| CTRI Number |
CTRI/2020/11/029147 [Registered on: 16/11/2020] Trial Registered Prospectively |
| Last Modified On: |
13/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study held to see the effect of madanadi lepa in treatment of padadari(cracked feet) |
|
Scientific Title of Study
|
Single arm clinical study to evaluate the effect of Madanadi lepa in Padadari ( Cracked feet) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Puja Sanjay Wagh |
| Designation |
MD Scholar Kayachikitsa |
| Affiliation |
Dr D Y Patil College Of Ayurveda And Research Centre Pimpri Pune |
| Address |
Opd no.5 and Ipd Kayachikitsa department Dr D Y Patil College Of Ayurved And Reseach Centre Sant Tukaram Nagar Pimpri Pune 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9552162316 |
| Fax |
|
| Email |
poojawagh330@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Gunvant Yeola |
| Designation |
Principal And HOD Kayachikitsa |
| Affiliation |
Dr D Y Patil College Of Ayurveda And Research Centre Pimpri Pune |
| Address |
Opd no.5 and Ipd Kayachikitsa department Dr D Y Patil College Of Ayurved And Reseach Centre Sant Tukaram Nagar Pimpri Pune 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9028321955 |
| Fax |
|
| Email |
gunvantayurved@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Puja Sanjay Wagh |
| Designation |
MD Scholar Kayachikitsa |
| Affiliation |
Dr D Y Patil College Of Ayurveda And Research Centre Pimpri Pune |
| Address |
Department of kayachikitsa Opd no.5 and Ipd Kayachikitsa department ofrr Dr D Y Patil College Of Ayurved And Reseach Centre Sant Tukaram Nagar Pimpri Pune 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9552162316 |
| Fax |
|
| Email |
poojawagh330@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil College Of Ayurved and Research Centre |
|
|
Primary Sponsor
|
| Name |
Dr Puja Sanjay Wagh |
| Address |
Dr D Y Patil College Of Ayurved and Research Centre Pimpri pune |
| Type of Sponsor |
Other [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 |
| Puja Wagh |
Dr D Y Patil College Of Ayurved And research Centre Pimpri Pune |
OPD NO 5 and IPD of kayachikitsa Dr D Y Patil College Of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA |
9552162316
poojawagh330@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Padadari (Cracked feet)
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Madanadi Lepa |
TO be applied locally as per requirement on the washed feet daily in the afternoon. Duration of study will be 14 days(with follow-ups on 7th day and 14th day) |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed cases of padadari will be enrolled for the study.
|
|
| ExclusionCriteria |
| Details |
Patient suffering from any dermal lesions.
Patient suffering from Diabetes Mellitus, Tuberculosis, Skin Cancer, Chronic Illness. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To get cured of padadari(cracked feet). |
The cure shall be assessed in 2 follow ups in 14 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Getting cured of marked symptoms on the skin and adding to cosmetic effect. |
14 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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
18/11/2020 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of the study is to see the effectiveness of Madanadi lepa in management of Padadari (Cracked feet). The study will be conducted with 40 patients showing signs and symptoms of Padadari (Cracked feet). Local application of madanadi lepa will be done once in a day between 4pm to 6pm (vatakala) for 30 minutes after washing the feet. After 30 min it will be removed with wet cloth. This is to be applied for 14 days and follow up will be done on 7 and 14th day and conclusion will be drawn on the basis of proper statistical methods. |