CTRI

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CTRI Number

CTRI/2025/03/082285 [Registered on: 13/03/2025] Trial Registered Prospectively

Last Modified On:

12/03/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Randomized, Parallel Group Trial

Public Title of Study

To study the efficacy of ushir churna with godugdha in decreased milk secretion .

Scientific Title of Study

An open randomized controlled clinical study to evaluate the efficacy of ushir churna with godugdha in 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	Kalyani Harishchandra Sapkal
Designation	PG Student Streeroga Prasutitantra
Affiliation	Yashwant Ayurvedic College Postgraduate training and Research centre Kodoli, District Kolhapur
Address	Department of Streeroga Prasutitantra OPD no 08 and 15 Yashwant Ayurvedic College Postgraduate training and Research centre Kodoli, District Kolhapur Kolhapur MAHARASHTRA 416114 India
Phone	8412086413
Fax
Email	hskalyani1282@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Smita Chodankar
Designation	Assistant professor
Affiliation	Yashwant Ayurvedic College Postgraduate training and Research centre Kodoli, District Kolhapur
Address	Yashwant Ayurvedic College Postgraduate training and Research centre Kodoli, District Kolhapur Yashwant Ayurvedic College Postgraduate training and Research centre Kodoli, District Kolhapur Kolhapur MAHARASHTRA 416114 India
Phone	8888721639
Fax
Email	dr.chodankarsmita@gmail.com

Details of Contact Person
Public Query

Name	Kalyani Harishchandra Sapkal
Designation	PG student Streeroga Prasutitantra
Affiliation	Yashwant Ayurvedic College Postgraduate training and Research centre Kodoli
Address	Department of Streeroga Prasutitantra OPD no 08 and 15 Yashwant Ayurvedic College Postgraduate training and Research centre Kodoli, District Kolhapur Kolhapur MAHARASHTRA 416114 India
Phone	8412086413
Fax
Email	hskalyani1282@gmail.com

Source of Monetary or Material Support

Yashwant Ayurvedic college and research centre, kodoli, kolhapur , Maharashtra, India Pincode -416114

Primary Sponsor

Name	Dr Kalyani Harishchandra Sapkal
Address	Yashwant Ayurvedic College Kodoli ,Kolhapur,Maharashtra,India Pincode-416114
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
Nil

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Kalyani Harishchandra Sapkal	Yashwant Ayurvedic Hospital Kodoli	Opd no 8 Stree roga prasuti tantra of Yashwant Ayurvedic hospital kodoli Kolhapur Kolhapur MAHARASHTRA	8412086413 hskalyani1282@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

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:O924\|\|Hypogalactia. Ayurveda Condition: STANYAKSHAYAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: Ushir Churna, Reference: Charak Samhita Sutrastan 4/17, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Godugdha), Additional Information: Nil
2	Comparator Arm	Drug	Classical		(1) Medicine Name: Shatavari Churna, Reference: Bhavaprakash Nighantu,Guduchyadi varg shlok186, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Godugdha), Additional Information: Nil

Inclusion Criteria

Age From	21.00 Year(s)
Age To	35.00 Year(s)
Gender	Female
Details	IN MOTHER 1)Patients willingly participating in the trial and giving informed written consent form. 2)Age group of patients between 21 to 35 years 3)Patients having sign and symptoms of stanyakshaya . 4)Patients from third day of Post partum (both LSCS and FTND) 5) Patients irrespective of primigravida or multigravida were selected. IN BABY 1) Full term normal weight (2.5 to 3.5kg) mother side baby.

ExclusionCriteria

Details

IN MOTHER
1)Cracked or flat nipples.
2)Mastitis
3) History of breast trauma and surgery.
4) Patient under epileptic and Psychotic drugs.

IN BABY
1)Low birth weight baby(not allowing breast milk).

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
To evaluate the efficacy of Ushir Churna with Godugdha in Stanyakshay	On 7th day, 15th day , 30th day

Secondary Outcome

Outcome	TimePoints
1)To increase Breastmilk secretion. 2)To assess stanza vruddhi by subjective parameter. 3)To study stanyakshaya in detail as per Ayurveda 4)To achieve the outcome of study in 7 days.	On 7th day , 15th day, 30th day

Target Sample Size

Total Sample Size="100"
Sample Size from India="100"
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)

01/04/2025

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="6"
Days="0"

Recruitment Status of Trial (Global)

Not Yet Recruiting

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 [hskalyani1282@gmail.com].

For how long will this data be available start date provided 18-03-2025 and end date provided 18-03-2030?
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

This is randomised open controlled clinical study to evaluate the efficacy of Ushir Churna with Godugdha in stanyakshay observation will be made upon symptoms of Stanyakshay in sutika .Study will be carried out in OPD and IPD of stree roga prasuti tantra department of Yashwant ayurvedic rugnalaya, kodoli.