Determining and comparing the severity of nausea, frequency of vomiting and frequency of burping in two groups of users of the product "Quince" product and vitamin B6
Design
A clinical trial with two intervention groups with parallel randomized groups was conducted on 120 patients in a simple randomization manner.
Settings and conduct
The first group was given one tablespoon of fruit product 3 times a day and the second group were given 20 mg of vitamin B6 three times a day for one week, and the variables were recorded by the patient every day based on a questionnaire. The severity of the disease before and after the treatment, the effectiveness of the treatment and the rate of recurrence of symptoms one week after the end of the treatment were re-examined in both groups. Sampling was done in Taleghani hospital clinic.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18-40 Years
GA of 6-16 week
Singleton pregnancy with a live and healthy fetus
Mild and moderate pregnancy nausea and vomiting
Reading and writing literacy
No Severe nausea and vomiting of pregnancy that requires hospitalization.
N/V have not been caused by a cause other than pregnancy.
N/V caused by a cause other than pregnancy.
Multiple pregnancy, EP and multiple moles rolled out.
Do not have pregnancy complications such Abortion.
There is no history of chronic disease, addiction, smoking and drug allergy.
They have not taken anti emetic medication in the 48 hours before visit.
Intervention groups
This product is prepared as a paste from fruit and is completely herbal and does not have any special side effects. Therefore, one group was given a common medicine for the initial treatment of pregnancy nausea, vitamin B6, and the other group was given a paste product.
Main outcome variables
Severity of nausea and vomiting; duration of nausea and vomiting; frequency of vomiting; frequency of burping; amount of sleep; appetite
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231030059899N1
Registration date:2024-03-14, 1402/12/24
Registration timing:retrospective
Last update:2024-03-14, 1402/12/24
Update count:0
Registration date
2024-03-14, 1402/12/24
Registrant information
Name
zahra Torkamani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7738 3261
Email address
zahra.torkamani0@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2021-01-20, 1399/11/01
Actual recruitment start date
2020-09-22, 1399/07/01
Actual recruitment end date
2021-01-20, 1399/11/01
Trial completion date
2021-02-14, 1399/11/26
Scientific title
Comparison of the effectiveness of "Quince" (CydoniaOblonga) product and vitamin B6 for treatment nausea and vomiting of pregnancy.
Public title
Investigating the effect of Quince fruit product for treatment nausea and vomiting of pregnancy.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Single pregnant woman with a healthy fetus
With a gestational age of 6 to 16 weeks
With mild to moderate nausea and vomiting
Not taking anti emetic medication in the last 48 hours
No history of specific disease
Literacy for reading and writing
Exclusion criteria:
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Actual sample size reached:
91
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization of the individual has been done, based on the clients, one person will receive the common treatment of vitamin B6 and the next person will be given the fruit product.
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 Shahid Beheshti University of Medical Sciences
Street address
Shahid Arabi Ave، Velenjak
City
Tehran
Province
Tehran
Postal code
1995711151
Approval date
2023-10-24, 1402/08/02
Ethics committee reference number
IR.SBMU.MSP.REC.1402.391
Health conditions studied
1
Description of health condition studied
Hyperemesis Gravidarum
ICD-10 code
021.0
ICD-10 code description
Hyperemesis gravidarum, mild or unspecified, starting before the end of the 22nd week of gestation
Primary outcomes
1
Description
Severity of nausea and vomiting
Timepoint
Measure improvement over two weeks on days 4 and 11
Method of measurement
Measurement of improvement based on PUQE-24 and severity based on VAS scoring system
2
Description
Duration of nausea and vomiting
Timepoint
Measure improvement over two weeks on days 4 and 11
Method of measurement
Measurement of improvement based on PUQE-24 and severity based on VAS scoring system
3
Description
Frequency of vomiting
Timepoint
Measure improvement over two weeks on days 4 and 11
Method of measurement
Measurement of improvement based on PUQE-24 and severity based on VAS scoring system
4
Description
Frequency of retching
Timepoint
Measure improvement over two weeks on days 4 and 11
Method of measurement
Measurement of improvement based on PUQE-24 and severity based on VAS scoring system
5
Description
Amount of sleep
Timepoint
Measure improvement over two weeks on days 4 and 11
Method of measurement
Measurement of improvement based on PUQE-24 and severity based on VAS scoring system
6
Description
Appetite
Timepoint
Measure improvement over two weeks on days 4 and 11
Method of measurement
Measurement of improvement based on PUQE-24 and severity based on VAS scoring system
Secondary outcomes
empty
Intervention groups
1
Description
Control group: patients were given vitamin B6 tablets
Category
Treatment - Drugs
2
Description
Intervention group: And it was given Quince product to the intervention
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Taleghani educational and therapeutic hospital
Full name of responsible person
Zahra Torkamani
Street address
Shahid Arabi Ave., Velenjak
City
Tehran
Province
Tehran
Postal code
1995711151
Phone
+98 21 2243 2582
Email
info@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Mojgan Tansaz
Street address
Arabi Ave., Velenjak., Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1985717444
Phone
+98 21 8877 3521
Email
sitm@sbmu.ac.ir
Web page address
https://sbmu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
80
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
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Torkamani
Position
Gynecologist
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 32, Second Central Ave., Shahid Motahari Ave., Ghanat Kousar
City
Tehran
Province
Tehran
Postal code
1689914864
Phone
+98 21 7738 3261
Email
zahra.torkamani0@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
professor Saghar Salehpour
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Taleghani hospital., Shahid Arabi Ave., Velenjak
City
Tehran
Province
Tehran
Postal code
1995711151
Phone
+98 21 2303 1307
Email
saghar.salehpour2014@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Torkamani
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No32, second central ave, Shahid Motahari blv, Ghanat kousar area
City
Tehran
Province
Tehran
Postal code
1689914864
Phone
+98 21 7738 3261
Fax
Email
zahra.torkamani0@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Undecided - It is not yet known if there will be 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 can potentially be shared after de-identifying individuals in an Excel file
When the data will become available and for how long
This file is now accessible
To whom data/document is available
It will be available for researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Only for scientific purposes and for the production of herbal products
From where data/document is obtainable
For information, contact Dr. Zahra Torkmani at phone number 09120728852
torkamanizahra330@gmail.com
What processes are involved for a request to access data/document
You will be informed as soon as you contact Dr. Torkmani