The aim of this study is to Compare the effect of Ginger with Ondanstron on Nausea and Vomiting in pregnancy.
Design
This study is a randomized double-blind clinical trial with two intervention and control groups (with parallel design)
Settings and conduct
This is a double-blind clinical trial conducted on 116 pregnant women referred to Mahshahr health centers who suffer from moderate and severe gestational nausea and vomiting.Drugs are sealed to the required number for each group inside numbered brown bag, which matches to the number of patients. A special code is assigned to each bag and drug package. Putting pills into the brown bag and numbering them is done by someone outside of the research team. In this research, the patient, the researcher, and the providers of medical services are blinded to the pharmaceutical diet.
Participants/Inclusion and exclusion criteria
The inclusion criteria include: Age between 18-35 years; Gestational age of 10-15 weeks; Single pregnancy ; LMP or ultrasound precision; Ability to read and write.
The exclusion criteria include: The presence of diseases such as kidney, high blood pressure, epilepsy, diabetes and hepatitis, digestive diseases;Unwanted pregnancy; Malignant vomiting of pregnancy; Smoking; Symptoms of abortion;
Infertility; Undesirable events in the past; Taking iron pills over the past week; The patient has used anti-nausea and vomiting drugs for at least 3 days; Sensitivity to ginger.
Intervention groups
Control group: administration of Ginger tablet, 500 mg, every 8 hours for three days
Intervention group: administration of Ondanstron tablet, 4 mg, every 8 hours for three days
Main outcome variables
Nausea; Vomiting
General information
Reason for update
Acronym
NVP
IRCT registration information
IRCT registration number:IRCT20171007036600N1
Registration date:2018-02-18, 1396/11/29
Registration timing:prospective
Last update:2018-02-18, 1396/11/29
Update count:0
Registration date
2018-02-18, 1396/11/29
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5235 8388
Email address
khalilimoghadam.z@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2018-06-21, 1397/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison The effect of Ondansetron versus Ginger on Nausea and Vomiting in pregnancy
Public title
Ginger and Ondansetron tablets on Nausea and Vomiting in pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18-35 years
Gestational age 10-15 weeks
Single pregnancy
knowing the exact time of last menstrual period (LMP) or having a precised sonographic result
Ability to read and write
Exclusion criteria:
The presence of diseases such as kidney disease, high blood pressure, epilepsy, diabetes and hepatitis, digestive diseases that may lead to nausea and vomiting
Unwanted pregnancy
Severe vomiting in pregnancy
Smoking
Symptoms of abortion; miscarriage or molar pregnancy
Pregnancy following infertility
Undesirable events in the past, such as severe disagreement with a partner, death of spouse or first degree relatives
Consuming agents such as iron that exacerbate nausea and vomiting during the last week
Consuming anti-inflammatory drugs for at least 3 days
Sensitivity to ginger
Age
From 18 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
116
Randomization (investigator's opinion)
Randomized
Randomization description
Table of random numbers using the computer - on an individual basis
Blinding (investigator's opinion)
Double blinded
Blinding description
Drugs are sealed to the required number for each group inside numbered brown bag, which matches to the number of patients.A special code is assigned to each bag and drug package. Putting pills into the brown bag and numbering them is done by someone outside of the research team. In this research, the patient, the researcher, and the providers of medical services are blinded to the pharmaceutical diet.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Ahvaz JundiShapur University of Medical Sciences
Street address
اهواز، شهر دانشگاهي ، معاونت توسعه پژوهش و فن آوری دانشگاه علوم پزشكي و خدمات بهداشتی درمانی جندی شاپور اهواز
City
اهواز
Province
Khouzestan
Postal code
61357-15794
Approval date
2017-11-21, 1396/08/30
Ethics committee reference number
IR.AJUMS.REC.1396.618
Health conditions studied
1
Description of health condition studied
Nausea and Vomiting in pregnancy
ICD-10 code
O21.9
ICD-10 code description
Vomiting of pregnancy, unspecified
Primary outcomes
1
Description
severity of Nausea
Timepoint
Before intervention and three days after that
Method of measurement
Rodes standard questionnaire
2
Description
Rate of Nausea
Timepoint
Before intervention and three days after that
Method of measurement
Rodes standard questionnaire
3
Description
Duration of Nausea
Timepoint
Before intervention and three days after that
Method of measurement
Rodes standard questionnaire
4
Description
Severe Vomiting
Timepoint
Before intervention and three days after that
Method of measurement
Rodes standard questionnaire
5
Description
Rate of Vomiting
Timepoint
Before intervention and three days after that
Method of measurement
Rodes standard questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Control group: administration of Ginger tablet, 500 mg, every 8 hours for three days
Category
Treatment - Drugs
2
Description
Intervention group: administration of Ondanstron tablet, 4 mg, every 8 hours for three days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Health center of Mahshahr city
Full name of responsible person
Zahra khalili Moghadam
Street address
Mahshahr Imam Musa Kazem Hospital, In front of overpass, After the bus terminal
City
Mahshahr
Province
Khouzestan
Postal code
6351984406
Phone
+98 61 5232 6051
Fax
+98 61 5235 8388
Email
khalilimoghadam.z@ajums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Badavi
Street address
Ground floor, vice chancellor for research, Ahvaz Junishapur University of Medical Science and Health Services, Shahre Daneshgahi, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8383
Fax
+98 61 3361 5443
Email
itc@ajums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Mitra Tadayon Najafabady
Position
Master of Science
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, JundiShapur University of Medical Sciences, Golestan boulevard, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8331
Fax
+98 61 3373 8333
Email
mitratadayon2000@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mitra Tadayon Najafabady
Position
Master of Science
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, JundiShapur University of Medical Sciences, Golestan boulevard, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8331
Fax
+98 61 3373 8333
Email
mitratadayon2000@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Zahra khalili Moghadam
Position
Master student in Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, JundiShapur University of Medical Sciences, Golestan boulevard, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61333738331
Fax
+98 61 3373 8333
Email
khalilimoghadam.z@ajums.ac.ir
Web page address
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