Ayurvedic treatment of insufficient lactatio
- Conditions
- Health Condition 1: O998- Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium
- Registration Number
- CTRI/2019/08/020579
- Lead Sponsor
- ICMR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1 Proportion of mothers complaining of insufficient lactation at the end of the study period. <br/ ><br>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 Outcome Measures
Name Time Method 1. Proportion of babies crying even after breast feeding. <br/ ><br>2. Clinical safety of the investigational product assessed through LFT & KFT. <br/ ><br>3. No. of participants reporting any ADR/AE.Timepoint: Time frame: 1. Baseline and every two weeks up to the end of 14 weeks. <br/ ><br>2. Time frame: Baseline and at the end of the treatment <br/ ><br>3. Time frame: Baseline and every two weeks up to the end of 14 weeks