| CTRI Number |
CTRI/2025/12/099519 [Registered on: 19/12/2025] Trial Registered Prospectively |
| Last Modified On: |
19/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
It is a Study to See How Much Effective is Ayurvedic Medicine Shikharirasadi Lepa And Varadi Yog in The Treatment of Tinea Versicolor in Children |
|
Scientific Title of Study
|
Single Arm Clinical Study To Assess The Efficacy Of Shikharirasadi Lepa Locally And Varadi Yog Orally In The Management Of Sidhma Kushtha With Special Reference To Tinea Versicolor In Children Of Age Group 8 to 16 Years |
| 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 Sunil Rathod |
| Designation |
PG Scholar |
| Affiliation |
LRP Ayurvedic Medical College and Hospital Urun Islampur |
| Address |
LRP Ayurvedic medical college and hospital, PG Institute and research centre urun Islampur
Pediatric department 2 nd floor LRP Ayurvedic medical college and hospital PG Institute and Research center Urun Islampur
LRP Ayurvedic Medical College and Hospital PG Institute and Research Centre Urun Islampur Kaumarbhritya Department OPD 2 Sangli MAHARASHTRA 415409
Sangli
MAHARASHTRA
415409
India |
| Phone |
9545866239 |
| Fax |
|
| Email |
sunilrathod1241997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyotsna Ahir |
| Designation |
HOD & Professor |
| Affiliation |
LRP Ayurvedic Medical College and Hospital Urun Islampur |
| Address |
LRP Ayurvedic Medical College and Hospital PG Institute and Research Centre Urun Islampur Kaumarbhritya Department OPD 2
LRP Ayurvedic Medical College and Hospital PG Institute and Research Centre Urun Islampur Kaumarbhritya Department OPD 2 Sangli MAHARASHTRA 415409
Sangli
MAHARASHTRA
415409
India |
| Phone |
7276538181 |
| Fax |
|
| Email |
drjyotsnaahir@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyotsna Ahir |
| Designation |
PG Scholar |
| Affiliation |
LRP Ayurvedic Medical College and Hospital Urun Islampur |
| Address |
LRP Ayurvedic Medical College and Hospital PG Institute and Research Centre Urun Islampur Kaumarbhritya Department OPD 2
LRP Ayurvedic Medical College and Hospital PG Institute and Research Centre Urun Islampur Kaumarbhritya Department OPD 2 Sangli MAHARASHTRA 415409
Sangli
MAHARASHTRA
415409
India |
| Phone |
7276538181 |
| Fax |
|
| Email |
drjyotsnaahir@gmail.com |
|
|
Source of Monetary or Material Support
|
| LRP Ayurvedic medical college and hospital, PG Institute and Research center, Urun Islampur 415409
|
|
|
Primary Sponsor
|
| Name |
Dr Sunil Rathod |
| Address |
LRP Ayurvedic Medical College And Hospital Urun Islampur
Sangli Maharashtra 415409 |
| 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 Sunil Babasaheb Rathod |
LRP Ayurvedic Medical College and Hospital PG Institute and Research Centre Urun Islampur |
Kaumarbhritya Department OPD 2 Urun Islampur Sangli MAHARASHTRA 415409 India
Sangli
MAHARASHTRA |
9545866239
sunilrathod1241997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Loknete Rajarambapu Patil Ayurved Medical College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: SIDHMAH, (2) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: SIDHMAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shikharirasadi Lepa, Reference: Bhaishajya Ratnavali , Route: Topical, Dosage Form: Lepa Churna, Dose: 1(NA), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 21 Days, Reference: No, Route: -, Dosage Form: Lepa Churna, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (3) Medicine Name: Varadi Yoga , Reference: Astanga Hrdaya , Route: Oral, Dosage Form: Churna/ Powder, Dose: 3.5(g), Frequency: bd, Bhaishajya Kal: Madhyabhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -Tiala Madhu ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Children With Sign And Symptoms Of Sidhma Kushtha Like Itching Skin Lesions Scaling
Children Between 8- 16 Years Of Age Group Irrespective of Sex Caste Religion And
Socioeconomic Status |
|
| ExclusionCriteria |
| Details |
Children Suffering With Known Case Of Any Autoimmune Disorder
Children With Known Case Of Chronic Skin Disease or Allergic Skin Disease Other
Than Sidhma Kushtha
Children of Sidhma Kushtha with Secondary infections |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| study the effect of Shikharirasadi Lepa and Varadi Yog in the management of Sidhma Kushtha |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the efficacy of Shikharirasadi Lepa Locally and Varadi Yog Orally in
children with Ayurvedic perspective in detail
To study the literature related to Sidhma Kushtha
To study the ‘Sidhma kushtha’in children from ayurvedic and contemporary medical
literature
To study the concept of Lepa preparation
To evaluate the recurrence of Disease when Treatment stops |
21 days study with follow up on 7th 14th 21st day |
| |
|
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
30/12/2025 |
| 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="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
|
Ayurveda is indeed a holistic system of natural medicine originating from ancient India It is a system of natural medicine It deals with physical mental and spiritual wellbeing of the human It focuses firstly on being healthy Swasthasya Swasthyarakshnam and secondly on Cure Of The Condition emerged Aturasya Vikar Prashmanam
Skin is important organ of communication with external world The skin is largest organ of the body having surface area of 2m Square and measuring approximately 50 Percent of body weight Any Alternation in nutritional status hygiene circulation immunity and psychological cause is easily depicted by the changes in the skin due nidana sewana the doshas get vitiated enters the siras and vitiate twak rakta lasika and mansa create vaivarnya in twak it is not treated properly spread into Dhatu It is a skin disorder Characterized by rash over chest Shoulders neck back and upper extremities which is caused by malassezia furfur malassezia globusa fungas In infants and young children lesions are often located in the face
Tinea versicolor is the second most common superficial fungal infection Among all individuals at puberty Tinea versicolor shows highest prevalence mainly in the age group of 8 to 20 years It shows that Tinea Versicolor is most commonly found in pediatric age group There has been very few study conducted in pediatric age group for Tinea Versicolor |