The aim of this study was to compare the effect of ondansetron and ginger for nausea and vomiting of pregnancy.
Design
Clinical trial without control group, with parallel groups, three-way blind, simple randomized, phase 3 on 150 patients
Settings and conduct
The statistical population in this study is all pregnant women referred to the prenatal clinic of Booali Hospital in Tehran who have mild to moderate nausea and vomiting according to the questionnaire.The study of the sampling method is first done in an improbably easy method and among the available samples with inclusion criteria, then the units are randomly divided into two comparative groups of ginger, ondansetron and consumption.
Participants/Inclusion and exclusion criteria
Gestational age 6-16 weeks, With mild to moderate nausea and vomiting
Single pregnancy, No Known insensitivity to ginger and ondansetron, No known underlying disease, No risk of pregnancy, Do not take anticoagulants
Intervention groups
Solid capsules will be filled and encoded by ondansetron powder, ginger. Ginger capsules contain 500 mg of ginger root powder and ondansetron capsules contain 8 mg of this drug powder. Each sample will be given an envelope with a specific code and in the same package, each of which contains 12 capsules. The method of taking the drug is one capsule every 12 hours for up to 4 days. People will record the severity of their nausea and vomiting every day based on the questionnaire.
Main outcome variables
Dependent variables: Severity of nausea, Severity of vomiting, Complications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210303050564N1
Registration date:2021-04-14, 1400/01/25
Registration timing:registered_while_recruiting
Last update:2021-04-14, 1400/01/25
Update count:0
Registration date
2021-04-14, 1400/01/25
Registrant information
Name
Marjan Akhavan Amjadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2270 0769
Email address
marjan_akhavan2003@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-09, 1400/01/20
Expected recruitment end date
2021-08-11, 1400/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing Ondansetron and Ginger for the treatment of nausea and vomiting in pregnancy on pregnant women attending prenatal clinic
Public title
Comparing Ondansetron and Ginger for the treatment of nausea and vomiting in pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age 6-16 weeks
Mild to moderate nausea and vomiting
Single pregnancy
Exclusion criteria:
Known underlying disease
Risk of pregnancy
Take anticoagulants
Known insensitivity to ginger and ondansetron
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random
Blinding (investigator's opinion)
Triple blinded
Blinding description
Each sample will be given an envelope with a specific code and in the same package, each of which contains 12 capsules. It should be noted that based on the three-sided blindness of the research, the researcher, research units and statisticians will not know any of the drugs used.
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, Tehran
Street address
Nyaiesh, Hashemi Rafsanjani Bulvar, Valiasr Ave
City
Tehran
Province
Tehran
Postal code
3817-14155
Approval date
2021-01-29, 1399/11/10
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.1009
Health conditions studied
1
Description of health condition studied
Nausea and vomiting in pregnancy
ICD-10 code
O21.0
ICD-10 code description
O21.0 Mild hyperemesis gravidarum
Primary outcomes
1
Description
The severity of nausea and vomiting
Timepoint
Measure the severity of nausea and vomiting at the beginning of the study and daily during treatment
Method of measurement
Rhodes Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: ondansetron Ondansetron powder is prepared from a pharmaceutical company. Then, in Tehran Shahid Beheshti School of Pharmacy, monochromatic capsules will be filled and coded with 8 mg of ondansetron powder. Each sample will be given an envelope with a specific code and in the same package, each of which contains 12 capsules. They will not know the type of medicine used. The method of taking the drug is one capsule every 12 hours for up to 4 days. People will record the severity of their nausea and vomiting every day based on the questionnaire.
Category
Treatment - Drugs
2
Description
Intervention group: ginger Ginger root powder is prepared from a reputable center. Then, in Tehran Shahid Beheshti School of Pharmacy, monochromatic capsules will be filled and coded with 500 mg of ginger root powder. Each sample will be given an envelope with a specific code and in the same package, each of which contains 12 capsules. They will not know the type of medicine used. The method of taking the drug is one capsule every 12 hours for up to 4 days. People will record the severity of their nausea and vomiting every day based on the questionnaire.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Prenatal Clinic of Bu Ali Hospital
Full name of responsible person
Faraz Mojab
Street address
The Beginning of Damavand Street, Imam Hossein Square
City
Tehran
Province
Tehran
Postal code
17117
Phone
+98 21 3334 8040
Fax
+98 21 3378 6182
Email
marjan_akhavan2003@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maria Tavakoli Ardakani
Street address
Vali Asr St. Niayesh Cross Section
City
Tehran
Province
Tehran
Postal code
14155-1817
Phone
+98 21 8820 0118
Email
mariatavakoli@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Faraz Mojab
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Vali Asr St. Niayesh Cross Section
City
Tehran
Province
Tehran
Postal code
14155-1817
Phone
+98 21 8820 9627
Fax
+98 21 8820 9627
Email
sfmojab@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Faraz Mojab
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Vali Asr St, Niayesh Cross Section
City
Tehran
Province
Tehran
Postal code
14155-1817
Phone
+98 21 8820 9627
Email
sfmojab@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Marjan Akhavan Amjadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Khaqani St, Shariati St
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
22006660
Email
marjan_akhavan2003@yahoo.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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Total data
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
For academics
Under which criteria data/document could be used
Academic use
From where data/document is obtainable
marjan_akhavan2003@yahoo.com
What processes are involved for a request to access data/document