This study assesses the effects of ginger on nausea and vomiting caused by pregnancy, and compares it with metoclopramid. This study is a randomized double-blind controlled trail. The patients will be randomly assigned to three study groups. Metoclopramid, ginger and placebo are putted in similar capsules. The medicines will be administered three times a day for 5 days, then the Rhodes questionnaire is completed and its score will be calculated. Inclusion criteria are: single pregnancy and inefficacy of food regimens in controlling vomiting and nausea. The patients who suffer from other diseases that need drugs for treatment, hepatitis, gastritis, rise of intra cranial pressure, pancreatitis, ginger intolerance, metoclopramid side effects (extra pyramidal side effects) will be excluded.
General information
Acronym
Ginger on the treatment of pregnancy nausea
IRCT registration information
IRCT registration number:IRCT201105266596N1
Registration date:2011-06-12, 1390/03/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-06-12, 1390/03/22
Registrant information
Name
Fariba Farhadifar
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 1666 1752
Email address
fariba.farhadifar@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kurdistan University of Medical Sciences
Expected recruitment start date
2010-08-23, 1389/06/01
Expected recruitment end date
2011-02-20, 1389/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of ginger and metoclopramid on the treatment of pregnancy nausea
Public title
Comparing the effects of ginger and metoclopramid on the treatment of pregnancy nausea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Single pregnancy and inefficacy of food regimens in controlling vomiting and nausea.
Exclusion criteria: Suffering from other diseases that need drugs for treatment; hepatitis, gastritis, rise of intra cranial pressure and pancreatitis; ginger intolerance, metoclopramid extra pyramidal side effects; pregnancy side effects such as abortion risk, bleeding and pyelonephritis
.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kurdistan University of Medical Sciences
Street address
Kurdistan University of Medical Sciences, Pasdaran Ave
City
Sanandaj
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
p14p10576
Health conditions studied
1
Description of health condition studied
Pregnancy nausea and vomiting
ICD-10 code
O21.9
ICD-10 code description
Vomiting of pregnancy, unspecified
Primary outcomes
1
Description
Nausea and vomiting
Timepoint
Daily for 5 days
Method of measurement
Rhodes Index questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: 10 mg of metoclopramid are administered tree time per day for 5 days.
Category
Treatment - Drugs
2
Description
Intervention group 2: 200 mg of ginger are administered tree time per day for 5 days.
Category
Treatment - Drugs
3
Description
In placebo group 200 mg of flour are administered tree time per day for 5 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Fariba Farhadifar
Street address
City
Sanandaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kurdistan University of medical Sciences
Full name of responsible person
Ataollah Heidari
Street address
Vice chancellor for research, Kurdistan University of Medical Sciences, Pasdaran Ave
City
Sanandaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kurdistan 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
Kurdistan University of Medical Sciences
Full name of responsible person
Fariba Farhadifar
Position
Associated Professor
Other areas of specialty/work
Street address
Gynecology Ward, Besat Hospital, Keshavarz Ave,
City
Sanandaj
Postal code
Phone
+98 918 171 0636
Fax
Email
fariba.farhadifar@muk.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Fariba Farhadifar
Position
Associated Professor
Other areas of specialty/work
Street address
Gynecology Ward, Besat Hospital, Keshavarz Ave
City
Sanandaj
Postal code
Phone
+98 918 171 0636
Fax
Email
Fariba.farhadifar@muk.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Fariba Farhadifar
Position
Associated Professor
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)