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Assessment of the effect of Bilinoeid drop on neonatal jaundice

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History
# Registration date Revision Id
4 2020-02-25, 1398/12/06 133458
3 2018-09-28, 1397/07/06 88589
2 2018-06-25, 1397/04/04 57882
1 2018-03-05, 1396/12/14 39300
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  • Protocol summary

    Control group: The infant with jaundice will receive placebo. Intervention Group 1: The infant with jaundice will receive Cotoneaster drop. Cotoneaster drop for mother
    Control group: The infant with jaundice will receive placebo. Intervention Group: The infant with jaundice will receive Cotoneaster drop.
    گروه کنترل: در این گروه نوزاد دچار زردی دارونما دریافت می¬کند. گروه مداخله 1 : در این گروه نوزاد دچار زردی مورد درمان با قطره شیرخشت واقع می¬شود . قطره شیر خشت برای مادر
    گروه کنترل: در این گروه نوزاد دچار زردی دارونما دریافت می کند. گروه مداخله: در این گروه نوزاد دچار زردی مورد درمان با قطره شیرخشت واقع می شود .

  • Primary outcomes

    #1
    every 24 hour til 3 days
    every 24 hour til 5 days
    هر 24 ساعت تا سه روز
    هر 24 ساعت تا پنج روز

  • Secondary outcomes

    #1
    Every 24 hours for 3 days
    Every 24 hours for 5 days
    هر 24 ساعت تا 3روز
    هر 24 ساعت تا 5 روز
    #2
    Every 24 hours for 3 days
    Every 24 hours for 5 days
    هر 24 ساعت تا 3 روز
    هر 24 ساعت تا 5 روز
    #3
    every 24 hour til 3 days
    every 24 hour til 5 days
    هر 24 ساعت تا سه روز
    هر 24 ساعت تا پنج روز

  • Intervention groups

    #1
    گروه مداخله: در این گروه نوزاد دچار زردی مورد درمان با قطره شیر خشت واقع می¬شود . قطره شیر خشت به نوزاد به مقدار 5 قطره به ازای هر کیلوگرم وزن بدن نوزاد هر 8 ساعت تا 5 روز.قطره شیر خشت برای مادر به مقدار 5 میلی لیتر برای مادر هر 8 ساعت تا 5 روز.
    گروه مداخله: در این گروه نوزاد دچار زردی مورد درمان با قطره شیر خشت واقع می شود . قطره شیر خشت به نوزاد به مقدار 1 گرم شیر خشت روزانه هر 8 ساعت تا 5 روز.

  • Recruitment centers

    #1
    Name of recruitment center - English: Boo Ali Hospital
    Name of recruitment center - Persian: بیمارستان بوعلی
    Full name of responsible person - English: Roya Farhadi
    Full name of responsible person - Persian: رویا فرهادی
    Street address - English: Boo Ali Hospital, Pasdaran Blv, Imam Squ, Sari, Mazandaran, Iran Mazandaran
    Street address - Persian: ایران، مازندران، ساری، میدان امام، بلوار پاسداران، بیمارستان بوعلی ساری
    City - English: Sari
    City - Persian: ساری
    Province: Mazandaran
    Country: Iran (Islamic Republic of)
    Postal code: 48178
    Phone: +98 11 2233 0111
    Fax:
    Email: mmfir@yahoo.com
    Web page address:
    Name of recruitment center - English: Boo Ali Hospital
    Name of recruitment center - Persian: بیمارستان بوعلی
    Full name of responsible person - English: Roya Farhadi
    Full name of responsible person - Persian: رویا فرهادی
    Street address - English: Boo Ali Hospital, Pasdaran Blv, Imam Squ, Sari, Mazandaran, Iran
    Street address - Persian: ایران، مازندران، ساری، میدان امام، بلوار پاسداران، بیمارستان بوعلی ساری
    City - English: Sari
    City - Persian: ساری
    Province: Mazandaran
    Country: Iran (Islamic Republic of)
    Postal code: 48178
    Phone: +98 11 2233 0111
    Fax:
    Email: mmfir@yahoo.com
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr Majid Saeidi
    Full name of responsible person - Persian: دکتر مجید سعیدی
    Street address - English: Vice chancellor for research, Moalem square, Sari
    Street address - Persian: ساری،میدان معلم، معاونت پژوهشی ساری مازندران ایران
    City - English: Sari
    City - Persian: ساری
    Province: Mazandaran
    Country: Iran (Islamic Republic of)
    Postal code: 48178
    Phone: +98 11 3325 7230
    Fax:
    Email: mmfir@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr Majid Saeidi
    Full name of responsible person - Persian: دکتر مجید سعیدی
    Street address - English: Vice chancellor for research, Moalem square, Sari
    Street address - Persian: ساری، میدان معلم، معاونت پژوهشی
    City - English: Sari
    City - Persian: ساری
    Province: Mazandaran
    Country: Iran (Islamic Republic of)
    Postal code: 48178
    Phone: +98 11 3325 7230
    Fax:
    Email: mmfir@yahoo.com
    Web page address:

  • Person responsible for general inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Mohammad Azadbakht
    Full name of responsible person - Persian: محمد آزادبخت
    Position - English: Ph.D of Farmacognosy
    Position - Persian: دکتری تخصصی فارماکوگنوزی
    Latest degree: phd
    Area of specialty/work: 74
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: 18th Km, Khazar Abad Road, Mazandaran University of Medical Sciences
    Street address - Persian: کیلومتر 18 جاده خزرآباد، دانشگاه علوم پزشکی مازندران ساری مازندران ایران
    City - English: Sari
    City - Persian: ساری
    Province: Mazandaran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 48178
    Phone: +98 11 3354 3728
    Mobile: +98 911 152 0601
    Fax:
    Email: mazadbakht110@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Mohammad Azadbakht
    Full name of responsible person - Persian: محمد آزادبخت
    Position - English: Ph.D of Farmacognosy
    Position - Persian: دکتری تخصصی فارماکوگنوزی
    Latest degree: phd
    Area of specialty/work: 74
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: 18th Km, Khazar Abad Road, Mazandaran University of Medical Sciences
    Street address - Persian: ساری، کیلومتر 18 جاده خزرآباد، دانشگاه علوم پزشکی مازندران
    City - English: Sari
    City - Persian: ساری
    Province: Mazandaran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 48178
    Phone: +98 11 3354 3728
    Mobile: +98 911 152 0601
    Fax:
    Email: mazadbakht110@gmail.com
    Web page address:

  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: mazandaran university of medical science
    Name of organization / entity - Persian: دانشگاه علوم پزشکی مازندران
    Full name of responsible person - English: Roya Farhadi
    Full name of responsible person - Persian: رویا فرهادی
    Position - English: Neonatal Specialist
    Position - Persian: فوق تخصصص نوزادان
    Latest degree: specialist
    Area of specialty/work: 74
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Amir Mazandarani Blv, Imam Khomeini Hospital
    Street address - Persian: ساری، بلوار امیر مازندرانی، بیمارستان امام خمینی
    City - English: Sari
    City - Persian: ساری
    Province: Mazandaran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 48178
    Phone: +98 11 3336 1700
    Mobile: +98 911 351 1884
    Fax:
    Email: dr_royafarhadi@yahoo.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Mazandaran University of Medical Science
    Name of organization / entity - Persian: دانشگاه علوم پزشکی مازندران
    Full name of responsible person - English: Roya Farhadi
    Full name of responsible person - Persian: رویا فرهادی
    Position - English: Neonatal Specialist
    Position - Persian: فوق تخصصص نوزادان
    Latest degree: specialist
    Area of specialty/work: 74
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Amir Mazandarani Blv, Imam Khomeini Hospital
    Street address - Persian: ساری، بلوار امیر مازندرانی، بیمارستان امام خمینی
    City - English: Sari
    City - Persian: ساری
    Province: Mazandaran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 48178
    Phone: +98 11 3336 1700
    Mobile: +98 911 351 1884
    Fax:
    Email: dr_royafarhadi@yahoo.com
    Web page address:

  • Person responsible for updating data


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Moloud Fakhri
    Full name of responsible person - Persian: مولود فخری
    Position - English: Senior lecturer, Ph.D student
    Position - Persian: هیات علمی، دانشجوی ph.D
    Latest degree: master
    Area of specialty/work: 58
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: 18th Km, Khazar Abad Road, Sari
    Street address - Persian: کیلومتر 18 جاده خزرآباد، دانشگاه علوم پزشکی مازندران
    City - English: Sari
    City - Persian: ساری
    Province: Mazandaran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 48178
    Phone: +98 11 3354 3081
    Mobile: +98 911 152 0601
    Fax:
    Email: mmfir@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Moloud Fakhri
    Full name of responsible person - Persian: مولود فخری
    Position - English: Assistant Professor
    Position - Persian: هیات علمی، استادیار
    Latest degree: phd
    Area of specialty/work: 58
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: 18th Km, Khazar Abad Road, Sari
    Street address - Persian: ساری، کیلومتر 18 جاده خزرآباد، دانشگاه علوم پزشکی مازندران
    City - English: Sari
    City - Persian: ساری
    Province: Mazandaran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 48178
    Phone: +98 11 3354 3081
    Mobile: +98 911 152 0601
    Fax:
    Email: mmfir@yahoo.com
    Web page address:

Protocol summary

Study aim
Therapeutic effect of jaundice among infants undergoing phototherapy
Design
The present randomized double-blind clinical trial is conducted on two groups of infants; Group 1: The infant with jaundice receive placebo. The sample size is determined using mean difference formula as 50 infants in each group, making a total sample size of 100 infants.
Settings and conduct
Conduct and randomization: A computer software program is used to produce random numbers to allocate the medication and placebo to two groups. Adequate medication and placebo for each group will be placed in a special envelope marked with patient number and medication code. Thus, patients, doctor and assessor will have no knowledge of the nature of medication or group allocation. Bilinoeid and placebo drops (medication and placebo) are provided by the laboratory of Sari Pharmacy Faculty.
Participants/Inclusion and exclusion criteria
Inclusion criteria: infants present with jaundice Exclusion criteria: incompatible blood group (RH), fauvism, preterm, needing blood transfusion, suffering from infection or being the case of hemolysis
Intervention groups
Control group: The infant with jaundice will receive placebo. Intervention Group: The infant with jaundice will receive Cotoneaster drop.
Main outcome variables
1. Baby serum total bilirubin 2. The frequency of defecation 3. Length of hospitalization days 4. The incidence of complications arising from the use of Cotoneaster

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160531028188N4
Registration date: 2018-03-05, 1396/12/14
Registration timing: registered_while_recruiting

Last update: 2019-05-03, 1398/02/13
Update count: 3
Registration date
2018-03-05, 1396/12/14
Registrant information
Name
Moloud Fakhri
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7343
Email address
m.fakhri@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of Bilinoeid drop on neonatal jaundice
Public title
Effect of Bilinoeid drop on neonatal jaundice
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All infants who present with jaundice with weight between 2500 -4000 gr
Exclusion criteria:
Blood incompatibility; Rh incompatibility; Fauvism; immaturity; need for blood transfusions; infection; hemolysis
Age
From 1 day old to 14 days old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment to intervention and control groups
Blinding (investigator's opinion)
Double blinded
Blinding description
Patient, physician, and evaluator of the nature of the drug and the type of group will be unaware.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Moalem square, Vice chancellor for research, Mazandaran University of Medical Sciences, Sari, Mazandaran
City
Sari
Province
Mazandaran
Postal code
48178
Approval date
2015-04-08, 1394/01/19
Ethics committee reference number
IR.Mazums.REC.941316

Health conditions studied

1

Description of health condition studied
Neonatal jaundice
ICD-10 code
P59.9
ICD-10 code description
Neonatal jaundice, unspecified

Primary outcomes

1

Description
neonatal total bilirubin
Timepoint
every 24 hour til 5 days
Method of measurement
lab test

Secondary outcomes

1

Description
Length of hospitalization days
Timepoint
At the time of discharge
Method of measurement
From the time of admission to discharge

2

Description
The incidence of complications arising from the use of Cotoneaster
Timepoint
Every 24 hours for 5 days
Method of measurement
Observation and complete check list

3

Description
Evaluation of side effects in case of Cotoneaster
Timepoint
Every 24 hours for 5 days
Method of measurement
Observation and complete check list

4

Description
frequency of defecation
Timepoint
every 24 hour til 5 days
Method of measurement
observation

Intervention groups

1

Description
Intervention group: The infant with jaundice will receive Cotoneaster drop. Infants will receive 5 drops of Cotoneaster per kg every 8 hours for 5 days.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Boo Ali Hospital
Full name of responsible person
Roya Farhadi
Street address
Boo Ali Hospital, Pasdaran Blv, Imam Squ, Sari, Mazandaran, Iran
City
Sari
Province
Mazandaran
Postal code
48178
Phone
+98 11 2233 0111
Email
mmfir@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Majid Saeidi
Street address
Vice chancellor for research, Moalem square, Sari
City
Sari
Province
Mazandaran
Postal code
48178
Phone
+98 11 3325 7230
Email
mmfir@yahoo.com
Grant name
Grant code / Reference number
941316
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari 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
Mazandaran University of Medical Sciences
Full name of responsible person
Mohammad Azadbakht
Position
Ph.D of Farmacognosy
Latest degree
Ph.D.
Other areas of specialty/work
Pediatrics
Street address
18th Km, Khazar Abad Road, Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
48178
Phone
+98 11 3354 3728
Email
mazadbakht110@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Science
Full name of responsible person
Roya Farhadi
Position
Neonatal Specialist
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Amir Mazandarani Blv, Imam Khomeini Hospital
City
Sari
Province
Mazandaran
Postal code
48178
Phone
+98 11 3336 1700
Email
dr_royafarhadi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Moloud Fakhri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
18th Km, Khazar Abad Road, Sari
City
Sari
Province
Mazandaran
Postal code
48178
Phone
+98 11 3354 3081
Email
mmfir@yahoo.com

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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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