| CTRI Number |
CTRI/2024/07/070253 [Registered on: 09/07/2024] Trial Registered Prospectively |
| Last Modified On: |
06/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the effect of Bhringraj Tail in the management of Darunaka in 1-16 year age group |
|
Scientific Title of Study
|
Single arm clinical study of bhringraj taila in the management of darunaka with special reference to pityriasis capitis in children in 1-16 year age group |
| 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 Rajnandini More |
| Designation |
PG Scholar |
| Affiliation |
LRP Ayurvedic medical college and hospital, PG Institute and Research center |
| Address |
LRP Ayurvedic medical College and hospital PG Institute and Research centre, Urun Islampur dist.sangli,Department of kaumarbhritya,unit no.2,room no.2
Sangli
MAHARASHTRA
415409
India |
| Phone |
8600681155 |
| Fax |
|
| Email |
rajnandinimore119@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Patil |
| Designation |
Associate professor |
| Affiliation |
LRP Ayurvedic medical college and hospital, PG Institute and Research center |
| Address |
LRP Ayurvedic medical College and hospital PG Institute and Research centre, Urun Islampur Dist.sangali Department of kaumarbhritya,Unit no.2,Room no.2
Sangli
MAHARASHTRA
415409
India |
| Phone |
8329442696 |
| Fax |
|
| Email |
sandeep.patil76.sp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajnandini More |
| Designation |
PG Scholar |
| Affiliation |
LRP Ayurvedic medical college and hospital, PG Institute and Research center |
| Address |
LRP Ayurvedic medical College and hospital PG Institute and Research centre, Urun Islampur Dist.sangli Department of Kaumarbhritya , Unit no.2,Room NO.2
Sangli
MAHARASHTRA
415409
India |
| Phone |
8600681155 |
| Fax |
|
| Email |
rajnandinimore119@gmail.com |
|
|
Source of Monetary or Material Support
|
| LRP Ayurvedic medical College and hospital PG Institute and Research centre, Urun Islampur 415409 |
|
|
Primary Sponsor
|
| Name |
Dr Rajnandini More |
| Address |
LRP Ayurvedic medical College and hospital PG Institute and Research centre, 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 Rajnandini More |
LRP Ayurvedic medical college and hospital post graduate institue and research center |
LRP Ayurvedic medical college and hospital and Research center, Urun Islampur Dist.Sangli Department of Kaumarbhritya,Unit no.2,Room no.2
Sangli
MAHARASHTRA |
8600681155
rajnandinimore119@gmai.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| LRP AMC AND RC INSTITUTIONAL ETHICS COMMITTE |
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: Bhringraj Taila, Reference: Sharangdhar samhita Adhyay no-9 shloka no-161, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: hs, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: For external application |
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1) Age group between 1-16years of Irrespective sex, cast, Socieo economic status.
2) Patient with symptoms of kandu, keshbhoomi Rukshata, twaksphutan, kesh chyuti. |
|
| ExclusionCriteria |
| Details |
1)Children suffering with K/C/O any systemic and genetic disease.
2) Patient who are restricted to take bath like Asyroga, karna roga, netra roga and Shiroroga.
3)Children with K/C/O chronic scalp disease other than Darunaka or allergic scalp disease. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To decrease the symptoms of Darunak |
21 day study with follow up of 3rd,7th,14th,21th day(0,3,7,14,21) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the effects of ayurvedic formulations |
21 days study with follow upof 3rd,7th,14th,21th day(0,3,7,14,21) |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
26/07/2024 |
| 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="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
|
Darunak is a disease concern with scalp and hair root can be compared with dandruff.Darunak is most comman disorder in prepuberty age.In infancyscalp dandruff commanly knows as cradal cap and in preadolscent age it is knows as pityariasis capitis. Darunak is very comman self limiting non inflamatory scaling condition of scalp.Darunak is main cause of hair loss and fore head acne occurs in pre puberty age. According to ayurveda Darunak is characterized by Kandu, Rukshta, Keshchuti, Twaksputan . Here Shiroabhyang of Bhringraj Tail will be done. In this procedure massage of scalp is done with taila.Bhringraj Tail is mentioned as a treatment of darunak in sharangdhar samhita.Where Bhringraj,Triphala,Tila all are discribed as keshya dravya while sarivais act as vat kaphgnha and mandur is krimighna vatghna. Hence the study is taken to evaluate the effect of Bhringraj tail in Darunak in 1-16 year age group.This is single arm study in which ayurvedic formulation will be providedto 100 petients showing sign and symptoms of Darunak.The age group taken for study trial will be between 1-16 year.Ayurvedic formulation will be given on 0th,3rd,7th,14th,21th day.And the total duration of whole study is 1 year . Final conclusion will be drawn on the basis of statistical methods. |