Health Condition 1: O80- Encounter for full-term uncomplicated delivery
Conditions
Interventions
Intervention1: Quista Momz: This is an open label clinical study. Initially, subjects will be initiated for the informed consent process and then adequate subjects will be screened to have 40 evaluabl
Sponsors
The Himalaya Drug Company
Eligibility
Inclusion criteria
Inclusion criteria: Lactating mothers aged >=18 years 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of HQMZ111831 and overall compliance to the product Timepoint: Schedule visits for the study would be Day 1, Day 30 days (telephonic visit), Day 60 days. | — |
Countries
India
Contacts
Public ContactDr Palaniyamma
The Himalaya Drug Company
Outcome results
None listed