Protocol summary

Study aim
Determining the effect of balang paste on the control of nausea and vomiting of pregnancy in pregnant women referring to health centers of Kashan University of Medical Sciences in 2024.
Design
This study is not blinded due to the impossibility of making a placebo paste in a way that has no effect on nausea and has a consistency, taste and smell similar to Balang paste. The method of assessing the severity of the patient's nausea is done through two questionnaires PUQE-24 (50-52) and VAS (53). At the beginning of the study, all patients will be given the necessary explanations for the intervention group about how to take the drugs along with a complete brochure of drug information. In addition, they will be followed up by a trained nurse during one week after visiting the health centers of Kashan University of Medical Sciences.
Settings and conduct
The proposed method is a Randomized Concurrent Controlled Trial study, which is conducted on women who refer to specialized clinics and medical centers covered by Kashan University of Medical Sciences in 1403 due to nausea and vomiting during pregnancy. People who are 18-40 years old and the gestational age is 6-16 weeks (61) (7) (based on the last menstrual cycle or ultrasound; of course, in cases where they did not have an ultrasound in the first visit, the gestational age will be confirmed by ultrasound in the next visit turns).
Participants/Inclusion and exclusion criteria
Women who refer to health centers of Kashan University of Medical Sciences due to nausea and vomiting during pregnancy in 2024
Intervention groups
Women who refer to health centers of Kashan University of Medical Sciences due to nausea and vomiting during pregnancy in 2024
Main outcome variables
NVP/gestational age/age/nausea severity based on PUQE-24 questionnaire/nausea severity based on VAS questionnaire/pregnancy grade/delivery grade/treatment group

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240703062322N1
Registration date: 2024-07-11, 1403/04/21
Registration timing: prospective

Last update: 2024-07-11, 1403/04/21
Update count: 0
Registration date
2024-07-11, 1403/04/21
Registrant information
Name
Mohammad mehdi Haghighat lari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5224 0739
Email address
haghighat1998@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-17, 1403/04/27
Expected recruitment end date
2024-08-17, 1403/05/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of Citrus medical paste on the control of Nausea and Vomiting of Pregnancy
Public title
the effect of Citrus medical paste on the control of Nausea and Vomiting
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
o Pregnant women aged 18-40 who have experienced mild to moderate NVP (based on PUQE-24). Therefore, people who need hospitalization in the first visit (severe NVP) are not included in the plan. The gestational age should be 16-6 weeks (based on the last menstrual period or ultrasound; of course, in cases where they did not have an ultrasound during the first visit, the gestational age will be confirmed with an ultrasound during the next visit). Absence of nausea and vomiting before pregnancy Not taking anti-nausea drugs 24 hours before the visit (such as ondansetron, metoclopramide, promethazine) Absence of allergy to citron (compound) Absence of severe pregnancy complications such as bleeding, risk of miscarriage No history of chronic diseases, alcoholism, smoking and drug addiction No history of diabetes before pregnancy Absence of gestational diabetes
Exclusion criteria:
Need for hospitalization during intervention (severe NVP) Taking anti-nausea drugs during the intervention (such as ondansetron, metoclopramide, promethazine) The presence of an allergy to citron (compound) during interventions Failure to refer for the second or third visit Non-cooperation in taking medication or placebo as prescribed. In case of forgetting to use it three times, the patient is excluded from the intervention (in case of forgetting or not using 3 to 5 doses in a row, the person should be excluded from the study) Nausea of ​​pregnancy due to causes other than pregnancy (secondary) Occurrence of severe pregnancy complications such as bleeding, risk of miscarriage during intervention
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 140
Randomization (investigator's opinion)
Randomized
Randomization description
Then, the patients will be divided into two intervention and control groups by random blocks of 4.
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
IR.KAUMS.NUHEPM
Street address
Qutb Rawandi Blvd
City
kashan
Province
Isfehan
Postal code
8715985191
Approval date
2024-07-01, 1403/04/11
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1403.024

Health conditions studied

1

Description of health condition studied
Nausea and vomiting of pregnancy
ICD-10 code
O21
ICD-10 code description
Excessive vomiting in pregnancy

Primary outcomes

1

Description
Various studies have reported the prevalence of nausea in 50 to 80% of pregnancies and the prevalence of vomiting and belching in 50% of cases (1). Its prevalence in Iran has not been widely evaluated, but in the study of Hamedan, the prevalence was 69.7% (37.4% of total cases were mild, 46.7% were moderate, and 16% were severe) (12) and in Kashan, the prevalence was reported to be 71.5% (26.5% of total cases). mild, 63.6% moderate and 9.8% severe) (13).
Timepoint
Each patient is visited on four occasions (on arrival, on the third and seventh days of treatment, and on the sixth day after the end of treatment).
Method of measurement
In each appointment, the PUQE and VAS questionnaires are completed, and in addition, in the first visit, the demographic information of the patients (including age, gestational age, number of pregnancies, number of births) and the drugs used are asked, and the self-limiting nature of the disease is explained. In the second to fourth visit, the remaining drugs are collected to check the compliance of the patients and the side effects of the interventions are recorded (in the side effects form).

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Balang paste one tablespoon (10 grams) half an hour before breakfast and dinner for a week. The maximum amount of use of balang paste was not found in Iranian medical sources and modern articles, but since the maximum dosage of balang jam is 22.7 grams (5 shekels) in Iranian medical sources, the maximum daily use of balang paste is 20 grams per day. was taken (35). The case group is not deprived of receiving the main treatment.
Category
Treatment - Drugs

2

Description
Control group: Treatment with pyridoxine 40 mg at a dose of 20 mg every eight hours for one week.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Cyrus Saki
Street address
Qutb Rawandi Blvd
City
kashan
Province
Isfehan
Postal code
8715973447
Phone
+98 31 5500 9999
Fax
+98 31 5558 9200
Email
beheshtihospital@kaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Cyrus Saki
Street address
Qutb Rawandi Blvd
City
kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5544 3022
Email
info@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Fatima Atouf
Position
Assistant Professor of Biostatistics
Latest degree
Ph.D.
Other areas of specialty/work
Biostatistics
Street address
Qutb Rawandi Blvd
City
kashan
Province
Isfehan
Postal code
8715973449
Phone
+98 31 5510 3642
Email
atoof-fa@kaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Fatemeh Atoof
Position
Assistant Professor of Biostatistics
Latest degree
Ph.D.
Other areas of specialty/work
Biostatistics
Street address
Qutb Rawandi Blvd
City
kashan
Province
Isfehan
Postal code
8715973449
Phone
+98 31 5510 3642
Email
atoof-fa@kaums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
mohammad mehdi haghighat lari
Position
Master's degree student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Qutb Rawandi Blvd
City
kashan
Province
Isfehan
Postal code
8715985191
Phone
+98 71 5224 0739
Email
haghighat1998@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
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
Only a part of the data, such as the information related to the main result or the like, can be shared.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Your data will only be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
If requested by the organization or special bodies, this will be reviewed.
From where data/document is obtainable
Mrs. Dr. Fateme Atouf, Assistant Professor of Biostatistics, Department of Biostatistics and Epidemiology, Faculty of Health, Kashan University of Medical Sciences As the first executive of the plan
What processes are involved for a request to access data/document
After sending an email and requesting to receive the data to the first executive, if approved, the data will be sent within a month.
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