The efficacy of Cassia Fistula syrup on constipation in pregnant women
Design
This study has a control group with parallel design. Sample size, for the error typeI, 5% and power of 80%, in each group was calculated as 22. Considering 20% dropout rate, the final sample size was calculated 35 in each group. Samples were randomly divided into intervention and control groups. permuted block Randomization will be used with block of 4.
Settings and conduct
This study will be carried out on 70 pregnant women referred to Rouhani hospital in Babol, Mazandaran, Iran.
The intervention group will use the syrup, in addition to the nutritional and physical activity recommendations. Three days later, if there is no defecation, 25% added to the dose.
Patients are checked in one and two weeks and the constipation checklist will be completed.
The control group also received nutrition and physical activity recommendations, and the checklists will be completed in the first and second weeks after the start.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 17-35 years. Gestational age 28-40 weeks. constipation was based on the criteria of the study (less than 3 times/week defecation, pain while defecation, stool stiffness).
exclusion criteria: high risk pregnancy. The history of inflammatory bowel disease,intestinal surgery,smoking,drug abuse,history of Rheumatologic diseases
Intervention groups
In the intervention group, cassia fistula syrup will be given to 35 women who had a diagnosis of constipation based on the criteria of the study, twice a day for 2weeks, in addition to nutritional and physical activity recommendations. In the control group, 35women who matched with the intervention group received only nutritional and physical activity recommendations
Main outcome variables
The frequency of defecation per week
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100704004306N11
Registration date:2020-02-13, 1398/11/24
Registration timing:registered_while_recruiting
Last update:2020-02-13, 1398/11/24
Update count:1
Registration date
2020-02-13, 1398/11/24
Registrant information
Name
Masoumeh Golsorkhtabar Amiri
Name of organization / entity
Fatemeh-Zahra infertility and Reproductive Health Research center, Babol University of Medical Scien
Country
Iran (Islamic Republic of)
Phone
+98 11 1227 4881
Email address
s.esmaeelzadeh@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-09, 1398/11/20
Expected recruitment end date
2020-05-09, 1399/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of cassia fistula syrup on constipation in pregnant women
Public title
The efficacy of cassia fistula syrup on constipation in pregnant women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction with entering the study
Age between 35 and 17 years
Gestational age 28-40 weeks
Diagnosis of constipation based on study criteria (defecation less than 3 times a week, pain while defecating and stool stiffness)
Exclusion criteria:
High risk pregnancy (twin pregnancy, abortion, placenta previa, preterm labor, fetal anomaly)
History of inflammatory bowel disease (Crohn's disease, ulcerative colitis)
History of intestinal surgery
Smoking and drug abuse
Rheumatologic diseases
Age
From 17 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is performed for two groups in blocks of 4. Patients will randomly divide into two groups: intervention 1 and intervention 2 (intervention 1: nutritional and physical activity recommendations and intervention 2: dietary recommendations and physical activity + cassia fistula syrup).
Random permuted blocks (blocks containing 4 of A and B) will be prepared and eligible samples will be assigned to two intervention groups.
Intervention groups 1 and 2 are each marked with one of the letters A and B, and cards with different quadruple combinations of letters A and B will be produced.
Picking up the cards randomly will determine the following 4 patients will be placed in which of the intervention groups.
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 Babol University of Medical Sciences
Street address
Ganj Afrooz ave.
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Approval date
2019-03-03, 1397/12/12
Ethics committee reference number
IR.MUBABOL.REC.1397.058
Health conditions studied
1
Description of health condition studied
Constipation in pregnant wemon
ICD-10 code
K59.0
ICD-10 code description
Constipation
Primary outcomes
1
Description
frequency of defecation per week
Timepoint
Before intervention and one and two week after intervention
Method of measurement
Constipation cheklist
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group (35 pregnant women) will received nutritional and physical activity recommendations. Also, for two weeks,1 tbsp containing 10 cc of the cassia fistula syrup ("Flubel" syrup produced by Sanabel Daru Co.) twice a day will be given. If constipation does not improve, patients can increase the dose of the drug to 30 cc daily and record this amount.
Category
Treatment - Drugs
2
Description
In the control group (35 pregnant women) only nutritional and physical activity recommendations are given.These recommendations include a written text on the need for adequate fluids, fiber foods, and the need for regular daily physical activity.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Rouhani Hospital
Full name of responsible person
روژینا طهماسبی
Street address
Ganj Afrooz ave,Babol University of Medical Sciences
City
babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3227 4481
Fax
+98 11 3227 4480
Email
tahmasebi.r2@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Vice Chancellor for research of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganjafrooz Avenue, Babol
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 4719
Fax
+98 11 3219 4719
Email
info@mubabol.ac.ir
Web page address
http://research.mubabol.ac.ir/
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
Rozhin tahmasbi
Position
Resident of Obstetrics and Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ganj Afrooz ave,Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3227 4881
Fax
+98 11 3227 4881
Email
tahmasebi.r2@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Rozhin tahmasbi
Position
Resident of Obstetrics and Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ganj Afrooz ave,Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3227 4480
Fax
+98 11 3227 4480
Email
tahmasebi.r2@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Neda mehdinezhad gorji
Position
Responsible for Research Center
Latest degree
Master
Other areas of specialty/work
Reproductive Biology
Street address
Old Amol road in Babol, after brige Mohammad Hassan Khan, Fatemeh Al-Zahra Reproductive Health and Infertility Center
City
Babol
Province
Mazandaran
Postal code
4719173716
Phone
+98 11 3227 4480
Fax
+98 11 3227 4881
Email
n.mahdinejad@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
Undecided - It is not yet known if there will be 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
The result will be sharing
When the data will become available and for how long
The results of the study will be published at least one year after sampling and analyzing the data.
To whom data/document is available
Academic researchers can apply to study documents
Under which criteria data/document could be used
Available for systematic review studies
From where data/document is obtainable
Dr. Seyyed Ali Mozaffarpur is responsible for reviewing requests and information.
Call: 00989111139105 or email: seyyedali1357@gmail.com
What processes are involved for a request to access data/document
Dr. Seyyed Ali Mozaffarpur is responsible for reviewing requests and information.