| CTRI Number |
CTRI/2026/02/103792 [Registered on: 13/02/2026] Trial Registered Prospectively |
| Last Modified On: |
13/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Study Of Two Ayurvedic Medicine Bhumikushmand Choorna And Shatavari Choorna In Stanyakshaya(Hypogalactia) |
|
Scientific Title of Study
|
A Comparative Clinical Study Of Bhumikushmand Choorna And Shatavari Choorna In The Management Of Stanyakshaya 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 Nayan Rajendra Arage |
| Designation |
Post Graduate Scholar |
| Affiliation |
Ashvin Rural Ayurved College Manchi Hill Sangmaner |
| Address |
Ashvin Rural Ayurved College and Hospital Prasuti Tantra Evum Streeroga department Opd number 04 Sadhavi Preetsudhaji Maharaj Nagar Manchi Hill Tal Sangamner Dist Ahmednagar
Ahmadnagar
MAHARASHTRA
413714
India |
| Phone |
7020911323 |
| Fax |
|
| Email |
nayanarage5080@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Vidya Sarode |
| Designation |
M. S Prasuti Tantra Evum Streeroga |
| Affiliation |
Ashvin Rural Ayurved College Manchi Hill Sangmaner |
| Address |
Ashvin Rural Ayurved College and Hospital Prasuti Tantra Evum Streeroga department Opd number 04 Sadhavi Preetsudhaji Maharaj Nagar Manchi Hill Tal Sangamner Dist Ahmednagar
Ahmadnagar
MAHARASHTRA
413714
India |
| Phone |
8975019105 |
| Fax |
|
| Email |
vidya.sarode18@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nayan Rajendra Arage |
| Designation |
Post Graduate scholar |
| Affiliation |
Ashvin Rural Ayurved College Manchi Hill Sangmaner |
| Address |
Ashvin Rural Ayurved College and Hospital Prasuti Tantra Evum Streeroga department Opd number 04 Sadhavi Preetsudhaji Maharaj Nagar Manchi Hill Tal Sangamner Dist Ahmednagar
Ahmadnagar
MAHARASHTRA
413714
India |
| Phone |
7020911323 |
| Fax |
|
| Email |
nayanarage5080@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Nayan Rajendra Arage |
| Address |
Ashvin Rural Ayurved College and Hospital Prasuti Tantra Evum Streeroga department opd number 04 Sadhavi Preetsudhaji Maharaj Nagar Manchi Hill Ashvi BK Tal Sangamner dist Ahmednagar 413714 |
| 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 Nayan Rajendra Arage |
Ashvin Rural Ayurved college and Hospital |
Ashvin Rural Ayurved college and hospital Prasuti Tantra Evum Streeroga department opd number 04 Sadhavipreetsudhaji maharajnagar Manchi Hill tal Sangmaner dist Ahmednagar 413714
Ahmadnagar
MAHARASHTRA |
7020911323
nayanarage5080@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ashvin Rural Ayurved college and hospital Manchi Hill Sangmaner |
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: Bhumikushmand choorna , Reference: Yogratnakor Uttarardh, ksheerdosh chikitsa Adhyaya, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Ksheer), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shatavari choorna , Reference: Yogratnakor Uttarardh ksheerdosh chikitsa Adhyaya Shlok No.2 Page No. 433, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1)Patients after delivery up to 6 months
2) Patients of Stanyakshaya in Sutika Awastha,
3) Sutika with breast feeding frequency less than 6-7 times a day.
4)Patient having history of lactational deficiency. |
|
| ExclusionCriteria |
| Details |
In Mother-1. Patients having any pathological condition or disease related with breast like Breast abscess, Mastitis, Cracked Nipple etc.
2. Known case of systemic diseases like active pulmonary Tuberculosis, AIDS.
3. Puerperal psychosis.
4 Patients taking anti-epileptic, anti-psychotic, antithyroid, anticancer drug.
In Baby-1. Severe degree of cleft palate.
2. Congenital anomaly oesophageal atresia, gastrointestinal disease.
3. Galactosemia. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of improvement in the mother symptoms of stanyakshaya such as stan mlanta(laxity of breast),stanya pravartan, stanya praman(frequency of breast feeding with satisfaction of baby) and in baby sharirbhar( weight of the baby),mutrapravruti (frequency of urination),Nidra (sleep),Rodan(cry),evaluated using a predefined symptom scoring scale before treatment and after completion of treatment. |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Study aims to compare the effects of bhumikushmand choorna and shatavari choorna in managing stanyakshaya in sutika focusing on both their efficacy
1)Detailed analysis of guna and karma of both drugs.
2)A comparative assessment of the efficiency of both tails in managing symptoms. |
21 days |
|
|
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)
|
27/02/2026 |
| 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="0"
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
|
In ayurveda, breast milk (stanya) is characterized as an updhatu of rasdhatu, which is produced from well digested food and processed bydhatavgni. In embodies most nourishing essence of the maternal diet and sufficiently meets the nutritional requirements of the infant during the initial six months of life. Stanyakshaya is primarily linked to the depletion of rasdhatu. Breast milk is regarded as amrut (nectar) for the newborn, offering optimum nutrition, Immonuligical defence and fostering physical, emotional, cognitive psycomotor growth. Lactational deficiency is prevalent, impacting 30-40% of mothers in India and 23%-63% globally. The who recommends for exclusive breastfeeding for the first 6 months . After that, complementary food should be introduced while continuing breast feeding up to two years or even longer. |