CTRI/2019/08/020579RecruitingPhase 2
Clinical evaluation of the efficacy of ââ?¬Å?Ayush SS Granulesââ?¬? in exclusively breast feeding mothers with Insufficient Lactation (Stanyalpata)- A Randomized Double blind placebo control trial
ICMR0 sites0 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1 Exclusively breast feeding mothers with complaint of insufficient lactation.
- •2 Age between 20-40 years
- •3 Full Term Delivery ââ?°Â¥ 37 weeks
- •4 Primi or multipara with singleton baby
- •5 Willing and able to give written consent
- •6 Baby with birth weight ââ?°Â¥ 2.5 kg who has not attained actual birth weight by 14 days
- •7 After 14 days of age weight gain less than 20gm/day from 15th day of birth to 3rd month of birth
- •8 Urination less than 6 times/day
Exclusion Criteria
- •1 Mothers with active herpes breast/breast abscess/retracted nipple/severely cracked nipples, having HbsAg+ve, HIV+ve, Tuberculosis, Chronic medical conditions.
- •2 Mother is taking medicine like Pseudoephedrine, methargin, bromocriptine, any other galactogogues (Allopathic/Ayurvedic)
- •3 Mother having Malignancy and Diabetes melitus
- •4 Neonate with congenital malformations which may interfere in breast feeding or requiring surgery in first six months of life.
- •5 Baby with acute respiratory infection, pneumonia, urinary tract infection, infective diarrhoea, meningitis at the time of recruitment
- •Subjects will be enrolled in to the study after satisfying the inclusion/exclusion criteria. Each subject will be assigned a unique subject number, which identifies the individual.
Investigators
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