| CTRI Number |
CTRI/2026/03/106140 [Registered on: 13/03/2026] Trial Registered Prospectively |
| Last Modified On: |
10/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A Clinical trial to study the effects of Virechana Karma, Prithvisar Taila (external) and Pashupati churna (internal) in patients of Ekakustha (Psoriasis) |
|
Scientific Title of Study
|
A Clinical Study to evaluate the efficacy of Prithvisar Taila (external) & Pashupati Churna (internal) with and without Virechana karma in cases of Ekakushtha 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 RAGINI GUPTA |
| Designation |
M.D Student |
| Affiliation |
Postgraduate department of Kayachikitsa State Ayurvedic College & Hospital Lucknow |
| Address |
Postgraduate department of Kayachikitsa,State Ayurvedic College ,Tulsidas Marg Tudiyaganj Lucknow ,Uttarpradesh
Lucknow UTTAR PRADESH 226004 India |
| Phone |
7850927159 |
| Fax |
|
| Email |
guptasragini@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shachi Srivastava |
| Designation |
Reader |
| Affiliation |
State Ayurvedic College & Hospital Lucknow |
| Address |
Post Graduate Department of Kayachikitsa, State Ayurvedic College and Hospital, Tulsidas Marg, Tudiyaganj, Lucknow, Uttar Pradesh, 226004
Lucknow UTTAR PRADESH 226004 India |
| Phone |
9415063998 |
| Fax |
|
| Email |
drshachi09@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shachi Srivastava |
| Designation |
Reader |
| Affiliation |
State Ayurvedic College & Hospital Lucknow |
| Address |
Post Graduate Department of Kayachikitsa, State Ayurvedic College and Hospital, Tulsidas Marg, Tudiyaganj, Lucknow, Uttar Pradesh, 226004
Lucknow UTTAR PRADESH 226004 India |
| Phone |
9415063998 |
| Fax |
|
| Email |
drshachi09@gmail.com |
|
|
Source of Monetary or Material Support
|
| P.G. Department Of Kayachikitsa, State ayurvedic College , Lucknow India 226004 |
|
|
Primary Sponsor
|
| Name |
State Ayurvedic College & Hospital Lucknow |
| Address |
Post Graduate Department of Kayachikitsa ,State Ayurvedic
College and Hospital ,Tulsidas Marg ,Tudiyaganj ,Lucknow 226003 Uttarpradesh India |
| 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 Ragini Gupta |
State Ayurvedic College and Hospital, Lucknow |
P.G. Department of Kayachikitsa, State Ayurvedic College and Hospital, Tulsidas Marg, Lucknow Lucknow UTTAR PRADESH |
7850927159
guptasragini@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee State Ayurvedic College and Hospital, Lucknow |
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 | Procedure | - | virecana-karma, विरेचन-कर्म | (Procedure Reference: Charaka Chikitsa 7/41, Procedure details: Purvakarma-Deepan Pachana-Panchkol churna 3-6gms twice a day before meal
Snehpana-Murchhit Go ghrita 3-7 days
Swedan-Gurupravaran
Pradhan Karma-Virechana with kwath of Haritaki ,Amaltas,Nishoth ,Kutki & Eranda Sneha
Pashchat Karma-Samsarjana krama)
| | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Pashupati churna, Reference: Gadanigraha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Sabhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -plain water), Additional Information: -(2) Medicine Name: Pruthvisara Taila, Reference: Bhaishajya Ratnavali, Route: Topical, Dosage Form: Taila, Dose: 2.5(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patient of age between 21 to 50years will be included with irrespective of caste sex and religion.
All socioeconomic people.
Patient voluntarily willing to participate in the trial.
Patient of Ekakushtha having all essential criteria, with or without non-essential criteria will be selected for the clinical trial. |
|
| ExclusionCriteria |
| Details |
Patient not from the age group mentioned in the inclusion criteria.
In pregnant and lactacting women.
Known case of Malignacy ,IHD,CHF and any other vascular disease.
Uncontrolled Diabetes Mellitus &Hypertension &other life threatening &Complicated diseases.
Any other known systemic disease.
Cases under high doses of corticosteroid therapy and methotrexate. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
PRIMARY OBJECTIVE-
To assess the effectiveness of Shamana chikitsa &Shodhana chikitsa in relieving the
symptoms in patients of Ekakushtha.
|
D0,D15,030,D45,D60,D75,D90
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To get a better insight of the etiopathology of Ekakushtha in terms of Ayurveda.
• To understand the efficacy of Pashupati churna along with Virechana karma.
• To assess the effectiveness of trial drug in improving the condition of disease.
• To assess the side effects of drug if any.
• To assess the improvement in cases of Ekakushtha w.s.r to psoriasis based on PASI score.
|
D0,D15,030,D45,D60,D75,D90 |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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 |
|
Date of First Enrollment (India)
|
06/04/2026 |
| 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="1" Months="0" Days="0" |
|
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
|
The presented synopsis entitled “A Clinical Study to Evaluate the Efficacy of Prithvisar Taila for external application and Pashupati Churna for internal administration with and without Virechana Karma in cases of Ekakushtha with special reference to Psoriasis” aims to compare the therapeutic efficacy of Prithvisar Taila used externally along with oral administration of Pashupati Churna with and without Virechana Karma in the management of Ekakushtha which is correlated with Psoriasis in modern medicine. The primary objective of the study is to assess the effectiveness of Shamana Chikitsa and Shodhana Chikitsa in relieving the symptoms of Ekakushtha while the secondary objectives include understanding the etiopathology of Ekakushtha according to Ayurveda evaluating the efficacy of Pashupati Churna along with Virechana Karma assessing the effectiveness of the trial drugs in improving the condition of the disease observing any possible side effects of the drugs and evaluating the improvement in patients based on PASI score. The study is designed as a double armed open label Phase II clinical trial with computer generated randomization and a minimum sample size of forty patients with approximately ten percent dropout. Patients aged between twenty one to fifty years irrespective of sex caste religion and socio economic status who are willing to participate and presenting with essential criteria of Ekakushtha such as Aswedana Mahavastu Matsyashakalopama and Kandu with or without non essential criteria like Vaivarnya Srava and Daha will be included in the study. Patients outside the specified age group pregnant and lactating women and patients suffering from malignancy ischemic heart disease congestive heart failure vascular diseases uncontrolled diabetes mellitus hypertension other systemic or life threatening diseases and those receiving high dose corticosteroids or methotrexate therapy will be excluded from the study. The patients will be divided into two groups in which both groups will receive Pashupati Churna six gram twice daily after meals with lukewarm water and local application of Prithvisar Taila twice daily in the morning after bath and in the evening for a duration of two months while patients in group B will undergo Virechana Karma before the initiation of drug therapy. The total duration of the clinical trial will be ninety days including a follow up period of fifteen days without medication and the registered patients will be assessed fortnightly on day zero day fifteen day thirty day forty five day sixty day seventy five and day ninety. The results will be assessed on the basis of overall effect of Samshodhana and Samshamana Chikitsa on subjective and objective parameters along with changes in PASI score and will be categorized as relieved improved not improved and worsened where relieved indicates more than seventy five percent improvement improved indicates twenty five to seventy four percent improvement not improved indicates less than twenty five percent improvement and worsened indicates increase in number or size of lesions hypopigmentation depigmentation of normal skin development of complications along with increase in baseline PASI score. |