Objectives: To assess the effect of Jalinus syrup versus Ondansetron syrup on nausea and vomiting in pregnant women.
Design: A randomized clinical trial.
Setting and conduct: The eligible pregnant women who will refer to Comprehensive Health Centers during the study period will be enrolled into the trial.
Inclusion criteria: Age of 18 to 40 years; singleton pregnancy; gestational age of 8 to 9 weeks; first pregnancy; desire for pregnancy; mild to moderate nausea or vomiting (with a minimum and maximum score of 3 to 12).
Exclusion criteria: Taking any medication simultaneously (except folic acid); using anti-nausea and vomiting drugs within the last 24 hours; molar pregnancy; symptoms of abortion; alcohol and cigarette smoking; mental disorder; family disputes over the past 6 months; pyelonephritis; thyroid dysfunction; digestive disease.
Intervention Group 1: Jalinus syrup consisting of quince fruit, ginger, vinegar and honey, made by Barij Essence Company 5 ml twice a day for 2 weeks.
Intervention group 2: Ondansetron syrup, serotonin receptor antagonist, made by Oxir Pharmaceuticals Company 5 ml twice a day for 2 weeks
Primary outcome: Assessing nausea and number of vomiting before intervention and one week after that using PUQE standard questionnaire.
Randomization: Random assignment of the patients to the intervention and control groups through drawing of lots.
Blinding: Not possible.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201709079014N184
Registration date:2017-09-19, 1396/06/28
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-09-19, 1396/06/28
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Jalinus syrup versus Ondansetron syrup on nausea and vomiting in pregnant women: a randomized clinical trial
Public title
Comparison of the effect of Jalinus syrup versus Ondansetron syrup on nausea and vomiting in pregnant women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age of 18 to 40 years; singleton pregnancy; gestational age of 8 to 9 weeks; first pregnancy; desire for pregnancy; mild to moderate nausea or vomiting (with a minimum and maximum score of 3 to 12).
Exclusion criteria: Taking any medication simultaneously (except folic acid); using anti-nausea and vomiting drugs within the last 24 hours; molar pregnancy; symptoms of abortion; alcohol and cigarette smoking; mental disorder; family disputes over the past 6 months; pyelonephritis; thyroid dysfunction; digestive disease
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: Random assignment of the patients to the intervention and control groups through drawing of lots.
Blinding: Not possible.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Approval date
2017-09-02, 1396/06/11
Ethics committee reference number
IR.UMSHA.REC.1396.407
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
Assessing nausea and number of vomiting
Timepoint
before intervention and one week after that
Method of measurement
using PUQE standard questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group 1: Jalinus syrup consisting of quince fruit, ginger, vinegar and honey, made by Barij Essence Company 5 ml twice a day for 2 weeks.
Category
Treatment - Drugs
2
Description
Intervention group 2: Ondansetron syrup, serotonin receptor antagonist, made by Oxir Pharmaceuticals Company 5 ml twice a day for 2 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive Health Centers
Full name of responsible person
Arezoo Shayan
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Arezoo Shayan
Position
Master of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0572
Fax
Email
arezoo.shayan2012@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Arezoo Shayan
Position
Master of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0717
Fax
Email
arezoo.shayan2012@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)