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Clinical evaluation for safety and efficacy of Lactohil Plus (Banana Flavour) in the management of inadequacy of lactation (Stanyakshaya)

A single center randomized single blind comparative clinical trial to evaluate the safety and efficacy of Lactohil Plus (Banana Flavour) in the subjects suffering with inadequacy of lactation (Stanyakshaya).

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/10/046518
Enrollment
60
Registered
2022-10-14
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O925- Suppressed lactation

Interventions

None listed

Sponsors

HLL Lifecare Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Lactating mothers age between 21 to 35 years Lactating mothers who delivered at term without complication Baby weight not less than 2000 g at birth Baby between 10-180 days of age Failure to regain infant’s birth weight at 15 days of life Mothers supplementing top feed =250 ml/day after 4 weeks of birth

Exclusion criteria

Exclusion criteria: Mothers Chronic diseases such as Tuberculosis, malignancy and AIDS Breast abscess, cracked nipples, epilepsy, psychosis, alcohol addiction, and mastitis Had previous breast surgery Infants Weight less than 2000g Prematurity and inborn errors

Design outcomes

Primary

MeasureTime frame
Total elimination or significant reduction in volume of supplementary feed and weight gain of the babyTimepoint: on baseline, 15th day, 30th day, 45th day, 60th day

Secondary

MeasureTime frame
improvement in subjective satisfaction of mothers regarding the well being and happiness of babies, feeling fullness in the breast during breast feeding, contra lateral ejection of the milk, and mother’s observation regarding increase in milk.Timepoint: at baseline, 15th day, 30th day, 45th day, 60th day

Countries

India

Contacts

Public ContactBHARATHI KUMARAMANGALAM

National Institute of Ayurveda

baruhunt@gmail.com9492047131

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026