| CTRI Number |
CTRI/2024/05/067348 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
14/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Clinical study of efficacy of Tilkusumadi Lepa in the treatment of Vipadika Kushtha(Cracked feet) in children. |
|
Scientific Title of Study
|
A Randomised controlled clinical study to evaluate the efficacy of local application of Tilkusumadi Lepa in the treatment of Vipadika Kushtha in children. |
| 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.Rushikesh Khandu Borase |
| Designation |
PG Scholar(Kaumarbhritya) |
| Affiliation |
Government Ayurved College and Hospital,Nanded. |
| Address |
Department of Kaumarbhritya,Government Ayurved College and Hospital,Nanded,Vazirabad,Nanded,Maharashtra
Nanded
MAHARASHTRA
431601
India |
| Phone |
9699939745 |
| Fax |
|
| Email |
rushikeshborase1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Deokumar W. Raut |
| Designation |
Assistant Professor(Kaumarbhritya) |
| Affiliation |
Government Ayurved College and Hospital,Nanded. |
| Address |
Department of Kaumarbhritya,Government Ayurved College and Hospital,Nanded,Vazirabad,Nanded,Maharashtra
Nanded
MAHARASHTRA
431601
India |
| Phone |
9823935698 |
| Fax |
|
| Email |
rautdeokumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deokumar W Raut |
| Designation |
Assistant Professor |
| Affiliation |
Government Ayurved College and Hospital,Nanded,Vazirabad,Nanded,Maharashtra |
| Address |
Department of Kaumarbhritya,Government Ayurved College and Hospital,Nanded,Vazirabad,Nanded,Maharashtra
Nanded
MAHARASHTRA
431601
India |
| Phone |
9823935698 |
| Fax |
|
| Email |
rautdeokumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurved College and Hospital Nanded,Vazirabad,Nanded,Maharashtra,India.Pincode 431601 |
|
|
Primary Sponsor
|
| Name |
Dr.Rushikesh Khandu Borase |
| Address |
Department of Kaumarbhritya,Government Ayurved College and Hospital,Nanded,Vazirabad,Nanded,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 Rushikesh Khandu Borase |
Government ayurved college and hospital,Nanded. |
Department of Kaumarbhritya,Government ayurved college and hospital Nanded,Maharashtra.
Nanded
MAHARASHTRA |
9699939745
rushikeshborase1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee,Government Ayurved College,Nanded |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L988||Other specified disorders of the skin and subcutaneous tissue. Ayurveda Condition: VIPADIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: Ashtang Hrudaya (Chikitsasthan 19/78), Procedure details: Jivantyadi Yamak will be applied over the affected area of Vipadika kushtha twice in a day for 28 days.)
| | 2 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Bhaishajya Ratnavali,3rd edition,Kushthachiktsa,Vipadikachiktsa,Page no 644, Procedure details: Tilkusumadi Lepa will be applied over the affected area of Vipadika kushtha twice in a day for 28 days.Tilkusumadi Lepa is prepared by a mixture of Tilkusum/Sesame flowers,Sarshapa taila/seal oil,Gomutra/Cow urine,Saindhava/Sodium chloride.)
|
|
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1)Age group between 4 years to 14 years will be selected irrespective of gender,
socioeconomic status & religion.
2)Patients presenting with Panipadasphutan (cracks on the feet /plantar region) and
with any of the following symptoms will be selected -
1) Tivravedana (Severe pain)
2) Alpakandu (Mild itching)
3) Raga (Inflammation) |
|
| ExclusionCriteria |
| Details |
1)Patients below 4 years and above 14 years of age.
2)Patients having systemic disorders like Diabetes mellitus which interfere with the
course of treatment.
3)Known allergy to any of the control/ trial group
4)Patient suffering from other dermatological /systemic diseases.
5)Vipadika Kushtha with secondary infection. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Tilkusumadi Lepa on Vipadika Kushtha in children. |
29 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To compare the effect of Tilkusumadi Lepa with Jivantyadi Yamaka in the
treatment of Vipadika kushtha.
2) To observe adverse effects if any. |
29 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
25/05/2024 |
| 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="2"
Months="0"
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
|
This study is a randomized,controlled,clinical study to evaluate the efficacy of local application of Tilkusumadi Lepa in the treatment of Vipadika Kushtha in children.Tilkusumadi Lepa will be applied locally as per requirement to the age group 4 to 14 years twice in a day for 28 days and follow up on 15 th and 29 th day.This study will be carried out in 2 years of PG course
|