| CTRI Number |
CTRI/2025/07/091737 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| 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
|
To study the role of Karpasi Beej Churna with Milk in lactating females who has lactation insufficiency |
|
Scientific Title of Study
|
A Randomised Controlled Clinical Trial To Study The Role Of Karpasi Beej Churna With Godugdha In Management Of Stanyakshaya |
| 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 Apeksha Babasaheb Waghe |
| Designation |
PG schoolar Streerog and Prasutitantra |
| Affiliation |
Matoshree Asarabai Darade Ayurved college Bahulgaon Yeola |
| Address |
Department of Streerog and Prasutitantra
Matoshree Asarabai Darade Ayurved College Bahulgaon Yeola.Tal- Yeola .Dist- Nashik
Nashik
MAHARASHTRA
423401
India |
| Phone |
9763502179 |
| Fax |
|
| Email |
apekshawaghe1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Deepti Paithankar |
| Designation |
Professor and Guide |
| Affiliation |
Matoshree Asarabai Darade Ayurved College Bahulgaon Yeola.Tal- Yeola .Dist- Nashik |
| Address |
Department of Streerog and Prasutitantra
Matoshree Asarabai Darade Ayurved College Bahulgaon Yeola.Tal- Yeola .Dist- Nashik
Nashik
MAHARASHTRA
423401
India |
| Phone |
8668735193 |
| Fax |
|
| Email |
deeptisonawane3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Apeksha Babasaheb Waghe |
| Designation |
PG schoolar Streerog and Prasutitantra |
| Affiliation |
Matoshree Asarabai Darade Ayurved college Bahulgaon Yeola |
| Address |
Department of Streerog and Prasutitantra
Matoshree Asarabai Darade Ayurved College Bahulgaon Yeola.Tal- Yeola .Dist- Nashik
Nashik
MAHARASHTRA
423401
India |
| Phone |
9763502179 |
| Fax |
|
| Email |
apekshawaghe1999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Matoshree Asarabai Darade Ayurved college Bahulgaon Yeola Pincode 423401 India |
|
|
Primary Sponsor
|
| Name |
Dr Apeksha Babasaheb Waghe |
| Address |
PG student Streerog and Prasutitantra Department
Matoshree Asarabai Darade Ayurved college Bahulgaon Yeola Pincode 423401 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| DrApeksha Babasaheb Waghe |
Matoshree Asarabai Darade Ayurved Hospital Bahulgaon Yeola |
Streerog and Prasutitantra department .OPD 8 ground floor,Nashik Maharashtra
Nashik
MAHARASHTRA |
9763502179
apekshawaghe1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O912||Nonpurulent mastitis associated with pregnancy, the puerperium and lactation. Ayurveda Condition: STANYAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vidarikand, Reference: Bhavprakash purvakhanda Mishraprakaran Guduchyadi varga shlok 155, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -Milk), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Karpasi Beej , Reference: Bhavprakash purvakhanda Mishraprakaran Guduchyadi varga Shlok 130-131, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -Milk), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Patients willingly participating in trail and giving Informed written consent form.
2. Patients of Stanyakshaya in Sutika Awastha.
3. Age group of patients between 19-35 years.
3. Patients from third day Post partum (both LSCS and normal delivery)
4. Sutika with breast feeding frequency less than 6-7 times a day.
5. Patient having completed 37 weeks of gestation irrespective of primigravida or multigravida.
IN BABY-
1.Full term baby of normal weight (2.5 to 3.5kg)
|
|
| ExclusionCriteria |
| Details |
In Mother -
1. Known case of systemic diseases like active pulmonary Tuberculosis, AIDS
2. Patients having any pathological condition or disease related with breast like Breast abscess, Mastitis, Cracked Nipple etc.
3. Puerperal psychosis
4. Patients taking anti-epileptic, anti-psychotic, antithyroid, anticancer drug.
In Baby –
1. Severe degree of cleft palate
2. Congenital anomaly Esophagealatresia, gastrointestinal disease.
3. Galactosemia,
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
TO STUDY THE ROLE OF KARPASI BEEJ CHURNA WITH GODUGDHA IN THE MANAGEMENT OF STANYAKSHAY
|
1week ,2 week 3 week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To achieve improvement in stanyakshaya condition within 21 days
• To give cost effective alternatives for the management of stanyakshaya.
• To study the effect of KARPASI BEEJ CHURNA on Sutika.
|
1 week 2 week 3 week |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
07/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
07/08/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [apekshawaghe1999@gmail.com].
- For how long will this data be available start date provided 15-05-2025 and end date provided 15-05-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Breast feeding is the Gold Standard for newborn which can’t be replaced any formula feeding.This Randomised Controlled Clinical Trial will study the Role of Karpasi Beej Churna with Godugdha in patients of Stanyakshaya present in OPD and IPD of Matoshree Asarabai Darade Ayurved Hospital Bahulgaon. Stanya means breast milk and Kshaya means decrease in quantity i.e. Stanyakshaya means decrease in quantity of breast milk or not fully meeting the nutrition needs to her neonate/infant. It is also called as lactation failure or hypogalactia or hypogalactorrhoea. The result will be assessed on the basis of clinical improvement which will be reported after treatment the results will be expressed in the term of marked, moderate, mild and poor improvement.
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