CTRI/2019/09/021400Not yet recruitingPhase 2
An Open Label Single Arm Clinical Study to Evaluate the Safety and Efficacy of HQMZ111831 as a Lactation Support in Lactating Mothers
The Himalaya Drug Company1 site in 1 country40 target enrollmentStarted: January 10, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- The Himalaya Drug Company
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- To assess the efficacy of HQMZ111831 in improving the lactation in lactating mothers.
Study Overview
Brief Summary
This is an open labelclinical study. Initially, subjects will be initiated for the informed consentprocess and then adequate subjects will be screened to have 40 evaluable subjectsenrolled for the study post eligibility check. All 40 eligible subjects will receive 25g ofHQMZ111831 twice daily oral with 200ml lukewarm milk for a period of 60 days. Schedule visits for the study would be Day 1,Day 30± 3 days (telephonic visit), Day 60± 3 days.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 40.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •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.
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.
Outcomes
Primary Outcomes
To assess the efficacy of HQMZ111831 in improving the lactation in lactating mothers.
Time Frame: Schedule visits for the study would be Day 1, Day 30 days (telephonic visit), Day 60 days.
Secondary Outcomes
- To assess the safety and tolerability of HQMZ111831 and overall compliance to the(product)
Investigators
Study Sites (1)
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