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
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Effect of trial drug over stanya kshaya (lactation failure)assessed by the assessment parameter
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 21.00 Year(s) to 40.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Effect of trial drug over stanya kshaya (lactation failure)assessed by the assessment parameter
Time Frame: 15th day 30th day 45th day
Secondary Outcomes
- To see the long term effect of drug over stanya kshaya (lactation failure)assessed by the assessment parameter(15th day 30th day 45th day)
Investigators
Dr Sreelekha Sethi
Sdmt Ayurvedic Medical College Danigond Post Graduation Centre