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CTRI Number  CTRI/2024/06/069564 [Registered on: 26/06/2024] Trial Registered Prospectively
Last Modified On: 26/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Other 
Public Title of Study   To Study the Efficacy of Priyalbeejadi Lepa in the Management of Darunaka w.s.r Pityriasis Capitis 
Scientific Title of Study   A Randomized Open Labelled Controlled Clinical Study to evaluate the Efficacy of Priyalbeejadi Lepa in the Management of Darunaka w.s.r Pityriasis Capitis 
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 DEEKSHANT THAKUR 
Designation  PG SCHOLAR  
Affiliation  JAMMU INSTITUTE OF AYURVEDA AND RESEARCH JAMMU 
Address  P.G. DEPARTMENT OF KAYACHIKITSA,JAMMU INSTITUTE OF AYURVEDA AND RESEARCH,NARDNI,JAMMU,JAMMU AND KASHMIR

Jammu
JAMMU & KASHMIR
181123
India 
Phone  9103709219  
Fax    
Email  thakurdeekshant9295@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR POONAM GUPTA 
Designation  ASSOCIATE PROFESSOR 
Affiliation  JAMMU INSTITUTE OF AYURVEDA AND RESEARCH JAMMU 
Address  P.G. DEPARTMENT OF KAYACHIKITSA,JAMMU INSTITUTE OF AYURVEDA AND RESEARCH,NARDNI,JAMMU,JAMMU AND KASHMIR

Jammu
JAMMU & KASHMIR
181123
India 
Phone  9149696904  
Fax    
Email  drpoonamgupta03@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR POONAM GUPTA 
Designation  ASSOCIATE PROFESSOR 
Affiliation  JAMMU INSTITUTE OF AYURVEDA AND RESEARCH JAMMU 
Address  P.G. DEPARTMENT OF KAYACHIKITSA,JAMMU INSTITUTE OF AYURVEDA AND RESEARCH,NARDNI,JAMMU,JAMMU AND KASHMIR

Jammu
JAMMU & KASHMIR
181123
India 
Phone  9149696904  
Fax    
Email  drpoonamgupta03@gmail.com  
 
Source of Monetary or Material Support  
JAMMU INSTITUTE OF AYURVEDA AND RESEARCH,NARDNI ,JAMMU,JAMMU AND KASHMIR 181123 INDIA 
 
Primary Sponsor  
Name  JAMMU INSTITUTE OF AYURVEDA AND RESEARCH JAMMU 
Address  JAMMU INSTITUTE OF AYURVEDA AND RESEARCH,NARDNI ,JAMMU,JAMMU AND KASHMIR 181123 INDIA 
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 DEEKSHANT THAKUR  JAMMU INSTITUTE OF AYURVEDA AND RESEARCH JAMMU  P.G. DEPARTMENT OF KAYACHIKITSA,OPD and IPD of hospital,NARDNI, JAMMU, JAMMU AND KASHMIR- 181123
Jammu
JAMMU & KASHMIR 
9103709219

thakurdeekshant9295@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE JAMMU INSTITUTE OF AYURVEDA AND RESEARCH JAMMU  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
1Comparator ArmProcedure-lepa, लेप (Procedure Reference: Shribhava Prakash , Procedure details: Initially the patient will be advised to clean the head with cold water. Application of Aamrabeeja Haritaki Churna is mixed with Milk to form thick paste and is applied on the affected areas. Thickness of the Lepa-1/4 angula Patient is asked to wash the head with cold water before the lepa dries. Application of lepa for 30 days on alternative days)
2Intervention ArmProcedure-lepa, लेप (Procedure Reference: Astang Samgraha Uttarsathana 28/33 , Procedure details: Initially the patient will be advised to clean the head with cold water. Application of Priyalbeejadi churna mixed with Madhu to form thick paste and is applied on the affected areas. Thickness of the Lepa-1/4 angula Patient is asked to wash the head with cold water before the lepa dries. Application of lepa for 30 days on alternative days)
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1.Subjects aged between 16-40 years.
2.Patient representing signs and symptoms of Darunaka who will be willing to participate in the study.
3.Subjects willing to participate with written informed consent, which is conveyed in the language which the subject can understand.

 
 
ExclusionCriteria 
Details  1.Eczema of scalp.
2.Psoriasis of scalp.
3.Immune- compromised conditions.
4.Conditions in which head wash is restricted like Pratishyaya , injuries to scalp etc.
5.Pregnant and lactating women.
6.Subjects with uncontrolled systemic illness including diabetes mellitus, hypertension.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Patients of both sexes age group 16 to 40 years of Darunaka will be selected for relieving sign and symptoms  Patients of both sexes age group 16 to 40 years of Darunaka will be selected for relieving sign and symptoms 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/01/2025 
Date of Study Completion (India) 07/05/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="1"
Days="15" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

Ayurveda is the first and foremost spiritual science that offers a scientific approach to live in harmony with nature. Ayurveda is the most ancient healing science and ideal approach for an appropriate life style. According to this science, proper choice of Ahara  and Vihara helps to achieve healthy life by maintaining and / or restoring equilibrium of the body and mind.

In Ayurveda, Shira is said to be root of the plant for possessing all special senses and Prana, so one has to protect and care the Shira. Acharyas have explained different Shiroroga out of which Darunaka is one among them. Acharya Vagbhata have described 19 Shiroroga out of which 9 are Shirokapalaroga and “Darunaka” is one among them. Acharya Sushruta has included “Darunaka” under Kshudrarogas. It is a Roga affecting mainly the Kapala,  that is scalp and it also hampers the normal healthy status of hair.Shirapradeshi Kandu (itching), Rukshata (dryness), Shirotwaka Sphutanam (cracking of the scalp skin with fine flakes), and Keshachyuti (hair-fall) are the cardinal symptoms of Darunaka which involves mainly vitiated Vata and Kapha Doshas.

Darunaka can be correlated with Pityriasis capitis also referred to as Pityriasis simplex capitis,  it is generally referred to as Dandruff. Pityriasis capitis is a disease characterized by itchy scalp and flakiness .Several microbial and non-microbial etiologies are considered for pathogenesis. Increased presence of Malassezia restricta has been reported as the key microbial etiological factor. Increased sebaceous gland activity, decreased skin hydration, skin irritation, immune suppression, or oxidative stress have also been proposed as non-microbial etiologies.

 Due to frequent recurrences, Pityriasis Capitis represented as a very common dermatologic scalp condition in a wide range of population with estimating prevalence of 60.1% in South Asia, whereas 50% worldwide.Pityriasis Capitis is a scalp disorder affecting more than half of the global population. A survey in the United States showed that 50 million people suffer from dandruff annually and the prevalence is sharply increasing due to rapid urbanization.It occurs more frequently in adolescents, young adults.

Pityriasis Capitis is a scalp disorder with high rate of prevalence .There are many market preparations which are advised by modern dermatologists but it has some limitations as the effect is not long-lasting or cost of treatment is very high. As satisfactory results are not available, Patients are continuously looking with hope towards Ayurveda. Ayurveda plays an important role in the management of Darunaka as its unique treatment modality provides long-lasting results through three basic principles of treatment that is Nidana Parivarjana, Shodhana Chikitsa, and Shamana Aushadhis. Sthanika Chikitsa in terms of Lepa and Dhavana is also important in order to relieve the symptoms and nourish the hair.In present study one such formulation of Lepa which is given in Astang Samgraha Uttarsathana 28/33  is Priyalbeejadi Lepa(Trial drug) is taken to assess its efficacy on Darunaka wsr  to Pityriasis Capitis  and  compared with Aamrabeeja Haritaki Lepa (controlled)

 
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