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CTRI Number  CTRI/2025/07/091373 [Registered on: 22/07/2025] Trial Registered Prospectively
Last Modified On: 22/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of oral versus rectal administration of Panchatikta Ghrit in patients of Psoriasis. 
Scientific Title of Study   Evaluation of efficacy of oral versus rectal administration of Panchatikta Ghrita in Plaque Psoriasis : A Randomized Clinical Trial 
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 Paresh R Deshmukh 
Designation  Ph.D. Scholar in Dept of Kayachikitsa 
Affiliation  CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Chhatrapati Sambhajinagar 
Address  OPD No 13 Dept of Kayachikitsa CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Paithan Road Chhatrapati Sambhajinagar Aurangabad

Aurangabad
MAHARASHTRA
431001
India 
Phone  9860430247  
Fax    
Email  drpareshd@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shrikant G Deshmukh 
Designation  Professor in Dept of Kayachikitsa 
Affiliation  CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Chhatrapati Sambhajinagar 
Address  OPD No 13 Dept of Kayachikitsa CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Paithan Road Chhatrapati Sambhajinagar Aurangabad

Aurangabad
MAHARASHTRA
431001
India 
Phone  9921553999  
Fax    
Email  dr.shrikantgdeshmukh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shrikant G Deshmukh 
Designation  Professor in Dept of Kayachikitsa 
Affiliation  CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Chhatrapati Sambhajinagar 
Address  OPD No 13 Dept of Kayachikitsa CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Paithan Road Chhatrapati Sambhajinagar Aurangabad

Aurangabad
MAHARASHTRA
431001
India 
Phone  9921553999  
Fax    
Email  dr.shrikantgdeshmukh@gmail.com  
 
Source of Monetary or Material Support  
Chhatrapati Shahu Maharaj Shikshan Sansthas Ayurved Mahavidyalaya and Rugnalaya Kanchawadi Chhatrapati Sambhajinagar Aurangabad MAHARASHTRA 431001 INDIA 
 
Primary Sponsor  
Name  Dr Paresh Rameshrao Deshmukh 
Address  C502 Pride my home Behind Podar International School Mayurban colony Keshav Nagari Chh. Sambhajinagar 
Type of Sponsor  Other [Self] 
 
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 Paresh R Deshmukh  Chhatrapati Shahu Maharaj Shikshan Sansthas Ayurved Mahavidyalaya and Rugnalaya   OPD No 13 Kayachikitsa Department Chhatrapati Shahu Maharaj Shikshan Sansthas Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Paithan Road Chhatrapati Sambhajinagar
Aurangabad
MAHARASHTRA 
9860430247

drpareshd@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee , Chhatrapati Shahu Maharaj Shikshan Santhsas Ayurved Mahavidyalaya and Rugnalaya  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: EKAKUSHTHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Panchatikta Ghrita, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Ghrita, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Koshna jala), Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Panchatikta Ghrita, Reference: Bhaishajya Ratnavali, Route: Rectal, Dosage Form: Ghrita, Dose: 40(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients of Plaque Psoriasis will be selected irrespective of sex, religion and socioeconomic status
2. Age group- 18 to 60 years
3. Patients who are willing to provide written informed consent to get included in the study
 
 
ExclusionCriteria 
Details  1. Skin conditions other than Plaque Psoriasis
2. Patients having any other systemic complications or any other major diseases like TB, DM, AIDS, Renal and Cardiac problems
3. Pregnant & lactating women
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
PASI Score should be decreased , and Rukshata (dryness), Bahalatva (Thickening), Raktavarna (Eryhtma), , Matsyashakalopama (Scaling), and Kandu (itching) at the site should be decreased  90 days 
 
Secondary Outcome  
Outcome  TimePoints 
DLQI Score should be improved.  90 days 
 
Target Sample Size   Total Sample Size="92"
Sample Size from India="92" 
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/ Phase 3 
Date of First Enrollment (India)   10/09/2025 
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="10"
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  

In the context of today’s fast-paced and stressful lifestyle, diseases linked to improper diet (Ahara), irregular daily routines (Vihara), and environmental pollutants are on the rise. Among them, Psoriasis stands out as a chronic, autoimmune skin disorder influenced by multiple triggers such as psychological stress, incompatible food habits, environmental factors, and certain medications. Characterized by well-defined, scaly, red plaques, Psoriasis affects both men and women equally and is not just a skin-deep condition—it has a profound psychological and social impact. Patients often suffer from low self-esteem, social withdrawal, and emotional distress. With an alarming global prevalence (120–180 million cases) and a reported Indian adult prevalence ranging from 0.44% to 2.8%, psoriasis demands more attention in terms of diagnosis and long-term management. Ayurveda classifies all skin disorders under the term Kushtha, which is broadly divided into two categories: Mahakushtha (major skin disorders) and Kshudra Kushtha (minor skin disorders). The seven types of Kushtha mentioned in Mahakushtha and eleven types of Kshudra Kushtha where Ekakushtha is listed under Kshudra Kushtha and is considered to closely resemble plaque psoriasis, highlighting improper lifestyle and diet as root causes.

Despite various treatment options in modern medicine, many patients remain dissatisfied due to the lack of lasting relief and potential side effects of conventional therapies. A U.S. National Psoriasis Foundation survey revealed that 78% of patients with severe psoriasis expressed frustration with current treatments. This underscores the urgent need for safe, effective, and affordable alternatives. Ayurveda offers a promising solution with its holistic approach and minimal side effects. Panchatikta Ghrita, a classical Ayurvedic formulation, has shown efficacy in managing plaque psoriasis, and while it is traditionally used orally, its rectal administration (basti) may enhance absorption, compliance, and therapeutic outcomes. Considering the need for long-term, palatable treatments, exploring such alternative routes of administration aligns with Ayurvedic principles and can offer sustainable relief, improving both physical symptoms and overall quality of life.

 
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