Health Condition 1: O998- Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium
Conditions
Interventions
None listed
Sponsors
Central Council for Research in Ayurvedic Sciences
Eligibility
Inclusion criteria
Inclusion criteria: i. Exclusively breast feeding mothers of age between 20-40 years with the complaint of insufficient lactation ii. Primi or multipara with full term Delivery (greater than or equal to 37 weeks) and singleton baby from healthy pregnancy iii. Mother of Baby with birth weight greater than or equal to 2 kg who has not attained actual birth weight by 10 days OR After 10 days of age weight gain less than 20gm per day from 11th day of birth to 3rd month of birth iv. Urination of baby less than 6 times per day v. Mother willing and able to give written consent
Exclusion criteria
Exclusion criteria: i. Mothers with active herpes breast/breast abscess/retracted nipple/severely cracked nipples, ii. Mother is a known case of Hepatitis B, HIV, Tuberculosis, Malignancy or other Chronic medical conditions. iii. Mothers with engorgement of the breast/fullness of breast. iv. Mother is taking medicine like Pseudoephedrine, methergine, bromocriptine or any other galactogogues (Allopathic/Ayurvedic) v. Mother is a known case of Diabetes mellitus . vi. Mother of neonate with congenital malformations which may interfere in breast feeding or necessitating surgery in first six months of life. vii. Mother of baby presenting with acute respiratory infection, pneumonia, urinary tract infection, infective diarrhoea, meningitis at the time of recruitment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of mothers exclusively breast feeding. Weight gain greater than twenty gram per day among these exclusively breast fed babies.Timepoint: Baseline and every four weeks up to the end of 12weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of the safety of Ayush- SS Granules (Assessed through laboratory parameters LFT, KFT) during the study periodTimepoint: Baseline and at the end of 12weeks ; Assessment of the tolerability of Ayush - SS Granules (Assessed through reported withdrawal of participants due to incidence of Treatment emergent adverse events (GIT-related AE specifically) during the study periodTimepoint: Baseline and every four weeks up to the end of 12weeks ; Assessment of treatment adherence through participant self-reported compliance log and used medication containers/strips/sachetsTimepoint: Baseline and every four weeks up to the end of 12weeks | — |
Countries
India
Contacts
Public ContactDr Bhagwan Sahai Sharma
Central council For Research In Ayurvedic Sciences
Outcome results
None listed