| CTRI Number |
CTRI/2025/08/093320 [Registered on: 20/08/2025] Trial Registered Prospectively |
| Last Modified On: |
19/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Whether mashaparni churna increases quantity of milk in lactational deficiency] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
STUDY OF EFFECT OF MASHAPARNI CHURNA IN THE MANAGEMENT OF STANYAKSHAYA |
|
Scientific Title of Study
|
RANDOMIZED CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY OF MASHAPARNI CHURNA WITH GODUGDHA IN THE 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 Priyanka babasaheb kamble |
| Designation |
PG Scholar |
| Affiliation |
Yashwantrao chavan ayurvedic medical College and hospital |
| Address |
OPD No.110 Prasutitantra evum Streeroga Department Yashvantrao Chavan Ayurvedic Medical College and Hospital Nipani Bhalgaon, Beed Bypass Rd Chhatrapati Sambhajinagar
Aurangabad
Aurangabad
MAHARASHTRA
431007
India |
| Phone |
9284092685 |
| Fax |
|
| Email |
priynkakamble1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shilpa Desai |
| Designation |
Professor |
| Affiliation |
Yashwantrao chavan ayurvedic medical College |
| Address |
OPD No.110 Prasutitantra evum Streeroga Department Yashvantrao Chavan Ayurvedic Medical College and Hospital Nipani Bhalgaon, Beed Bypass Rd Chhatrapati Sambhajinagar
Aurangabad
Aurangabad
MAHARASHTRA
431007
India |
| Phone |
9511716046 |
| Fax |
|
| Email |
drshilpadesai81@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shilpa Desai |
| Designation |
Professor |
| Affiliation |
Yashwantrao Chavan Ayurvedic Medical College and Hospital |
| Address |
OPD No.110 Prasutitantra evum Streeroga Department Yashvantrao Chavan Ayurvedic Medical College and Hospital Nipani Bhalgaon, Beed Bypass Rd Chhatrapati Sambhajinagar
Aurangabad
OPD No.110 Prasutitantra evum Streeroga Department Yashvantrao Chavan Ayurvedic Medical College and Hospital Nipani Bhalgaon, Beed Bypass Rd Chhatrapati Sambhajinagar
Aurangabad
Aurangabad
MAHARASHTRA
431007
India |
| Phone |
9511716046 |
| Fax |
|
| Email |
drshilpadesai81@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwantrao chavan ayurvedic medical College and hospital Nipani Bhalgaon, Beed ypass Rd Chhatrapati Sambhajinagar 431007 |
|
|
Primary Sponsor
|
| Name |
Priyanka Babasaheb Kamble |
| Address |
OPD No. 110 Prasutitantra evum Streeroga Department Yashvantrao Chavan Ayurvedic Medical College and Hospital Nipani Bhalgaon, Beed Bypass Rd Chhatrapati Sambhajinagar, Maharashtra, India. Pin code- 431007 |
| 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 |
| Priyanka Babasaheb Kamble |
Yashwantrao Chavan Ayurvedic college and hospital |
OPD No 110 Prasutitantra evum Streeroga Department, Yashavantrao Chavan Ayurvedic College and Hospital, Nipani Bhalgaon, Beed Bypass Rd, Chhatrapati Sambhajinagar 431007
Aurangabad
MAHARASHTRA
Aurangabad
MAHARASHTRA |
9284092685
priynkakamble1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical Committee Yashavantrao Chavan Ayurvedic College and Hospital |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Mashparni churna, Reference: Shodhal nighantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Godugdha), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vidarikand , Reference: Bhavprakash , Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Godugdha ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Patient either primi gravida or multigravida will be selected.
Patient of diagnosed stanyakshaya in sutika avastha.
Lactating mother from partum upto 6 month having low breast feeding frequency i.e less than 4 to 5 times per day. |
|
| ExclusionCriteria |
| Details |
For mother
Patient with congenital abnormalities, Breast cancer, Breast atrophy, Cracked or sore nipples, Mastitis.
History of Breast trauma and Surgery.
Patient having history of systemic diseases.
Mother with history of insulin dependent diabetes mellitus.
Mother who is not attached emotionally and psychologically will be excluded.
Mother taking treatment of milk suppression, antiepileptic,antipsychotic and anticancer drug.
Female with Hormonal imbalance. e.g. Hypo/ Hyperthyroidism,PCOD /PCOS.
For babies
Baby with congenital anomalies, Birth trauma, premature baby, having Pathological conditions |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the efficacy of Mashaparni churna in the management of Stanyakshaya |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To Study and Understand Stanyakshya in detail with ayurvedic and Modern references.
To study the properties of Mashaparni Churna . |
18 months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
30/08/2025 |
| 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 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
|
Breast feeding promotes close physical and emotional bonding between mother and child. Stanyakshaya is common with primiparous women during first four months after delivery. Lactational deficiency or Stanyakshya is important because of its impact on baby i.e Inadequate nutrition, weight gain issues, increased risk of infections. Impact on mother, emotional distress, physical discomfort like Engorgement, mastitis etc. so we found drug which can promote Galactagogue mentioned in Ayurveda.Teramnus labialis i.e Mashaparni is an Ayurvedic herb available in various regions in India which supports Lactation, Galactagogue properties increased milk production, improved milk quality, rich in nutrients. whereas Pueraria tuberosa is used commonly in Lactational deficiency due to galactagogue property. Here Mashaparni is mentioned in Shodhal nighantu for the galactagogue property. Mashaparni churna with godughdha madhur rasatmak dravya is vatashamak, Vrushya, jivaniya, shukrajanan, madhur skandha dravya.Mashaparni churna with godughdha help in dhatushodhan and dhatuposhan and helps in Brihan karya and overcomes Dhatukshinata and improves the process of Galactogenesis and poesies. An Animal experiment is already conducted which has proved the major bioactive phytoconstituents are fraxidin, Galactomannan. Methanolic extract of Teramnus labialis fruit dose increase milk production. Serum Prolactin and cortisol level and protein and Glycogen content of mammary gland show significant increase in milk production. |