| CTRI Number |
CTRI/2024/08/073120 [Registered on: 29/08/2024] Trial Registered Prospectively |
| Last Modified On: |
29/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Action OF MUSTA CHURNA AND SHATAVARI CHURNA IN STANYA KSHAYA (lack of milk production) |
|
Scientific Title of Study
|
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 Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sreelekha Sethi |
| Designation |
PG Scholar |
| Affiliation |
Sdmt Ayurvedic Medical College Danigond Post Graduation Centre |
| Address |
Sdm Trusts Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital And Research Centre Dr Siddhant Nagar Terdal 587315 Karnataka India
Sdm Trusts Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital And Research Centre Dr Siddhant Nagar Terdal 587315 Karnataka India
Bagalkot
KARNATAKA
587315
India |
| Phone |
8249438906 |
| Fax |
|
| Email |
sreelekhasethi1792@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sukanya Patil |
| Designation |
Professor |
| Affiliation |
Sdmt Ayurvedic Medical College Danigond Post Graduation Centre |
| Address |
Sdm Trusts Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital And Research Centre Dr Siddhant Nagar Terdal 587315 Karnataka India
Sdm Trusts Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital And Research Centre Dr Siddhant Nagar Terdal 587315 Karnataka India
Bagalkot
KARNATAKA
587315
India |
| Phone |
8249438906 |
| Fax |
|
| Email |
drsukanyapatil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sreelekha Sethi |
| Designation |
PG Scholar |
| Affiliation |
Sdmt Ayurvedic Medical College Danigond Post Graduation Centre |
| Address |
Sdm Trusts Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital And Research Centre Dr Siddhant Nagar Terdal 587315 Karnataka India
Sdm Trusts Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital And Research Centre Dr Siddhant Nagar Terdal 587315 Karnataka India
Bagalkot
KARNATAKA
587315
India |
| Phone |
8249438906 |
| Fax |
|
| Email |
sreelekhasethi1792@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM Trusts Ayurvedic Medical College And Padma Hospital 2nd Floor Room No 3rd Terdal Karnataka India 587315 |
|
|
Primary Sponsor
|
| Name |
Dr Sreelekha Sethi |
| Address |
Sdm Trusts Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital And Research Centre Dr Siddhant Nagar Terdal 587315 Karnataka India
|
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr sreelekha |
SDMTs ayurvedic college and hospital terdal |
SDMTs ayurvedic college and hosptal Padma hospital ptsr department room no 3 floor no 2 terdal padma nagar 587315
Bagalkot
KARNATAKA |
8249438906
sreelekhasethi1792@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sdmts Ayurvedic Medical College And Padma Ayurvedic Hospital Institutional Ethics Committee For Research On Human Subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O925||Suppressed lactation. Ayurveda Condition: STANYAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shatavari churna, Reference: Susruta Samhita, Sharira Sthan 10/34, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Godugdha), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Musta Churna, Reference: Dr Tripathy Indradeva Chakradatta of Sri Chakrapanidatta Vaidya prabha hindi commentary pg no 391, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Godugdha), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of trial drug over stanya kshaya (lactation failure)assessed by the assessment parameter |
15th day 30th day 45th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To see the long term effect of drug over stanya kshaya (lactation failure)assessed by the assessment parameter |
15th day 30th day 45th day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |