroalcoholic extract of Roses (which was produced at the Yasuj Medical Science Research Station and prepared as a capsule and dosed with the desired dosage) at a dose of 10 milligrams per body weight twice a day which should be consumed for a month
Category
Treatment - Drugs
2
Description
Control group: Patients with Chronic iodopathic constipation treated with lactulose(Alborz daroo) which should be consumed for a month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Sajjad Hospital, Shahid Mofateh Clinic
Full name of responsible person
Majid Alamdari
Street address
Imam Sajjad Hospital
City
yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994579
Phone
+98 74 2233 0163
Email
jokar4132@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Dr. Hossein Mari Oryad
Street address
Motahari Blvd, Yasuj University of Medical Sciences،Adjutancy of research
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3334 6078
Email
Oryad.hossein@yums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Sajad Hasanzadeh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Sajjad Hospital
City
yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994579
Phone
+98 74 2233 0163
Email
hasanzadeh_sajad@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
dr sajad hasanzadeh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Sajjad Hospital
City
yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994579
Phone
+98 74 2233 0163
Email
hasanzadeh_sajad@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Majid Alamdari
Position
Internal Medicine Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Imam Sajjad Hospital
City
yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994579
Phone
+98 74 2233 0163
Email
jokar4132@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only, information about the outcome of the study will be published.
When the data will become available and for how long
The publication time after the publication of the results will be in a journal.
To whom data/document is available
Anyone who wants to have access to information after publishing in a journal.
Under which criteria data/document could be used
It can be used with citation conditions.
From where data/document is obtainable
Yasuj University of Medical Sciences / Imam Sajjad Hospital, Yasuj, IranAfter publication in a journal can go to the website of the journal.
Refer to this email:hasanzadeh_sajad@yahoo.com
What processes are involved for a request to access data/document
After the publication of the study information in a journal, it can immediately access the information.