The Safety and Efficacy of HQMZ111831 as a Lactation Support to feeding Mothers
- Conditions
- Health Condition 1: O80- Encounter for full-term uncomplicated delivery
- Registration Number
- CTRI/2019/09/021400
- Lead Sponsor
- The Himalaya Drug Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Lactating mothers aged >=18 years <=40 years and has completed 48 hours of post-partum period, who are planning at least three months of breast feeding to the infant
Mother confirms her intention to breastfeed and refrains from joining work outside during the study period.
Mother is non-smoker and non-alcoholic.
Infant is judged to be in good health.
Mothers planning only with the conventional breast feeding method and not intending to use breast pump.
Mother confirms her intention to breastfeed and refrains from taking any other
supplement or galactogogues during the study period.
Mother has any anatomical defect in the breast or nipple like mastectomy, retracted nipples which may interfere with the normal breast feeding.
Mother is allergic or intolerant to any ingredient found in the study product.
An adverse maternal, fetal or infant medical history that has potential effects on child growth and or development.
Mother and or newborn infant has major illness that requires intensive care admission.
Infant has major congenital anomaly.
Infant with cleft lip, palate which may impair breast feeding.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the efficacy of HQMZ111831 in improving the lactation in lactating mothers.Timepoint: Schedule visits for the study would be Day 1, Day 30 days (telephonic visit), Day 60 days.
- Secondary Outcome Measures
Name Time Method To assess the safety and tolerability of HQMZ111831 and overall compliance to the <br/ ><br>product <br/ ><br>Timepoint: Schedule visits for the study would be Day 1, Day 30 days (telephonic visit), Day 60 days.