| CTRI Number |
CTRI/2025/02/079869 [Registered on: 03/02/2025] Trial Registered Prospectively |
| Last Modified On: |
01/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Healing Cracked Nipples: A Study on the Effectiveness of a Traditional Medicine |
|
Scientific Title of Study
|
Randomized Open Controlled Clinical Trial To Evaluate The Efficacy Of Yashtimadhu Siddha Ghrita In Stanavrana With Special Reference To Cracked Nipples In Breastfeeding Mothers.
|
| 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 Ghazala Bano Sheikh |
| Designation |
PG Scholar in Prasuti Tantra Evum Stree Roga |
| Affiliation |
Late Kedari Redekar Ayurvedic Hospital And Research Centre |
| Address |
Stree roga Evum Prasuti Tantra OPD No: 5 and IPD , Ground floor
Late Kedari Redekar Ayurvedic College , Hospital And Research Centre P2,M.I.D.C.,Shendri Mal ,Gaghinglaj - 416502, District:Kolhapur
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
8554070768 |
| Fax |
|
| Email |
ghazalabano1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suhas Bajirao Thorat |
| Designation |
MS in Prasuti Tantra Evum Stree Roga |
| Affiliation |
Late Kedari Redekar Ayurvedic Hospital And Research Centre |
| Address |
Stree roga Evum Prasuti Tantra OPD No: 5 and IPD , Ground floor
Late Kedari Redekar Ayurvedic College , Hospital And Research Centre P2,M.I.D.C.,Shendri Mal ,Gaghinglaj - 416502, District:Kolhapur
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9850366952 |
| Fax |
|
| Email |
drsuhasthorat26@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suhas Bajirao Thorat |
| Designation |
MS in Prasuti Tantra Evum Stree Roga |
| Affiliation |
Late Kedari Redekar Ayurvedic Hospital And Research Centre |
| Address |
Stree roga Evum Prasuti Tantra OPD No: 5 and IPD , Ground floor
Late Kedari Redekar Ayurvedic College , Hospital And Research Centre P2,M.I.D.C.,Shendri Mal ,Gaghinglaj - 416502, District:Kolhapur
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9850366952 |
| Fax |
|
| Email |
drsuhasthorat26@gmail.com |
|
|
Source of Monetary or Material Support
|
| Late Kedari Redekar Ayurvedic College , Hospital And Research Centre P2,M.I.D.C.,Shendri Mal ,Gaghinglaj - 416502, District:Kolhapur ,Maharashtra,India |
|
|
Primary Sponsor
|
| Name |
Dr Ghazala Bano Sheikh |
| Address |
Qtr No 165/1, Infront Of Masjid ,New Chankapur Colony ,Khaperkheda, District:Nagpur ,Tehsil: Saoner -441109 ,Maharashtra |
| 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 Ghazala Bano Sheikh |
Late Kedari Redekar Ayurvedic Hospital And Research Centre |
Stree roga Evum Prasuti Tantra OPD No: 5 and IPD , Ground floor ,
Late Kedari Redekar Ayurvedic College , Hospital And Research Centre P2,M.I.D.C.,Shendri Mal ,Gaghinglaj - 416502, District:Kolhapur ,Maharashta,India
Kolhapur
MAHARASHTRA |
08554070768
ghazalabano1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Late Kedari Redekar Ayurvedic Hospital And Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O921||Cracked nipple associated with pregnancy, the puerperium, and lactation. Ayurveda Condition: GHRUSHTAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kurubak Taila , Reference: Rasa Ratna Samucchaya , Route: Topical, Dosage Form: Taila, Dose: 30(g), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: Kurubak Taila will be used for lepa | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Yashtimadhu Siddha Ghrita , Reference: Ashtang Sangraha Samhita , Route: Topical, Dosage Form: Ghrita, Dose: 30(g), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: Yashtimadhu Siddha Ghrita will be used for lepa |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Lactating mothers having Stanavrana( cracked nipple)with pain and discharge |
|
| ExclusionCriteria |
| Details |
Patients having mastitis
Patients with breast diseases like cancer,abscessor breast lump
Pre-diagnosed patients of HbsAg ,HIV.T.B,Hepatitis A,Diabetes
Pregnant patients will be excluded
Non breast feeding patients |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study efficacy of yashtimadhu siddha ghrita local application and kurubak taila in the management of stanavrana w.s.r to cracked nipple |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To study Efficacy Of Yashtimadhu Siddha Ghrita Local Application In The Management Of Stanavrana w.s.r To Cracked Nipple
2)To Compare The Efficacy Of Yashtimadhu Siddha Ghrita Local Application With Kurubak Taila Local Application In The Management Of Stanavrana w.s.r To Cracked Nipple
|
1 WEEK |
|
|
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)
|
14/02/2025 |
| 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 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* Randomized Open Controlled Clinical Trial to Evaluate the Efficacy of Yashtimadhu Siddha Ghrita in Stanavarna with Special Reference to Cracked Nipples in Breastfeeding Mothers.
*Objective* To assess the efficacy of Yashtimadhu Siddha Ghrita in treating cracked nipples in breastfeeding mothers, grounded in Ayurvedic principles.
Randomized Comparative Clinical study Study will be conducted on 60 diagnosed patients of Stanavrana Written consent of patient will be taken
Selected 60 patients will be randomly distributed into two
equal groups each comprising of 30 patients.
Groups will be named as Group A and Group B.
Group A - Yashtimadhu Siddha Ghrita Patients in number: 30
Group B - Kurubak Taila Patients in number: 30
Route of administration
Local (after breast feeding) 3 time a day
Duration 7days
Follow up 0TH ,3RD,5TH & 7TH DAYS
Statistical analysis using appropriate statistical test
Discussion |