The purpose of present study was to examine the preventive effects of purgative manna on neonate’s icter. It was a double blind clinical Trial study conducted among neonates who was born on Be’sat Hospital, Sanandaj, Iran. The sample size was 70 neonates in each group. . An inclusion criterion was being full term neonate and exclusion criteria were congenital anomalies and icter in day 1. Patients were divided into two groups using blocked randomization. Twenty four hours after birth, for three days, five drops of oral purgative manna drop (BiliNaster produced by Sobhan Co.) was given to intervention group three times a day, and placebo, produced by the same company, was given to infants in control group. Bilirobin and clinical evaluation for determining icter were measured during the third to fifth days.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138901223666N2
Registration date:2010-11-26, 1389/09/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-11-26, 1389/09/05
Registrant information
Name
Majid Mansoury
Name of organization / entity
Kurdistan University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 1324 7594
Email address
dr_m_mansory@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Kurdistan University of medical sciences
Expected recruitment start date
2009-04-21, 1388/02/01
Expected recruitment end date
2010-01-20, 1388/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Preventive effects of purgative manna (vs. placebo) on neonate’s icter
Public title
Evaluation the preventive effects of purgative manna on neonate’s icter in Sanandaj, Iran
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Full term neonate.
Exclusion criteria: Congenital anomalies, Icter in day 1
Age
From 1 year old to 3 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kurdistan University of medical sciences
Street address
Pasdaran Ave
City
Sanandaj
Postal code
Approval date
2009-04-13, 1388/01/24
Ethics committee reference number
3755 پ 14 پ
Health conditions studied
1
Description of health condition studied
neonatal icterus
ICD-10 code
P59
ICD-10 code description
Neonatal jaundice from other and unspecified causes
Primary outcomes
1
Description
Icterus
Timepoint
Day 3-5
Method of measurement
clinical examination and Lab exam
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: Bilinaster drop produced by Sobhan Co. oral 5 drop/TDS (Twenty four hours after birth, for three days)
Category
Treatment - Drugs
2
Description
Control: Placebo drop produced by Sobhan Co. oral 5 drop/TDS
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Majid Mansouri
Street address
City
Sanandaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kurdistan University of medical sciences
Full name of responsible person
Dr Heidary
Street address
Pasdaran Ave
City
Sanandaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kurdistan 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
Name of organization / entity
Kurdistan University of medical sciences
Full name of responsible person
Dr Majid Mansouri
Position
Fellow in neonatology
Other areas of specialty/work
Street address
Besat hospital, Keshavarz Ave.
City
Sanandaj
Postal code
Phone
+98 87 1324 7594
Fax
Email
Magidmansoori@Yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kurdistan University of medical sciences
Full name of responsible person
Dr Majid Mansouri
Position
Fellow in neonatology / Assistant Prof.
Other areas of specialty/work
Street address
Besat Hospital, Keshavarz Ave.
City
Sanandaj
Postal code
Phone
+98 87 1324 7594
Fax
Email
Magidmansoori@Yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Majid Mansouri
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)