| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L400||Psoriasis vulgaris. Ayurveda Condition: EKAKUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (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: - | | 2 | Intervention Arm | Drug | Classical | | (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. |