| CTRI Number |
CTRI/2025/12/099940 [Registered on: 29/12/2025] Trial Registered Prospectively |
| Last Modified On: |
28/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Ayurvedic formulation] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparitive Clinical Study in Lactating women to evaluate two ayurvedic medicine for improving Breast Milk Production |
|
Scientific Title of Study
|
A Comparitive Clinical Study on the Efficacy of Bhavprakashokta Jeevaniya Gana and Charakakokta Stanyajanan Gana 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 Preeti Mandre |
| Designation |
PG Scholar Prasuti Tantra Evam Stree Roga |
| Affiliation |
Rani Dullaiya Smriti Ayurved PG College and Hospital |
| Address |
P.G.Department of Prasuti Tantra Evam Stree Roga,OPD no. 8,Rani Dullaiya Smriti Ayurved PG College and Hospital,Barkhedi Kalan Bhopal Madhya Pradesh.
P.G.Department of Prasuti Tantra Evam Stree Roga,OPD no. 8,Rani Dullaiya Smriti Ayurved PG College and Hospital,Barkhedi Kalan Bhopal Madhya Pradesh.
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
9630874297 |
| Fax |
|
| Email |
preeti.preeti500@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Reetu Pandey |
| Designation |
Associate Professor Department of Prasuti Tantra Evam Stree Roga |
| Affiliation |
Rani Dullaiya Smriti Ayurved PG College and Hospital |
| Address |
P.G.Department of Prasuti Tantra Evam Stree Roga,OPD no. 8,Rani Dullaiya Smriti Ayurved PG College and Hospital,Barkhedi Kalan Bhopal Madhya Pradesh.
P.G.Department of Prasuti Tantra Evam Stree Roga,OPD no. 8,Rani Dullaiya Smriti Ayurved PG College and Hospital,Barkhedi Kalan Bhopal Madhya Pradesh.
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
9805150593 |
| Fax |
|
| Email |
vdreetupandey@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Preeti Mandre |
| Designation |
PG Scholar Prasuti Tantra Evam Stree Roga |
| Affiliation |
Rani Dullaiya Smriti Ayurved PG College and Hospital |
| Address |
P.G.Department of Prasuti Tantra Evam Stree Roga,OPD no. 8,Rani Dullaiya Smriti Ayurved PG College and Hospital,Barkhedi Kalan Bhopal Madhya Pradesh.
P.G.Department of Prasuti Tantra Evam Stree Roga,OPD no. 8,Rani Dullaiya Smriti Ayurved PG College and Hospital,Barkhedi Kalan Bhopal Madhya Pradesh.
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
9630874297 |
| Fax |
|
| Email |
preeti.preeti500@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Preeti Mandre |
| Address |
PG Scholar, Rani Dullaiya Smriti Ayurved PG College and Hospital,Barkhedi Kalan,Bhopal,Madhya Pradesh India 462044 |
| 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 Preeti Mandre |
Rani Dullaiya Smriti Ayurved Hospital Bhopal |
P.G. Department of Prasuti Tantra Evam Stree Roga,OPD no. 8,Rani Dullaiya Smriti Ayurved PG College and Hospital,Barkhedi Kalan Bhopal Madhya Pradesh.
Bhadbhada Road,Barkhedi Kalan,Kopal,Bhopal,Madhya Pradesh.
Bhopal
MADHYA PRADESH |
9630874297
preeti.preeti500@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Rani Dullaiya Smriti Ayurved PG College & Hospital |
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: Stanyajanan gana churna, Reference: Charak Samhita Sutra Sthan 4/17, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Sukoshna godugdha), Additional Information: -Charakokta Stanyajanan gana churna administered 6gm twice a day after meal with sukoshna godugdha. | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Jeevaniya gana churna, Reference: Bhavprakash purvakhand 6-4/57-59, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Sukoshna godugdha), Additional Information: -Bhavprakashokta Jeevaniya gana churna administered 6gm twice a day after meal with sukoshna godugdha. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Patient with clinical features of Stanyakshaya in Sutikaavastha,from fifth day of delivery till 6th month of delivery,breast feeding frequency less than 10 times a day,or with precious history of Stanyakshaya. |
|
| ExclusionCriteria |
| Details |
Patient with Congenital anomalies,breast atrophy,breast carcinoma,retracted nipples and having history of alcoholism,smoking and systemic diseases,patient with post partum hypopituitarism,known case of Diabetes Mellitus,obesity. |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increase in breast milk secretion |
baseline and day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Stana mlanta,Breast feeding frequency,Baby urinary output,Stanya Pramana,Breast engorgement,Increase in baby weight |
baseline ,day 15,day 30,day 45 |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
15/01/2026 |
| 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="0"
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 - NO
|
|
Brief Summary
|
Breast milk, known as Stanya in Ayurveda, is considered as nectar for a growing child,promoting strength, long life, and overall development.Colostrum, or first milk, is the first form of milk produced by the mammary glands of humans and other mammals immediately following delivery of the newborn. From the digested food the rasa is formed. Madhur part of this rasa circulating through entire body by the action of vyan vayu reaches breast and termed as stanya.Three or four days after delivery the Dhamnis originating from hridya open and allow the breast milk to flow.The breast milk which has varna, gandha, rasa, rupa ,sparsha in prakrut condition and which evenly mix in water, such pure milk is beneficial to baby. Normal stanyapraman is 2 anjali.Stanyakshay occurs due to agnidushti, srotoavarodha, rasadhatu kshaya, psychological factors of mother (krodha, shoka, bhaya, and avatsalyatwa).Stanya kshaya can be compared to lactational deficiency, hypogalactia in modern parlance on the basis of its signs and symptoms.In Sutika-awasta there is over all Dhatu-kshaya-awastha due to development of the foetus, Pravahana vedana& loss of Raktaand kleda during prasava cause certain emptiness. So women get deprived in mamsa, bala, agni, this state is complicated by Apathyasewana as a result, there is Vata-pradhana-tridosha-prakopa leading to Rasadhatu-kshaya and Upadhatukshaya.Laxity of breasts along with decrease in quantity or absence of milk secretion are the clinical features of stanyakshay. Achaya Bhavmishra mentioned the same.Today Stanya kshaya (hypogalactia) or stanya nasa(agalactia) is a very common problem, especially with primiparous mothers. It is a great irony that such an important problem that is directly associated with the health of the mother and child is largely neglected. Ayurveda explained many drugs which are safe and effective in lactating mothers. Among them Acharya Bhavmishra specially mentioned 10 drugs under Jeevaniya gana as ‘stanya kapha kruta ’ and Acharya Charaka mentioned 10 drugs under Stanyajanan gana as ‘stanyajanan’which seems to be promising in the management of stanyakshaya .Here an attempt will be made to compare the efficacy of Bhavprakashokta Jeevaniya gana and Charakokta Stanyajanan gana in the management of stanyakshaya.Currently, India suffers economic losses because only 55% of children are exclusively breastfed. These economic losses are the result of Higher health systems costs, as children and mothers develop illnesses that could have been prevented by breastfeeding practices,Lost productivity, as children who were not breastfed are less likely to fully develop and fully contribute to the economy, and Higher household expenditures, as families need to purchase breastmilk substitutes like formula when they do not breastfeed their children.Improving the duration of exclusive breastfeeding is a national and international priority. Insufficient milk supply is one of the most commonly cited reasons for early cessation or decreased exclusivity in women who have initiated breastfeeding. Bhavprakash Jeevaniya gana and Charakokta Stanyajanan gana , includes shleshma-vardhakadravyas having ksheer-vraddhi properties which may increase the quantity and quality of breast milk for the effective management of stanyakshaya. |