| CTRI Number |
CTRI/2025/04/085341 [Registered on: 22/04/2025] Trial Registered Prospectively |
| Last Modified On: |
20/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Compare two interventional group to study the efficacy of Pippali churna and Vidarikand Churna in the management of stanyakshay |
|
Scientific Title of Study
|
Radomised comparative clinical study to evaluate the efficacy of Pippali Churna and Vidarikand Churna in the management of Stanyakshay |
| 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 Sheela Nathrao Bhalerao |
| Designation |
PG Scholar |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalya Gadhinglaj Prasuti evum Striroga department |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya Gadhinglaj
Prasuti evum Striroga department
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9209803263 |
| Fax |
|
| Email |
sheelabhalerao2880@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasad Lomte |
| Designation |
Professor of Prasuti and Striroga department |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalay Gadhinglaj Kolhapur Prasuti evum Striroga department |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya Gadhinglaj
Kolhapur Prasuti evum Striroga department
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
8275917687 |
| Fax |
|
| Email |
prasad.lomate969@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prasad Lomte |
| Designation |
Professor of Prasuti and Striroga department |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalay Gadhinglaj Kolhapur Prasuti evum Striroga department |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya Gadhinglaj Kolhapur Prasuti evum Striroga department
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
8275917687 |
| Fax |
|
| Email |
prasad.lomate969@gmail.com |
|
|
Source of Monetary or Material Support
|
| Daily OPD patient of Late Kedari Redekar Ayurvedic Mahavidyalaya Gadhinglaj Dist Kolhapur Maharashtra 416502 |
|
|
Primary Sponsor
|
| Name |
Dr Sheela Natharo Bhalerao |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya Gadhinglaj
Kolhapur |
| 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 Sheela Natharo Bhalerao |
Late Kedari Redekar Dharmaday Rugnalay Gadhinglaj Kolhapur |
Late Kedari Redekar Ayurvedic Mahavidyalaya Gadhinglaj Dist Kolhapur416502, Prasuti evum Striroga department
Kolhapur
MAHARASHTRA |
9209803263
sheelabhalerao2880@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Late Kedari Redekar Ayurvedic Mahavidhyala Gadhinglaj Kolhapur |
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: Pippali churna , Reference: Yogratnakar kshirdoshchikitsa , Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Godugdha ), Additional Information: Pippali churna with godugdha given to 40 patient of group A for 21 days | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vidarikand churna , Reference: Bhavprakash purvakhand 4/9, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Godugdha ), Additional Information: Vidarikand churna with godugdha given to 40 patient of group B for 21 days |
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients of Stanyakshaya in Sutika Awastha.
2. Age group of patients between 19-35 years.
3. Patients after delivery up to 3 months
4. Sutika with breast feeding frequency less than 6-7 times a day.
5. Patient having history of lactational deficiency |
|
| ExclusionCriteria |
| Details |
Known patients of systemic disorder like renal failures , hepatic disorder
Antomical pathologies of mother like engorgement,cracked nipples, mastitis, flat/inverted nipples
Mothers having stanya dushti,
Baby having infectious diseases,
Infant with cleft palate,
Infant with disorganized sucking reflex |
|
|
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 |
| There is no significant difference between Pippali churna and Vidarikand churna in the management of stanyakshay |
0,7th,14th,21th days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Vidarikand churna is better than Pippali churna in the management of stanyakshay |
0,7th,14th,21th days |
| Pippali Churna is better than Vidarikand churna in the management of stanyakshay |
0,7th, 14th, 21th days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
21/05/2025 |
| 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="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
|
This study is randomised comparative clinical study to evaluate the efficacy of Pippali churna and Vidarikand churna in the management of stanyakshay . Study will be carried in the opd of Striroga and prasutitantra department of Late Kedari Redekar Ayurvedic College and hospital Gadhinglaj Observation would be drawn on the basis of result after treatment given |