CTRI/2025/10/095959 [Registered on: 13/10/2025] Trial Registered Prospectively
Last Modified On:
12/10/2025
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Drug Ayurveda
Study Design
Single Arm Study
Public Title of Study
A study to assess the outcome of Panchakarma procedures in psoriasis (Kitibha) through hsCRP and PASI scoring.
Scientific Title of Study
Efficacy of Panchakarma treatment protocol including Kashayadhara, Vamana and Manibhadragula in the management of Kitibha (Psoriasis) assessed with hsCRP and PASI Score - Open label Single arm 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 Shalini Singh
Designation
PG Scholar
Affiliation
All India Institute of Ayurveda, Delhi
Address
OPD 6, Department of Panchakarma, All India Institute of Ayurveda,
Gautampuri, Sarita Vihar
Room no 725, Department of
Panchakarma, Academic Block, All India Institute of Ayurveda,New Delhi
New Delhi DELHI 110076 India
Phone
8400714949
Fax
Email
sshalinisingh096@gmail.com
Details of Contact Person Scientific Query
Name
Prof Dr Anandaraman PV
Designation
Head of Department, Panchakarma
Affiliation
All India Institute of Ayurveda, Delhi
Address
Room no 725, Department of Panchakarma, Academic Block,
All India Institute of Ayurveda, Gautampuri, Sarita Vihar,New Delhi
New Delhi DELHI 110076 India
Phone
9495130595
Fax
Email
dr.ananthramsharma@gmail.com
Details of Contact Person Public Query
Name
Dr Prasanth Dharmarajan
Designation
Associate Professor,Panchakarma
Affiliation
All India Institute of Ayurveda, Delhi
Address
Room no 725, Department of Panchakarma, Academic Block,
All India Institute of Ayurveda, Gautampuri, Sarita Vihar,New Delhi
New Delhi DELHI 110076 India
Phone
9895174060
Fax
Email
drprashanthd@gmail.com
Source of Monetary or Material Support
All India Institute of Ayurveda Gautampuri, Sarita Vihar, New Delhi 110076
Primary Sponsor
Name
All India Institute of Ayurveda
Address
All India Institute of Ayurveda Gautampuri, Sarita Vihar, New Delhi 110076
Type of Sponsor
Research institution and hospital
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 Shalini Singh
All India Institute of Ayurveda
Department of Panchakarma ,OPD no.6, All India Institute of Ayurveda Gautampuri, Sarita Vihar, New Delhi 110076 New Delhi DELHI
(Procedure Reference: Sharangdhara, Procedure details: Deepana and Pachana
Karma play an important role as Purvakarma of Shodhana (bio-purification) procedures.) (1) Medicine Name: Trikatu, Reference: Bhavprakash Nighantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Duration: 3 Days
2
Intervention Arm
Procedure
-
kaShAyadhArA, कषायधारा
(Procedure Reference: Sahasrayoga Dharakalpa, Procedure details: Kashaya Dhara is a classical Ayurvedic therapy where warm herbal decoctions are poured over the body in a continuous stream in a rhythmic manner.) (1) Medicine Name: Aragwadha Patra +Haridra, Reference: Charaka Sutra, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 4000(ml), Frequency: od, Duration: 5 Days
3
Intervention Arm
Procedure
-
snehapAna-karma, स्नेहपान-कर्म
(Procedure Reference: Ashtanga Hridaya, Procedure details: Snehapanam is a therapeutic procedure in Ayurveda involving the oral intake of medicated ghee or oils, primarily used as a preparatory step for detoxification therapies like Panchakarma) (1) Medicine Name: Indukantha Ghrita, Reference: Sahasrayoga, Route: Oral, Dosage Form: Ghrita, Dose: 30(ml), Frequency: od, Duration: 5 Days
(Procedure Reference: Ashtanga Hridaya, Procedure details: Vamana is one of the five main cleansing treatments (Panchakarma) in Ayurveda. It primarily cleanses the body by expelling excess Kapha and Pitta dosha from the stomach through the oral route.
) (1) Medicine Name: Jeemutaka ksheera, Reference: Charaka Sidhi Sthana, Route: Oral, Dosage Form: Ksheerpaka, Dose: 6(g), Frequency: od, Duration: 1 Days
Rasayana arhas mentioned in classics.
Vamana arhas mentioned in classics.
Duration = Up to 10 years of chronicity
Patients having the clinical features of kitibha.
Plaque and Guttate Psoriasis.
PASI Score more than 7
hsCRP level (Moderate and above)
Moderate- 1.0 and 3.0 mg/L
ExclusionCriteria
Details
Patients with severe systemic disorders other than psoriasis.
Erythrodermic and Pustular Psoriasis.
Patients Ayogya for Snehapana.
Patients with known major illness like Hypertension, ischemic heart disease, Diabetes mellius,inflammatory disorders like SLE, rheumatoid arthritis.
Mentally ill/retarded patients.
Comorbidities like CRF, known case of Hepatitis B, Tuberculosis, HIV.
Pregnant Women and lactating mothers.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Change in hsCRP levels measured at various intervals:
Change in Psoriasis Area and Severity Index (PASI) score
Baseline(0th day)
14th day
49th day
79th day
Secondary Outcome
Outcome
TimePoints
Change in Dermatology Life Quality Index (DLQI) and Skindex29
Patient-reported outcomes (itching, burning, discomfort)
Photographic documentation of lesions
Baseline(0th day)
14th day
49th day
79th day
Target Sample Size
Total Sample Size="36" Sample Size from India="36" 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
N/A
Date of First Enrollment (India)
01/03/2026
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 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
INTRODUCTION:-
Psoriasis is a chronic, immune-mediated skin disorder marked by erythematous plaques and scaling, significantly affecting quality of life. The exact etiology of Psoriasis is still unknown, but it is believed to have a genetic component. Multifactorial inheritance, most likely a familial history of psoriasis, is found in 30% of patients. It is mediated by T-Cells. Psoriasis is seen worldwide in all races and both sexes with a prevalence from 0.1 to 3%. (1) It is associated with systemic inflammation. The blood levels of various inflammatory markers are increased in psoriasis. One of them is high-sensitivity C-reactive protein (hsCRP). The serum level of hs-CRP is increased in many inflammatory diseases like psoriasis, cardiovascular diseases, infections, arthritis, and others. In psoriasis, hsCRP is a reliable biomarker of systemic inflammatory burden, with elevated levels correlating with disease severity, beyond its role in tracking skin involvement. It also reflects the risk of associated comorbidities like cardiovascular disease and metabolic syndrome. The high-sensitivity CRP (hsCRP) test accurately measures low levels of C-reactive protein to identify low but persistent levels of inflammation. As a diagnostic and prognostic tool, hsCRP is valuable for monitoring therapeutic outcomes and bridging clinical symptoms with underlying systemic pathology. In Ayurveda, the nearest entity to psoriasis is Kitibha, a Vata-Kapha predominant skin disease. Treatment focuses on balancing doshas and the removal of the morbid doshas. the treatment
principle includes repeated Shodhana, Bahirparimarjana Chikitsa, and Shamana medications. Key interventions include Vamana (therapeutic emesis), Kashayadhara (herbal decoction pouring), and Manibhadra Gula, a classical polyherbal formulation known for its detoxifying and skin-healing properties. In the present study, we are planning to determine the serum level of hs-CRP in psoriasis to its PASI score, which is a subjective method to determine the severity of the disease, when managed with Kashaya Dhara, Vamana, and Manibhadra Gula as Shamana medication.hs- CRP is an objective and more reliable method, and to have a better idea of systemic inflammatory process caused by psoriasis.
This open-label, single-arm study evaluates the effectiveness of this Panchakarma protocol in managing Kitibha (psoriasis), using PASI score and hsCRP levels as clinical and biochemical outcome measurements.
NEED OF THE STUDY:-
Psoriasis is a chronic, immune-mediated skin condition linked to systemic inflammation and reduced quality of life. High-sensitivity C-reactive protein (hsCRP), a marker of low-grade inflammation, is often elevated in psoriatic patients and offers greater sensitivity than conventional CRP tests. While CRP is a simple, cost-effective, and known prognostic marker, even though the data on hsCRP in psoriasis are limited. Ayurvedic medicine shows promise in
managing psoriasis, but its effect on inflammatory markers like hsCRP remains underexplored. This study investigates the impact of an Ayurvedic treatment protocol on hsCRP levels, aiming to assess its potential in monitoring and managing systemic inflammation in psoriasis.
OBJECTIVES:-
PRIMARY OBJECTIVE:
3. To evaluate the effect of Panchakarma treatment protocol on hsCRP levels.
4. To assess clinical improvement in Kitibha (psoriasis) symptoms and PASI score.
SECONDARY OBJECTIVE:
1. To evaluate improvement in quality of life using DLQI and Skindex.
METHODOLOGY:
This study is a prospective, single-arm interventional clinical trial with an open-label design, conducted over a period of 2.5 years on diagnosed cases of psoriasis, in both outpatient and inpatient departments (OPD & IPD) of the All India Institute of Ayurveda (AIIA).