This research is a randomized clinical trial that performed with 2 intervention group and a control group. Mainly aim of the study is to determine the effect of herbal tea fenugreek seed and fennel on breast feeding. Through random sampling 129 Mother with baby girl 0-4 months will be divide in two intervention group and one control group with Double-blind. The inclusion criteria includes: Infant girls 0 to 4 months were born between 37-42 weeks and is able to sucking milk natural؛ Baby and mother with no underlying disease that is causing the contraindications are breast-feeding؛ Mother did not use formula and Galactagogue and consumes a diet with high in dairy products. The exclusion criteria includes: unwilling to continue participate in research؛ the use of any chemical drugs or herbal medicines increases milk during the study. Sampling starts on 10/15/92. The samples will be entering in study with a demographic and Breastfeeding questionnaire. To assess the situation before the intervention, a follow-up form will be given to the mother for 2 days and she will be asked to record the frequency of urinary excretion, Frequency of defecation and frequency of infant feeding in 24 hours. Weight, height and head circumference will be measured and recorded by researcher. The first intervention group will receive Herbal tea containing 7/5 g powder of Fennel seed +3 grams of powder ordinary tea three times a day, The second intervention group will receive Herbal tea containing 7/5 g powder of Fenugreek seed +3 grams of powder ordinary tea three times a day and the control group will receive Herbal tea containing 3 grams of powder ordinary tea three times a day. Drugs will be given weekly for 4 weeks and in the each visit of mother, weight, height and head circumference will be measured and recorded by researcher. A follow-up form will be given to mother for every week and she will be asked to record the frequency of urinary excretion,frequency of defecation and frequency of infant feeding in 24 hours. During the 4-week follow-up and at the end of 4 weeks, Different signs of sufficient breast milk in Interventions and control groups will be assessed by using the follow-up form and measuring growth parameters.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201312102751N10
Registration date:2013-12-19, 1392/09/28
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-12-19, 1392/09/28
Registrant information
Name
Masoomeh Kheirkhah
Name of organization / entity
Iran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8247 1000
Email address
kheirkhah@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-01-05, 1392/10/15
Expected recruitment end date
2014-05-05, 1393/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of Fenugreek seeds and Fennel herbal tea on Signs of adequate breast milk in mothers with baby girl 0-4 months
Public title
The effect of Fenugreek seeds and Fennel herbal tea on Signs of adequate breast milk in mothers with baby girl 0-4 months
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria includes: Infant girls 0 to 4 months were born between 37-42 weeks and is able to sucking milk natural؛ Baby and mother with no underlying disease that is causing the contraindications are breast-feeding؛ Mother did not use formula and Galactagogue and consumes a diet with high in dairy products. The exclusion criteria includes: unwilling to continue participate in research؛The use of any chemical drugs or herbal medicines increases milk during the study.
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
129
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
Tehran University Of Medical Sciences
Street address
Central Apartment Of Tehran University Of Medical Sciences, Keshavarz blvd
City
Tehran
Postal code
Approval date
2013-11-23, 1392/09/02
Ethics committee reference number
1913/130/د/92
Health conditions studied
1
Description of health condition studied
Breast feeding
ICD-10 code
P92.8
ICD-10 code description
Other feeding problems of newborn
Primary outcomes
1
Description
Frequency of defecation
Timepoint
Within 24 hours for 4 weeks
Method of measurement
Follow-up form
2
Description
Frequency of infant feeding
Timepoint
Within 24 hours for 4 weeks
Method of measurement
Follow-up form
3
Description
Weight infant
Timepoint
Weekly for 4 weeks
Method of measurement
Weight scale
4
Description
Height infant
Timepoint
Weekly for 4 weeks
Method of measurement
Meter
5
Description
Head circumference of infants
Timepoint
Weekly for 4 weeks
Method of measurement
Meter
6
Description
Frequency of urinary excretion
Timepoint
Within 24 hours for 4 weeks
Method of measurement
Follow-up form
Secondary outcomes
empty
Intervention groups
1
Description
Herbal tea containing 7/5 g powder of Fenugreek seed +3 grams of powder ordinary tea three times a day for 4 weeks
Category
Treatment - Drugs
2
Description
Herbal tea containing 7/5 g powder of Fennel seed +3 grams of powder ordinary tea three times a day for 4 weeks
Category
Treatment - Drugs
3
Description
Pelasebo Herbal tea containing 3 grams of powder ordinary tea three times a day for 4 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Centers in Southern Tehran
Full name of responsible person
Vida Ghasemi
Street address
Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Masood Younesian
Street address
Central Building of Tehran University of Medical Sciences, the Qods Street, Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
School of Nursing and Midwifery Tehran University of Medical Science
Full name of responsible person
Masoome Kheirkhah
Position
Ms Midwifery/Master of Science
Other areas of specialty/work
Street address
Mirkhani street, Tohid square, Tehran
City
Tehran
Postal code
1419733171
Phone
+98 21 6693 7120
Fax
Email
kheirkhah.m@iums.ac.ir
Web page address
www.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery Tehran University of Medical Science
Full name of responsible person
Masoome kheirkhah
Position
Ms Midwifery/Master of Science
Other areas of specialty/work
Street address
School of Nursing and Midwifery, East Nosrat Ave,Tohid SQ
City
Tehran
Postal code
1419733171
Phone
+98 21 6693 7120
Fax
Email
kheirkhah.m@iums.ac.ir
Web page address
www.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing and Midwifery Tehran University of Medical Science
Full name of responsible person
Masoome kheirkhah
Position
Ms Midwifery/Master of Science
Other areas of specialty/work
Street address
School of Nursing and Midwifery, East Nosrat Ave,Tohid SQ
City
Tehran
Postal code
1419733171
Phone
+98 21 6693 7120
Fax
Email
kheirkhah.m@iums.ac.ir
Web page address
www.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)