| CTRI Number |
CTRI/2023/03/050628 [Registered on: 13/03/2023] Trial Registered Prospectively |
| Last Modified On: |
16/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Bhrungaraja Taila Shiroabhyanga in the management of Darunaka(Dandruff) |
|
Scientific Title of Study
|
A Single Arm Clinical Study to evaluate the efficacy of Bhrungaraja Taila Shiroabhyanga in the management of Darunaka(Dandruff) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Snehal Aldar |
| Designation |
MD PG Scholar |
| Affiliation |
Dr. D. Y. Patil College of Ayurved and Research center. |
| Address |
Panchakarma Department
OPD No.9
DR. D. Y. Patil College of Ayurved and Research center, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra, India.
Pune
MAHARASHTRA
411018
India |
| Phone |
9022894733 |
| Fax |
|
| Email |
aldarsneha145@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaishali R Chaudhari |
| Designation |
MD Panchakarma |
| Affiliation |
Dr. D. Y. Patil College of Ayurved and Research center. |
| Address |
DR. D. Y. Patil College of Ayurved and Research center, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra, India.
Pune
MAHARASHTRA
411018
India |
| Phone |
9822964710 |
| Fax |
|
| Email |
vaishalidhandes@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Snehal Aldar |
| Designation |
MD PG Scholar |
| Affiliation |
Dr. D. Y. Patil College of Ayurved and Research center. |
| Address |
Panchakarma Department
DR. D. Y. Patil College of Ayurved and Research center, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra, India.
Pune
MAHARASHTRA
411018
India |
| Phone |
9022894733 |
| Fax |
|
| Email |
aldarsneha145@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D. Y. Patil College of Ayurved and Research center, Pimpri, Pune. |
|
|
Primary Sponsor
|
| Name |
Dr. Snehal Aldar |
| Address |
Sant Tukaram Nagar, Near Fire Station, YCM Road, Pimpri, Pune, Maharashtra.411018 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Vaishali R Chaudhari |
Dr. D. Y. Patil College of Ayurved and Research center, Sant Tukaram Nagar, Pimpri, Pune, Maharshtra, India 411018 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Snehal Aldar |
Dr. D. Y. Patil College Of Ayurved and Research center,pimpri |
Department of Panchakarma OPD No.9
Dr. D. Y. Patil College of Ayurved and Research Center,Sant Tukaram Nagar Pimpri, Pune 411018
Pune
MAHARASHTRA |
9022894733
aldarsneha145@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR. DYPCA AND RC INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L219||Seborrheic dermatitis, unspecified. Ayurveda Condition: DARUNAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Siro~aBya~ggaH, शिरोरऽà¤à¥à¤¯à¤‚ग | (Procedure Reference: Ashtanga Hrudaya Sutrasthana, Procedure details: Head massage with Bhrungaraja Taila for 7 Days.)
(1) Medicine Name: Bhrungraja taila, Reference: Basavarajeeyam Kshudraroganidanalakshanachikitsa 22nd Adhyaya, Route: Topical, Dosage Form: Taila, Dose: 15(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age between 18-60 years irrespective of their sex, Having classical symptoms of Darunaka like Kandu (Itching), Twak Sphutana (Scaling of scalp), Kesha Chyuti (Hair fall), Rukshata(Dryness of scalp) |
|
| ExclusionCriteria |
| Details |
Known case of :
1)Psoriasis of scalp
2)Eczema of scalp
3)Ring worm infection of scalp
4)Alopecia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief from the symptoms like hairfall, Dryness of scalp, Itching. |
7 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To access the reduction of hairfall and dryness of scalp.
|
7 days. |
|
|
Target Sample Size
|
Total Sample Size="49"
Sample Size from India="49"
Final Enrollment numbers achieved (Total)= "49"
Final Enrollment numbers achieved (India)="49" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/04/2023 |
| Date of Study Completion (India) |
27/05/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
27/05/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is a clinical study to evaluate the effect of Bhrungaraja Taila Shiroabhyanga in the management of Darunaka (Dandruff ).
Study design is Single arm clinical study.
Total 49 patients will be enrolled.
Assessment of patients on 1st and 7th day.
Follow up on 14 th day.
Total duration of study will be 18 months.
|