| CTRI Number |
CTRI/2024/05/067098 [Registered on: 09/05/2024] Trial Registered Prospectively |
| Last Modified On: |
10/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the effectiveness of Tintidakadi lepa in management of Padadari(Cracked heel) |
|
Scientific Title of Study
|
A Single Arm Clinical Study to evaluate the efficacy of Tintidakadi Lepa in the management of Padadari(Cracked heel) |
| 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.Rekha siwach |
| Designation |
PG Scholar |
| Affiliation |
Dr.D.Y.Patil college of Ayurved and Reseach center,Pimpri,Pune,Maharastra. |
| Address |
Department of Panchakarma,OPD No.09,Dr.D.Y.Patil College of Ayurved and Research center,Pimpri,Pune,Maharastra,India.
Pune
MAHARASHTRA
411018
India |
| Phone |
7988355912 |
| Fax |
|
| Email |
rekhasiwach44@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Mamata Nakade |
| Designation |
MD,PhD Kayachikitsa |
| Affiliation |
Dr.D.Y.Patil college of Ayurved and Reseach center,Pimpri,Pune,Maharastra,India. |
| Address |
Department of Panchakarma,OPD N0. 09,Dr.D.Y.Patil College of Ayurved and Research center,Pimpri,Pune,Maharastra,India.
Pune
MAHARASHTRA
411018
India |
| Phone |
9850241887 |
| Fax |
|
| Email |
mamtaraut1966@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Rekha siwach |
| Designation |
PG Scholar |
| Affiliation |
Dr.D.Y.Patil college of Ayurved and Reseach center,Pimpri,Pune,Maharastra,India |
| Address |
Department of Panchakarma,OPD No. 09,Dr.D.Y.Patil College of Ayurved and Research center,Pimpri,Pune,Maharastra,India.
Pune
MAHARASHTRA
411018
India |
| Phone |
7988355912 |
| Fax |
|
| Email |
rekhasiwach44@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.D.Y.Patil College of Ayurved and Research center,Pimpri,Pune. |
|
|
Primary Sponsor
|
| Name |
rekha siwach |
| Address |
Dr.D.Y.Patil College of Ayurved and Research center,Pimpri,Pune-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 |
| DrRekha Siwach |
Dr.D.Y.Patil College of Ayurved and Research center. |
Department of Panchakarma,OPD No.09,Dr.D.Y.Patil College of Ayurved and Research center,Pimpri,Pune,Maharastra,India-411018
Pune
MAHARASHTRA |
7988355912
rekhasiwach44@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR. DYPCA AND RC INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L98||Other disorders of skin and subcutaneous tissue, not elsewhere classified. Ayurveda Condition: PADADARI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Sharangadhara, Procedure details: (Procedure Reference: Sharangadhara samhita, Procedure details: Materials required for the preparation of lepa will be kept.Patient should wash his feet properly and drying up his feet.Tintidaka twaka powder,guda,saindhav,ghrita each drug should be taken in equal part and mixed properly with required amount of gomutra to prepare it in paste form as per the literature in Bhaisajyaratnavali.Lepa should be applied all over the affected area till all the cracks are covered properly with medicine in )
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients having classical sign and symptoms of Padadari(Cracked heel)-Dari,Rukshata,Saruja.
Age between 20-80 years. |
|
| ExclusionCriteria |
| Details |
Patients having any suppurative infections,patients who are known case of Athlete foot,Psoriasis,Eczema,Chilblains. |
|
|
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 Tintidakadi lepa in reduction of Dari(cracks)by using ordinal scale. |
07 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of Tintidakadi lepa in reduction of Saruja(Pain) by using VAS(Visual Analogue Scale) and Rukshata(Dryness) by using ODS-J(Overall Dryskin Scale) |
07 days |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
16/05/2024 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
It is a Clinical trial to evaluate the effectiveness of Tintidakadi lepa in the management of Padadari(Cracked heel) Study design is Single arm clinical study Total 45 patients will be enrolled Assessment of patients on 1st and 7th day Total duration of study will be 18 months |