| CTRI Number |
CTRI/2024/07/071672 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
29/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Study Efficacy of Darvi Twak Siddh Ghrita In management of Cracked Nipples In Breast Feeding Mothers |
|
Scientific Title of Study
|
A SINGLE ARM CLINICAL STUDY TO EVALUATE THE EFFICACY OF DARVI TWAK SIDDH GHRITA IN THE MANAGEMENT OF CRACKED NIPPLES (STANAGAT VRANA) IN BREAST FEEDING 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 |
Bhanu Sharma |
| Designation |
Pg scholar |
| Affiliation |
Dr.D.Y.Patil College of Ayurveda and Research Centre , Pimpri,Pune |
| Address |
OPD No 2, Department Of Stree Roga & Prasuti Tantra, Dr.D.Y.Patil College of Ayurveda and Research Centre , Sant Tukaram Nagar , Pimpri ,Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9416398371 |
| Fax |
|
| Email |
bhanu997sharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradnya Shirke |
| Designation |
Professor |
| Affiliation |
Dr.D.Y.Patil College of Ayurveda and Research Centre , Pimpri,Pune |
| Address |
OPD No 2, Department Of Stree Roga & Prasuti Tantra, Dr.D.Y.Patil College of Ayurveda and Research Centre , Sant Tukaram Nagar , Pimpri ,Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9623446110 |
| Fax |
|
| Email |
pradnyashirke2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradnya Shirke |
| Designation |
Professor |
| Affiliation |
Dr.D.Y.Patil College of Ayurveda and Research Centre , Pimpri,Pune |
| Address |
OPD No 2, Department Of Stree Roga & Prasuti Tantra, Dr.D.Y.Patil College of Ayurveda and Research Centre , Sant Tukaram Nagar , Pimpri ,Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9623446110 |
| Fax |
|
| Email |
pradnyashirke2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.D.Y.Patil College of Ayurveda and Research Centre , Sant Tukaram Nagar , Pimpri ,Pune, Maharashtra, India Pincode 411018 |
|
|
Primary Sponsor
|
| Name |
Bhanu Sharma |
| Address |
Dr.D.Y.Patil College of Ayurveda and Research Centre , Sant Tukaram Nagar , Pimpri ,Pune , Maharastra ,India Pincode 411018 |
| 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 Bhanu Sharma |
Dr.D.Y.Patil College of Ayurveda and Research Centre ,Pimpri ,Pune |
OPD No 2, Department Of Stree Roga and Prasuti Tantra ,Dr.D.Y.Patil College of Ayurveda and Research Centre , Sant Tukaram Nagar , Pimpri ,Pune
Pune
MAHARASHTRA |
9416398371
bhanu997sharma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR.DYPCA & RC INSTITUTIONAL ETHICS COMMITTEE PIMPRI, PUNE-18 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O910||Infection of nipple associated with pregnancy, the puerperium and lactation. Ayurveda Condition: VRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Darvi Twak siddh Ghrita, Reference: Charka Samhita , Route: Topical, Dosage Form: Ghrita, Dose: 3(ml), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Lactating mother from 01-42 days
Lactating Mothers suffering from symptoms such as cracks, dryness,red irritation skin, pain of varying intensity |
|
| ExclusionCriteria |
| Details |
Ante natal Patients
Patients having mastitis
breast abscess |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of Darvi Twak Side Ghrita in the management of pain and Tenderness in cracked nipples (stanagat vrana) |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the other effect of darvi twak siddh ghrita |
15 days |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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 |
|
Date of First Enrollment (India)
|
10/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/08/2024 |
| 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
|
TITLE - A SINGLE ARM CLINICAL STUDY TO EVALUATE THE EFFICACY OF DARVI TWAK SIDDH GHRITA IN THE MANAGEMENT OF CRACKED NIPPLES (STANAGAT VRANA) IN BREAST FEEDING MOTHERS
STUDY DESIGN - Single arm clinical study
NO OF PARTICIPANTS - 38
INTERVENTION - DARVI TWAK SIDDH GHRITA is to be applied topically on cracked nipples (stanagat vrana) for 15 days ASSESSMENT will be done on 7th and 15th day
DURATION - 18 Months |