Evaluation the Effect of Combined Fig-Walnut Syrup compared to fig syrup and placebo on functional Constipation and Quality of Life in Pregnant Women: A Randomized Controlled Clinical Trial
To determine the effect of combined fig-walnut syrup on functional constipation and quality of life in pregnant women
Design
A controlled clinical trial with three parallel groups, double blinded, randomized with blocking method, phase three on 90 patients. The randomizer software will be used for randomization.
Settings and conduct
This study will be performed in Al-Zahra and Taleghani hospitals and health Centers of Tabriz. The first group will use the combined fig-walnut syrup, the second group will use fig syrup, and the third group will use placebo, 15 ml every night, half an hour before going to bed, for two weeks. The participants, researcher and data analyst will be blinded. Drugs and placebo will be similar in appearance and will be prepared in similar opaque bottles.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Healthy singleton pregnant women with constipation; Gestational age less than 32 weeks; Being literate in reading and writing.
Non-inclusion criteria: Receiving medication for constipation less than one week before the study; Having Intestinal diseases; Having a high-risk pregnancy; Having an addiction to drugs and smoking; Previous allergy to figs or walnuts
Intervention groups
The first intervention group will use the combined fig-walnut syrup, the second intervention group will use fig syrup, and the control group will use placebo, 15 ml every night, half an hour before going to bed, for two weeks.
Main outcome variables
Number of defecation per week; average quality of life score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120718010324N79
Registration date:2023-07-12, 1402/04/21
Registration timing:prospective
Last update:2023-07-12, 1402/04/21
Update count:0
Registration date
2023-07-12, 1402/04/21
Registrant information
Name
Mojgan Mirghafourvand
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6969
Email address
mirghafourvandm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-01, 1402/05/10
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the Effect of Combined Fig-Walnut Syrup compared to fig syrup and placebo on functional Constipation and Quality of Life in Pregnant Women: A Randomized Controlled Clinical Trial
Public title
Effect of combined fig and walnut syrup on constipation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy singleton pregnant women with constipation
Gestational age less than 32 weeks
Being literate in reading and writing
Exclusion criteria:
Receiving medication for constipation less than one week before the study
Endocrine disorders (hypothyroidism)
Intestinal diseases such as Hirschiprong, intestinal obstruction, colon cancer, intestinal hernia or stricture, inflammatory bowel disease, previous gastrointestinal surgery, spinal abnormalities and anorectal injuries such as fistula according to the person's own statement
Having a high-risk pregnancy including diabetes (people with overt diabetes and disturbed GTT and people who have fasting blood sugar higher than normal range in the first trimester tests), high blood pressure, chronic diseases that affect pregnancy such as heart, vascular, lung diseases and .... according to the person's own statement and the medical record
Having an addiction to drugs and smoking
Previous allergy to figs or walnuts
Age
From 15 years old to 49 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The participants in the study will be assigned to two intervention groups (recipients of combined fig-walnut syrup, recipient of fig syrup) and a control group (recipient of placebo) using a random block method with a block size of six and with an allocation ratio of 1:1:1. A computerized program ( randomizer software) will be used to create the allocation sequence. For allocation concealment, the allocation sequence will be determined by someone not involved in the study. For blinding, drugs and placebo will be provided in the same opaque bottles that numbered sequentially.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The participants, researcher and data analyst will be blinded completely in this study. Drug and placebo will be similar in appearance (shape, color, smell) and will be prepared in similar opaque bottles.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Reaserch department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht street, Azadi street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Approval date
2023-06-26, 1402/04/05
Ethics committee reference number
IR.TBZMED.REC.1402.271
Health conditions studied
1
Description of health condition studied
Functional constipation
ICD-10 code
K59.0
ICD-10 code description
Constipation
Primary outcomes
1
Description
Number of bowel movements per week
Timepoint
Before the intervention, the first, second, third and fourth weeks
Method of measurement
Questionnaire of functional constipation
2
Description
Quality of life score
Timepoint
Before starting the intervention, End of the fourth week
Method of measurement
Specific quality of life questionnaire during pregnancy
Secondary outcomes
1
Description
Straining during defecation
Timepoint
In the first, second, third and fourth weeks after the intervention
Method of measurement
Questionnaire of constipation
2
Description
Sensation of incomplete evacuation
Timepoint
In the first, second, third and fourth weeks after the intervention
Method of measurement
Questionnaire of constipation
3
Description
Sensation of anorectal obstruction
Timepoint
In the first, second, third and fourth weeks after the intervention
Method of measurement
Questionnaire of constipation
4
Description
Manual maneuvers to facilitate defecation
Timepoint
In the first, second, third and fourth weeks after the intervention
Method of measurement
Questionnaire of constipation
5
Description
Stool consistency
Timepoint
In the first, second, third and fourth weeks after the intervention
Method of measurement
Questionnaire of constipation
6
Description
Use of magnesium milk
Timepoint
At the end of the intervention
Method of measurement
Checklist
7
Description
First time of elimination of symptoms and improvement in constipation
Timepoint
At the end of the intervention
Method of measurement
Questionnaire of constipation
8
Description
Satisfaction
Timepoint
At the end of the first, second, third and fourth weeks
Method of measurement
Checklist
Intervention groups
1
Description
Intervention group 1: The participants (30 people) in the first group will use the combined fig-walnut syrup every night, half an hour before going to sleep, in the amount of 15 ml, for two weeks.
Category
Treatment - Drugs
2
Description
Intervention group 2: The participants (30 people) in the second group will use the fig syrup every night, half an hour before going to sleep, in the amount of 15 ml, for two weeks.
Category
Treatment - Drugs
3
Description
Control group: Participants (30 people) in the control group will use 15 ml of placebo syrup every night, half an hour before going to bed, for two weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Roghayyeh Valizadeh
Street address
Alzahra Hospital, Artesh street
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 3553 9161
Email
alzahrahospital@tbzmed.ac.ir
Web page address
https://alzahrahosp.tbzmed.ac.ir
2
Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Roghayyeh Valizadeh
Street address
Rah-Ahan square
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 3442 8990
Email
taleghani.hos@tbzmed.ac.ir.com
Web page address
https://taleghanihosp.tbzmed.ac.ir
3
Recruitment center
Name of recruitment center
Community health centers of Tabriz
Full name of responsible person
Roghayyeh Valizadeh
Street address
Community health centers of Tabriz
City
tabriz
Province
East Azarbaijan
Postal code
5143814998
Phone
+98 41 3444 0057
Email
iro@tbzmed.ac.ir
Web page address
http://tabriz-phc.tbzmed.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Parviz Shahabi
Street address
Research Department, third floor, Central Construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3335 5921
Email
dabirkhanecent@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Roghayyeh Valizadeh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, South Shariati street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5135963777
Phone
+98 41 3523 0741
Email
r.valizadeh31@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mojgan Mirghafourvand
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
mirghafourvandm@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mojgan Mirghafourvand
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
mirghafourvandm@tbzmed.ac.ir
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
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available