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CTRI Number  CTRI/2026/04/108811 [Registered on: 20/04/2026] Trial Registered Prospectively
Last Modified On: 09/04/2026
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   To access the effect of aragwadhadi lepa and dhatryadi yoga in psoriasis 
Scientific Title of Study   A comparative clinical study to assess the efficacy of aragwadhadi lepa and dhatryadi yoga in kitibha kushtha w.s.r 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  Shilpa Verma 
Designation  Research scholar 
Affiliation  Sriganganagar College of Ayurvedic Science and Hospital  
Address  Room no.9 OPD of Swathavritta Evum Yoga Sri Ganganagar College of Ayurvedic Science and Hospital Tantia University Sri Ganganagar RAJASTHAN 335002 India

Ganganagar
RAJASTHAN
335002
India 
Phone  9772341225  
Fax    
Email  dr.shilpaverma.sv@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrAnupam Pathak 
Designation  Professor  
Affiliation  Sriganganagar College of Ayurvedic Science and Hospital 
Address  Room no.9 OPD of Swathavritta Evum Yoga SriGanganagar College of Ayurvedic science and Hospital Tantia University, Hanumangarh road, Sriganganagar, Rajasthan-335002

Ganganagar
RAJASTHAN
335002
India 
Phone  9414985631  
Fax    
Email  drpathakanupam@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrAnupam Pathak 
Designation  Professor  
Affiliation  Sriganganagar College of Ayurvedic Science and Hospital 
Address  Room no.9 OPD of Swathavritta Evum Yoga SriGanganagar College of Ayurvedic science and Hospital Tantia University, Hanumangarh road, Sriganganagar, Rajasthan-335002

Ganganagar
RAJASTHAN
335002
India 
Phone  9414985631  
Fax    
Email  drpathakanupam@gmail.com  
 
Source of Monetary or Material Support  
Sriganganagar College of Ayurvedic Science and Hospital, Tantia University, Hanumangarh road, Sriganganagar Rajasthan-335002  
 
Primary Sponsor  
Name  Sriganganagar College of Ayurvedic Science and Hospital  
Address  Sriganganagar College of Ayurvedic Science and Hospital, Tantia University, Hanumangarh road, Sriganganagar, Rajasthan-335002  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Sriganganagar College of Ayurvedic Science and Hospital   Sriganganagar College of Ayurvedic Science and Hospital, Tantia University, Hanumangarh road, Sriganganagar, Rajasthan-335002  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rishu Sharma  Sriganganagar College of Ayurvedic Science and Hospital   Room no.9 OPD of Swathavritta Evum Yoga SriGanganagar College of Ayurvedic Science and Hospital, Tantia University, Hanumangarh road, Sriganganagar Rajasthan-335002
Ganganagar
RAJASTHAN 		 9456071970

ayurvedsgnr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethic committee, Faculty of Ayurveda, Tantia University, Sriganganagar   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L400||Psoriasis vulgaris. Ayurveda Condition: KITIBAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Dhatryadi Yoga, Reference: Sushrut samhita, Chikitsa sthana, adhyay 09, shloka 44, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -Jala), Additional Information: -
2Comparator ArmProcedure-lepa, लेप (Procedure Reference: Charak samhita, Sutrasthana, adhyay 3, shlok 3-7, Procedure details: Application of lepa twice a day)
(1) Medicine Name: Aragwadhadi Lepa, Reference: Charak samhita, Sutrasthana, adhyay 3, shlok 3-7, Route: Topical, Dosage Form: Lepa Churna, Dose: 20(g), Frequency: bd, Duration: 2 Months
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Psoriatic lesions showing classical symptoms & signs of Kitibha Kushtha as described in Ayurvedic Samhitas as Shyava varna (dark/brownish discoloration), Kina sparsha (thickened skin), Khara sparsha (roughness), Parusham (hardness) Ugra Kandu (severe itching).
2.Patients having cardinal symptom of psoriasis like erythematous papules/plaques covered with dry brittle, Auspitz sign, Kobner phenomenon, Candle grease sign, silvery grayish white micaceaous scale etc.
3.Psoriatic lesions present on common sites such as elbows, knees, scalp or back, with disease duration generally less than 5 - 10 years.
4.Participants capable of understanding the study and willing to provide informed consent. 
 
ExclusionCriteria 
Details  1.Complicated cases of psoriasis like pustular psoriasis, psoriasis with arthritis or any other such type of complication.
2.Patients having cardiac disease, renal disease and endocrine disorders were excluded from the study.
3.Pregnant and lactating woman.
4.Patients having any allergy history or sensitivity will be excluded from study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate reduction in percentage of body surface area affected by psoriasis with help of both Aragwadhadi lepa and Dhatryadi yoga after every follow up  2 months  
 
Secondary Outcome  
Outcome  TimePoints 
The study is expected to compare the clinical efficacy of Aragwadhadi Lepa and Dhatryadi Yoga in patients of Kitibha Kushta (Psoriasis). The outcome will be assessed by reduction in PASI score and improvement in subjective and objective parameters such as itching, scaling, erythema, and thickness of lesions.   6 months  
 
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)   27/04/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  27/04/2026 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
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   Psoriasis is a chronic inflammatory, hyper proliferation skin disease that significantly affects patients quality of life. Psoriasis affects approximately 1.5- 3% of Caucasians but is less common in Asian, South American and African populations. It occurs equally in both genders and at any age; more than 50% of patients present before the age of 30 years. The age of onset follows a bimodal distribution, with an early-onset type in the teenage or early adult years, often with a family history of psoriasis. The later onset type is typically seen between 50 and 60 years, usually without a family history and with a less severe disease course. It affects approximately 2-3 % of the global population is characterized by a relapsing, remitting course. Despite the availability of various modern therapeutic modalities such as topical steroids, immunosuppressants, and biologics complete remission remains challenging, and long-term use is often associated with adverse effects, high cost, and the risk of relapse. Therefore, there is a growing interest in safer, affordable, and more sustainable therapeutic options. In Ayurveda, Kitibha Kushtha closely resembles the clinical features of psoriasis, including scaling, dryness, discoloration, and chronicity. Classical Ayurvedic texts emphasize both Bhahya Chikitsa (external therapy) and Abhyantara Chikitsa (internal therapy) in the management of Kushtha. In this study, an attempt will be made to provide patients with a safe, effective, and affordable form of preventive and curative management through the use of Aragwadhadi Lepa and Dhatryadi Yoga. Although both formulations are mentioned for skin disorders, comparative evidence based clinical studies evaluating their individual and combined efficacy in Kitibha Kushtha (psoriasis) are limited. Thus the study is necessary to bridge the gap between classical Ayurvedic knowledge and modern clinical evidence, contributing to the development of effective, holistic management strategies for psoriasis /Kitibha Kushtha. 
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