Health Condition 1: O924- Hypogalactia
Conditions
Interventions
Intervention1: Lactare Plus plus non-pharmacological interventions: Lactare Plus , one capsule administered orally twice daily for 30 consecutive days, preferably post-breastfeeding with adequate wa
Sponsors
Mankind Pharma Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy female trial participants aged more than or equal to 19 years undergone an uncomplicated delivery 2. Trial participants willing to provide written informed consent and comply with the study visit schedule and procedures. 3. Singleton/twin live birth, gestational age more than or equal 37 weeks. 4. Absence of lactation within 72 hours post-delivery, or as determined by the Principal Investigator. 5. Intends to continue breastfeeding for at least 5 weeks.
Exclusion criteria
Exclusion criteria: 1. Infants with malformations that could affect feeding or growth. 2. Infants with illness or mothers with severe illness or severe malnutrition. 3. Lactating women who have a diagnosis of mastitis. 4. Lactating women with debilitating chronic illness. 5. Lactating women consuming any other galactagogue. 6. Any other medical conditions or medications, according to the investigator, would interfere directly with the results of the study or jeopardize the health of the participant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of exclusive breastfeeding, post-delivery as measured by scores on the Humenick or Hill Lactation Scale (HHLS) and Breastfeeding Self-Efficacy Scale - Short Form (BSES-SF) questionnaire.Timepoint: Baseline and EOS | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Reduction in supplemental milk intake. 2. Mean change in infant weight gain. 3. Mean change in serum prolactin levels 4. Total volume of supplemental milk required for infants. 5. Incidence and severity of adverse events (AEs) and treatment-emergent adverse events (TEAEs) related to Lactare Plus supplementation. Timepoint: 1. Baseline and EOS 2. Baseline and EOS 3. Baseline and EOS 4. Baseline and EOS 5. throughout the study period | — |
Countries
India
Contacts
Public ContactAmardeep Sharma
Mankind Pharma Ltd.
Outcome results
None listed