The comparison of the effect of bitter orange and ondansetron on treatment of nausea and vomiting in pregnant women between weeks 6 till 20 of pregnancy
The comparison of the effect of bitter orange peel and ondansetron on treatment of nausea and vomiting in pregnant women between weeks 6th and 20th of pregnancy
Design
Clinical trial with control group; with parallel groups; double blinded; randomized; design of 80 patients
Settings and conduct
Patient will be assigned into 2 groups with block randomization method, 40 patients will be treated by ondansetron and 40 patients will be received bitter orange peel. Both groups will also request to fill in a questionnaire before start and after two weeks of treatment. Drugs are named to A and B and have been administered in the similar bottle.The participants complete the questionnaire based on their responses to questions about general changes in nausea and vomiting, method of drugs were taken and complete SF-36 questionnaire after treatment too.
Participants/Inclusion and exclusion criteria
Inclusion criteria include gestational age between 6-20 weeks of pregnancy, having mild to moderate nausea and vomiting without a need of hospitalization, singleton pregnancy with a live normal fetus, not having any known gastrointestinal disorder, without a history of smoking or drug use, lack of a known mental illness such as severe anxiety and depression, and not having any known allergy or hypersensitivity to herbal medications. Exclusion criteria are having any other symptoms showing pathologic problems, having any known gastrointestinal or any other systemic disorder or any drug use except common supplementation
Intervention groups
80 subjects with nausea and vomiting of pregnancy disorder will be assigned into 2 groups with block randomization method, 40 patients will be treated by ondansetron and 40 patients will be received bitter orange peel.
Main outcome variables
Intensity of nausea and vomiting, Quality of life score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140525017827N11
Registration date:2021-08-14, 1400/05/23
Registration timing:prospective
Last update:2021-08-14, 1400/05/23
Update count:0
Registration date
2021-08-14, 1400/05/23
Registrant information
Name
Nasrin Asadi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1233 2365
Email address
asadin@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effect of bitter orange and ondansetron on treatment of nausea and vomiting in pregnant women between weeks 6 till 20 of pregnancy
Public title
The comparison of the effect of bitter orange and ondansetron on treatment of nausea and vomiting of pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
gestational age between 6-20 weeks of pregnancy (according to a reliable LMP and ultrasound confirmation of the first trimester)
Having mild to moderate nausea and vomiting without a need of hospitalization
Singleton pregnancy with a live normal fetus
Not having any known gastrointestinal disorder
Without a history of smoking or drug use
Lack of a known mental illness such as severe anxiety and depression
Not having any known allergy or hypersensitivity to herbal medications
Exclusion criteria:
Severe nausea and vomiting needing hospitalization
No acceptance for herbal medicine
Having any other symptoms showing pathologic problems such as diarrhea
Having any known gastrointestinal or any other systemic disorder or any drug use except common supplementation (folic acid)
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The treatment allocation list is already designed on Block Balanced Randomization Method by software ( https://mahmoodsaghaei.tripod.com/Softwares/randalloc.html) (A), 2 (B), 3 (B), 4 (B), 5 (A),……. Any eligible patient will be given a 1 to 80 code after obtaining informed consent in order to visit the clinic and based on above block, they receive A or B drug.
Blinding (investigator's opinion)
Double blinded
Blinding description
Ondansetron and bitter orange peel have been administered in the similar bottles, so patients and researchers were unable to detect which one was Ondansetron or bitter orange peel. Our nurse colleague in this study in hospital delivered formulations to the participants of the study according to Block Balanced Randomization Method by software. She was unaware of the content of the bottles. The researcher had no information about formulation used by each patient while visiting them. At the end of the study, the formulations were decoded and the patients assigned to each group were identified.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Committee of Shiraz University of Medical Sciences
Street address
Headquarters Of Shiraz University of Medical Sciences - Zand St - Shiraz
City
Shiraz
Province
Fars
Postal code
34786-71946
Approval date
2021-06-27, 1400/04/06
Ethics committee reference number
IR.SUMS.MED.REC.1400.185
Health conditions studied
1
Description of health condition studied
Nausea & vomiting in pregnancy
ICD-10 code
O21.9
ICD-10 code description
Vomiting of pregnancy, unspecified
Primary outcomes
1
Description
Intensity of nausea and vomiting
Timepoint
Before start and two weeks later of treatment
Method of measurement
Visual analog scale
Secondary outcomes
1
Description
Quality of life score
Timepoint
Before start and two weeks later of treatment
Method of measurement
Short Form 36 Health Survey (SF-36)
Intervention groups
1
Description
Intervention group: Treatment of one group with bitter orange
Category
Treatment - Drugs
2
Description
Intervention group: The other group with ondansetron
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat zeynab Clinic of Shiraz University of Medical Sciences
Full name of responsible person
Farrokh khani
Street address
Square defae moghaddas
City
Shiraz
Province
Fars
Postal code
7153813311
Phone
+98 71 3726 6819
Email
farrokhkhani1368@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Abbas Reazaeian Zade
Street address
Building of Shiraz University of Medical Sciences, Zand Ave
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3235 7282
Email
rezaiana@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Farrokh khani
Position
Resident of obstetrics and gynecology
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of obstetrics and gynecology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3612 8258
Email
Farrokhkhani1368@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nasrin asadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of obstetrics and gynecology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3612 8258
Email
nasadi2012@yahoo.ca
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nasrin asadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of obstetrics and gynecology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3612 8258
Email
nasadi2012@yahoo.ca
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
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
Statistical Results
When the data will become available and for how long
6 month after the project completion
To whom data/document is available
By obtaining a license from the ethics committee and for scientific and research use in coordination with the main researchers
Under which criteria data/document could be used
The data is for use in this design only. If necessary, after obtaining the necessary permits from the ethics committee
From where data/document is obtainable
To researchers responsible for responding to this plan
What processes are involved for a request to access data/document
Written request Coordinated by the ethics committee 2 months