A single center randomized single blind comparative clinical trial to evaluate the safety and efficacy of Lactohil Plus (Banana Flavour) in the subjects suffering with inadequacy of lactation (Stanyakshaya).

Breast milk is the ideal food for newborns and infants. Exclusive breastfeeding is recommended up to 6 months of age, with continued breastfeeding along with appropriate complementary foods up to two years of age or beyond. If breastfeeding were scaled up to near universal levels, about 820 000 child lives would be saved every year . Globally, only 40% of infants under six months of age are exclusively breastfed. WHO actively promotes breastfeeding as the best source of nourishment for infants and young children? This fact file explores the many benefits of the practice, and how strong support to mothers can increase breastfeeding worldwide . Every infant and child has the right to good nutrition according to the "Convention on the Rights of the Child". Undernutrition is associated with 45% of child deaths. Globally in 2016, 155 million children under 5 were estimated to be stunted (too short for age), 52 million were estimated to be wasted (too thin for height), and 41 million were overweight or obese . It has been estimated that 23 to 63 % incidence of inadequacy of lactation is found during the first 4 months after delivery . Hence, galactagogues are used to increase milk production. Although certain medicines like metoclopramide and domperidone are being used for augmenting lactation but are seldom recommended in view of their limited efficacy prospects and major safety concern. graded scale ranging from 1 to 5 (1 denoting unsatisfactory and 5 representing highly satisfactory) Thus, there has been no effective western medical treatment for the illness so far. However, from earliest times of mankind a multitude of plant galactagogues has been used in the folk medicine of all human cultures. Some herbs i.e. Shatavari (Asparagous racemosus), Kash (saccharaum spontaneum), Ikshu (Saccharum officinarum), Usheera (Viveria zizanoides) and Gundra (Typha elephantia) etc. These are said as having Stanyajana properties. After a complete systemic review, some most effective which are available in market, modern studies also prove their safety and efficacy, cheaper in cost, having higher nutrition values are selected and a new formulation was developed and named as Lactohil Plus. So here in the present study clinical study of Lactohil Plus has been planned. AIM: The aim of the study is to evaluate the efficacy of Lactohil Plus in the management of inadequacy of lactation (Stanyakshaya).

OBJECTIVES:  To evaluate the effect of the formulation on subjective and objective parameters (end points).To observe and analyze any adverse event occurs during trial duration and follow up to evaluate the safety of the trail drug.

 Null Hypothesis: Lactohil Plus has no curative effect in the subject suffering from inadequacy of lactation(Stanyakshaya).

 Alternative hypothesis: Lactohil Plus has significant curative effect on the subjects suffering from inadequacy of lactation (Stanyakshaya) and it is better or comparative to shatavari.

 Research Question: Does Lactohil Plus has curative effect in the management of inadequacy of lactation (Stanyakshaya)? The reference(s)of the Drug(s) as given in Ayurvedic texts are cited,(photocopies of original references are attached) My project involves drug intervention in human subjects

CRITERIA OF ASSESSMENT: The efficacy of test drug will be assessed by observing the increase in milk production. At baseline and after treatment the mothers will asked about following criteria:  Clinical Features of Lacto-genesis  Elimination or significant reduction in supplementary feeds  Baby weight gain The efficacy will be assessed by considering successful lactation in if the following subjective and objective criteria were fulfilled.  Subjective Parameters  Tingling sensation or feeling of fullness in the breast before and while breast feeding  Contra lateral ejection of milk flow during feeding  Satisfaction of baby after breastfeeding  Satisfaction of mother and observation regarding increase in breast milk  Objective Parameters  Total elimination or significant decrease in quantity of artificial milk or supplementary feed to the child per day  Baby weight gain INVESTIGATIONS: 1. LFT, RFT, Glucose Profile