FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/07/055147 [Registered on: 12/07/2023] Trial Registered Prospectively
Last Modified On: 23/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Bhringarajaadi Taila and Gunjaadi Taila in Dandruff. 
Scientific Title of Study   A Randomized comparative clinical study of Bhringarajaadi Taila and Gunjaadi Taila as external application in the management of Darunaka 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 Mital G Rabadiya 
Designation  PG Scholar 
Affiliation  National Institute of Ayurveda, jaipur 
Address  Department of Dravaguna Vigyana, National institute of Ayurveda, Deemed to be University(De-novo) Jorawar singh gate, Amer road, Jaipur
Department of Dravaguna Vigyana, National institute of Ayurveda, Deemed to be University(De-novo) Jaipur
Jaipur
RAJASTHAN
302002
India 
Phone  7046226624  
Fax    
Email  mitalrabadiya15@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Tarun Sharma 
Designation  Assistant Professor 
Affiliation  National Institute of Ayurveda, jaipur 
Address  Department of Dravaguna Vigyana, National institute of Ayurveda, Deemed to be University(De-novo) Jorawar singh gate, Amer road, Jaipur
Department of Dravaguna Vigyana, National institute of Ayurveda, Deemed to be University(De-novo) Jaipur
Jaipur
RAJASTHAN
302002
India 
Phone  9887701733  
Fax    
Email  tarunsharma1286@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mital G Rabadiya 
Designation  PG Scholar 
Affiliation  National Institute of Ayurveda, Jaipur 
Address  Department of Dravaguna Vigyana, National institute of Ayurveda, Deemed to be University(De-novo) Jorawar singh gate, Amer road, Jaipur
Department of Dravaguna Vigyana, National institute of Ayurveda, Deemed to be University(De-novo) Jaipur
Jaipur
RAJASTHAN
302002
India 
Phone  7046226624  
Fax    
Email  mitalrabadiya15@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda, jaipur, Rajasthan 
 
Primary Sponsor  
Name  National Institute of Ayurveda department Jaipur, Rajasthan 
Address  National Institute of Ayurveda department Jaipur, Rajasthan 
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 Mital G Rabadiya  National Institute Of Ayurveda  Department of Dravaguna Vigyana,
Jaipur
RAJASTHAN 
7046226624

mitalrabadiya15@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics comittee of Ayurveda deemed to be university  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L210||Seborrhea capitis. Ayurveda Condition: DARUNAKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Gunjaadi Taila, Reference: Yogaratnakara/ Kshudraroga/ 107, Route: Topical, Dosage Form: Taila, Dose: 15(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Bhringarajaadi Taila, Reference: Yogaratnkara/ Kshudraroga/ 106, Route: Topical, Dosage Form: Taila, Dose: 15(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Patients of irrespective gender & socio-economic status.
2 Patients between age group of 18-60 years.
3 Patients with symptoms of Darunaka (Dandruff).
4 Known cases of Darunaka (Dandruff) who are willing to participate to study.
 
 
ExclusionCriteria 
Details  1 Patients with clinically significant systematic disease eg. Immunological deficiency, AIDS,
current malignancies, uncontrolled diabetes mellitus etc.
2 Other scalp disorders like Psoriasis, Tinea capitis etc.
3 Pregnant and lactating woman
4 Systemic treatment with corticosteroids, antibiotics, immune suppressants etc, 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   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
relief in Darunaka(Dandruff)  6 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Relief in itching
Control in hair fall
 
6 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/ Phase 3 
Date of First Enrollment (India)   16/08/2023 
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  

There is nothing like healthy hair to make an individual feel confident and beautiful. Unhealthy hair is always a reason of concern not just for females but also for males. Damaged hair and scalp are always frustrating factor for youth. Hair is associated with youthfulness and beauty in women and muscularity in men; so, it is no surprise that hair loss can make any men and women feel self-conscious. Pollution. unhygienic conditions and many more factors can cause hair problem.

Darunaka is classified as one among kapalagataroga by Acharya Vagbhatta & Sharangdhara and one among kshudraroga by Acharya Sushruta & others. Darunaka is characterized by kandu(itching), keshbhoomiprapatyate(scaling of the scalp), rukshata (dryness and roughness of scalp) etc and all these symptoms are due to vitiation of Kapha and Vata doshas[1].

दारुणाकण्डुरारूक्षाकेशभूमिःप्रपाट्यते॥

कफवातप्रकोपेणविद्याद्दारुणकंतुतम्॥ [सु०नि०१३/३४]

Darunaka can be correlated to dandruff in contemporary science. Dandruff is a common disorder affecting half of the population at the pre pubertal age and of any gender and ethnicity.[2] Dandruff is 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 pruritis and can have marked erythema.[3]

The word dandruff (dandruff, dandriffe) is of Anglo-Saxon origin, a combination of ‘tan’ meaning ‘tetter’ and ‘drof’ meaning ‘dirty’. Dandruff affects aesthetic value and often causes itching. It has been well established that keratinocytes play a key role in the expression and generation of immunological reactions during dandruff formation.[4]

There are several microbial and nonmicrobial causes of dandruff like over shampooing, frequent combing, dust, dirt, dry skin, Seborrheic dermatitis sensitivity to hair care products or yeast. Among the several etiopathology pathway’s role of lipophilic yeast belongs to genus Malassezia was widely accepted. Seven species of Malassezia (i.e., M. globose, M. restricta, M. obtuse, M. sloofiae, M.sympodialis, M.furfur and M. pachydermatis) have been recognized in dandruff formation.(5) Among these, Malassezia globose and Malassezia restricta are recognized as the most important pathogenic organisms in the development of dandruff.[6]

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 Bhringarajaadi Taila are medicinal preparations mentioned in Yogaratanakara which are small and simple preparations being used in Darunaka. All ingredients of both Taila are easily available and cheaper in cost so every patient can afford easily. Comparison of Gunjaadi Taila, Kantkari Taila and Tila Taila has been done in our department previously in which GunjadiTaila found more effective in comparison to Kantkari Taila and Tila Taila.So we are comparing here Bhringarajaadi Taila with Gunjaadi Taila. Therefore, this study is planned to evaluate and compare the efficacy of Bhringarajaadi Taila and Gunjaadi Taila in the patients of darunaka (dandruff).

 
Close