| CTRI Number |
CTRI/2024/06/069223 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
03/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Effect Of Vachadi Yoga In Lactation Insufficiency |
|
Scientific Title of Study
|
A Clinical Study To Evaluate The Efficacy Of Vachadi Yoga On Stanyakshaya W.S.R To Lactation Insufficiency |
| 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 Sakshi Patidar |
| Designation |
Pg Scholar |
| Affiliation |
MMM Government Ayurved College |
| Address |
Pg Department Of Prasuti Tantra Evam Striroga MMM Government Ayurved College Ambamata Udaipur Rajasthan
Pg Department Of Prasuti Tantra Evam Striroga MMM Government Ayurved College Ambamata Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
8290691871 |
| Fax |
|
| Email |
sakshinogama15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Narendra Kumar Meena |
| Designation |
Associate Proffesor And Guide |
| Affiliation |
MMM Government Ayurved College |
| Address |
Pg Department Of Prasuti Tantra Evam Striroga MMM Government Ayurved College Ambamata Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9950129673 |
| Fax |
|
| Email |
narendermeena42@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Narendra Kumar Meena |
| Designation |
Associate Proffesor And Guide |
| Affiliation |
MMM Government Ayurved College |
| Address |
Pg Department Of Prasuti Tantra Evam Striroga MMM Government Ayurved College Ambamata Udaipur Rajasthan
RAJASTHAN
313001
India |
| Phone |
9950129673 |
| Fax |
|
| Email |
narendermeena42@yahoo.com |
|
|
Source of Monetary or Material Support
|
| MMM Government Ayurved College Ambamata Udaipur Rajsthan 313001 |
|
|
Primary Sponsor
|
| Name |
MMM Government Ayurved College |
| Address |
MMM Government Ayurved College Ambamata Udaipur Rajasthan 313001 |
| Type of Sponsor |
Government 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 |
| DRSakshi Patidar |
MMM Government Ayurved College Udaipur Rajsthan |
MMM Government Ayurved College Udaipur Rajsthan 313001
Udaipur
RAJASTHAN |
8290691871
sakshinogama15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee MMM Government Ayurved College |
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: Vachadi Yoga, Reference: Chakradtta, Route: Oral, Dosage Form: Khanda /Granules, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Kshir), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Patient Having Lactional Insufficiency
Patient Who Are Agree For Written Consent
Brest Feeding Frequency Less Than 4-5 Time/Day
|
|
| ExclusionCriteria |
| Details |
Patient not willing for trial.
Patient with congenital anomalies of breast
Patient with breast atrophy and inverted nipple, mastitis, breast abscess, breast cancer
Patient with known case of systemic disease like Diabetes mellitus.
Patient who is taking anti prolactin drug which suppress lactation.
Patient with HIV Hepatitis B |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Laxity Of breast Amount of Lactation Breast Engorgement |
Laxity Of breast Amount of Lactation Breast Engorgement |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Bby Weight Breast Milk Manual Ejection Serum Prolactin Level |
90 Day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 2 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| 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="0"
Months="6"
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
|
THIS STUDY IS A CLINICAL STUDY TO EVALUATE THE EFFICACY OF VACHADI YOGA IN THE MANAGEMENT OF THE STANYAKSHAYA W.S.R. TO LACTATION INSUFFICIENCY.THERE WILL BE 1 GROUP IN THE STUDY, PATIENT WILL BE SELECTED RANDOMLY AND CLINICALLY DIAGNOSED 30 PATIENT OF STANYAKSHAYA LACTION INSUFFICIENCY . TRIAL WILL BE CONDUCTED FOR A PERIOD OF 3 MONTH. FOLLOW UP OF THE CASE WILL BE DONE AFTER COMPLETION OF 15 DAY. |