Evaluation of Cassia Fistula syrup compared to lactulose syrup in improving constipation in the elderly
Design
A double-blind randomized clinical trial study is performed with a control group. 70 elderly patients referred to the gastrointestinal clinic of Ayatollah Rouhani Hospital in Babol with the diagnosis of constipation, randomly assigned to two groups of cassia fistula and lactulose, and are followed for two weeks.
Settings and conduct
Elderly patients referred to the gastroenterology clinic of Ayatollah Rouhani Hospital in Babol after the diagnosis of constipation based on the Rome IV checklist are included in the study.
Patients in two parallel groups are followed for two weeks and the information is recorded in the questionnaire.
Patients and evaluators are blind to the study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Age over 60 years
2- Diagnosis of constipation based on ROME IV criteria
Exclusion criteria:
1. The presence of organic diseases is the basis for constipation
2. Presence of cardiovascular, neurological, metabolic, Hematologic or mental disorders or malignancy
Intervention groups
Intervention group: Cassia fistula syrup in 250 cc containers, 30 ccs daily (in three separate doses) is given to patients for two weeks.
Control group: Lactulose syrup in 250 cc containers, 30 ccs daily (in three separate doses) is given to patients for two weeks.
Main outcome variables
Frequency of defecation, Feeling of incomplete emptying after defecation, Number of times to use the manual maneuver, Stiffness of stools
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200105046009N3
Registration date:2020-07-17, 1399/04/27
Registration timing:registered_while_recruiting
Last update:2020-07-17, 1399/04/27
Update count:0
Registration date
2020-07-17, 1399/04/27
Registrant information
Name
Seyyed Ali Mozaffarpur
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 4728
Email address
dr.mozaffarpur@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-22, 1399/04/02
Expected recruitment end date
2020-10-23, 1399/08/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Cassia Fistula syrup in geriatrics consipation in comparison with the lactulose
Public title
The effect of Cassia Fistula syrup in geriatrics consipation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 60 years
Diagnosis of constipation based on ROME IV criteria
Exclusion criteria:
The presence of organic diseases is the basis for constipation
Presence of cardiovascular disease, neurological disease, metabolic disease or mental disorders. Hematologic disease or malignant tumor (unless recurrent in the last 5 years)
History of alcohol use or substance abuse
Age
From 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
The size of the blocks is 4. Drugs in two categories (drug and standard treatment) are poured into identical containers by the study pharmacist and sent to the study statistics specialist. The statistician encodes them and places them in blocks of 4 (containing 2 numbers from each group). And is given to the researcher in blind form. Unlock codes will be done after reading. In case of side effects, the drug code will be unlocked.
Blinding (investigator's opinion)
Single blinded
Blinding description
Lactulose and Floss syrup in a single form, with the same label, will be prepared by a pharmacist in the Medicinal Plants Laboratory of the Faculty of Iranian Medicine, Babol University of Medical Sciences. The only person who knows the nature of the syrups is the pharmacist involved in the project. Due to the fact that the consistency and shape of the drugs are different, it is not possible to blind the patient in this regard. Therefore, the study will be done one-way blind (evaluator blinding)
Placebo
Used
Assignment
Parallel
Other design features
In this study, a total of 70 patients will be admitted and patients will be randomly divided into two groups. The first group are patients who receive floss syrup and the second group are patients who receive lactulose syrup. The data required for this study will also be collected through questionnaires 1 to 6.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Shiraz University of Medical Sciences
Street address
Ganjafrooz Street
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2020-06-28, 1399/04/08
Ethics committee reference number
IR.MUBABOL.HRI.REC.1399.116
Health conditions studied
1
Description of health condition studied
geriatrics consipation
ICD-10 code
K59.0
ICD-10 code description
Constipation
Primary outcomes
1
Description
Frequency of defecation
Timepoint
Number per week
Method of measurement
counting and recording the number of defecation per week
Secondary outcomes
1
Description
Feeling of incomplete emptying after defecation
Timepoint
Before intervention and 7 and 14 days after intervention
Method of measurement
Daily questionnaire on quality of defecation
2
Description
Number of times of manual maneuver in defecation
Timepoint
Before intervention and 7 and 14 days after intervention
Method of measurement
Daily questionnaire on quality of defecation
3
Description
Stiffness of stool
Timepoint
Before intervention and 7 and 14 days after intervention
Method of measurement
Visual Analogue Scale
4
Description
Quality of Life
Timepoint
Before intervention and 14 days after intervention
Method of measurement
Patient Assessment of Constipation Quality of Life Questionnaire (the Persian Version)
Intervention groups
1
Description
Intervention group: Cassia fistula syrup prepared and standardized in the Laboratory of Medicinal Plants of Babol School of Traditional Medicine, 30 cc daily (in three separate doses) for 14 days for the elderly with constipation and on days 0 (before Drug initiation), 7 and 14 are evaluated.
Category
Treatment - Drugs
2
Description
Control group: Lactulose syrup (made by Exir Company), 30 cc daily (in three separate doses) for 14 days for the elderly with constipation and on days 0 (before Drug initiation), 7 and 14 are evaluated.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Roohani Hospital
Full name of responsible person
Seyyed Ali Mozaffarpur
Street address
Ganjafrooz Street
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 4730
Email
seyyedali1357@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
Ganjafrooz Street
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 4730
Email
seyyedali1357@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
seyyed Ali Mozaffarpur
Position
Associated Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Ganjafrooz Street
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 4730
Email
seyyedali1357@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
seyyed Ali mozaffarpur
Position
Associated Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Ganjafrooz Street
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 4730
Email
seyyedali1357@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
seyyed Ali Mozaffarpur
Position
Associated Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Ganjafrooz Street
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3279 4730
Email
seyyedali357@gmail.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
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
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
all data will be accessable
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
people working in academic institutions
Under which criteria data/document could be used
systematic review and meta-analysis on data
From where data/document is obtainable
Submit a request via email seyyedali1357@gmail.com and after checking by the project manager
What processes are involved for a request to access data/document
Submit a request via email seyyedali1357@gmail.com and after checking by the project manager