This study is about “Effect of Fenoculum Vulgrate on serum prolactin level in lactating women". In this controlled trial study, 46 lactating women will be recruited from Asiabad's Health center of Ahvaz & taking 4 Fenoculum Vulgrate's handmade capsul by orall each day in 15 days. So serum prolactin level will be compared after & before of the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012121011710N1
Registration date:2013-01-10, 1391/10/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-01-10, 1391/10/21
Registrant information
Name
Fatemeh Honarvar
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
00986113738621،00986113738394،00986113738331
Email address
f_honarvar@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2013-01-09, 1391/10/20
Expected recruitment end date
2013-04-21, 1392/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Fenoculum vulgrate on serum prolactin level in lactating women
Public title
The effect of Fenoculum vulgrate on serum prolactin level
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Exclusive Breast feeding; perimyparity; BMI 19.8-26; age 18-35 years old; Term delivery; 4-6 months after birth; Mothers who say about shortage of their milk despite correct's way Breast feeding; Amenoreha after delivery. Exclusion criteria: Any type of mental disease, liver diseases & cancer; use of hormone contraceptive; Any kind of events during stud; Stopping Breast feeding; Consume of Antagonist's Dopamin's Drug.
Age
From 18 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan's Way
City
Ahvaz
Postal code
61357- 15794
Approval date
2012-12-01, 1391/09/11
Ethics committee reference number
ETH-628
Health conditions studied
1
Description of health condition studied
Serum prolactin level
ICD-10 code
Y49.8
ICD-10 code description
Prolactin- adverse effect in theraputic use
Primary outcomes
1
Description
Serum prolactin level blood
Timepoint
before intervention, 15 days after intervention
Method of measurement
Elisa kit, Elisa Rider system
Secondary outcomes
empty
Intervention groups
1
Description
This study is consists of 1 group intervention. They are supposed to take 1 gr hand madee's Capsul of Fenoculum Vulgrate, 4 times aday in 15 days by Oral.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Asiabad's Health center of Ahvaz
Full name of responsible person
Fatemeh Honarvar
Street address
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Mostafa Feghhi
Street address
Golestan's Way
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Fatemeh Honarvar
Position
Post graduate student
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan's Way