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Protocol summary
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.
Conduct and randomization: The study setting will be in Bu Ali Hospital in Sari. 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.
Conduct and randomization: The study setting will be in Bu Ali Hospital in Sari. 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.
کور سازی و تصادفی سازی: به منظور مراعات تخصیص تصادفی با استفاده از برنامه کامپیوتری اعداد تصادفی استخراج و از آنها کدهایی براساس بلوک بندی نوزادان به2گروه تهیه شده و بر روی دارو و دارونما نصب میگردد. سپس برای هر گروه دارو و دارو نما داخل پاکت مخصوص گذاشته شده و روی پاکت شماره بیمار و کد مربوط به دارو درج می گردد. لذا بیمار و پزشک و ارزیابی کننده از ماهیت دارو و نوع گروه بدون اطلاع خواهند بود. قطره بیلی نوئید و قطره پلاسبو (دارو و دارو نما) توسط لابراتوار دانشکده داروسازی ساری تهیه شده است.
کور سازی و تصادفی سازی: مرکز مورد مطالعه بیمارستان بوعلی ساری می باشد. به منظور مراعات تخصیص تصادفی با استفاده از برنامه کامپیوتری اعداد تصادفی استخراج و از آنها کدهایی براساس بلوک بندی نوزادان به2گروه تهیه شده و بر روی دارو و دارونما نصب میگردد. سپس برای هر گروه دارو و دارو نما داخل پاکت مخصوص گذاشته شده و روی پاکت شماره بیمار و کد مربوط به دارو درج می گردد. لذا بیمار و پزشک و ارزیابی کننده از ماهیت دارو و نوع گروه بدون اطلاع خواهند بود. قطره بیلی نوئید و قطره پلاسبو (دارو و دارو نما) توسط لابراتوار دانشکده داروسازی ساری تهیه شده است.
کور سازی و تصادفی سازی: مرکز مورد مطالعه بیمارستان بوعلی ساری می باشد. به منظور مراعات تخصیص تصادفی با استفاده از برنامه کامپیوتری اعداد تصادفی استخراج و از آنها کدهایی براساس بلوک بندی نوزادان به2گروه تهیه شده و بر روی دارو و دارونما نصب میگردد. سپس برای هر گروه دارو و دارو نما داخل پاکت مخصوص گذاشته شده و روی پاکت شماره بیمار و کد مربوط به دارو درج می گردد. لذا بیمار و پزشک و ارزیابی کننده از ماهیت دارو و نوع گروه بدون اطلاع خواهند بود. قطره بیلی نوئید و قطره پلاسبو (دارو و دارو نما) توسط لابراتوار دانشکده داروسازی ساری تهیه شده است.
General information
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Information editing
Information editing
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ویرایش اطلاعات
ویرایش اطلاعات
Blood incompatibility; Rh incompatibility; Fauvism; immaturity; need for blood transfusions; infection; hemolysis
Blood group or Rh incompatibility
Fauvism
immaturity
need for blood transfusions
hemolysis
infection
Blood incompatibility;group or Rh incompatibility; Fauvism; immaturity; need for blood transfusions; hemolysis infection; hemolysis
نوزادان با ناسازگاری گروه های خونی یا ارهاش؛ فاویسم؛ نارسی؛ نیاز به تعویض خون؛ ابتلا به همولیز یا عفونت
نوزادان با ناسازگاری گروه های خونی یا ارهاش
فاویسم
نارسی
نیاز به تعویض خون
ابتلا به همولیز
عفونت
نوزادان با ناسازگاری گروه های خونی یا ارهاش؛ فاویسم؛ نارسی؛ نیاز به تعویض خون؛ ابتلا به همولیز یا عفونت
Random assignment to intervention and control groups
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.
Random assignmentA computer software program is used to interventionproduce random numbers to allocate the medication and controlplacebo to two groups. Adequate medication and placebo for each group will be placed in a special envelope marked with patient number and medication code.
اختصاص تصادفی به گروههای مداخله و کنترل
به منظور مراعات تخصیص تصادفی با استفاده از برنامه کامپیوتری اعداد تصادفی استخراج و از آنها کدهایی براساس بلوک بندی نوزادان به2گروه تهیه شده و بر روی دارو و دارونما نصب میگردد. سپس برای هر گروه دارو و دارو نما داخل پاکت مخصوص گذاشته شده و روی پاکت شماره بیمار و کد مربوط به دارو درج می گردد.
اختصاصبه منظور مراعات تخصیص تصادفی به گروههای مداخلهبا استفاده از برنامه کامپیوتری اعداد تصادفی استخراج و کنترلاز آنها کدهایی براساس بلوک بندی نوزادان به2گروه تهیه شده و بر روی دارو و دارونما نصب میگردد. سپس برای هر گروه دارو و دارو نما داخل پاکت مخصوص گذاشته شده و روی پاکت شماره بیمار و کد مربوط به دارو درج می گردد.
Patient, physician, and evaluator of the nature of the drug and the type of group will be unaware.
For blinding in this trial, similarity of interventions in the two treatment groups under study was anticipated. The placebo was prepared in similar packages, with all the same physical and similar properties (in terms of color, odor, consistency, etc.). The amount of ingestion and the number of times a day was the same in both products. The only difference in these two products was the code inserted (numerical code) on the package and the corresponding box. 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.
PatientFor blinding in this trial, physiciansimilarity of interventions in the two treatment groups under study was anticipated. The placebo was prepared in similar packages, with all the same physical and evaluatorsimilar properties (in terms of color, odor, consistency, etc.). The amount of ingestion and the number of times a day was the same in both products. The only difference in these two products was the code inserted (numerical code) on the package and the corresponding box. Patients, doctor and assessor will have no knowledge of the nature of the drugmedication or group allocation. Bilinoeid and placebo drops (medication and placebo) are provided by the typelaboratory of group will be unawareSari Pharmacy Faculty.
بیمار و پزشک و ارزیابی کننده از ماهیت دارو و نوع گروه بدون اطلاع خواهند بود.
برای اعمال کورسازی در این کارآزمایی، مشابهت مداخلات در دو گروه درمانی تحت مطالعه، پیش بینی شده بود. دارونما در بسته های مشابه، با کلیه خواص فیزیکی و ظاهری مشابه (از نظر رنگ، بو، قوام ظاهری و ...) تهیه شد. مقدار مصرف و تعداد بار مصرف در روز نیز در هر دو فراورده، یکسان بود. تنها تفاوت در این دو فراورده، کد درج شده (کد عددی) بر روی بسته و جعبه مربوطه بود. بیمار و پزشک و ارزیابی کننده از ماهیت دارو و نوع گروه بدون اطلاع خواهند بود. قطره بیلی نوئید و قطره پلاسبو (دارو و دارو نما) توسط لابراتوار دانشکده داروسازی ساری تهیه شده است.
برای اعمال کورسازی در این کارآزمایی، مشابهت مداخلات در دو گروه درمانی تحت مطالعه، پیش بینی شده بود. دارونما در بسته های مشابه، با کلیه خواص فیزیکی و ظاهری مشابه (از نظر رنگ، بو، قوام ظاهری و ...) تهیه شد. مقدار مصرف و تعداد بار مصرف در روز نیز در هر دو فراورده، یکسان بود. تنها تفاوت در این دو فراورده، کد درج شده (کد عددی) بر روی بسته و جعبه مربوطه بود. بیمار و پزشک و ارزیابی کننده از ماهیت دارو و نوع گروه بدون اطلاع خواهند بود. قطره بیلی نوئید و قطره پلاسبو (دارو و دارو نما) توسط لابراتوار دانشکده داروسازی ساری تهیه شده است.
Intervention groups
#1
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.
Intervention group: The neonate with jaundice will receives cotoneaster manna drop which is prescribed about 1 g manna per day that is divided into 3 doses (every 8 hour) and at most until 5 days.
Intervention group: The infantneonate with jaundice will receive Cotoneasterreceives cotoneaster manna drop. Infants will receive 5 drops of Cotoneaster which is prescribed about 1 g manna per kg day that is divided into 3 doses (every 8 hours forhour) and at most until 5 days.
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.
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 منقسم به 3 دوزهر 8 ساعت حداکثرتا 5 روزداده میشود.
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 هرمنقسم به 3 دوزهر 8 ساعت تاحداکثرتا 5 روزروزداده میشود.
#2
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Treatment - Drugs
treatment-drugs
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Control group: The neonate with jaundice will receive placebo. The number of placebo drops per day is similar to the number of cotoneaster drops that is divided into 3 doses (every 8 hour) and at most until 5 days.
Control group: The neonate with jaundice will receive placebo. The number of placebo drops per day is similar to the number of cotoneaster drops that is divided into 3 doses (every 8 hour) and at most until 5 days.
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گروه کنترل: در این گروه نوزاد دچار زردی دارونما دریافت می کند. تعداد قطره پلاسبو به نوزاد مشابه با تعداد قطرات شیر خشت منقسم به سه دوز هر 8 ساعت حداکثر 5 روز داده می شود.
گروه کنترل: در این گروه نوزاد دچار زردی دارونما دریافت می کند. تعداد قطره پلاسبو به نوزاد مشابه با تعداد قطرات شیر خشت منقسم به سه دوز هر 8 ساعت حداکثر 5 روز داده می شود.
Sponsors / Funding sources
#1
Sari University of Medical Sciences
Mazandaran University of Medical Sciences
SariMazandaran University of Medical Sciences
دانشگاه علوم پزشکی ساری
دانشگاه علوم پزشکی مازندران
دانشگاه علوم پزشکی ساریمازندران
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: 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:
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: Mazandaran University of Medical Sciences, 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 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, 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 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: Imam Khomeini Hospital, Amir Mazandarani Blv, Sari
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: Imam Khomeini Hospital, Amir Mazandarani Blv, Imam Khomeini HospitalSari 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: 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:
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: Mazandaran University of Medical Science, 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:
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: Mazandaran University of Medical Science, 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: The study setting will be in Bu Ali Hospital in Sari. 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
Information editing
Acronym
IRCT registration information
IRCT registration number:IRCT20160531028188N4
Registration date:2018-03-05, 1396/12/14
Registration timing:registered_while_recruiting
Last update:2020-05-08, 1399/02/19
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 group or Rh incompatibility
Fauvism
immaturity
need for blood transfusions
hemolysis
infection
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
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.
Blinding (investigator's opinion)
Double blinded
Blinding description
For blinding in this trial, similarity of interventions in the two treatment groups under study was anticipated. The placebo was prepared in similar packages, with all the same physical and similar properties (in terms of color, odor, consistency, etc.). The amount of ingestion and the number of times a day was the same in both products. The only difference in these two products was the code inserted (numerical code) on the package and the corresponding box. 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.
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 neonate with jaundice will receives cotoneaster manna drop which is prescribed about 1 g manna per day that is divided into 3 doses (every 8 hour) and at most until 5 days.
Category
Treatment - Drugs
2
Description
Control group: The neonate with jaundice will receive placebo. The number of placebo drops per day is similar to the number of cotoneaster drops that is divided into 3 doses (every 8 hour) and at most until 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
Mazandaran 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
Mazandaran University of Medical Sciences, 18th Km Khazar Abad Road, Sari
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
Imam Khomeini Hospital, Amir Mazandarani Blv, Sari
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
Mazandaran University of Medical Science, 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