Protocol summary

Study aim
Comparison of the effect of KN9 and ginger syrup on nausea and vomiting of pregnancy in pregnant women
Design
The present study is a randomized, single-blind clinical trial, which was conducted after obtaining an ethics permit with the code IR-GMU-REC.1401.009 from the ethics committee of Gonabad University of Medical Sciences on 44 pregnant women who referred to comprehensive health service centers in Gonabad It was done in in the year1402.
Settings and conduct
Individuals with the entry criteria and desired characteristics were selected as available and after obtaining written informed consent, they were randomly assigned to two groups. The method of blinding was that the pregnant mothers were asked not to tell the other mothers present in the study about the method used to reduce nausea and vomiting.
Participants/Inclusion and exclusion criteria
Single pregnancy, maternal age 18-40 years, gestational age less than 20 weeks, no high risk pregnancy, no illness with nausea and vomiting such as peptic ulcer, hepatitis, pyelonephritis, pancreatitis, cholecystitis, appendicitis, gastroenteritis, urinary tract infection, central nervous system disorders, esophageal reflux disease, hyperthyroidism, mental illness, lack of chronic diseases such as kidney disorders, hypertension, diabetes, nausea with or without Vomiting with mild and moderate severity (score 4-12 based on PUQE-24 questionnaire) of 24
Intervention groups
In one group, under the supervision of a specialist doctor, pregnant mothers were given Barij sorbet and ginger essential oil, prepared by Barij pharmaceutical company, and in the other group, mothers were given gentle pressure on the 9 K-K point for two minutes every two hours to the extent that they felt They brought it in for 4 days (days 4 to 7) so that they don't have any discomfort and it is tolerable.
Main outcome variables
Severe nausea and vomiting

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200720048144N3
Registration date: 2024-08-07, 1403/05/17
Registration timing: retrospective

Last update: 2024-08-07, 1403/05/17
Update count: 0
Registration date
2024-08-07, 1403/05/17
Registrant information
Name
Fatemeh Kameli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5726 2481
Email address
kameli.f@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-20, 1401/07/28
Expected recruitment end date
2023-01-02, 1401/10/12
Actual recruitment start date
2022-10-25, 1401/08/03
Actual recruitment end date
2023-01-02, 1401/10/12
Trial completion date
2023-01-02, 1401/10/12
Scientific title
Comparing the effect of K-K9 point acupressure and Quince and Ginger syrup on nausea and vomiting of pregnancy
Public title
Comparing the effect of K-K9 point acupressure and Quince and Ginger syrup on nausea and vomiting of pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Single pregnancy maternal age 18-40 years gestational age less than 20 weeks nausea with or without Vomiting with mild and moderate severity (score 4-12 based on PUQE-24 questionnaire) of 24
Exclusion criteria:
high risk pregnancy illness with nausea and vomiting such as peptic ulcer, hepatitis, pyelonephritis, pancreatitis, cholecystitis, appendicitis, gastroenteritis, urinary tract infection, central nervous system disorders, esophageal reflux disease, hyperthyroidism, mental illness Known insensitivity to extracts to ginger
Age
From 18 years old to 40 years old
Gender
Female
Phase
1-2
Groups that have been masked
  • Participant
Sample size
Target sample size: 44
Actual sample size reached: 44
Randomization (investigator's opinion)
Randomized
Randomization description
Pregnant mothers referring to community health service centers who meet the entry criteria and desired characteristics were selected as available. And after obtaining written informed consent, they will be randomly assigned in two groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding will be done in such a way that the pregnant mothers participating in the study will be asked not to tell the mothers in the opposite group about the method used to reduce their nausea and vomiting.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Gonabad University of Medical Sciences
Street address
Gonabad, near Asian Road, Gonabad University of Medical Sciences
City
gonabad
Province
Razavi Khorasan
Postal code
9691675781
Approval date
2022-04-11, 1401/01/22
Ethics committee reference number
IR.GMU.REC.1401.009

Health conditions studied

1

Description of health condition studied
Nausea and vomiting of pregnancy
ICD-10 code
O21.9
ICD-10 code description
Vomiting of pregnancy, unspecified

Primary outcomes

1

Description
Severity of nausea and vomiting based on PUQE-24 questionnaire
Timepoint
before the start of the intervention and on the 8th day after the start of the intervention
Method of measurement
Questionnaire PUQE-24

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:Intervention group: In one group, under the supervision of a specialist doctor, Sharbat Beh and Zanjabil Barij essential oil, prepared by Barij Pharmaceutical Company, were given and the amount and method of consumption were taught to the mothers. So that on days 4 to 7, one tablespoon is consumed one hour before each meal. This syrup is a standardized 120 ml container based on 26-22 mg of total phenolics (in terms of gallic acid) per 5 ml of syrup and its ingredients include betel nut, ginger and honey.
Category
Treatment - Drugs

2

Description
Intervention group: Intervention group: In the other group of mothers, from 7 am to 7 pm, every two hours for two minutes on the K-K point 9 (picture no. 1) gentle pressure to the extent that they do not feel uncomfortable and tolerable for 4 days (4 days) to 7) entered. The researcher taught mothers the exact location of the K-K9 point and the amount of pressure on it in a practical way.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
مراکز خدمات جامع سلامت شهر گناباد
Full name of responsible person
fateme kameli
Street address
مراکز خدمات جامع سلامت شهر گناباد
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 5027
Email
kameli.f@gmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Leila Sadegh Moghadam
Street address
Gonabad. Side of Asian Road. Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 5027
Email
kameli.f@gmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
fateme kameli
Position
مربی هیئت علمی
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
On the side of Asian Road, Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 5027
Email
kameli.f@gmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
fateme kameli
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
On the side of Asian Road, Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 5027
Email
kameli.f@gmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
fateme afshari
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
On the side of Asian Road, Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 5027
Email
f.afshar34@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
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
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