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Clinical Trials/CTRI/2026/03/106140
CTRI/2026/03/106140Not yet recruitingPhase 2

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

State Ayurvedic College & Hospital Lucknow1 site in 1 country40 target enrollmentStarted: April 6, 2026Last updated:

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Enrollment
40
Locations
1

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
21.00 Year(s) to 50.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.
  • Cases under high doses of corticosteroid therapy and methotrexate.

Investigators

Sponsor
State Ayurvedic College & Hospital Lucknow
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr RAGINI GUPTA

Postgraduate department of Kayachikitsa State Ayurvedic College & Hospital Lucknow

Study Sites (1)

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