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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
- 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
