The objective of the study is to determine the effect of cardamom powder on the severity of nausea and vomiting in pregnant. The researcher going to the selected health centers,will complete PUQE( pregnancy unique quetionnaire) quetionnaire for pregnant women 6to 22 weeks with nausea and vomiting and then, researcher will select 120 between them eligible volunteers that be signed the consent form. The prenatal care will be provided to women. The samples will be divided into placebo and cardamom powder groups( 60 samples in each group). In cardamom powder group, capsules containing 500 mg of powdered cardamom and in placebo group , capsules containing 500 mg lactose will be prescribe three times daily for 4 day. The participants will complete the PUQE questionnaire 2 times daily during intervention.At the end of intervention, researcher will complete the final questionnaire. Then, during and after intervention will be analyzed the severity of nausea and vomiting.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107016928N1
Registration date:2011-08-03, 1390/05/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-08-03, 1390/05/12
Registrant information
Name
mansoureh Gharaiagh Zandi
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2387 2206
Email address
s.zandi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2011-06-22, 1390/04/01
Expected recruitment end date
2011-09-23, 1390/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of Cardamom powder effect on the severity of nausea and vomiting in pregnant women referred to health centers in Chalus city 1389-90
Public title
Study of Cardamom powder effect on the severity of nausea and vomiting in pregnant women referred to health centers in Chalus city 1389-90
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Research units are Iranian and they have literacy in reading and writing;
Singleton and normal pregnancy with 6 to 22 weeks based on LMP and ultrasound; Not having molar pregnancy;Not having symptoms of Threatened abortion; Not having acute Pyelonephritis; Not having Thyroid dysfunction; Not having identified digestive diseases which may cause nausea and vomiting; having a normal pregnancy based on documents that be existing in health centers;
Having mild to moderate nausea and vomiting without hyperemsis gravidarum symptoms; Not to use anti emetic or emetic drugs( herbal or chemical drugs);
Not to use tobacco; Not having psychological problems and unpleasant event over 6 months ago according to pregnant women reporting; Not unexpected pregnancy according to pregnant women reporting.
Exclusion criteria:
Not taking two courses of drug or more and to use anti emetic herbal or chemical drugs during study; Having Threatened abortion; Having spotting and severe nausea and vomiting which is required to treatment; Having Cardamom powder consumption in daily diet.
Age
From 15 years old to 44 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)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Next to Taleghani hospital, Tabnak Ave, Evin, Chamran highway, Tehran, Iran, Islamic Republic Of
City
Tehran
Postal code
Approval date
2011-05-01, 1390/02/11
Ethics committee reference number
89-01-86-7624-1
Health conditions studied
1
Description of health condition studied
nausea and vomiting of pregnancy
ICD-10 code
R11
ICD-10 code description
Mild Hyperemesis gravidarum, mild or unspecified, starting before the end of the 22nd week of gestation
Primary outcomes
1
Description
Severity of nausea and vomiting of pregnancy
Timepoint
Before, during and after intervention
Method of measurement
Modified pregnancy- unique quantification of Emesis/ Nausea( PUQE)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Cardamom powder capsules 500 mg, three times a day orally for 4 days.
Category
Treatment - Drugs
2
Description
Control group: Placebo capsules 500 mg contained Lactose, three times a day orally for 4 days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Prenatal clinic of Razy hospital in Chalus city
Full name of responsible person
Hossein Ahmadi- Clinic manager
Street address
Razy hospital, Opposite Koorosh St, Chalus/ Noshahr Ring road, Chalus.
City
Chalus
2
Recruitment center
Name of recruitment center
Alavicola health center.
Full name of responsible person
Maryam Shabani.Midwife
Street address
Alavicola St, Emam Reza Blvd, Chalus.
City
Chalus
3
Recruitment center
Name of recruitment center
The health center NO.2( Bazar rooz).
Full name of responsible person
Mrs. Sam.Midwife
Street address
City
Chalus
4
Recruitment center
Name of recruitment center
The health center NO.1( Farhang).
Full name of responsible person
Dr. Hossein khajvand. Head of center
Street address
City
Chalus
5
Recruitment center
Name of recruitment center
Hachirood health center
Full name of responsible person
Mrs. Hosseinpoor.Midwife
Street address
Chalus, Hachirood.
City
Chalus
6
Recruitment center
Name of recruitment center
Taze abad health center
Full name of responsible person
Soheila Mansoori. Midwife
Street address
Taze Abad, Chalus.
City
Chalus
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Mohammad Rahmati Roodsari
Street address
Vice Chancellor for Research, Shahid Beheshti University of Medical Sciences, Next to Taleghani hospital, Tabnak Ave, Evin, Chamran highway, Tehran, Iran, Islamic Republic Of.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Nursing and Midwifery Faculty, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Gity Ozgoli
Position
M.Sc in Midfwifery Education & Academic Faculty Member