| CTRI Number |
CTRI/2026/03/106346 [Registered on: 17/03/2026] Trial Registered Prospectively |
| Last Modified On: |
16/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Comparing Karpasa Beeja Choorna and Bhumikushmanda Choorna to Increase Breast Milk in Mothers Aged 19–35 After Delivery |
|
Scientific Title of Study
|
Randomized Comparative Clinical Study Of Bhumikushmanda Choorna And Karpasa Beeja Choorna In The Management Of Stanyakshya In Sutika |
| 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 Srushti Prabhakar More |
| Designation |
Post graduate scholar |
| Affiliation |
Ashvin Rural Ayurved College Manchi Hill Sangamner |
| Address |
Ashvin Rural Ayurved College And Hospital Preeti Sudhaji Maharaj Nagar. At.Manchi Hill Post.Ashvi Bk Tal- Sangmner ,Dist- Ahemadnagar
Ahmadnagar
MAHARASHTRA
413714
India |
| Phone |
9890756883 |
| Fax |
|
| Email |
srushtimore9335@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishakha Vikas Pachore |
| Designation |
Professor |
| Affiliation |
Ashvin Rural Ayurved College Manchi Hill Sangamner |
| Address |
OPD no 3 Prasuti Tantra and Strirog Department Ashvin Rural Ayurved College And Hospital Preeti Sudhaji Maharaj Nagar. At.Manchi Hill Post.Ashvi Bk Tal- Sangmner ,Dist- Ahemadnagar
Ahmadnagar
MAHARASHTRA
413714
India |
| Phone |
9975271980 |
| Fax |
|
| Email |
vishakha.pachore@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Srushti Prabhakar More |
| Designation |
Post graduate student |
| Affiliation |
Ashvin Rural Ayurved College Manchi Hill Sangamner |
| Address |
Ashvin Rural Ayurved College And Hospital Preeti Sudhaji Maharaj Nagar. At.Manchi Hill Post.Ashvi Bk Tal- Sangmner ,Dist- Ahemadnagar
Ahmadnagar
MAHARASHTRA
413714
India |
| Phone |
9890756883 |
| Fax |
|
| Email |
srushtimore9335@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ashvin Rural Ayurved College And Hospital Manchi Hill Sangamner 413714 Maharashtra India |
| Ashvin Rural Ayurvedic College And Hospital Manchi Hill Sangamner 413714 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Dr Srushti Prabhakar More |
| Address |
OPD no 3 Prasuti Tantra and Strirog Department Ashvin Rural Ayurved College And Hospital Preeti Sudhaji Maharaj Nagar. At.Manchi Hill Post.Ashvi Bk Tal- Sangmner ,Dist- Ahemadnagar 413714 Maharastra, India |
| 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 |
| Dr Srushti Prabhakar More |
Ashvin Rural Ayurvedic College And Hospital Manchi Hill Sangamner 413714 |
OPD no 3 Prasuti Tantra and Strirog Department Ashvin Rural Ayurved College And Hospital Preeti Sudhaji Maharaj Nagar. At.Manchi Hill Post.Ashvi Bk Tal- Sangmner ,Dist- Ahemadnagar
Ahmadnagar
MAHARASHTRA |
9890756883
srushtimore9335@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee Ashvin Rural Ayurvedic College And Hospital Manchi Hill Sangamner |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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: Karpasa Beeja Choorna , Reference: Bhav prakasha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Godugdha), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Bhumikushmanda Choorna , Reference: Bhav prakasha , Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Godugdha ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1) Women within the age group of 19 to 35 years.
2) Mothers presenting with Stanyakshaya (insufficient lactation) during the Sutika Avastha
(postpartum period).
3) Mothers breastfeeding their infant less than 6–7 times per day.
4) Women exhibiting a reduced frequency or reluctance toward breastfeeding. |
|
| ExclusionCriteria |
| Details |
In Mothers–
1) Women with known breast pathologies, including mastitis, abscess, or cracked nipples.
2)Women suffering from chronic systemic illnesses, such as active pulmonary tuberculosis,
HIV/AIDS, or any other immunocompromised conditions.
3) Patients diagnosed with or having a history of puerperal psychosis or other psychiatric
disorders.
4)Mothers currently on medications that could interfere with lactation, including anti-
epileptic, anti-psychotic, anti-thyroid, or anticancer drugs either in the mother or infant25.
For Infants-
1. Babies with severe cleft palate that hinders effective breastfeeding.
2. Presence of congenital anomalies, such as esophageal atresia or other major
gastrointestinal abnormalities.
3. Infants diagnosed with metabolic disorders like Galactosemia that affect milk digestion |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the efficiency of Bhumikushmanda Choorna and Karpasa Beeja Choorna In The Management Of Stanyakshya In Sutika |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
Nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
04/04/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
04/04/2026 |
| 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 milk is essential for an infant’s growth, especially in the first six months. However, many postpartum women suffer from Stanyakshaya (breast milk insufficiency) due to stress, poor nutrition, and lifestyle changes. Ayurveda links Stanya to Rasa Dhatu and offers natural remedies through Stanyajanana dravyas. Bhumikushmanda choorna and Karpasa beeja are two Ayurvedic formulations traditionally used to promote lactation, but there is limited comparative clinical data on their effectiveness. Therefore, this study is needed to evaluate and compare their role in managing Stanyakshaya in Sutika, to support safe, natural, and effective postpartum care. While Bhumikushmanda Choorna has shown effectiveness in improving lactation, its availability and cost can be limiting factors for routine use in postpartum women. On the other hand, Karpasa Beeja Choorna is comparatively more affordable, easily available, and cost- effective, making it a potentially better alternative for large-scale clinical use, especially in economically weaker populations. |