| CTRI Number |
CTRI/2025/04/085446 [Registered on: 23/04/2025] Trial Registered Prospectively |
| Last Modified On: |
23/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Screening |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To find out the efficacy of Triphaladi yog virechan and Manibhadra modak in the management of Ekkushta |
|
Scientific Title of Study
|
Single arm clinical study to evaluate efficacy of Triphaladi Yog Virechan and Manibhadra Modak in the management of Ekkushta with special reference to Psoriasis |
| Trial Acronym |
Interventional |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priyanka Anil Kale |
| Designation |
MD Scholar Panchakarma (Ayurveda) |
| Affiliation |
LRP Ayurvedic Medical College and Hospital Islampur |
| Address |
Department of Panchkarma Unit 1 LRP Medical college and Hospital Post Graduate Institute and Research Centre Islampur Sangli Maharashtra
Sangli
MAHARASHTRA
415409
India |
| Phone |
9921100502 |
| Fax |
|
| Email |
priyankakale1395@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepak Kumar Parida |
| Designation |
HOD |
| Affiliation |
L R P Ayurvedic Medical College and Hospital Islampur |
| Address |
Department of Panchkarma Unit 1 LRP Medical college and Hospital Post Graduate Institute and Research Centre Islampur Sangli Maharashtra
Sangli
MAHARASHTRA
415409
India |
| Phone |
8830333050 |
| Fax |
|
| Email |
dpkparida@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepak Kumar Parida |
| Designation |
HOD |
| Affiliation |
L R P Ayurvedic Medical College and Hospital Islampur |
| Address |
Department of Panchkarma Unit 1 LRP Medical college and Hospital Post Graduate Institute and Research Centre Islampur Sangli Maharashtra 415409 India
Sangli
MAHARASHTRA
415409
India |
| Phone |
8830333050 |
| Fax |
|
| Email |
dpkparida@yahoo.co.in |
|
|
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 Hospital and Research Centre Address LRP Ayurvedic Medical College and Hospital P |
| 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 Priyanka Anil Kale |
LRP Ayurvedic Medical College and Hospital |
Department of Panchkarma Unit 1 LRP Medical college and Hospital Post Graduate Institute and Research Centre Islampur Sangli-415409 ,Maharashtra Sangli MAHARASHTRA
Sangli
MAHARASHTRA |
9921100502
priyankakale1395@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L989||Disorder of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: EKAKUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | virecana-karma, विरेचन-कर्म | (Procedure Reference: Sharangdhar samhita madhyamkhand chp 2, Procedure details: Purvakarma - Abhyntar snehpan 3 to 4 days with murchit goghrita Vishranti kal - 3 days
Sarvanga Abhynga with Til Tail
Bashpaswedan - plain tap water for 3 days
Pradhan karma - virechan given with Trivrutta,Danti, Triphala at 9 to 10 Am
Pashchat karm -Sansarjan kram - Mand, peya,vilepi,yavagu,mudga,yush,krushra,krut akrut yush according to shodhan
)
(1) Medicine Name: Manibhadra Modak, Reference: Bhaishajya Ratnavali Chikitsastan 9, Route: Oral, Dosage Form: Modaka, Dose: 5(g), Frequency: bd, Duration: 14 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients showing the classical sign and symptoms of Ekkusht according to the Charak Samhita such as Aswedanam Kandu Mahavastu Mastyashakalopmam 2. After Aampachan only patient is selected for Virechan karma 3. Patients of age group between 20 years to 60 years 4. Patients fit for Virechan karma 5. Patients of both gender with different economical state will be taken |
|
| ExclusionCriteria |
| Details |
1. Patients of age group below 20 years and above 60 years will be excluded 2. Patients unfit for Virechan karma 3. Patients suffering from any Systemic Disorders 4. Patients having any Fatal and Emaciated Disease |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate efficacy of Triphaladi Yog Virechan and Manibhadra Modak in management of Ekkushta. |
33 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the etiopathogenesis of Ekkushta according to ayurvedic classical text. To study the effect of virechan yog prepared with trivrutta, danti and triphala on Ekkushta. |
33 Days |
|
|
Target Sample Size
|
Total Sample Size="65"
Sample Size from India="65"
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)
|
25/05/2025 |
| 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 Yet Recruiting |
| 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
|
Skin is the envelope of internal structure.It is link between internal and external environment.As being the largest organ of body and being on surface,it is directly exposed tho microorganisms.By hampering the beauty of persons,it’s creats social and psychological impairment.Skin diseases are accountable for great deal of misery, suffering in capacity and economic loss. In Ayurveda all the skin diseases has been discussed under Kushta.Which are further divided in Mahakushta and Kshudra Kushta.Ekkushta is considered as one of Kshudra kushta.In Ekkushta Vata Kapha doshas are predominantly involved. According to madhav nidan, clinical features of Ekkushta is Aswedanam (dryness), Mahavastu (covers large portion), Matsyashakalopam (resembles like scales of fish).The clinical symptoms of Ekkushta describe in ayurveda resembles with the clinical symptoms of psoriasis.Psoriasis is chronic inflammatory skin diseases characterised by erythromatous scaly plaques affecting extensor surface, scalp. According to charak samhita virechan karma,balances vitiated vata,pitta ,kapha doshas which leads to reduction in symptoms like Mahavastu, Matsyashakalopam.Manibhadra Modak is kaphaghna,pittaghna, kledghna,kushtaghna, raktashudhikar,varnya karma , twakprasadak and Tikta,katu,kashat in nature which nourishes Rasa,Rakta dhatu.Its acts as Antibiotic, Anti-inflammatory.Hence,I anticipate that virechan karma and Manibhadra Modak is effective in psoriasis. |