| CTRI Number |
CTRI/2025/05/087216 [Registered on: 20/05/2025] Trial Registered Prospectively |
| Last Modified On: |
18/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Randomised controlled clinical study to evaluate the efficacy of Vasadi Lepa and Vachadi Lepa in the management of pama scabies in children three to fifteen years |
|
Scientific Title of Study
|
Randomised Controlled Clinical study to evaluate the efficacy of Vasadi Lepa and Vachadi Lepa in the management of pama scabies in children 3 to 15 year |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jayesh patil |
| Designation |
PG SCHOLOR |
| Affiliation |
PDEAs college of Ayurved and research Center |
| Address |
PDEAs college of Ayurved and research
Center, sector 25, nigdi pradhikaran Pune, Maharashtra 411044, india
PDEAs college of Ayurved and research
Center, sector 25, nigdi pradhikaran Pune, Maharashtra 411044, india
Pune
MAHARASHTRA
411044
India |
| Phone |
9923412711 |
| Fax |
|
| Email |
jayeshpatil25523000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Deepa Khajgiwala |
| Designation |
Assistant professor kaumarbhritya |
| Affiliation |
PDEAs college of Ayurved and research Center |
| Address |
PDEAs college of Ayurved and research
Center sector 25 nigdi pradhikaran Pune Maharashtra 411044
PDEAs college of Ayurved and research
Center sector 25 nigdi pradhikaran Pune Maharashtra 411044 india
Pune
MAHARASHTRA
411044
India |
| Phone |
9890077765 |
| Fax |
|
| Email |
drdeepajain@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Jayesh patil |
| Designation |
PG SCHOLOR |
| Affiliation |
PDEAs college of Ayurved and research Center |
| Address |
PDEAs college of Ayurved and research
Center, sector 25, nigdi pradhikaran Pune, Maharashtra 411044, india
PDEAs college of Ayurved and research
Center, sector 25, nigdi pradhikaran Pune, Maharashtra 411044, india
Pune
MAHARASHTRA
411044
India |
| Phone |
9923412711 |
| Fax |
|
| Email |
jayeshpatil25523000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jayesh Jagdish patil
PDEAs College Of Ayurved And Research Centre Sector No 27 Pradhikaran Nigdi Pimpri Chinchwad Maharashtra 411044 India |
|
|
Primary Sponsor
|
| Name |
Jayesh Jagdish Patil |
| Address |
PDEAs College Of Ayurved And Research Centre Sector No 27 Pradhikaran Nigdi PimpriChinchwad Maharashtra 411044 |
| Type of Sponsor |
Private medical college |
|
|
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 Jayesh Jagdish Patil |
PDEAs College Of Ayurved And Research Centre ground floor kaumarbhritya Opd |
PDEAs College Of Ayurved And Research Centre ground floor kaumarbhritya Opd Sector No 27 Pradhikaran Nigdi Pimpri Chinchwad Maharashtra 411044 India
Pune
MAHARASHTRA |
9923412711
jayeshpatil25523000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PDEAs college Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L088||Other specified local infections of the skin and subcutaneous tissue. Ayurveda Condition: KUSHTHAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vasadi Lepa , Reference: Charak Chikitsa sthan chapter no 7 shloka no 126 to 128, Route: Topical, Dosage Form: Lepa Churna, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 8 Days, anupAna/sahapAna: No, Additional Information: Nil | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vachadi lepa , Reference: Charak Chikitsa sthan chapter no 7 Shloka no 93, Route: Topical, Dosage Form: Lepa Churna, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 8 Days, anupAna/sahapAna: No, Additional Information: Nil |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Patient who will be clinically with two or more symptoms of scabies such as itching kandu pain toda burning daha eruption pitika discharge strava
Selection will be irrespective of gender religion and socioeconomic class age between 3 to 15 years |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the study of efficacy of Vasadi Lepa and Vachadi Lepa in Pama in children 3 to 15 years for 7 days |
To compare the study of efficacy of Vasadi Lepa and Vachadi Lepa in Pama in children 3 to 15 years for 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the adverse effects if any |
18 Months |
|
|
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 |
|
Date of First Enrollment (India)
|
29/05/2025 |
| 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 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
|
The human skin is the outer protective covering of the body Children have thinner and more delicate skin than adults so it’s more sensitive to irritation Childrens used to play or stay in groups either in school or at home and unable to maintain their hygiene so they are easily victimized by different skin infections. Scabies is one of the most common complaints in children.Skin diseases have high prevalence throughout the world Scabies is caused by burrowing and release of toxic or antigenic substances by the female mite Sarcoptic scabiei var hominid In infants and young children common sites of infestation include the scalp face neck palms of the hands and soles of the feet The prevalence & complications of scabies makes it a significant public health problem in the developing world With a disproportionate burden in children living in poor, over crowded areas overcrowding is an important factor in the spread of scabies Overwhelmingly the highest global rates of scabies are seen in countries with hot tropical climates If treatment of Pama can be done early stage it will avoid further recurrence
Vasadi Lepa is easily available and cost effective and easy to administer |