CTRI/2025/03/083240尚未招募3 期
Effectiveness and safety of AYUSH SS granules (Coded Ayurveda Formulation) in the management of Lactation insufficiency: A prospective single arm multi centric trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 480
- 试验地点
- 4
- 主要终点
- Proportion of mothers exclusively breast feeding. Weight gain greater than twenty gram per day among these exclusively breast fed babies.
研究概览
简要总结
The study is being conducted to assess the effectiveness of Ayush SS granules in exclusively breastfeeding mothers with lactation insufficiency. it is a prospective, multi-centric, single-arm study with a total sample size of 480. The primary outcome is the proportion of mothers exclusively breastfeeding and weight gain greater than 20g per day in these exclusively breastfed babies at the time points -baseline and at the end of every month up to the end of 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •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.
排除标准
- •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.
- •Mothers with engorgement of the breast/fullness of breast.
- •Mother is taking medicine like Pseudoephedrine, methergine, bromocriptine or any other galactogogues (Allopathic/Ayurvedic) v.
- •Mother is a known case of Diabetes mellitus .
- •Mother of neonate with congenital malformations which may interfere in breast feeding or necessitating surgery in first six months of life.
- •Mother of baby presenting with acute respiratory infection, pneumonia, urinary tract infection, infective diarrhoea, meningitis at the time of recruitment.
结局指标
主要结局
Proportion of mothers exclusively breast feeding. Weight gain greater than twenty gram per day among these exclusively breast fed babies.
时间窗: Baseline and every four weeks up to the end of 12weeks
次要结局
- • Assessment of the safety of Ayush- SS Granules (Assessed through laboratory parameters LFT, KFT) during the study period(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 period(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/sachets(Baseline and every four weeks up to the end of 12weeks)
研究者
Dr Sarada Ota
Central council For Research In Ayurvedic Sciences
研究点 (4)
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