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CTRI Number  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 
8400714949

sshalinisingh096@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L404||Guttate psoriasis. Ayurveda Condition: KITIBAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-dIpana , दीपन , Pachana (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
2Intervention ArmProcedure-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
3Intervention ArmProcedure-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
4Intervention ArmProcedure-vamana-karma/ pracCardanam, वमन-कर्म/ प्रच्छर्दनम् (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
5Intervention ArmDrugClassical(1) Medicine Name: Manibhadra Gula, Reference: Ashtang Hridaya , Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 28(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: -
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  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).

 
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