FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/12/098874 [Registered on: 11/12/2025] Trial Registered Prospectively
Last Modified On: 10/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Other 
Public Title of Study   Compare the clinical efficacy of Dhaturadi taila and Gunjadi taila as shiroabhyang for the management of Darunaka(Dandruff) in children aged 5 to 16 years 
Scientific Title of Study   A comparative clinical evaluation of the efficacy of Dhaturadi taila and Gunjadi taila as Shiroabhyang for the management of Darunaka(Dandruff)-An open-label randomized Controlled trial 
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 Gaurav Kumar 
Designation  PG SCHOLAR 
Affiliation  All India Institute of Ayurveda 
Address  room no- 403 4th floor department of kaumarbharitya bala roga academic block all india institute of ayurveda sarita vihar new delhi 110076

North East
DELHI
110094
India 
Phone  8799776550  
Fax    
Email  gk8799776550@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gaurav Kumar 
Designation  PG SCHOLAR 
Affiliation  All India Institute of Ayurveda 
Address  room no- 403 4th floor department of kaumarbharitya bala roga academic block all india institute of ayurveda sarita vihar new delhi 110076

North East
DELHI
110094
India 
Phone  8799776550  
Fax    
Email  gk8799776550@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Gaurav Kumar 
Designation  PG SCHOLAR 
Affiliation  All India Institute of Ayurveda 
Address  room no- 403 4th floor department of kaumarbharitya bala roga academic block all india institute of ayurveda sarita vihar new delhi 110076

North East
DELHI
110094
India 
Phone  8799776550  
Fax    
Email  gk8799776550@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  All India Institute of Ayurveda 
Address  Mathura Road,Gautampuri Awas, Sarita Vihar, New Delhi, Delhi 110076 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Gaurav Kumar  All India Institute of Ayurveda  room no- 403 4th floor department of kaumarbharitya bala roga academic block all india institute of ayurveda sarita vihar new delhi 110076
South
DELHI 		 8799776560

gk8799776550@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: DARUNAKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-aBya~ggaH, अभ्यंग  (Procedure Reference: charaka sutrasthana, Procedure details: shiroabhyanga)
(1) Medicine Name: gunjadi taila, Reference: chakradutta, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 21 Days
(2) Medicine Name: dhaturadi taila, Reference: sahasrayoga, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 21 Days
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  The patient, presenting with classical features of Darunaka, (as mentioned in the diagnostic criteria, or at least two symptoms - itching and flaking) will be included.
Patients aged 5 to 16 years of any gender falling in diagnostic criteria.
Patients who are willing to participate and give a written informed consent/assent.
 
 
ExclusionCriteria 
Details  1.Patients with other scalp disorders such as psoriasis etc.
2.Children with congenital anomalies, chronic diseases, or any other systemic illness.
3.Patients having fungal infection over the scalp other than dandruff.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare the clinical efficacy of Shiro Abhyang of Dhaturadi taila and Gunjadi taila in the management of Darunaka (Dandruff) based on changes in ASFS(adherent scalp flaking score) scale.
 		 7 days, 14 days, 21days, 35 days, 49 days 
 
Secondary Outcome  
Outcome  TimePoints 
1.Reduction in subjective symptoms such as itching, falling of hair &
loosely adherent flakes over the scalp.
2.Improvement in the quality of life of the child as per the Children’s Dermatological Life Qualit Index (CDLQI) (Expected 90% improvement)
 		 7 days, 14 days, 21days, 35 days, 49 days 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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)   01/01/2027 
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="0"
Months="1"
Days="20" 
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 titled A Comparative Clinical Evaluation of the Efficacy of Dhaturadi Taila and Gunjadi Taila as Shiro Abhyanga for the Management of Darunaka Dandruff is an open label randomized controlled trial conducted in children aged 5 to 16 yearsDandruff is a common scalp condition in which dryness itching and flaking occur due to irritation or imbalance of the scalp In Ayurveda the condition Darunaka is described as a disorder associated with roughness itching dryness scaling and hair fall caused by vitiated Vata and Kapha dosha Although Dhaturadi Taila and Gunjadi Taila are traditionally used for scalp disorders clinical comparative evidence in children is lacking Children aged 5 to 16 years presenting with at least two symptoms of Darunaka such as itching and flaking and whose parents provide consent will be included Children with psoriasis eczema scalp infections other systemic illnesses or hypersensitivity to the oils will be excluded The study will include 64 participants randomly allocated into two groups receiving either Dhaturadi Taila or Gunjadi Taila for daily Shiro Abhyanga for 21 days The primary outcome will be change in the Adherent Scalp Flaking Score and secondary outcomes include improvement in itching hair fall flakes and Childrens Dermatology Life Quality Index Follow up will be conducted up to day 49 The total study budget is Rupees 70000.
 
Close