| CTRI Number |
CTRI/2025/04/084281 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
02/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study of efficacy of Dhurdhurpatradi Taila Shiroabhyanga with Kantakari Taila Shiroabhyanga in the management of Dandruff |
|
Scientific Title of Study
|
Comparative clinical trial to evaluate the efficacy of Dhurdhurpatradi Taila and Kantakari Taila Shiroabhyanga in Darunak with reference to Dandruff |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kalyani Jagannath Bhelke |
| Designation |
MD Scholar Panchakarma |
| Affiliation |
PMTs Ayurved College Shevgaon |
| Address |
OPD No - 108 Department Of Panchakarma ground floor PMTs Ayurved College,Shevgaon
Taluka - Shevgaon Dist - Ahilyanagar, Maharashtra,India
Ahmadnagar
MAHARASHTRA
414502
India |
| Phone |
7875610080 |
| Fax |
|
| Email |
kalyanibhelke221@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vaidya Sachin Gandhi |
| Designation |
Head of department Panchakarma |
| Affiliation |
PMTs Ayurved College Shevgaon |
| Address |
OPD NO - 108 Department Of Panchakarma ground floor PMTs Ayurved College Shevgaon
Taluka - Shevgaon Dist - Ahilyanagar, Maharashtra, India
Ahmadnagar
MAHARASHTRA
414502
India |
| Phone |
9423389866 |
| Fax |
|
| Email |
arihantsai977@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vaidya Sachin Gandhi |
| Designation |
Head of department Panchakarma |
| Affiliation |
PMTs Ayurved College Shevgaon |
| Address |
OPD No - 108 Department Of Panchakarma ground floor PMTs Ayurved College Shevgaon
Taluka - Shevgaon Dist - Ahilyanagar, Maharashtra, India
MAHARASHTRA
414502
India |
| Phone |
9423389866 |
| Fax |
|
| Email |
arihantsai977@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kalyani Jagannath Bhelke
PMTs Ayurved College Shevgaon, Taluka -Shevgaon Dist- Ahilyanagar, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Kalyani Jagannath Bhelke |
| Address |
PMTs Ayurved College Shevgaon Taluka - Shevgaon Dist - Ahilyanagar Pincode - 414502, Maharashtra, India |
| 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 Kalyani Jagannath Bhelke |
Shri Eknath Ayurved Rugnalaya |
Pravara Medical Trust Ayurved Mahavidyalaya and Shri Eknath Rugnalaya Shevgaon Taluka -Shevgaon Dist-Aliyanagar Pincode -414502, Maharashtra, India
Ahmadnagar
MAHARASHTRA |
7875610080
kalyanibhelke221@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee PMTs Ayurved College Shevgaon |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L21||Seborrheic dermatitis. Ayurveda Condition: DARUNAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | SirobastiH, शिरोबस्तिः | (Procedure Reference: Ashtang hrudayam sutrasthana gandushadividhiradhyaya 22/24, Procedure details: Dhurdhurpatradi Taila Shiroabhyanga will be done in Darunak patient for 15 minutes on alternate days for 15 days )
(1) Medicine Name: Dhurdhurpatradi , Reference: Sahastrayogam taila prakaranam , Route: Topical, Dosage Form: Taila, Dose: 40(ml), Frequency: od, Duration: 15 Days | | 2 | Comparator Arm | Procedure | - | SirobastiH, शिरोबस्तिः | (Procedure Reference: Ashtang hrudayam sutrasthana gandushadividhiradhyaya 22/24, Procedure details: Kantakari Taila Shiroabhyanga will be done in Darunak patient for 15 minutes on alternate days for 15 days.)
(1) Medicine Name: Kantakari Taila , Reference: Rasa ratna samucchay 24/81, Route: Topical, Dosage Form: Taila, Dose: 40(ml), Frequency: od, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient having sign and symptoms of Darunak
Patient will be selected irrespective of sex , age, religion, occupation,food habits. |
|
| ExclusionCriteria |
| Details |
Patients suffering from severe scalp infection like psoriasis, eczema, urticarial rashes.
Patient currently or recently using other tropical treatment for Dandruff
Patients with known allergies or sensitivities to the ingredients in the study oils |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in symptoms of Kandu ,twak sputan,rukshta |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in symptoms of Keshchyuti,Twak sputan,kandu ,rukshta |
15days |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
25/04/2025 |
| 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
|
Study will be intervened by the treatment of Dhurdhurpatradi Taila and Kantakari Taila Shiroabhyanga to Group A and Group B respectively. The efficacy of therapy will be assessed on the basis of subjective and objective criteria for stastical analysis. According to severity of symptoms sub gradation will be done and appropriate scoring will be designed. The intensity of each system will be calculated before treatment and after treatment and after follow up. The result of treatment will be assessed on the basis of clinical sign and symptoms by adopting suitable grading and scoring system. |