| CTRI Number |
CTRI/2021/12/038806 [Registered on: 21/12/2021] Trial Registered Prospectively |
| Last Modified On: |
25/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Evaluate Safety and Efficacy of Pathadi Ghanavati and Pathadi Oil in Psoriasis |
|
Scientific Title of Study
|
A Single Arm Clinical Trial of Pathadi Ghanavati and Pathadi Oil in Psoriasis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rupali Ramadas Patil |
| Designation |
Assistant Professor Department of Kayachikitsa |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Ashta, Sangli |
| Address |
Department of Kayachikitsa
Hon Shri Annasaheb Dange Ayurved Medical College and Postgraduate Research center, Ashta,Sangli
Sangli MAHARASHTRA 416301 India |
| Phone |
9225633321 |
| Fax |
|
| Email |
rpcoolrupali@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr D G Dipankar |
| Designation |
Professor Department of Kayachikitsa |
| Affiliation |
Dr D Y Patil College of Ayurved and Research Center, pimpari, Pune |
| Address |
Department of Kayachikitsa
Dr D.Y.Patil College of Ayurved and Research center,Pimapari,Pune-18
Pune MAHARASHTRA 411018 India |
| Phone |
9822279321 |
| Fax |
|
| Email |
drdgdipankar@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Rupali Ramadas Patil |
| Designation |
Assistant Professor Department of Kayachikitsa |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Ashta, Sangli |
| Address |
Department of Kayachikitsa
Hon Shri Annasaheb Dange Ayurved Medical College and Postgraduate Research center, Ashta,Sangli
Sangli MAHARASHTRA 416301 India |
| Phone |
9225633321 |
| Fax |
|
| Email |
rpcoolrupali@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D. Y. Patil College of Ayurved and Research center, Pimpari, Pune-18 |
| Hon. Shri. Annasaheb Dange Ayurved Medical College & Post Graduate Research Center, Ashta, Tal Walwa Dist Sangli,416301 Sangli |
|
|
Primary Sponsor
|
| Name |
HON SHRI ANNASAHEB DANGE AYURVED MEDICAL COLLEGE AND POSTGRADUATE CENTER ASHTA SANGLI |
| Address |
Department Kayachikitsa Hon. Shri. Annasaheb Dange Ayurved Medical College & Post Graduate Research Center, Ashta, Tal Walwa Dist Sangli,416301 Sangli Maharashtra |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTER PIMPARI PUNE |
Department Kayachikitsa Dr D Y Patil College of Ayurved and Research center, Pimpari, Pune-18 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rupali Ranmadas Patil |
Hon Shri Annasaheb Dange Ayurved Medical College and Postgraduate Research Center,Ashta,Sangli |
Department Kayachikitsa OPD/IPD Sangli MAHARASHTRA |
9225633321
rpcoolrupali@gmail.com |
| Dr Rupali Ramadas Patil |
Dr D Y Patil College of Ayurved and Research Center, Pimpari, Pune |
Department Kayachikitsa OPD/IPD Pune MAHARASHTRA |
9225633321
rpcoolrupali@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Research and Recognition Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L409||Psoriasis, unspecified. Ayurveda Condition: KITIBAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Pathadi Ghanavati, Reference: Ashtang Hriday Kushta Chikitsa, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Koshna Jala), Additional Information: | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Pathadi Oil, Reference: Ashtang Hriday Kushta Chikitsa, Route: Topical, Dosage Form: Taila, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Muhurmuhu, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: To be applied on the affected area |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients who are having sign and symptoms of Psoriasis
2.Patients suffering from psoriasis with less than 50% of the body surface involvement
|
|
| ExclusionCriteria |
| Details |
1.Pregnant and lactating mothers
2.Patients having any severe systemic disorders like Diabetes Mellitus, Cancer etc.
3.Patients suffering from psoriasis with more than 50% of the body surface involvement and with other co morbidities
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Improvement in Dermatology Life Quality Index(DLQI)
2. Improvement in Signs and Symptoms of Psoriasis |
7th Day, 14th Day,21th Day,30th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Reduction in mean Simplified Psoriasis Area and Severity Index Score (SPASI)
2. Reduction in mean Physicians Global Assessment Scale Score (PGA)
3. Reduction in mean Physicians Global Assessment and Body Surface Area Scale Score |
7th Dya, 14th Day, 21th Day,30th Day |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/01/2022 |
| Date of Study Completion (India) |
30/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Introduction:
Psoriasis is a
chronic inflammatory skin disease affecting quality of life and associated with
systemic comorbidities. Although conventional therapies can be effective, they
are constrained by safety concerns, relapse after discontinuation, high costs,
and limited accessibility in low-resource settings. Ayurveda offers a holistic
approach to skin disorders; however, evidence mainly highlights purification
therapies, which are not always feasible. To address this, the polyherbal
compound Pathadi Yogah, referenced in Ashtanga Hridaya for treating skin
disorders, was standardized into tablet and oil formulations, making psoriasis
treatment more accessible.
Aim: To evaluate the clinical efficacy
of Pathadi Tablet (oral) and Pathadi Oil (topical) in patients with plaque
psoriasis.
Materials and
Methods: A
single-arm, open-label clinical trial was conducted with 50 patients (18–60
years) with mild-to-moderate plaque psoriasis. Patients received the Pathadi
Tablet (500 mg, twice daily before meals with lukewarm water) and Pathadi Oil
(topical, twice daily) for 30 days. Assessments were performed at baseline and
on days 7, 14, 21, and 30 using the Psoriasis Area and Severity Index (PASI),
Simplified PASI, Physician Global Assessment × Body
Surface Area (PGA×BSA), and Dermatology Life Quality Index (DLQI). Laboratory
parameters were measured at baseline and after treatment. Data were analyzed
using Friedman test, paired t-test, and repeated-measures ANOVA.
Results: Fifty patients (25 males, 25
females; mean age, 32.4 ± 10.8 years) completed the study. Erythema,
induration, scaling, and itching scores were significantly reduced
(p<0.001). The mean PASI declined from 6.04 ± 2.61 to 1.46 ± 1.10 (75.8%
reduction, p<0.001). DLQI improved from 17.74 ± 4.55 to 2.86 ± 2.55 (83.9%
reduction, p<0.001). PASI 50 was achieved in 96% (n=48), PASI 75 in 68%
(n=34), and PASI 100 in 18% (n=9) of the patients. The ESR decreased
significantly. No adverse events were observed, and patient compliance was
high.
Conclusion: Pathadi Tablet and Pathadi Oil
significantly improved disease severity and quality of life in patients with
plaque psoriasis within 30 days. The combined oral-topical approach proved
safe, affordable, and easily accessible alternative. Further, larger randomized
controlled trials with longer follow up are needed to validate the long-term
efficacy and relapse prevention. |