Comparison of the Effects of Zingiber officinale and Vitamin B6 in Nausea and Vomiting of Pregnancy in pregnant women referred to health centers in Hamadan City: A randomized clinical trial
The aim of this study is to determine the effect of Zingiber officinale and Vitamin B6 in nausea and vomiting of pregnancy in pregnant women referred to health centers in Hamadan, Iran.
Design
A randomized clinical trial , blinded, community based with a parallel group design with 80 patients, enrolled between March 2018 and June 2018
Settings and conduct
The present study is a clinical trial study with two-groups design with two stages of before and after intervention. The research Community consists of pregnant women referred to health centers in Hamadan, Iran. The research sample consisted of 80 pregnant women. The participants will randomly be assigned to one of four oral treatments groups: Zingiber officinale (240 mg/twice a day) or Vitamin B6 (40 mg/twice a day).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age of 18-40 years; Primi Para; No history of psychological illness; non-use of psychological drugs. exclusion criteria: Unwillingness to continue cooperation; Allergy to drug useage.
Intervention groups
Intervention group: The participants will be randomly selected in one of two oral treatments groups for one week : Zingiber officinale (240 mg/twice a day) or Vitamin B6 (40 mg/twice a day)
Main outcome variables
Nausea and vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110626006888N20
Registration date:2018-03-10, 1396/12/19
Registration timing:prospective
Last update:2018-03-10, 1396/12/19
Update count:0
Registration date
2018-03-10, 1396/12/19
Registrant information
Name
Fatemeh Shobeiri
Name of organization / entity
Hamadan Universiy of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 6051
Email address
shobeiri@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2018-06-20, 1397/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effects of Zingiber officinale and Vitamin B6 in Nausea and Vomiting of Pregnancy in pregnant women referred to health centers in Hamadan City: A randomized clinical trial
Public title
Comparison of the Effects of Zingiber officinale and Vitamin B6 in Nausea and Vomiting of Pregnancy in pregnant women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18-40 years
Primi Para
No history of psychological illness
non-use of psychological drugs
Exclusion criteria:
Unwillingness to continue cooperation
Allergy to drug useage
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
For this work, we prepared 4 sheets of paper, writing on 2 sheets “Z” for “Zingiber officinale” and on 2 sheets “V” for “Vitamin B6.”The sheets is pooled, placed in a container, and randomly drawn 1 at a time for each patient without replacement until all 4 sheets are drawn. The 4 sheets are then placed back into the container, and this action is repeated until the sample size is reached.
Blinding (investigator's opinion)
Double blinded
Blinding description
The eligible students are randomly assigned to 2 groups using the allocation concealment method. The allocations remained concealed during the study. For this purpose, the random allocation is conducted and labeled by a pharmacologist, so that neither the students nor the distributer, who elevate the effect of the interventions, are aware of the administered drugs, until the data are analyzed and the labels are decoded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical Sciences
Street address
No. 17, Department of Research and Technology, Hamadan University of Medical Sciences, Fahmideh street, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838678
Approval date
2018-02-27, 1396/12/08
Ethics committee reference number
IR.UMSHA.REC.1396.836
Health conditions studied
1
Description of health condition studied
Nausea and Vomiting during pregnancy
ICD-10 code
021
ICD-10 code description
Hyperemesis gravidarum, mild or unspecified, starting before the end of the 22nd week of gestation
Primary outcomes
1
Description
Nausea and vomiting
Timepoint
Before the intervention and one week after the intervention
Method of measurement
PUQE-24 questionnaire
Secondary outcomes
1
Description
Severity of nausea and vomiting
Timepoint
Before the intervention, and one week after the intervention
Method of measurement
PUQE-24 questionnaire
Intervention groups
1
Description
"Intervention group 1:" The participants will randomly be selected to oral treatments groups for one week : Zingiber officinale (240 mg/twice a day).
Category
Treatment - Drugs
2
Description
"Intervention group 2:" The participants will randomly be selected to oral treatments groups for one week : Vitamin B6 (40 mg/twice a day).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers in Hamadan city
Full name of responsible person
Fatemeh Shobeiri
Street address
No. 17, Hamdan University of Medical Sciences, Health centers, Street Shahid Fahmideh
City
Hamedan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3822 0123
Fax
+98 81 3838 0447
Email
fshobeiri@yahoo.com
Web page address
http://www.umsha.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
No. 7, Research and Technology Deputy, Hamadan University of Medical Sciences, Shahid Fahmideh street, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 0150
Email
fshobeiri@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Fatemeh Shobeiri
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
No. 17, Shahid Fahmideh street, Faculty of Nursing and Midwifery, Hamadan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 0150
Email
fshobeiri@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Fatemeh Shobeiri
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
No. 137, Shahid Fahmideh street, Faculty of Nursing and Midwifery, Hamadan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 0150
Email
fshobeiri@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Fatemeh Shobeiri
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
No. 17, Shahid Fahmideh street, Faculty of Nursing and Midwifery, Hamadan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 0150
Email
fshobeiri@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
Information on the main consequence of sharing is possible.
When the data will become available and for how long
Information on the main consequence of sharing is possible.
To whom data/document is available
Information on the main consequence of sharing is possible.
Under which criteria data/document could be used
Information on the main consequence of sharing is possible.
From where data/document is obtainable
Information on the main consequence of sharing is possible.
What processes are involved for a request to access data/document
Information on the main consequence of sharing is possible.
Comments
Information on the main consequence of sharing is possible.