Health Condition 1: O998- Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium
Conditions
Interventions
Intervention1: Ayush-SS granules: Trial Group-Ayush-SS granules 06 gms bd with milk along with Proper nutrition and adequate rest
Control Intervention1: Placebo: Placebo Control Group-Starch in the fo
Sponsors
ICMR
Eligibility
Inclusion criteria
Inclusion criteria: Mother 1 Exclusively breast feeding mothers with complaint of insufficient lactation. 2 Age between 20-40 years 3 Full Term Delivery � 37 weeks 4 Primi or multipara with singleton baby 5 Willing and able to give written consent Baby 6 Baby with birth weight � 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Proportion of mothers complaining of insufficient lactation at the end of the study period. 2 Proportion of babies with a Weight gain of 20gms/day in those who were exclusively breast feed.Timepoint: Time frame: Baseline and every two weeks up to the end of 14weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of babies crying even after breast feeding. 2. Clinical safety of the investigational product assessed through LFT & KFT. 3. No. of participants reporting any ADR/AE.Timepoint: Time frame: 1. Baseline and every two weeks up to the end of 14 weeks. 2. Time frame: Baseline and at the end of the treatment 3. Time frame: Baseline and every two weeks up to the end of 14 weeks | — |
Countries
India
Contacts
Public ContactDr Sarada Ota
VMMC Safdarjung Hospital New Delhi
Outcome results
None listed