CTRI/2026/02/104903Not yet recruitingNot Applicable
A Randomized, Multi-Centered, Two-Arm, Double-Blind, Placebo-Controlled Clinical Trial for Generating Evidence on The Efficacy of the Herbal Galactagogue Lactare Plus for Augmentation of Lactation Among Postpartum Mothers
Mankind Pharma Ltd3 sites in 1 country228 target enrollmentStarted: March 9, 2026Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 228
- Locations
- 3
Study Overview
Brief Summary
This randomized, multi-centered, two-arm, double-blind, placebo-controlled clinical study will enroll postpartum mothers experiencing delayed onset of lactation. Participants will be randomized in a 1:1 ratio using block randomization to receive either Lactare Plus® capsules combined with standardized non-pharmacological breastfeeding support or matching placebo capsules combined with standardized non-pharmacological breastfeeding support. This design will allow evaluation of the efficacy and safety of Lactare Plus® in augmenting lactation compared to placebo when both groups receive identical structured non-pharmacological breastfeeding support.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 19.00 Year(s) to 55.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Healthy female trial participants aged more than or equal to 19 years undergone an uncomplicated delivery
- •Trial participants willing to provide written informed consent and comply with the study visit schedule and procedures.
- •Singleton/twin live birth, gestational age more than or equal 37 weeks.
- •Absence of lactation within 72 hours post-delivery, or as determined by the Principal Investigator.
- •Intends to continue breastfeeding for at least 5 weeks.
Exclusion Criteria
- •Infants with malformations that could affect feeding or growth.
- •Infants with illness or mothers with severe illness or severe malnutrition.
- •Lactating women who have a diagnosis of mastitis.
- •Lactating women with debilitating chronic illness.
- •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.
Investigators
Dr Hanee Hemantkumar Patel
Harmony Hospital
Study Sites (3)
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