| CTRI Number |
CTRI/2025/07/091147 [Registered on: 18/07/2025] Trial Registered Prospectively |
| Last Modified On: |
18/07/2025 |
| 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
|
It is a study to see how much effective is ayurvedic medicine japa pushpa taila in the treatment if
disease pityriasis capitis. |
|
Scientific Title of Study
|
Randomized open controlled clinical study to evaluate the efficacy of japa pushpa taila in darunaka with special reference to pityriasis capitis in children of age group 0 to 18 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 Shreyas Bharat Warule |
| Designation |
PG scholar |
| Affiliation |
LRP Ayurvedic medical college and hospital, PG Institute and research centre urun Islampur |
| Address |
Pediatric department 2 nd floor LRP Ayurvedic medical college and
hospital PG Institute and Research center Urun Islampur Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
8766546756 |
| Fax |
|
| Email |
shreyaswarule1251@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Patill |
| Designation |
Assistant professor |
| Affiliation |
LRP Ayurvedic medical college and hospital, PG Institute and Research center ,Urun Islampur |
| Address |
Pediatric Department 2 nd floor LRP Ayurvedic medical college and
hospital PG Institute and Research center Urun Islampur Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
9860970379 |
| Fax |
|
| Email |
sandeep.patil76.sp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep Patill |
| Designation |
Assistant professor |
| Affiliation |
LRP Ayurvedic medical college and hospital, PG Institute and Research center ,Urun Islampur |
| Address |
Pediatric Department 2 nd floor LRP Ayurvedic medical college and
hospital PG Institute and Research center Urun Islampur Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
9860970379 |
| Fax |
|
| Email |
sandeep.patil76.sp@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 Shreyas Bharat Warule |
| Address |
LRP Ayurvedic medical college and hospital, PG Institute and
Research center, Urun Islampur 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 Shreyas Bharat Warule |
LRP Ayurvedic medical college and hospital, PG Institute and Research center Urun Islampur |
OPD 2 Pediatric Opd
Ground Floor.
Sangli
MAHARASHTRA
Sangli
MAHARASHTRA |
8766546756
shreyaswarule1251@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC- LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre, Islampur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L210||Seborrhea capitis. Ayurveda Condition: DARUNAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Japa pushpa taila , Reference: Yogaratnakara uttaradha darunak chikitsa adhyay , Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: hs, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -Overnight
application daily
for 30 days. | | 2 | Comparator Arm (Non Ayurveda) | | - | Ketoconazole shampoo | Twice a week for 5 to 10
min.
Before bath applying it on scalp. |
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1) Age group between 0-18 years of either sex, irrespective of cast,
socioeconomic status.
2) Patient with symptoms of kandu, keshbhoomi rukshata,
twaksphutan, keshchyuti. |
|
| ExclusionCriteria |
| Details |
1) Children suffering with K/C/O any systemic and genetic disease.
2) Patient who are restricted to take bath like, karna roga, netra roga
and shiroroga.
3)Children with K/C/O chronic scalp disease other than darunaka like
allergic scalp.
4) Children suffering with immunosuppressive disease. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To decrease the symptoms of Darunak . |
30 day with follow up on 0,15th,30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the effects of ayurvedic formulation. |
30 day with follow up on 0,15th,30th day . |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
11/08/2025 |
| 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 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
|
Aim-To evaluate the efficacy of japa pushpa taila in the management of darunaka with special
reference to pityriasis capitis in children of age group 0 to 18 years.
Objective - Primary To study the efficacy of Japa pushpa Taila in treatment of darunaka in
children with special reference to pityriasis capitis.
Secondary objective - 1) To study the preparation of Japa pushpa Taila and it’s standardization.
2) To study in detail the literature about darunaka.
3) To study the detail literature about pityriasis capitis in children.
4) To compare effect of Japa pushpa Taila and ketoconazole shampoo 2 percent.
a) Study design – Randomized, open labeled, controlled, clinical study.
b) Study setting- Patient will be selected randomly from OPD of
kaumarbhritya department in our hospital.
c) Duration of study- 18 months.
d) Study Population - Age groups 0 to 18 years of age irrespective of gender.
e) Sampling method – Open labeled sampling method. (lottery method).
Diagnostic criteria :
1)Patients will be diagnosed on the basis of clinical signs
and symptoms of darunaka.
Informed written consent will be taken prior to clinical study. Case will be recorded on specially designed proforma.
CRITERIA OF ASSESSMENT - Assessment will be done before and after treatment and will be done on
the basis of following criteria.
A) Subjective Parameter 1- kandu( Itching) 2-keshchutyi(Falling of hairs) 3-Twak Sphutan (Scaling of scalp) 4-Rukshata (Dryness) B. OBJECTIVE PARAMETERS:
1) ASFS (ADHERENT SCALP FLAKING SCORE)
After analyzing, data will be discussed in detail.
Conclusion will be drawn on the basis of data obtained and observation during study.
Data will be summarized on the basis of observation and results. |