| CTRI Number |
CTRI/2026/01/102254 [Registered on: 28/01/2026] Trial Registered Prospectively |
| Last Modified On: |
27/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the Efficacy of Jeerakadyarishta in lactation failure |
|
Scientific Title of Study
|
A SINGLE ARM CLINICAL STUDY TO EVALUATE THE EFFICACY OF JEERAKADYARISHTA IN THE MANAGEMENT OF STANYAKSHAYA (LACTATION FAILURE). |
| 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 Pooja Dattatraya Gore |
| Designation |
PG Scholar |
| Affiliation |
SDMTs AMC Post Graduation Centre Terdal |
| Address |
SDM TRUSTS AYURVEDIC MEDICAL COLLEGE DANIGOND POST GRADUATE
CENTRE AND PADMA AYURVEDIC HOSPITAL AND RESEARCH CENTRE DR
SIDDHANT NAGAR TERDAL-587315 BAGALKOT KARNATAKA India
587315
India
Bagalkot
KARNATAKA
587315
India |
| Phone |
9545431212 |
| Fax |
|
| Email |
pooja.gore.666@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parashuram K Rawal |
| Designation |
Professor and HOD Department of Kayachikitsa |
| Affiliation |
SDMTs AMC Post Graduation Centre Terdal |
| Address |
SDM TRUSTS AYURVEDIC MEDICAL COLLEGE DANIGOND POST GRADUATE
CENTRE AND PADMA AYURVEDIC HOSPITAL AND RESEARCH CENTRE DR
SIDDHANT NAGAR TERDAL-587315 BAGALKOT KARNATAKA
587315
India
Bagalkot
KARNATAKA
587315
India |
| Phone |
9880976151 |
| Fax |
|
| Email |
chaitanya.rawal5@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja Dattatraya Gore |
| Designation |
PG Scholar |
| Affiliation |
SDMTs AMC Post Graduation Centre Terdal |
| Address |
SDM TRUSTS AYURVEDIC MEDICAL COLLEGE DANIGOND POST GRADUATE
CENTRE AND PADMA AYURVEDIC HOSPITAL AND RESEARCH CENTRE DR
SIDDHANT NAGAR TERDAL-587315 BAGALKOT KARNATAKA India
587315
India
Bagalkot
KARNATAKA
587315
India |
| Phone |
9545431212 |
| Fax |
|
| Email |
pooja.gore.666@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM Trusts Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital And Research Centre Terdal bagalkot Karnataka |
|
|
Primary Sponsor
|
| Name |
Dr Pooja Dattatraya Gore |
| Address |
SDM Trusts Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital And Research Centre Terdal bagalkot Karnataka |
| 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 Pooja Dattatraya Gore |
Padma Ayurvedic Hospital And Research Centre |
SDM TRUSTS AYURVEDIC MEDICAL COLLEGE DANIGOND POST GRADUATE
CENTRE AND PADMA AYURVEDIC HOSPITAL AND RESEARCH CENTRE DR
SIDDHANT NAGAR TERDAL-587315 BAGALKOT KARNATAKA India
587315
India
Bagalkot
KARNATAKA |
9545431212
pooja.gore.666@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDMTs Ayurvedic Medical College And Padma Ayurvedic Hospital INSTITUTIONAL ETHICS COMMITTEE FOR RESEARCH ON HUMAN SUBJECTS |
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: Jeerakadyarishta, Reference: Bhaishajya Ratnavalli Streeroga Adhyaya, Route: Oral, Dosage Form: Arishta, Dose: 24(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -Sukoshna Jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1 Age group of patients is between 21 - 40 years.
2 Lactating mothers with classical signs and symptoms of Stanya Kshaya
3 Patients with feeding frequency less than 4 to 5 times per day.
4 Patients from 5th day of delivery to 6 months
5 Patient willing for consent |
|
| ExclusionCriteria |
| Details |
1 Known case of Mastitis, CA Breast, and Cystic breast disease, Psychiatric
illness and Diabetes.
2 Inverted Nipples, Cracked Nipples.
3 Patients with Congenital Breast Anomaly.
4 Patients with history of alcoholism, smoking.
5 Mother having a baby with congenital anomaly like cleft lip, cleft palate. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of Trial Drug on Improvement in the symptoms of Stanyakshaya (Lactation Failure) |
7day, 14day, 21day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety of trial drug and Adverse Drug Reaction Aggravation of Symptoms of Stanyakshaya |
7day, 14day, 21day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 3 |
|
Date of First Enrollment (India)
|
23/02/2026 |
| 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 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
|
Lactation failure is common concern in postnatal period, contributing to malnutrition in neonates and emotional stress in the mother. It is the condition where mother is not able to produce enough breast milk to meet her baby’s nutritional needs. Milk nourishes all Dhatus and helps to balance all the Doshas. After digestion of food the Rasa is formed, which is circulating through entire body by the action of Vyana vata reaches Stana and is termed as Stanya10. It is addressed as Jeevana due to the qualities like Pushtikara, Vruddhikara and Bala Vardhana. Stanyakshaya is the condition characterized by the Stana Mlanata, Stanya Asambhavata and Stanya Anupasthithi8 due to Krodha, Shoka and Avatsalya. Jeerakadyarishta is mentioned in the context of Sutika Amaya and known for its Ushna, Tikshna, Guna and Deepana, Pachana properties. In contemporary medical practices, various drugs are used, many of which have reported side effects as documented by FDA.So there is need for an alternative medicine which is effective and has less side effects. Hence, an attempt is made to validate the role of Jeerakadyarishta in the management of Stanyakshaya (Lactation Failure). |