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CTRI Number  CTRI/2021/04/033249 [Registered on: 29/04/2021] Trial Registered Prospectively
Last Modified On: 14/04/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Gunjaadi taila and Kantakaari taila in treatment of Dandruf 
Scientific Title of Study   A Randomized Comparative Clinical study to assess the safety and efficacy of Gunjaadi Taila and Kantakaari Taila in the patients of Daarunaka with special reference to Dandruff 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shweta Kumari Yadav 
Designation  Pg scholar Dravyaguna dept NIA Jaipur 
Affiliation  National institute of Ayurveda, Jaipur,Rajasthan,302002 
Address  National Institute of Ayurveda, Dravyguna department room number 137 ,jorawar singh gate amer road Jaipur Rajasthan
National Institute of Ayurveda, Dravyguna department room number 137 ,jorawar singh gate amer road Jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India 
Phone  8504000613  
Fax  0  
Email  dji05003@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sumit Nathani 
Designation  Associate Professor 
Affiliation  national institute of ayurveda jaipur rajasthan 302002 
Address  National Institute of Ayurveda Dravyguna Departement Room number 137 ,jorawar singh gate amer road Jaipur Rajasthan
National Institute of Ayurveda Dravyguna Departement Room number 137 ,jorawar singh gate amer road Jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India 
Phone  7665809886  
Fax  0  
Email  sumitnathani2@rediff.com  
 
Details of Contact Person
Public Query  
Name  Dr Shweta Kumari Yadav 
Designation  Pg scholar Dravyaguna dept NIA Jaipur 
Affiliation  National institute of ayurveda JAIPUR 
Address  National Institute of Ayurveda Dravyguna Department Room number 137, jorawar singh gate amer road Jaipur Rajasthan
National Institute of Ayurveda Dravyguna Department Room number 137, jorawar singh gate amer road Jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India 
Phone  8504000613  
Fax    
Email  dji05003@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda jorawar singh gate amer road jaipur 
 
Primary Sponsor  
Name  National institute of ayurveda jaipur 
Address  jorawar singh gate amer road jaipur rajasthan 302002  
Type of Sponsor  Research institution and hospital 
 
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 Shweta Kumari Yadav  National institute of ayurveda   OPD NO. 19 Dept of Dravyaguna jorawar singh gate amer road jaipur Rajasthan 302002
Jaipur
RAJASTHAN 		 8504000613

dji05003@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, National Institute of Ayurved Jaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L088||Other specified local infections of the skin and subcutaneous tissue. Ayurveda Condition: DARUNAKAH,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Gunjaadi taila Kantakaari taila tila taila  Group A- Dose: Gunjaadi taila as required for application (10-15 ml),twice in a week Duration: treatment period for 6 weeks ; follow up 2 weeks Route of administration: Local application on scalp and gentle massage for 5-10 min. Group B- Dose- Kantakaari taila as required for application(10-15 ml),twice in a week Duration –treatment period for 6 weeks ;follow up 2 weeks Route of administration: Local application on scalp and gentle massage for 5-10 min.  
Comparator Agent  Tila taila  Dose - Taila taila as required for application (10-15 ml)twice in a week. Duration -treatment peroid for 6 week:follow up Route of administration :local application on scalp and gentle massage for 5-10 min 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Inclusion criteria:
Patients of irrespective gender & socio economic status
Patients between age group of 18-60 years
Patients with symptoms of Daarunaka(Dandruff).
Known cases of Daarunaka (Dandruff) who are willing to participate to study. 
 
ExclusionCriteria 
Details  Exclusion criteria:
Any reaction shown after application of trial drug.
Patients with clinically significant systematic disease eg. Immunological deficiency,
AIDS, current malignanicies, uncontrolled diabetes mellitus etc.
Other scalp disorders like Psoriasis, Tineacapitis etc.
Pregnant and lactating woman
Systemic treatment with corticosteroids, antibiotics, immunosuppressantsetc , or topical
treatments applied to the scalp within 7 days before inclusion in the study and that could
interfere with the results of the study like ketoconazole, antidandruff shampoo etc. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
change in ASFS(Adherent scalp flaking score)
change in Score of prurites  		 6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
improvement in itching ,white scaly like structure ,dryness in scalp  6 weeks follow up 2 weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   15/06/2021 
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   none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Introduction Daarunaka as a disease is classified under kshudrarogas. This condition is manifested due to vitiation of vata and kapha doshas which results in dryness and itching in the scalp which further leads to scaling. Daarunaka has symptoms like itching, white scaly like structures, dryness in scalp. 1 दारुणाकण्डुरारुक्षाकेश्भूमिप्रपाटय़ते। कफवातप्रकोपेणववद्यात्दारुणकंतुति॥् सु०नि०१३/३४ Nearest correlate to Daarunaka is Dandruff which according to modern science is a common disorder affecting the scalp and can be an embarrassing condition. Dandruff is restricted to the scalp, and involves itchy, flaking skin without visible inflammation. Seborrheic dermatitis affects the scalp as well as face, retro-auricular area, and the upper chest, causing flaking, scaling, inflammation and pruritus, and can have marked erythema2 .Histologically, the major differences between the dandruff and non dandruff specimens were in the horny layer. Normally, the scalp horny layer consists of 25-35 fully keratinized, closely coherent cells arranged in an orderly pattern. In dandruff, the intact horny layer usually has fewer than 10 cells, parakeratotic cells are common, and the pattern is disordered3 . The aetiology of dandruff is multifactorial, influenced by Malassezia, sebum production and individual susceptibility. Dandruff affects about half of adults, with males more often affected than females. People in all areas of the world are affected. Onset is usually at puberty and it becomes less common after the age of 50.There are various reasons which can cause dandruff in hair, e.g. increased intake of dry, oily, cold, spicy, stress, anxiety, certain diseases such as psoriasis, seborrheic dermatitis, eczema, hyperactivity of the sebaceous glands such as sweat glands, environmental allergens such as dust, sunlight, soaps, shampoos and even certain types of food are sometimes responsible for dandruff4 .Dandruff (also called scurf or pityriasiscapitis) is caused due to excessive shedding of dead skin. It is characterized by scaling of the scalp, and is frequently associated with seborrhoea, which is the precursor of seborrheic dermatitis. The yeast, pityrosporumovale is the causative microorganism of dandruff5 . For the treatment of Daarunaka many formulations are mentioned In Ayurvedic texts, out of which Gunjaadi taila and Kantakaari taila have been taken for this study. Need of study: In the Current scenario many chemical substances are in use for treating dandruff and these agents have certain limitation such as recurrence of dandruff and their harmful effects on skin after using it for long period are common. Gunjaadi taila and Kantakaari taila are Ayurvedic medicinal preparations mentioned in Yogaratanakara which are small and simple preparations being used in Daarunaka. Ingredients of these tailas have been subjected to anti microbial studies with promising effect on Malasazia strains which care one of the main causes of Dandruff. Few studies on Gunjaadi taila have been conducted but no clinical study depicting the efficacy and safety of Kantakaari taila was found. Therefore this study is planned to evaluate and compare the efficacy and safety of Kantakaari taila and Gunjaadi taila.  
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