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CTRI Number  CTRI/2025/07/091329 [Registered on: 21/07/2025] Trial Registered Prospectively
Last Modified On: 21/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   To evaluate the efficacy of japakusum Lepa in the management of indralupta with special reference to alopecia areta 
Scientific Title of Study   Single arm clinical study to assess the efficacy of Japakusum lepa in Indralupta with special refernce to Alopecia Areata  
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 Nikita Arjun Thorat 
Designation  MS Scholar Shalakyatantra 
Affiliation  LRP Ayurvedic Medical College And Research Centre 
Address  Department of shalakyatantra Unit1 LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Centre Islampur Sangali

Sangli
MAHARASHTRA
415409
India 
Phone  9284298562  
Fax    
Email  nikithorat3@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pravin Chavan 
Designation  HOD and Professor 
Affiliation  LRP Ayurvedic Medical College And Research Centre 
Address  Department of shalakyatantra Unit1 LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Centre Islampur Sangali

Sangli
MAHARASHTRA
415409
India 
Phone  9822338613  
Fax    
Email  drpravin999@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pravin Chavan 
Designation  HOD and Professor 
Affiliation  LRP Ayurvedic Medical College And Research Centre 
Address  Department of shalakyatantra Unit1 LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Centre Islampur Sangali

Sangli
MAHARASHTRA
415409
India 
Phone  9822338613  
Fax    
Email  drpravin999@gmail.com  
 
Source of Monetary or Material Support  
LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Centre Islampur Sangli-415409 Maharashtra,India 
 
Primary Sponsor  
Name  LRP Ayurvedic Medical College and Research Centre 
Address  LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Centre Islampur Sangli-415409, Maharashtra,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 Nikita Arjun Thorat   LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Centre  Department of Shalakya Tantra Unit 1 LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Centre Islampur Sangli, Maharashtra Sangli MAHARASHTRA 415409 India
Sangli
MAHARASHTRA 
9284298562

nikithorat3@gmail.com  
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L638||Other alopecia areata. Ayurveda Condition: KSHUDRAROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Japakusum Lepa, Reference: Rajmartand shirorogadhikar 1/7, Route: Topical, Dosage Form: Lepa Churna, Dose: 105(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: -Doshagna lepa thickness 1/4th anguli
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1 Patients having signs and symptoms of Indralupta 2 Patient of Indralupta from any community irrespective of their religion socioeconomic status hygiene condition
3 Patient willing to give consent for clinical trial 
 
ExclusionCriteria 
Details  Patients below 18yrs and above 50 years of age group
2) Patients having systemic disease with complications which can lead to interference with the study
3) Unstable patients
4) Any other local treatment for Indralupta
5) Pregnant women
6) Patient on chemotherapy 
 
Method of Generating Random Sequence   Other 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Evaluation the efficacy of japakusum lepa in Indralupta   21 days  
 
Secondary Outcome  
Outcome  TimePoints 
To reduce the indralupta in 21 days To study the literature related to concept of indralupta To study the concept of japakusum lepa in indralupta  21 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 1/ Phase 2 
Date of First Enrollment (India)   05/08/2025 
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="2" 
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  
Ayurveda stands as the oldest surviving medical system globally with long record of clinical experience. The central objective of ayurveda is to promote individual well being by employing both preventive and curative method. Our Acharya divided ayurveda into 8 branches which deals with different parts of body. Among the astanga, urdhavaka chikitsa or shalakya chikitsa is described urdhvanga chikitsa is also known as urdhava jatrugata chikitsa .
    In todays world of advanced science many people still turn to Ayurveda for treating chronic disorders  for beauty treatments, primarily due to the minimal adverse effects associated with Ayurvedic medicines. Hair plays a significant role in personality, beauty, and confidence. For centuries, people have used various herbal packs, washes, and hairstyles to enhance their appearance. Common hair issues that affect an individuals beauty include graying, hair loss, roughness, brittle hair, split ends, and dandruff.
Indralupta described kapalgatroga by AcharyaVaghbhatta and in kshudraroga by Acharya Sushrut. Alopecia areata is an autoimmune disease characterized by patchy hair loss commonly on scalp and facial region can be correlated with Indralupta. Alopecia areata has become a significant health concern in the 21st century, largely due to changes in lifestyle, the widespread adaptation of western culture, unhealthy dietary habits and race for cosmetics.
Even though medical science has advanced to a great extent in the field of cosmetology and trichology, but still there is no definite cure for present condition. Treatment option include topical and systemic steroids. Topical irritants and immunotherapy which create an allergic reaction with the production of T-suppressor cells which inhibit an auto immune reaction.
Minoxidil  is an anti-hypertensive vasodilator primarily treating for hair loss common side effect includes eye irritation, itching redness and irritation at application site along with unwanted hair growth in other areas. Due to side effect and limitation of contemporary science, effective and harmless treatment procedure is expected from alternative medical science.
Ayurveda has great potential to treat such autoimmune disease. A study is being planned to develop an efficient remedy that could greatly beneficial for the patient who is suffering from Indralupta.
Acharya Sushruta has preferred upkrama like application of lepa etc in some cases. Indralupta is one such disorder where lepa has been advocated. lepa refer to application of medicated paste or packs on the affected area. The goal of lepa treatment in Indralupta is to stimulate growth and balance the doshas.
 
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