| CTRI Number |
CTRI/2025/12/099554 [Registered on: 19/12/2025] Trial Registered Prospectively |
| Last Modified On: |
16/12/2025 |
| 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
|
To study the efficacy of Spatika Churna jala kavala in mukhapaka with special reference to stomatitis. |
|
Scientific Title of Study
|
Randomized controlled clinical trial of spatika churna jala kaval in the management of mukhapaka with special reference to stomatitis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Avinash Digambar Shende |
| Designation |
PG Scholar |
| Affiliation |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute and Research centre. |
| Address |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute and Research centre.
Swasthavritta OPD no.3, LRP Ayurvedic Medical College and Hospital, Post Graduate Institute and Research Center Islampur, Tq. Walwa Dist. Sangli 415409
Sangli
MAHARASHTRA
415409
India |
| Phone |
9518717130 |
| Fax |
|
| Email |
avinashshende1398@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rahul B Nakil |
| Designation |
Professor and Head of Department |
| Affiliation |
LRP Ayurvedic Medical College and Hospital, Post Graduate Institute and Research Center Islampur. |
| Address |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute and Research centre.
Swasthavritta OPD no.3, LRP Ayurvedic Medical College and Hospital, Post Graduate Institute and Research Center Islampur, Tq. Walwa Dist. Sangli 415409
Sangli
MAHARASHTRA
415409
India |
| Phone |
9822287051 |
| Fax |
|
| Email |
rahul_nakil@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rahul B Nakil |
| Designation |
Professor and Head of Department |
| Affiliation |
LRP Ayurvedic Medical College and Hospital, Post Graduate Institute and Research Center Islampur. |
| Address |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute and Research centre.
Swasthavritta OPD no.3, LRP Ayurvedic Medical College and Hospital, Post Graduate Institute and Research Center Islampur, Tq. Walwa Dist. Sangli 415409
Sangli
MAHARASHTRA
415409
India |
| Phone |
9822287051 |
| Fax |
|
| Email |
rahul_nakil@yahoo.com |
|
|
Source of Monetary or Material Support
|
| LRP Ayurvedic Medical College and Hospital, Post Graduate Institute and Research Center, Islampur, Tq. Walwa Dist. Sangli Pin code 415409
Maharashtra India. |
|
|
Primary Sponsor
|
| Name |
Dr Avinash Digambar Shende |
| Address |
Dept. of Swasthavritta OPD no.3, LRP Ayurvedic Medical College and Hospital, Post Graduate Institute and Research Center,Islampur, Tq. Walwa Dist. Sangli |
| 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 Avinash Digambar Shende |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute and Research centre.Islampur |
Swasthavritta department, OPD no. 3
Sangli
MAHARASHTRA |
9518717130
avinashshende1398@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Loknete Rajarambapu Patil Ayurved Mahavidyalaya Sangli Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K121||Other forms of stomatitis. Ayurveda Condition: MUKHAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Lifestyle | - | - | Dinacarya: Khadir hima used for kaval in mukhapaka in morning after brush dose 50ml follow up on 3,5,7 days , Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:no, Pathya:, Apathya: | | 2 | Intervention Arm | Lifestyle | - | - | Dinacarya: 1 part of Spatika is taken and 6 part of clean water for kaval in mukhapaka in morning after brush dose should be 50 ml and follow up on 3,5,7 day , Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients suffering from clinical sign and symptoms of stomatitis like ulcer in mouth, redness, pain etc.
2) Age-Patient between the groups of 18 to 50yr.
3) Patients will be selected irrespective of gender, education status, Socio-economic status.
4) Only those patient will be selected who are willing to give written consent. |
|
| ExclusionCriteria |
| Details |
1)Unconscious, poisoned, weak person patient suffering from bleeding disorder.
2) Patient having chronic or carcinogenic ulcer in oral cavity.
3) Mukhapak due to any other disorder i.e-Syphilis, AIDS, Dengue haemorrhage fever and systemic disorders etc. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Spatika Churna jala kavala in the management of mukhapaka with special reference to stomatitis. |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To compare the effect of Spatika Churna jala Kavala and Khadira hima kavala in Mukhapaka.
2) To study mukhpaka in modern perspective as stomatiti |
7 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 |
|
Date of First Enrollment (India)
|
01/04/2026 |
| 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
|
Mukhpaka is primarily considered a Pittaja disorder, often arising from the vitiation of Pitta and Rakta dhatu (blood tissue), which leads to inflammation and ulceration in the oral cavity3
The management and prevention of such disorders are deeply rooted in classical
Ayurvedic routines and regimens such as Dinacharya (daily routine), Ritucharya
(seasonal routine), and Ahara-Vihara (diet and lifestyle). this study aims to Study the Effects of Spatika churna jala kaval in the
management of mukhpaka with special reference to Stomatitis Sample size of 60 patients mukhapaka will be taken and
divided into two groups Follow up on days 3rd, 5th and 7th days
|