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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  
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 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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L409||Psoriasis, unspecified. Ayurveda Condition: EKAKUSHTHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(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 TridoshasEk 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

 

 
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