| CTRI Number |
CTRI/2025/09/094663 [Registered on: 12/09/2025] Trial Registered Prospectively |
| Last Modified On: |
12/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study on the effect of Durdhuradi Taila in managing Dandruff (Darunaka) compared to Standard Therapy |
|
Scientific Title of Study
|
Standard controlled clinical evaluation of Durdhuradi Taila in Darunak |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aditi Bhatt |
| Designation |
PG Scholar |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD-3, Department of Shalakya Tantra, Patanjali Ayurved hospital, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7454873453 |
| Fax |
|
| Email |
aditibhatt922@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Kumar Agrawal |
| Designation |
Associate Professor |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD-3, Department of Shalakya Tantra, Patanjali Ayurved hospital, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9411551545 |
| Fax |
|
| Email |
agrawal.amitkumar308@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aditi Bhatt |
| Designation |
PG Scholar |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD-3, Department of Shalakya Tantra, Patanjali Ayurved hospital, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7454873453 |
| Fax |
|
| Email |
aditibhatt922@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar,Uttarakhand,India
Pin code 249405 |
|
|
Primary Sponsor
|
| Name |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar |
| Address |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar,Uttarakhand, India 249405 |
| Type of Sponsor |
Private medical college |
|
|
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 Aditi Bhatt |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar |
OPD-3, Department of Shalakya Tantra, Patanjali Ayurved hospital, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar
Hardwar
UTTARANCHAL |
7454873453
aditibhatt922@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan,Haridwar,249405 |
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 | Comparator Arm (Non Ayurveda) | | - | Ketoconazole shampoo | Dosage form: Topical shampoo
Strength: 2% w/v
Indication in India: Dandruff/seborrheic dermatitis of the scalp
Route of administration: Topical (scalp application)
Dose and regimen : Apply 10-15 mL, twice weekly for 30 days ( 8 applications) | | 2 | Intervention Arm | Procedure | - | mUrdhatailam/ Sirastailam, मूर्धतैलम्/ शिरस्तैलम् | (Procedure Reference: Su.Chi.24/30, Procedure details: Poorva Karma-Preparation of materials Medicated oil,Droni table or chair with head support Oil heating apparatus for maintaining lukewarm temperature
Pradhana Karma-Shiroabhyanga from Durdhuradi Taila for 10 minutes (400 Matra Kala) in night, twice a week, for 30 days(8 Applications).
Paschat Karma-Hair wash with lukewarm water in next morning.
)
(1) Medicine Name: Durdhuradi Taila, Reference: Sahasra Yogam Taila Prakaran, Route: Topical, Dosage Form: Taila, Dose: 15(ml), Frequency: od, Duration: 8 Days |
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.The patients presenting with classical features of Darunaka as mentioned in diagnostic
criteria will be selected irrespective of Sex and Socioeconomic status.
Diagnostic Criteria:
1.Itching at scalp (Kandu)
2. Diffuse hair fall (Keshachyuti)
3. Roughness of scalp (Rukshata)
4.Scaling of scalp skin (Twaksphutana)
2.Age group between 10-60 years. |
|
| ExclusionCriteria |
| Details |
1.Patient below the age of 10 and above 60yrs.
2.Associated with other dermatological conditions such as pityriasis steatoides, psoriasis, eczema etc.
3. Patients having Chronic infectious diseases (tuberculosis, leprosy etc.) and metabolic diseases (DM, hypothyroidism etc.).
4. Patient suffering from cancer and taking chemotherapy and radiotherapy.
5. Other types of Kapala gata roga.
6. Conditions in which head wash is restricted like Ardita,injuries to scalp. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment will be done on the basis of subjective parameter
Itching at scalp (Kandu) Diffuse hair fall (Keshachyuti)
Roughness of scalp(Rukshata)
Scaling of scalp skin (Twaksphutana) |
Baseline before treatment
End of treatment 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment will be done on the basis of subjective parameter
Itching at scalp (Kandu) Diffuse hair fall (Keshachyuti)
Roughness of scalp(Rukshata)
Scaling of scalp skin (Twaksphutana) |
Baseline before treatment
End of treatment 4 weeks |
|
|
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 |
|
Date of First Enrollment (India)
|
23/09/2025 |
| 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
|
This study is a Standard controlled clinical evaluation of Durdhuradi Taila in Darunak. This will be conducted on 100 patients from OPD/IPD of Shalakya - Tantra Department of Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar. Patients will be divided into two groups - 50 pateints will be given Durdhuradi Taila topically and 50 patients will be given Ketoconazole shampoo topically . 2 follow up at interval of 1 month after completion of treatment. Assessment will be done on the basis of subjective parameters as discussed earlier. |