| CTRI Number |
CTRI/2025/11/096940 [Registered on: 06/11/2025] Trial Registered Prospectively |
| Last Modified On: |
07/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Study To Evaluate The Efficacy Of Virechana Karma And Shashanka Lekhadi Churna In The Management Of Psoriasis |
|
Scientific Title of Study
|
A Clinical Study To Evaluate The Efficacy Of Virechana Karma And Shashanka Lekhadi Churna In The Management Of Ek Kushtha With Special Reference To Psoriasis |
| 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 Ayush Kamboj |
| Designation |
M.D. Scholar |
| Affiliation |
Government PG Ayurvedic College and Hospital, Chaukaghat, Varanasi |
| Address |
Department Of Panchakarma, Government PG Ayurvedic College and Hospital, Chaukaghat, Varanasi
Varanasi
UTTAR PRADESH
221001
India |
| Phone |
8449484358 |
| Fax |
|
| Email |
ayushka2628@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ayush Kamboj |
| Designation |
M.D. Scholar |
| Affiliation |
Government PG Ayurvedic College and Hospital, Chaukaghat, Varanasi |
| Address |
Department Of Panchakarma, Government PG Ayurvedic College and Hospital, Chaukaghat, Varanasi
Varanasi
UTTAR PRADESH
221001
India |
| Phone |
8449484358 |
| Fax |
|
| Email |
ayushka2628@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ayush Kamboj |
| Designation |
M.D. Scholar |
| Affiliation |
Government PG Ayurvedic College and Hospital, Chaukaghat, Varanasi |
| Address |
Department Of Panchakarma, Government PG Ayurvedic College and Hospital, Chaukaghat, Varanasi
Varanasi
UTTAR PRADESH
221001
India |
| Phone |
8449484358 |
| Fax |
|
| Email |
ayushka2628@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government PG Ayurvedic College and Hospital, Chaukaghat, Varanasi |
|
|
Primary Sponsor
|
| Name |
Government PG Ayurvedic College and Hospital,Chaukaghat, Varanasi |
| Address |
Department of Panchakarma, Government PG Ayurvedic College and Hospital,Chaukaghat, Varanasi, Uttar Pradesh 221001 |
| 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 Ayush Kamboj |
Government PG Ayurvedic College and Hospital, Chaukaghat, Varanasi |
OPD no.-8/11 of Kayachikitsa and Panchakarma, Government PG Ayurvedic College and Hospital, Chaukaghat, Varanasi, Uttar Pradesh 221001
Varanasi
UTTAR PRADESH |
08449484358
ayushka2628@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, Government Ayurveda College and Hospital, Varanasi, U.P.,Mahayogi Guru Gorakhnath AYUSH University, Gorakhpur, U.P. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L404||Guttate psoriasis. Ayurveda Condition: EKAKUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | | | 2 | Intervention Arm | Procedure | - | | (Procedure Reference: , Procedure details: )
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient presenting with cardinal symptoms of Ek Kushtha i.e. Aswednam Mahavastu and Matsyashaklopamam.
2.Symptoms of Psoriasis like Erythematous scaly
plaques Itching Dryness.
3.Patients with Immunosuppresive and Corticosteroid drugs as well as other modern medicine, if it will be tapped gradually with complete washout period
of 2 weeks.
4.History of Ek kushtha less than 1 year.
5.Patient indicated for Virechana Karma. |
|
| ExclusionCriteria |
| Details |
1.Patient not fitting in the criteria of Virechana karma.
2.Patient having history of other active Inflammatory or Rheumatic Disease Gouty Arthritis Severe Articular Inflammation.
3.Patients age above 60yrs.
4.Patient with severe Haematological and Hepatic, Renal disorders Tuberculosis patients of Autoimmune joint disorder or any other comorbidities. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in Erythematous scaly plaques, Itching, Dryness |
Relief in Erythematous scaly plaques, Itching, Dryness |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/12/2025 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
This study is Randomized, Parallel group study trial to evaluate the efficacy of Shashanka Lekhadi Churna and Virechana Karma in the management of Ek Kushtha(Psoriasis) Patients willbe selected randomly from OPD and iPD of Department of Kayachikitsa and Panchakarma, Government P.G. Ayurvedic College and Hospital, Varanasi. A total no. of 60 patients will be studied under two groups having 30 patients in each group- Group A: In this group, 30 patients will be administered with Virechana Karma Group B: In this group, 30 patients will be administered with Shashanka Lekhadi Churna for 30 days. Two follow ups will be done- First on 15th day of the treatment and Second follow up on 30th day in each group. |