Evaluation of the effects of oral consumption of Foeniculum Vulgare Mill capsule on some indicators of neonatal health and prolactin level in over weight or obese lactating mothers
This study is about"evaluation of the effects of oral consumption of Foeniculum vulgare Mill capsule on some indicators of neonatal health and prolactin level in over weight or obese lactating mothers referred to health and therapeutic centers in shiraz 2015".In this single blind randomized clinical trial the age of neonatal is 2 to 6 weeks.This investigation contains two groups:1-Examination group with consumption 3 gram oral powder of Foeniculum vulgare mill in 6 capsules daily.2-control group with consumption 3 gram oral powder of Starch in 6 capsules daily.The mothers will be receive medicines for 30 days.The study will be done on 66 persons after obtaining testimonial and filling questionnaire demographic.The level of prolactin and indicators of neonatal health include:Length,weight,head circumference will measure and compare before and after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015072623347N1
Registration date:2015-09-27, 1394/07/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-09-27, 1394/07/05
Registrant information
Name
Sareh Saeidjou
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 5422 9152
Email address
stud2471686214@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2015-08-09, 1394/05/18
Expected recruitment end date
2016-01-01, 1394/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of oral consumption of Foeniculum Vulgare Mill capsule on some indicators of neonatal health and prolactin level in over weight or obese lactating mothers
Public title
The effects of Foeniculum Vulgare Mill on indicators of neonatals health and serum prolactin level
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:Exclusive breastfeeding by lactating mothers ;Body mass index 25 and higher(According to the first trimester of pregnancy); term and single Delivery;two to six weeks after delivery;The mother complain about the lack of milk despite correct methods of breastfeeding; mother Age : 18-35;monthly cycle of period is not starting after delivery;Not using hormonal contraception(mini pills)
Exclusion criteria:The presence of mental illness;Liver Disease and Cancer;Consumption of dopamine antagonist drugs(Domperidone,Metoclopramide,Phenothiazine);Cessation of breastfeeding For whatever reason;The occurrence of any event during the study period;Dissuasion from participating in the study;Breast surgery and Removal of all or part of the breast or mastectomy;Breast plastic surgery;Babies with special problems that Who can not drink milk(Such as cleft lip or palate);Allergy to carrots, celery or other plants Apiaceae family;Sensitivity to drug;Use of herbal medicines;Squeeze of milk.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences Ethics Committee
Street address
Zand Street, Shiraz
City
Shiraz
Postal code
Iran
Approval date
2015-08-04, 1394/05/13
Ethics committee reference number
IR.SUMS.REC.1394.74
Health conditions studied
empty
Primary outcomes
1
Description
Serum Prolactin Level
Timepoint
before intervention,30 days after intervention
Method of measurement
Elisa kit, Elisa Rider System
Secondary outcomes
1
Description
Height,Weight And Head Circumference
Timepoint
before intervention and 30 days after intervention
Method of measurement
Tape Measure(Meter),Balance
Intervention groups
1
Description
Intervention group:6 capsules of Foeniculum vulgare mill daily(3gram per day) for 30 days
Category
Treatment - Drugs
2
Description
control group:placebo for 30 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Centers of Shiraz University of Medical Sciences
Full name of responsible person
Sareh Saeidjou
Street address
Zand Street,Shiraz,Fars
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Shiraz University of Medical Sciences
Full name of responsible person
GHolamreza Hatam
Street address
Zand Street
City
Shiraz
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 Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Sareh Saeidjou
Position
Master Student In Midwifery
Other areas of specialty/work
Street address
Zand Street
City
Shiraz
Postal code
Phone
+98 71364742518
Fax
Email
s.saeidjou65@gmail.com;stud2471686214@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Miss Azam Jokar
Position
Master's Degree In Midwifery, Faculty Member
Other areas of specialty/work
Street address
Zand Street
City
Shiraz
Postal code
Phone
+98 71364742518
Fax
Email
jokarhs@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Scienses
Full name of responsible person
Sareh Saeidjou
Position
Master Student In Midwifery
Other areas of specialty/work
Street address
Zand Street
City
Shiraz
Postal code
7418933314
Phone
+98 71 5422 9152
Fax
Email
s.saeidjou65@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)