| CTRI Number |
CTRI/2025/08/093089 [Registered on: 14/08/2025] Trial Registered Prospectively |
| Last Modified On: |
13/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Study to Evaluate the Effect of Panchapallava Gel and Stomatab Gel in the Management of Pittaja Mukapaka Aphthous Ulcer |
|
Scientific Title of Study
|
A Randomized comparative clinical study to evaluate the
efficacy of Panchapallava Gel and Stomatab Gel in Pittaja
Mukapaka with Special reference to Aphthous Ulcer |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Police Patil |
| Designation |
Professor |
| Affiliation |
BVVS Ayurved Medical College and Hospital Bagalkot |
| Address |
shalakya department
room number 8
Bagalkot
KARNATAKA
587101
India |
| Phone |
9448261405 |
| Fax |
|
| Email |
ppolicepatil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Police Patil |
| Designation |
Professor |
| Affiliation |
BVVS Ayurved Medical College and Hospital Bagalkot |
| Address |
BVVS Ayurved Medical College
Shalakya department
room number 8
Bagalkot
KARNATAKA
587101
India |
| Phone |
9448261405 |
| Fax |
|
| Email |
ppolicepatil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Police Patil |
| Designation |
Professor |
| Affiliation |
BVVS Ayurved Medical College and Hospital Bagalkot |
| Address |
BVVS Ayurved Medical College and Shalakya tantra room number 8
Bagalkot
KARNATAKA
587101
India |
| Phone |
9448261405 |
| Fax |
|
| Email |
ppolicepatil@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajiv Gandhi University of Health Sciences Banglore karnataka India 560041 |
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi University of Health Sciences |
| Address |
Banglore Jayanagar 4TH T Block Banglore India 560041 |
| Type of Sponsor |
Other [Rajiv Gandhi University of Health Sciences] |
|
|
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 |
| DrPushpavatiSPolicepatil |
BVVS Ayurved Medical College and Hospital |
room number 8 shalakya department
Bagalkot
KARNATAKA |
9448261405
ppolicepatil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC BVVS AYURVED MEDICAL COLLEGE AND HOSPITAL,BAGA LKOT,KARNATAK |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: MUKHAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | . pratisAraNam dितसारणम,ropaNagaNDUShaH रोपणग?ू षः | (Procedure Reference: Sushritha, Procedure details: Poorvakarma
Garling with warm water
Pradhanakarma
Application of gel thrice a day
Paschat karma
Maintain oral hygiene
)
(1) Medicine Name: Panchapallava gel, Reference: Yogartnakara, Route: Oral, Dosage Form: Malahara/ Ointment/ Balm, Dose: 00(NA), Frequency: tds, Duration: 10 Days | | 2 | Comparator Arm | Procedure | - | pratisAraNam dितसारणम्,ropaNagaNDUShaH रोपणग?ू षः | (Procedure Reference: Sushrita, Procedure details: Poorvakarma
Garling with warm water
Pradhanakarma
Application of gel thrice a day
Paschat karma
Maintain oral hygiene
)
(1) Medicine Name: Stomtab gel, Reference: Sagar pharma, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 00(NA), Frequency: tds, Duration: 10 Days |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients showing signs and symptoms of Pittaja
Mukhapaka( Aphthous ulcer)
Patients of both the sexes |
|
| ExclusionCriteria |
| Details |
Patient below the age of 16years above 40 years
Patients with other inflammatory condition
patients with oral carcinoma |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Toda Gurutva Daha to reduse these symptoms |
2 weeks |
|
|
Secondary Outcome
|
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
28/08/2025 |
| 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="0"
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
|
According to Acharya Vaghbhata ,Vata dosa moves in all directions and produces ulcer inside mouth which are red in colour ruksha lips becom Aruna Varna tongue cannot tolerate Seeta, Guru Ahara and is covered withthrons, patient opens his mouth wth difficulty this is feature of Mukapaka 2. The generalized disease in which mouth is covered with painful blisters all around is caused by Vata. feature of Pittaja Mukhapaka in which mouth is covered with red-yellow blisters associated with burning sensation3. Panchapallava , Amra, Jambu,Kapita,Bijapuraka,and Bilva poses the property deepana Pachana Grahi having kasaya rasa does Stambana karma and vruna ropan.Panchapallava kashaya is indicated in Mukhapaka. Aphthous is a common condition of the oral mucosa . It is characterized by multiple, erythematous, recurrent, small, round or ovoid ulcers with. Patient compliance and acceptance is extremely important for oral topical products. Gel bases have high water content and low surface friction and have better application on mucous membranes and burned or injured tissues |