In this study, we aimed to measure the impact of Ginger and Chamomile on the nausea and vomiting in pregnant women of our area. This triple-blind randomized placebo-controlled trial, included 105 pregnant women in 6-16 weeks of gestational age with a mild to moderate nausea and vomiting, who are referred to the prenatal care clinic in Dezyani hospital, Gorgan, Iran, 2009-2010. Rhodes index questionnaire had been given to all participants to be completed before bedtime for two weeks. In the first week no intervention was done, and prescribing the capsules was started in the next week. They were divided into 3 groups: In group 1, Ginger capsules twice a day for one week, in group 2; chamomile capsule twice daily and in placebo group glucose capsule was prescribed as well. Their scores were calculated and all data were entered into the spss16 software.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138905064462N1
Registration date:2010-10-11, 1389/07/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-10-11, 1389/07/19
Registrant information
Name
Saba Besharat
Name of organization / entity
Tehran university of medical scineces
Country
Iran (Islamic Republic of)
Phone
+98 21 8898 7382
Email address
besharat@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Master of science thesis
Expected recruitment start date
2009-10-22, 1388/07/30
Expected recruitment end date
2010-06-20, 1389/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Ginger and Chamomile on nausea and vomiting in pregnancy
Public title
Effect of Ginger and Chamomile on nausea and vomiting in pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1- Gestational age 6-16 weeks from LMP OR ultrasound. 2- Mild to moderate nausea and vomiting induced by pregnancy according to Rhodes index. 3- Single pregnancy with an alive and healthy fetus. 4- Without any GI diseases or other organs diseases. 5- Ability to read and write. 6- Age 18-35 years. 7- Not to have any allergy to herbal drugs. Exclusion criteria: 1- Severe nausea and vomiting that needs to be hospitalized. 2- Not to have any tendency to continue use of herbal medicines. 3- Other signs like diarrhea that show nausea and vomiting are pathological. 4- Each disease which makes or increases nausea and vomiting. 5- Allergy to Ginger or Chamomile.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
We translated Rhodes index to Persian, then content validity have done with experts and we used test-re-test method for reliability.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran unuversity of medical sciences
Street address
Ghods ave. Keshavarz blvd.
City
Tehran
Postal code
Approval date
2010-07-08, 1389/04/17
Ethics committee reference number
505/130/ص/89
Health conditions studied
1
Description of health condition studied
nausea and vomiting induced by pregnancy
ICD-10 code
O21.9
ICD-10 code description
Vomiting of pregnancy, unspecified
Primary outcomes
1
Description
frequency of vomiting
Timepoint
every 24hours
Method of measurement
Rhodes index
2
Description
frequency of nausea
Timepoint
every 24hours
Method of measurement
rhodes index
3
Description
distress from retching
Timepoint
every 24hours
Method of measurement
rhodes index
4
Description
frequency of retching
Timepoint
every 24hours
Method of measurement
Rhodes index
5
Description
vomiting distress
Timepoint
every 24hours
Method of measurement
Rhodes index
6
Description
amount of vomiting
Timepoint
every 24hours
Method of measurement
Rhodes index
7
Description
distress from nausea
Timepoint
every 24hours
Method of measurement
Rhodes index
8
Description
duration of nausea
Timepoint
every 24hours
Method of measurement
rhodes index
Secondary outcomes
1
Description
decrease of vomiting
Timepoint
at the end of study
Method of measurement
Rhodes index
2
Description
decrease of nausea
Timepoint
at the end of study
Method of measurement
rhodez index
Intervention groups
1
Description
Group 1: Ginger capsules 500mg for 7days, twice a day
Category
Treatment - Drugs
2
Description
Group2: Chamomile capsules 500mg for 7days, twice a day
Category
Treatment - Drugs
3
Description
Group 3: Placebo contain 500mg corn flour for 7days, twice a day
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Deziani hospital
Full name of responsible person
Street address
City
Gorgan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran nursing and midwifery faculty
Full name of responsible person
Maryam Modares
Street address
Tohid square
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran nursing and midwifery faculty
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
Tehran nursing and midwifery faculty
Full name of responsible person
Saba Besharat
Position
Msc of midwifery student
Other areas of specialty/work
Street address
Tehran nursing and midwifery faculti, Tohid square