Protocol summary

Summary
(1) Objectives: The study aims to compare the effects of Chamomile, Ginger and Vitamin B6 on nausea and vomiting during pregnancy, (2) Design: This triple-blind randomized trial includes 105 pregnant women in 6-20 weeks of gestational age who suffer from weak or moderate nausea and vomiting, who will attend the Health Centers in Qazvin city, Iran, between2015-2016, (3) Setting and Conduct: the researcher will go to Health Centers every day and apply randomized sampling between pregnant women with gestational age 6-20 weeks who suffer from mild or moderate nausea and vomiting. The Subjects will be selected randomly and divided into three groups of 35 patients including intervention group1 (green balls), intervention group2 (blue balls) and intervention group3 (red balls), (4) Major eligibility criteria: Participants are pregnant women with single fetus 6-20 weeks who suffer from mild or moderate nausea and vomiting induced by pregnancy. The following will be excluded fro the study: women with severe nausea and vomiting who will be needed to be hospitalized and those who will be allergic to Ginger, (5)Intervention and experiment : Ginger capsules were given to group 1, , Chamomile capsules were given to group 2, and vitamin B6 were given to group 3, the participants used them for 4 days. Then Rhodes index questionnaire was given to all participants to be completed before and after intervention, (6) Main outcome measures: Intensity and the number of times participants will experience nausea and vomiting before and after intervention will be measured.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201512011113N3
Registration date: 2016-12-18, 1395/09/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-12-18, 1395/09/28
Registrant information
Name
Fatemeh Ranjkesh
Name of organization / entity
Qazvin University Of Medical Scienes, Nursing & Midwifery school
Country
Iran (Islamic Republic of)
Phone
+98 28 1335 9501
Email address
franjkesh@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Qazvin University of Medical Sciences Barij Esans Company
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2016-11-21, 1395/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effects of Chamomile, Ginger and Vitamin B6 on nausea and vomiting due to pregnancy
Public title
Effect of Chamomile, Ginger and Vitamin B6 on nausea and vomiting due to pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Women with single fetus 6-20 weeks; mild or moderate nausea and vomiting induced by pregnancy, Exclusion criteria: Women with severe nausea and vomiting ; those who will be allergic to Ginger.
Age
From 19 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
Not used
Assignment
Parallel
Other design features
Randomized clinical trial

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Qazvin University of Medical Sciences
Street address
Bahonar Boulevar, Qazvin University of Medical Sciences
City
Qazvin
Postal code
34197-59811
Approval date
2015-10-04, 1394/07/12
Ethics committee reference number
IR.QUMS.REC.1394.178

Health conditions studied

1

Description of health condition studied
Nausea and Vomiting during pregnancy
ICD-10 code
O21.0
ICD-10 code description
Mild hyperemesis gravidarum

Primary outcomes

1

Description
The intensity and frequency of nausea and vomiting
Timepoint
Before and after the intervention
Method of measurement
Rhodes index questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
The intervention 1: In group 1, Ginger capsules 250 mg will be consumped three times for 4 days and the intensity and frequency of nausea and vomiting before and after intervention will be measured with Rhodes index questionnaire
Category
Treatment - Drugs

2

Description
The intervention 2: In group 2, Chamomile capsules 250 mg will be consumped three times for 4 days and the intensity and frequency of nausea and vomiting before and after intervention will be measured with Rhodes index questionnaire
Category
Treatment - Drugs

3

Description
The intervention 3: In group 3, Vit B6 capsules25 mg will be consumped three times for 4 days and the intensity and frequency of nausea and vomiting before and after intervention will be measured with Rhodes index questionnaire
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Centers in Qazvin City
Full name of responsible person
Fatemeh Ranjkesh
Street address
City
Qazvin

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Barij Esans Company
Full name of responsible person
Fatemeh Ranjkesh
Street address
Vali Asr Squarer
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Barij Esans Company
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
Qazvin University of Medical Sciences
Full name of responsible person
Fatemeh Ranjkesh
Position
Instructor/ Msc in Midwifery
Other areas of specialty/work
Street address
Vali Asr Squarer
City
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Fax
Email
fatemehranjkesh@yahoo.com; franjkesh@qums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fatemeh Ranjkesh
Position
Instructor/ Msc in Midwifery
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences
City
Qzvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Fax
Email
fatemehranjkesh@yahoo.com; franjkesh@qums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fatemeh Ranjkesh
Position
Instructor/Msc in Midwifery
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences
City
Qazvin
Postal code
Phone
Fax
Email
fatemehranjkesh@yahoo.com; franjkesh@qums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...