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临床试验/CTRI/2024/08/073120
CTRI/2024/08/073120尚未招募3 期

A Comparative Clinical Study To Evaluate The Effect Of Musta Churna And Shatavari Churna In The Management Of Stanya Kshaya W S R To Lactation Failure

Dr Sreelekha Sethi1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年9月10日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Effect of trial drug over stanya kshaya (lactation failure)assessed by the assessment parameter

研究概览

简要总结

The less formation of breast milk is known as Stanya Kshaya which can be co-related to Lactation Failure explained in modern science.

Stanya Kshaya is the common problem noticed in about 40% patients in our clinical practice. Lack of self-confidence, mental anxiety and physical stress in working women, incorrect breast-feeding practices, insufficient secretion due to lack of sleep are the main causes of lactation failure. Objectives of study is to evaluate the effect of Musta Churna in the management of Stanya Kshaya w.s.r to Lactation Failure. This is the randomized comparative clinical study. Total 40 patients of Stanya Kshaya selected and randomaly devided into two groups. Group A given musta churna and group B given shatavari churna. The subjective and objective parameters are selected for assessment. Total study duration is 45 days and contain 4 visits (0th day 15th day 30th day 45th day) which includes 30th days drug administration and 45th day post medication follows up. After study data will be collected from case report form and statistically analysed by using appropriate parametric and non-parametric tests and result will be obtained. On the basis of result conclusion will be drawn.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
21.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • Lactating mothers with classical signs and symptoms of Stanya Kshaya Patients with feeding frequency less than 4-5 times/day Patients from 5th day of delivery to 6 months Age group of patient is between 21 to 40 years.

排除标准

  • K/C/O Mastitis CA Breast and Cystic breast disease Patients with Congenital Breast Anomaly K/C/O Psychiatric illness Patients with history of alcoholism smoking Diagnosed cases of uncontrolled diabetes Mother having a baby with congenital anomaly like cleft lip cleft palate Patient denying consent.

结局指标

主要结局

Effect of trial drug over stanya kshaya (lactation failure)assessed by the assessment parameter

时间窗: 15th day 30th day 45th day

次要结局

  • To see the long term effect of drug over stanya kshaya (lactation failure)assessed by the assessment parameter(15th day 30th day 45th day)

研究者

发起方
Dr Sreelekha Sethi
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Sreelekha Sethi

Sdmt Ayurvedic Medical College Danigond Post Graduation Centre

研究点 (1)

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