| CTRI Number |
CTRI/2025/11/097071 [Registered on: 07/11/2025] Trial Registered Prospectively |
| Last Modified On: |
07/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Management Of Ek Kustha Through Shashankalekhadi Leha And Jivantyadi Lepa |
|
Scientific Title of Study
|
Effect of Shashankalekhadi Leha And Jivantyadi Lepa As Described In Ashtang Hridayam For The Management Of Ek Kustha W.S.R. To Psoriasis A Clinical Study |
| 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 ROHIT |
| Designation |
MD SCHOLAR |
| Affiliation |
Govt Ayurveda College Nipaniya Rewa MP |
| Address |
Dept of Samhita Siddhant Govt Ayurveda College Nipaniya
Rewa MP
Rewa
MADHYA PRADESH
486001
India
Rewa MADHYA PRADESH 486001 India |
| Phone |
7987865217 |
| Fax |
|
| Email |
rp199162@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR Vivek Shrivastava |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Govt Ayurveda College Nipaniya Rewa MP |
| Address |
Dept of Samhita Siddhant Govt Ayurveda College Nipaniya
Rewa MP
Rewa
MADHYA PRADESH
486001
India
Rewa MADHYA PRADESH 486001 India |
| Phone |
9827737208 |
| Fax |
|
| Email |
drvivek.stv@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR Vivek Shrivastava |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Govt Ayurveda College Nipaniya Rewa MP |
| Address |
Dept of Samhita Siddhant Govt Ayurveda College Nipaniya
Rewa MP
Rewa
MADHYA PRADESH
486001
India
Rewa MADHYA PRADESH 486001 India |
| Phone |
9827737208 |
| Fax |
|
| Email |
drvivek.stv@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt Ayurveda College Nipaniya Rewa MP |
|
|
Primary Sponsor
|
| Name |
Govt Ayurveda College Nipaniya Rewa MP |
| Address |
Govt Ayurveda College Nipaniya Rewa MP PIN CODE 486001 |
| Type of Sponsor |
Government medical college |
|
|
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 ROHIT |
Govt Ayurveda College Nipaniya Rewa MP |
Dept of Samhita Siddhant Govt Ayurveda College Nipaniya
Rewa MP
486001
Rewa
MADHYA PRADESH
486001
India Rewa MADHYA PRADESH |
07987865217
rp199162@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Govt Ayurveda college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L409||Psoriasis, unspecified. Ayurveda Condition: EKAKUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: SHASHANKALEKHADI LEHA, Reference: A.H.Chi. 19 by 46, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Til Tail), Additional Information: NIL |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Ek kustha patient which will diagnosed as per the criteria
Patient willing to sign consent from for trial |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women
Systemic Disorders as Diabetic patients cardiac problem paralysis malignancy HIV leprosy
Below 16years and above 70year Patients are excluded
Patient who will under going in any surgery
Disease chronicity more than 5 year
Patients suffering from psoriatic Arthritis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| improvement in subjective parameters like Itching Sweating Erythema Eruption |
ON 0 DAYS TO 30 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvement in subjective parameters like Itching Sweating Erythema Eruption |
ON 0 DAYS TO 30 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 3 |
|
Date of First Enrollment (India)
|
30/04/2026 |
| 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="2" Months="0" 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
|
TITLE EFFECT OF SHASHANKALEKHADI LEHA AND JIVANTYADI LEPA AS DESCRIBED IN ASHTANG HRIDAYAM FOR THE MANAGEMENT OF EK-KUSTHA W.S.R. TO PSORIASIS A CLINICAL STUDY In Ayurveda all skin disorders are classified under Kustha, which arises from the aggravation of Tridoshas. Ek Kustha a type of Kshudra Kustha is mainly caused by the vitiation of Vata and Kapha doshas and closely resembles psoriasis a chronic autoimmune skin disease characterized by erythematous scaly plaques on areas like the elbows knees and scalp Samprapti Due to Nidana sevan Tridosha become vitiated and cause shithilatain Twak Rakta Mamsa and Ambu dhatus resulting in the manifestation of Ek Kustha Symptoms Rashes dryness fissures scaling itching redness and joint stiffness are common Need for Research Psoriasis affects 0.44 to 2.8 of Indians, more common in males. The disease has significant psychological impacts including depression and suicidal tendencies Conventional treatments like steroids and immunosuppressants have long-term side effects creating a need for safe and effective Ayurvedic alternatives Study Design An openlabeled single arm prospective clinical trial on 30 patients for 30 days with a 2 month followup Patients aged 16 to 70 years were selected based on Ayurvedic diagnostic criteria Exclusion Criteria Pregnancy systemic diseases chronic cases over 5 years psoriatic arthritis or those unwilling to continue were excluded Probable Mode of Action Shashankalekhadi Leha Contains Bakuchi Vidanga Pippali Chitraka Amalaki and Mandoor Bhasm Balances Vata and Kapha dosha Amalaki and Mandoor Bhasma reduce inflammation, act as antioxidants, and have Rasayana and Kushtaghna effects Bakuchi’s psoralen compounds inhibit epidermal proliferation and modulate immune activity Jivantayadi Lepa Contains Jivanti Manjistha Daru Haridra Kampillaka Madar Tutha Sarjarasa and Madhuchista Reduces itching redness and dryness Possesses antiinflammatory, antibacterial woundhealing and Kushtaghna properties TREATMENT REGIMEN Drug SHASHANKALEKHADI LEHA JIVANTYADI LEPA Form Leha lepa Dose 3gm BD ¼ anguli Route of Administration Oral Local application Time of Administration Morning and evening Morning and evening Treatment Course 30 days 30 days Follow up 2 months 2 months Anupan Til Taila |