Clinical evaluation for safety and efficacy of Lactohil Plus (Banana Flavour) in the management of inadequacy of lactation (Stanyakshaya)
Phase 2
- Conditions
- Health Condition 1: O925- Suppressed lactation
- Registration Number
- CTRI/2022/10/046518
- Lead Sponsor
- HLL Lifecare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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 infantâ??s birth weight at 15 days of life
Mothers supplementing top feed >=250 ml/day after 4 weeks of birth
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method