| CTRI Number |
CTRI/2026/03/106197 [Registered on: 13/03/2026] Trial Registered Prospectively |
| Last Modified On: |
12/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Amruta Churna on improving breast milk production in mothers with low milk supply. |
|
Scientific Title of Study
|
Randomized controlled clinical trial to determine the effect of Amruta churna in management of stanyakshaya W.S.R.to Hypogalactia |
| 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 Mayuri Keshav ingle |
| Designation |
Pg scholar |
| Affiliation |
Sangam sevabhavi trust |
| Address |
Department of Stri rog evum prasuti tantra Sangam sevabhavi trust nashik pune road opps prasad cafe, sangamner ahamdnagar maharashtra india 422605
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
7875137066 |
| Fax |
|
| Email |
mayuriingle1941996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit shinde |
| Designation |
Professor & Hod |
| Affiliation |
Sst ayurved mahavidyalaya sangamner |
| Address |
Department of Stri rog evum prasuti tantra Sangam sevabhavi trust nashik pune road opps prasad cafe, sangamner ahamdnagar Maharashtra India 422605
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
919881303593 |
| Fax |
|
| Email |
amitshinde112@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit shinde |
| Designation |
Professor & Hod |
| Affiliation |
Sst ayurved mahavidyalaya sangamner |
| Address |
Department of Stri rog evum prasuti tantra Sangam sevabhavi trust nashik pune road opps prasad cafe, sangamner ahamdnagar Maharashtra India 422605
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
919881303593 |
| Fax |
|
| Email |
amitshinde112@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sst ayurved mahavidyalaya sangamner nashik pune road opposite to prasad cafe sangamner ahamdnagar maharashtra india 422605 |
|
|
Primary Sponsor
|
| Name |
Dr Mayuri Keshav ingle |
| Address |
Department of Stree rog evum prasuti tantra Sangam sevabhavi trust nashik pune
road opps prasad cafe
sangamner ahamdnagar maharashtra india 422605 |
| 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 Mayuri Keshav ingle |
Sst ayurved college sangamner ahamdnagar |
OPD division 1 st floor room number 1 stri roga evum prasuti tantra OPD,SST Ayurved college,nashik pune road , opposite Prasad hotel,Dist ahamadnagar
Ahmadnagar
MAHARASHTRA |
7875137066
mayuriingle1941996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sst ayurved college |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vidarikand churna , Reference: Bhavprakash guduchyadi varga, dhanvantari nighantu guduchyadi varga,madhanpal nighantu abhyadivarga , Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 56 Days, anupAna/sahapAna: Yes(details: -godughdh ), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Amruta churna , Reference: Asthang sangrah sutrasthan adhyay 16 shlok number 6,chakrapani charak sutrasthan adhyay 4 shlok number 8, bhavprakash nighantu guduchyadi varga adhyaya 4 shlok number 7, rajnighantu 3 guduchyadi varga , Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 56 Days, anupAna/sahapAna: Yes(details: -godugdh ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
1) postpartum females of 18 to 49 years age who are already to sign informed consent form
2) postpartum females of 18 to 49 years of age for 7 th days of delivery upto 1 and 1/2 months with stanyakshaya in sutikavastha having stana mlanata (laxity of breast) minimal or low breast breast fullness and stanya praman (delayed or absent milk,low and insufficient milk production)
3) selection will be irrespective of parity, caste, religion |
|
| ExclusionCriteria |
| Details |
In mother 1) postpartum females having any pathology condition or disease related with breast, breast abscess, mastitis, cracked nipple
2) postpartum females having k/c/o pituitary tumour, tuberculosis,AIDS,severe anemia and puerperal psychosis
3) postpartum females taking anti- epileptic,anti- psychotic,anti- thyroid,anti- cancerous drugs.
In baby
1) premature baby ( baby unable to suck)
2) congenital anomaly that is cleft palate
3) very ill baby . |
|
|
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 |
Reduction in sign and symptoms in sutika sutika stanaya mlanata,stanya praman.
In baby lag in growth of baby with symptoms in weight gain,rodan,anidra, alpamutrapravrutti,and alpamalapravrutti within 8 weeks |
Total duration of treatment -56days
Total duration of study -18 months
Assessment -2,4,6,8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
26/03/2026 |
| 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="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
|
Title Randamized controlled clinical trial to determine the effect of Amruta churna in the manegement of stanyakshaya wst hypoglycemia
Introduction: Lactation (Stanya) is considered the best and most natural source of nutrition for newborns. Breast milk provides essential nutrients, immunoglobulins, and enzymes that support the growth and immunity of infants. In Ayurveda, Stanya is considered an Upadhatu of Rasa Dhatu and plays an important role in the nourishment of the baby. Due to various physical and psychological factors such as stress, fatigue, improper diet, and emotional disturbances, Stanyakshaya (hypogalactia) has become common in postpartum women. When breast milk production is inadequate, it may affect the growth and health of the infant. Therefore, this study aims to evaluate the effectiveness of Amruta Churna in the management of Stanyakshaya (hypogalactia).
Sample size-Total sample size for study will be 70 participants divided equally between trail and control group
Null hypothesis Amruta churna is not significantly effective in the manegement of stanyakshaya.
Alternative hypothesis Amruta churna is significantly effective in the manegement of stanyakshaya |