| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L638||Other alopecia areata. Ayurveda Condition: KSHUDRAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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. |