Randomized controlled clinical study to evaluate the efficacy of pathyadi yog in the management of stanyakshaya
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- To study the effect of Pathyadi Yog in the management of Stanyakshaya (Hypogalactia).
研究概览
简要总结
Ayurveda is an ancient science which deals with not only the diseased condition but also the normal health of human. In Ayurveda so many Acharya’s explained the importance of Stanya.
Breast milk is a perfect food for neonates. It is the best gift a mother can give to her baby. Breast feeding is the ideal form of infants feeding.
Breast milk provides primary source of nutrition for neonates and infants till 6th months. Breast milk is composed of Immunoglobulin IgA, Fat, Proteins, Carbohydrates, Minerals, Digestive enzymes, Antibodies, Lymphocytes. So, Breast milk is best than any other type of feeding. Artificial feeding exposes to the infants leads to gastrointestinal infections like diarrhea, vomiting, sometimes allergic reactions or fever.
According to Ayurveda Breast milk is the essence of Rasadhatu which is formed from the digested food circulating in the whole body, when it gets collected in breast it is termed as Stanya. As it is formed from Prasad Bhaga of Aahar Rasa it contains best of all nutrients needed for the child. Hence Stanyakshaya is associated with Rasadhatu Kshaya.
The decrease secretion may occur from beginning and continue through entire period of lactation or it may be normal initially and decrease gradually. Keeping these aspects in mind, this study has been undertaken. It is an attempt to verify the claim that Magadhi, Nagari, Pathya are Galactogogue.
Lactational deficiency is a public concern and major problem worldwide. Therefore, for the management of Stanyakshaya Ayurvedic treatment have multiplied over the recent years which is non hormonal, non-surgical, effective, safer and without any adverse effect.
Study will conducted on 92 diagnosed patients of Stanyakshaya. Written consent will be taken. Initial assessment will be done. Patients treated with interventional group Pathyadi Yog and control group Haridradi Churna. Patients will be assessed at follow ups. Observations and results will be noted and Statistical Analysis, Discussion and Conclusion will be drawn.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 21.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Mothers who complain Stanyakshya symptoms after delivery upto 6 months.
- •2.Age group from 21 years to 40 years.
- •3.Mother having a 5th day neonate to 12 month baby.
- •4.Breast milk quantity less than 300ml per day.
- •5.Patients who will willing to give consent for this study.
排除标准
- •1.Known case of Breast abscess, Mastitis, Cracked nipples and Breast cancer.
- •2.Infant with cleft lip and cleft palate.
- •3.Mother having a history of hormonal disorder.
- •4.Patients suffering from Stanyakshaya due to any secondary cause like HIV, TB.
结局指标
主要结局
To study the effect of Pathyadi Yog in the management of Stanyakshaya (Hypogalactia).
时间窗: Baseline - 7th, 14th, 21th day
次要结局
- 1.To study Stanyakshaya according to Ayurveda.(2. To study Stanyakshaya according to Modern.)