1
Clinical Trial Protocol
Iranian Registry of Clinical Trials
05 Nov 2022
The effect of Purgative meinna and clofibrate on neonatal hyperbilirobinemia
Protocol summary
Summary
This study will be performed on 3 group neonate with jaundice ( each group 20 patients) .One group will receive only phototherapy, one group phototherapy and oral purgative meinna, and another group phototherapy and oral clofibrate. Inclusion criteria: term( gestational age between 37-42 pregnancy ) ; weight between 2500-4000gr ;age more than 2 days till 10days ; existence of nonhemolytic non-conjugated
hyperbilirubinemia ;breastfeeding ;disposal of the first meconium ;bilirubin more than 12 mg/dl ; candidate for phototherapy.Exclusion criteria: neonate with hemolytic non-conjugated hyperbilirubinemia; neonate with risk factor and associated diseases; non breasfeeding infants;
neonate whose mothers are suffering from diseases ; neonate with conjugated hyperbilirubinemia. After approval of project by research department of medical college , confirmation by the ethics committee of university and obtaining written parental consent, the eligible patients will be divided in three groups according balanced block randomization. The randomization and blinding will be performed by someone outside of project. In present study the data collector and data analyst will not be aware of the type of treatment applied.
General information
Acronym -
IRCT registration information
IRCT registration number: IRCT2016110412897N2 Registration date: 2016-11-19, 1395/08/29 Registration timing: prospective
Last update:
Update count: 0 Registration date
2016-11-19, 1395/08/29 Registrant information
Name
Abolfazl Mahyar
Name of organization / entity Qazvin University of Medical Sciences Country
Iran (Islamic Republic of) Phone
+98 28133348089 Email address
amahyar@qums.ac.ir Recruitment status
Recruitment complete Funding source
Qazvin University of Medical Sciences
Expected recruitment start date 2016-12-21, 1395/10/01
Expected recruitment end date 2017-10-23, 1396/08/01 Actual recruitment start date
empty
Actual recruitment end date empty
Trial completion date empty
Scientific title
The effect of Purgative meinna and clofibrate on neonatal hyperbilirobinemia
Public title
The effect of Purgative meinna and clofibrate on neonatal hyperbilirobinemia
Purpose Treatment
Inclusion/Exclusion criteria
Inclusion criteria: term( gestational age between 37-42 pregnancy ) ; weight between 2500-4000gr ;age more
2 than 2 days till 10days ; existence of nonhemolytic non-
conjugated hyperbilirubinemia ;breastfeeding ;disposal of the first meconium ;bilirubin more than 12 mg/dl ; candidate for phototherapy.Exclusion criteria:neonate with hemolytic non-conjugated
hyperbilirubinemia;neonate with risk factor and associated diseases;non breasfeeding infants;neonate whose mothers are suffering from diseases ; neonate with conjugated hyperbilirubinemia.
Age
From 2 days old to 10 days old Gender
Both Phase
N/A
Groups that have been masked No information
Sample size
Target sample size: 60
Randomization (investigator's opinion) Randomized
Randomization description Blinding (investigator's opinion)
Double blinded Blinding description Placebo
Not used Assignment
Parallel
Other design features -
Secondary Ids
1
Registry name -
Secondary trial Id -
Registration date empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of medical Sciences
Street address
No 184 -Blvd shahid bahonar -Qazvin University of Medical Sciences -Qazvin
City Qazvin Postal code Approval date
2016-10-30, 1395/08/09
Ethics committee reference number IR.QUMS.REC.1395.116
Health conditions studied
1
Description of health condition studied jaundice
ICD-10 code P59.9
ICD-10 code description neonatal jaundice
Primary outcomes
1
Description Bilirubin Timepoint
Before and after intervention Method of measurement
serum bilirubin measurement
Secondary outcomes
1
Description Complications Timepoint
After intervention Method of measurement
Questionnaire
Intervention groups
1
Description
The case group(B) will receive phototherapy and purgative meinna .The phototherapy apparatus will be Tosan model with 8 lamps made in Iran ( Life span of each lamp 2500 hours, wave lengh of 42-470nm ,made in Germany) . The lamps will be located in height 20 cm of neonate. For administration of purgative meinna we will use bilinester drop with 3 drop /kg three times /day(sobhan darou,Rasht industrial city,Rasht,Iran ,Batch No:1228023378)
Category
Treatment - Drugs
2
Description
The case group(C) will receive phototherapy and clofibrate .The phototherapy apparatus will be Tosan model with 8 lamps made in Iran ( Life span of each lamp 2500 hours, wave lengh of 42-470nm ,made in Germany) . The lamps will be located in height 20 cm of neonate.
Clofibrate with dose of 30 mg/kg/ oral single dose will be administrated ( Zahravi pharmacy company , Tabriz, Iran, Batch No: 218, registration number: 1228098598)
3 Category
Treatment - Drugs
3
Description
The control group(A) will receive only phototherapy. The phototherapy apparatus will be Tosan model with 8 lamps made in Iran ( Life span of each lamp 2500 hours, wave lengh of 42-470nm ,made in Germany) . The lamps will be located in height 20 cm of neonate.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center Qods hospital
Full name of responsible person Abolfazl Mahyar
Street address
Qods square -Qods hospital City
Qazvin
Sponsors / Funding sources
1 Sponsor
Name of organization / entity
Vice Chancellor for research of Qazvin University of Medical Sciences
Full name of responsible person Zahra shamekhi
Street address
No 184 -Blvd shahid bahonar -Qazvin University of Medical Sciences -Qazvin
City Qazvin Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Qazvin University of Medical Sciences
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Vice Chancellor for research of Qazvin University ofMedical sciences
Full name of responsible person Abolfazl mahyar
Position Pediatrician
Other areas of specialty/work Street address
Qods hospital City
Qazvin Postal code Phone
+98 28 3333 4809 Fax
amahyar@qums.ac.ir Web page address
Person responsible for updating data
Contact
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
