| CTRI Number |
CTRI/2026/02/104433 [Registered on: 20/02/2026] Trial Registered Prospectively |
| Last Modified On: |
19/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Nimbadi Ghrita Lepam and Nimbadi Capsule in Vipadika (Palmoplantar Psoriasis) |
|
Scientific Title of Study
|
Single Arm Open Label Clincal Trial of Nimbadi Ghrita Lepam
and Nimbadi Capsule in Vipadika (Palmoplantar 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 |
Dr Swarnima Amrutraj Mane Deshmukh |
| Designation |
Post Graduate Student |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College and Post Graduate Research Center Ashta |
| Address |
Department of Kayachikitsa Dhanvantari Hospital Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta Tal Walwa Dist Sangli 416301 Maharashtra India
Sangli
MAHARASHTRA
416301
India |
| Phone |
7038424596 |
| Fax |
|
| Email |
mdswarnima2001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rupali Ramadas Patil |
| Designation |
Associate Professor Department of Kayachikitsa |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College and Post Graduate Research Center Ashta |
| Address |
Department of Kayachikitsa Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta Tal Walwa Dist Sangli 416301 Maharashtra India
Sangli
MAHARASHTRA
416301
India |
| Phone |
9225633321 |
| Fax |
|
| Email |
rupalipatil@adamc.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rupali Ramadas Patil |
| Designation |
Associate Professor Department of Kayachikitsa |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College and Post Graduate Research Center Ashta |
| Address |
Department of Kayachikitsa Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta Tal Walwa Dist Sangli 416301 Maharashtra India
Sangli
MAHARASHTRA
416301
India |
| Phone |
9225633321 |
| Fax |
|
| Email |
rupalipatil@adamc.ac.in |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College and Post Graduate Research Center Ashta Sangli 416301 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Dr Swarnima Amrutraj Mane Deshmukh |
| Address |
Department of Kayachikitsa Hon Shri Annasaheb Dange Ayurved Medical College and Post Graduate Research Center Ashta Tal Walwa Dist Sangli 416301 Maharashtra India |
| 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 Swarnima Amrutraj Mane Deshmukh |
Hon Shri Annasaheb Dange Ayurved Medical College and Research Center Ashta |
Department of Kayachikitsa OPD no 1/IPD Dhanvantari Hospital Hon Shri Annasaheb Dange Ayurved Medical College and Research Center Ashta
Sangli
MAHARASHTRA |
7038424596
mdswarnima2001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L409||Psoriasis, unspecified. Ayurveda Condition: VIPADIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Nimbadi Capsule, Reference: Gada Nigraha Kushtha Chikitsa Adhyay 36/214, Route: Oral, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -Koshna Jala), Additional Information: -3 bhavanas of khadirodak will be given to the Nimba Panchang churna and the prepared churna will be filled in the capsule. | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Nimbadi Ghrita Lepam, Reference: Gada Nigraha Kushtha Chikitsa Adhyay 36/214, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: -Before applying the Nimbadi Ghrita Lepam the patient is advised to wash their palms and feet with lukewarm water and pat them dry with a clean cloth and then apply the Nimbadi Ghrita Lepam twice a day (as per requirement) |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group between 18 to 60 years.
2. Patients with signs and symptoms of vipadika (palmoplantar psoriasis).
3. Patients will be selected irrespective of their gender, religion, occupation.
4. Patients willing to participate in the study, who give written consent. |
|
| ExclusionCriteria |
| Details |
1. Pregnant, lactating women.
2. Patient suffering with severe systemic diseases like diabetes, cancer, guttate
psoriasis, psoriasis present on the areas other than palms and feet, systemic infections
like HIV, etc. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Nimbadi Grita Lepam and Nimbadi Capsule is Effective in Vipadika (Palmoplantar Psoiasis) |
7th, 14th, 21th, 28th Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in PPASI Score, VAS Score.
Improvement in DLQI.
|
After 28 days |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
15/03/2026 |
| 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="6"
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
|
Palmoplantar psoriasis is a chronic painful and disabling immune mediated autoimmune skin disorder affecting approximately 2 to 3 percent of the global population with palmoplantar involvement seen in nearly 10 to 30 percent of psoriasis cases often associated with fissuring pain and marked impairment in quality of life Due to its chronic relapsing nature and limited long term safety of conventional immunosuppressive therapies there is a growing need for cost effective and holistic treatment modalities In Ayurveda palmoplantar psoriasis shows close clinical resemblance to Vipadika a Kshudra Kushtha characterized by pani pads sphutana tivra vedana kandu raga and pidika arising from tridosha vitiation with predominance of Vata and Kapha Classical Ayurvedic management of Kushtha emphasizes a combined systemic and local approach wherein Shamana Chikitsa and Bahiparimarjana Chikitsa play a pivotal role The concept of Yamaka Sneha the synergistic use of Ghrita and Taila is particularly advocated in Vipadika for its enhanced penetrability dosha pacification wound healing and immune modulatory effects The present study is designed as a single arm open label clinical trial to evaluate the efficacy of Nimbadi Capsule oral and Nimbadi Ghrita Lepam topical Yamaka Sneha formulation prepared from the classical Panchanimbaka formulation described in Gada Nigraha A total of 45 patients aged 18 to 60 years diagnosed with Vipadika or palmoplantar psoriasis will receive the intervention for 28 days Clinical assessment will be carried out using the Palmoplantar Psoriasis Area and Severity Index Dermatology Life Quality Index Visual Analogue Scale and subjective parameters The study aims to generate scientific evidence for the role of Ayurvedic therapy as effective and integrative approach in the management of palmoplantar psoriasis |