| CTRI Number |
CTRI/2025/03/082001 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [curative treatment] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluate efficacy of shatavari granules and magadhyadi yoga in management of stanyakshaya |
|
Scientific Title of Study
|
A Comparitive Clinical Study To Evaluate the Effect of Magadhyadi Yoga and Shatavari Granules 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 |
Drshweta sanjay yadav |
| Designation |
2nd year PG DEPT-Striroga and prasutitantra |
| Affiliation |
Dr N A Magdum Ayurvedic medical college Ankali |
| Address |
Dr N A magadum ayurvedic medical college research centre and hospital ankali Dept-striroga and prasutitantra OPD No 1
AP-ankali Tal-Chikodi Dist-Belgavi Karnataka
Dr N A Magdum Ayurvedic medical college Ankali
Tal-Chikodi
Dist-belgavi
Karnataka 591213
Belgaum
KARNATAKA
591213
India |
| Phone |
7028197095 |
| Fax |
|
| Email |
shwetayadav2106@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr deepali koli |
| Designation |
Associate professor |
| Affiliation |
Dr N A Magdum Ayurvedic medical college Ankali |
| Address |
Dr N A Magdum ayurvedic medical college research centre and hospital Ankli tal-chikodi dist-belgavi karnataka
591213
Dr N A Magdum ayurvedic medical college research centre and hospital Ankli tal-chikodi dist-belgavi karnataka
591213
Belgaum
KARNATAKA
591213
India |
| Phone |
8975953456 |
| Fax |
|
| Email |
drdeepali5119@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Drshweta sanjay yadav |
| Designation |
2nd year PG DEPT-Striroga and prasutitantra |
| Affiliation |
Dr N A Magdum Ayurvedic medical college Ankali |
| Address |
Dr N A magadum ayurvedic medical college research centre and hospital ankali Dept-striroga and prasutitantra OPD No 1 AP-ankali Tal-Chikodi Dist-Belgavi Karnataka
Dr N A Magdum Ayurvedic medical college Ankali
Tal-Chikodi
Dist-belgavi
Karnataka 591213
Belgaum
KARNATAKA
591213
India |
| Phone |
7028197095 |
| Fax |
|
| Email |
shwetayadav2106@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr N A magadum ayurvedic medical college research centre and hospital ankali Dept-striroga and prasutitantra OPD No 1
Ankali tal chikkodi Dist belgavi
karnataka
pin code 591213 |
|
|
Primary Sponsor
|
| Name |
Dr shweta sanjay yadav |
| Address |
Dr N A magadum ayurvedic medical college research centre and hospital ankali Dept-striroga and prasutitantra OPD No 1 Tal chikodi Dist Belgaum karnataka |
| Type of Sponsor |
Other [] |
|
|
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 |
| Drshweta sanjay yadav |
Dr.N.AMagdum hospital ,Striroga and prasuti OPD no 3 |
Dr N A magadum ayurvedic medical college research centre and hospital ankali Dept striroga and prasutitantra OPD No 1 Tal chikodi Dist Belgaum karnataka591213
Belgaum
KARNATAKA |
7028197095
shwetayadav2106@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. NAMAMC-IEC |
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: shatavari grannules, Reference: bhvaprakash nighantu guduchyadi varga shloka no 186 187, Route: Oral, Dosage Form: Khanda /Granules, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -milk), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: magadhyadi yoga, Reference: harita samhita 53 adhyaya , Route: Oral, Dosage Form: Khanda /Granules, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -milk), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
A) Primi and multipara of above 18 years.
B) Stanyakshaya and baby in Ksirapa avastha (up to 1Yr) were included in the study.
|
|
| ExclusionCriteria |
| Details |
A) Subjects below 18 years of age.
B) Patient suffering from Stanya Dushti.
C) Hypothyroidism, hypopitutarism, inadequate breast tissue.
D) Athelia, Retracted or flat nipples and diseases of breast.
E) Using certain medication such as bromocriptine, cabergolin, diuretics or antihistaminic.
F) Babies suffered from acute and chronic debilitating illnesses, Babies on bottle feed were also excluded.
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate effect of Magadhyadi yoga in management of Stanyakshaya
To evaluate effect of Shatavari granules in management of Stanyakshaya
|
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To review existing literature on Stanyakshaya
Modern lactation literature pathophysiology and endocrinology
To study in detail of magadhyadi yoga shatavari granules and its comparative effect
|
30 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
20/03/2025 |
| 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
|
The present title “A COMPARITIVE CLINICAL STUDY TO EVALUATE THE EFFECT OF MAGADHYADI YOGA AND SHATAVARI GRANULES IN THE MANAGEMENT OF STANYAKSHAYA” clinical study with total numbers of 40 registered breastfeeding stanyakshaya mother will be selected and randomly allocated into 2 groups in each 20. Groupn A will be administered with shatavari grannules 6 g BID with milk Group B will be administered with magadhyadi yoga 6 g BID with milk Assesment will be done with subjective objective criteria for 30 days
|