Protocol summary

Study aim
Determine the effect of chicory extract consumption by mothers on frequency of icter and neonatals, bilirubin in referrals to birth preparation classes of Sirjan ، 2018
Design
Clinical randomised trial with two arm parallel group
Settings and conduct
The research population includes pregnant women referring to birth Preparation Classes and their newborns . The sampling method will be convenience. To assign the samples and to prevent the samples from contacting each other, they are taken from a center of intervention group samples and taken from another center of the control group. The sample size was estimated based on the statistical formula of 100 people in each group. In the intervention group, it is recommended that mothers take chicory sweats from the 36th week of gestation, 70 cc three times a day and continue this process during the first 2 weeks of lactation. In the first two weeks of birth, the neonates are followed up and the frequency of the physiologic and pathologic icter and the mean serum bilirubin (24 hours after birth and 3 days after birth) are measured and recorded using a BILI-CHECK device.
Participants/Inclusion and exclusion criteria
The gestational age is more than 36 weeks, Iranian nationality and willing to participate in the study are inclusion criteria. History of using chemical or herbal medicines, history of abortion, heart disease, thyroid diseases, gestational diabetes, and regular consumption of chicory are exclusion criteria.
Intervention groups
In the intervention group, it is recommended that mothers take chicory extract from the 36th week of gestation, 70 cc three times per day , and continue this process during the first 2 weeks of lactation. There is no intervention in the control group.
Main outcome variables
Frequency of icter Mean serum bilirubin

General information

Acronym
IRCT registration information
IRCT registration number: IRCT20150713023190N6
Registration date: 2018-08-19, 1397/05/28
Registration timing: registered_while_recruiting

Last update: 2018-08-19, 1397/05/28
Update count: 0
Registration date
2018-08-19, 1397/05/28
Registrant information
Name
Tabandeh Sadeghi
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 5900
Email address
t.sadeghi@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-06, 1397/05/15
Expected recruitment end date
2019-02-19, 1397/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of chicory extract consumption by mothers on frequency of icter and neonatals, bilirubin in referrals to birth preparation classes of Sirjan ، 2018
Public title
Effect of chicory on icter in neonatals
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age>36 week Consent for participation Iranian nationality Decide to deliveryin Sirjan positive blood group
Exclusion criteria:
Taking chemical drugs Taking herbal medicine Gestational diabetes, heart or thyroid disorders Taking chicory regularly history of abortion history of sensitivity to herbal medicine
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
None
Sample size
Target sample size: 200
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Rafsanjan University of Medical Sciences
Street address
Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2018-06-13, 1397/03/23
Ethics committee reference number
IR.RUMS.REC.1397.059

Health conditions studied

1

Description of health condition studied
Icter
ICD-10 code
P59
ICD-10 code description
Neonatal jaundice from other and unspecified causes

Primary outcomes

1

Description
Frequency of Icter
Timepoint
First two weeks of birth
Method of measurement
Checklist for record of Icter

2

Description
Mean of serum bilirubin
Timepoint
First day and three day post birth
Method of measurement
Bilicheck device

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: From the 36th week of gestation, it consumes three times a day, 70 cc Chicory each times, made by Sha'af Shiraz, and continues the process until the first two weeks of lactation.
Category
Prevention

2

Description
Control group: There is no intervention
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Gharazi Hospital
Full name of responsible person
Leila Badieneshin
Street address
Shafa Ave., Malekashtar Blvd
City
Sirjan
Province
Kerman
Postal code
7817835816
Phone
+98 34 4142 2200
Email
leila.badiye95@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali Shamsizadeh
Street address
Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0097
Email
vcrt@rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Tabandeh Sadeghi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Imam Ali Blvd., Rafsanjan, Iran
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3425 5900
Fax
+98 34 3425 8497
Email
t.sadeghi@rums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Tabandeh Sadeghi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3425 5900
Fax
Email
t.sadeghi@rums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Tabandeh Sadeghi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Imam Ali Blvd., Rafsanjan, Iran
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3425 5900
Fax
+98 34 3425 8497
Email
t.sadeghi@rums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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