A Comparative Study of the Effects of Rose and Metoclopramide on Nausea and Vomiting due to Pregnancy
Design
In this assessment, 40 pregnant women with inclusion criteria were included in the study. Participants are randomly coded and classified. Based on this, patients are divided into two treatment groups.
Settings and conduct
In this assessment, in one group, in the Pilot form during nausea and vomiting attacks, place two drops of Rose Essence on the napkin and place it near to the nose within three centimeters interval and ask the patient to breath 3 seconds through the nose and take 15 drops of placebo in three time, and in the other group we used of 15 drops of metoclopramide drop by three times (6 am, 1 pm and 9 o'clock) with placebo, as an inhaled nasal spray. Then patients are evaluated after 5 days of treatment. Then, the data from treatment in both groups. This is a double-blind study, Therefore, patient and researcher do not know dividing approach and treatment groups and their classification is based on coding.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Women with first and second pregnancies who have mild to moderate Longing, between 7 and 14 weeks of gestation.
Exclusion Criteria: Systemic disease and complications of pregnancy.
Intervention groups
In one group we have use of herbal remedies, and in the other group, metoclopramide has used as an interventional medicine.
Main outcome variables
nausea and vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170628034792N4
Registration date:2018-02-23, 1396/12/04
Registration timing:retrospective
Last update:2018-02-23, 1396/12/04
Update count:0
Registration date
2018-02-23, 1396/12/04
Registrant information
Name
bahare mohammadipour yazdi
Name of organization / entity
mashhad university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 913 633 0656
Email address
mohammadipourb881@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
mashhad university of medical science
Expected recruitment start date
2017-07-16, 1396/04/25
Expected recruitment end date
2017-09-16, 1396/06/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of inhaled aromatherapy with rose and metoclopramide on nausea and vomiting in pregnancy in Pregnant women
Public title
Comparison of the effect of rose and metoclopramide on nausea and vomiting in pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
women with first and second intentionally pregnancy
between 7 to 14 weeks of gestation
mild to moderate nausea and vomiting
nausea and vomiting have not improved with diet and usual dietary regimens
not having other systemic diseases and multiple pregnancies
mild to moderate Longing
Exclusion criteria:
Hepatitis, gastritis, increased intracranial pressure and pancreatitis
complications of pregnancy including threatened abortion
bleeding
pyelonephritis.
requirement the person to take medication
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Randomized block randomized allocation method has been used. Accordingly, patients are divided into two groups.
Randomization Units: The randomization unit of the patients was as groups and patients are separated based on this.
Randomization tools: for separation of patients we have used the relevant tables.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to blind the study, patients in each group of other therapeutic groups had no information. The choice of patients was based on the numbering of the checklist, and the researcher did not know the type of treatment performed in patients. Accordingly, this study was double blinded.
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic's committee of Mashhad University of Medical Science
Street address
9177948564, Mellat Park, Vakilabad Boulevard, Mashhad
City
mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2016-06-22, 1395/04/02
Ethics committee reference number
ir.mums.fm.rec.1395.88
Health conditions studied
1
Description of health condition studied
nausea and vomiting during pregnancy
ICD-10 code
021.0
ICD-10 code description
nausea and vomiting of pregnancy
Primary outcomes
1
Description
nausea and vomiting
Timepoint
In 5 days after treatment and three times per day
Method of measurement
visual scale and Rhodes Index 1 to 10
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group was 20 cases, in which the Rose Essence was piloted by the patient during nausea and vomiting attacks. Two drops of Rose Essence are placed on the napkin and three centimeters away from the nose and the patient is asked to breathe for three seconds, in addition they are asked to take 15 drops of the placebo three times.
Category
Treatment - Drugs
2
Description
Control group: The other group was 20, in which 15 ml of drop of metoclopramide droppings were used for three times (6 am, 1 pm and 9 am) with placebo essential oil inhalation at nausea time.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza and Omol Banin hospitals
Full name of responsible person
Malihe Safi
Street address
9177948564, Mellat Park, Vakilabad Boulevard, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 8888
Fax
Email
afiatm@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 1801 2851
Email
layeghpo@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
mashhad university of medical science department of gynecology
Full name of responsible person
Dr.Malihe Afiat
Position
Assistant Professor of Obstetrics and Gynecology
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
9177948564, Ibn Sina St, The margin of Imam Reza Square (AS), Mashhad,
City
mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3802 2000
Fax
Email
afiatm@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Obstetrics and Gynecology, Mashhad University of Medical Sciences
Full name of responsible person
Dr.Malihe Afiat
Position
Assistant Professor of Obstetrics and Gynecology
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam Reza hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3802 2000
Fax
Email
afiatm@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Obstetrics and Gynecology, Mashhad University of Medical Sciences
Full name of responsible person
Dr.Malihe Afiat
Position
Assistant Professor of Obstetrics and Gynecology
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
9177948564, Ibn Sina Avenue, on the edge of Imam Reza Square (AS), Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 8888
Email
afiatm@mums.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
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