| CTRI Number |
CTRI/2026/01/101934 [Registered on: 23/01/2026] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| 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
Kiratatiktkadi Kashaya-yog Pratisaran with madhu in Mukhapaka w.s.r to
Stomatitis. |
|
Scientific Title of Study
|
Randomized Open Controlled Clinical Trial to Study the efficacy of
Kiratatiktkadi Kashaya-yog Pratisaran with madhu in Mukhapaka w.s.r to
Stomatitis. |
| 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 Dipali Vilas Katkar |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurvedic Medical College PGT and RC Kodoli |
| Address |
Yashwant ayurvedic medical college PGT and RC
Kodoli Shalakya tantra department OPD no 5 Kodoli Dist Kolhapur
Maharashtra
Kolhapur
MAHARASHTRA
416114
India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9130896809 |
| Fax |
|
| Email |
dipalikatkar2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kiran Patil |
| Designation |
Professor of Shalakyatantra Department |
| Affiliation |
Yashwant Ayurvedic Medical College PGT and RC Kodoli |
| Address |
Yashwant Ayurvedic Medical College PGT and RC Kodoli
Shalakyatantra Department OPD no 5 Kodoli Dist Kolhapur
MAHARASHTRA
Kolhapur
MAHARASHTRA
416114
India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7020519271 |
| Fax |
|
| Email |
dr.kp1976@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kiran Patil |
| Designation |
Professor of Shalakyatantra Department |
| Affiliation |
Yashwant Ayurvedic Medical College PGT and RC Kodoli |
| Address |
Yashwant Ayurvedic Medical College PGT and RC Kodoli
Shalakyatantra Department OPD no 5 Kodoli Dist Kolhapur
MAHARASHTRA
Kolhapur
MAHARASHTRA
416114
India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7020519271 |
| Fax |
|
| Email |
dr.kp1976@gmail.com |
|
|
Source of Monetary or Material Support
|
| Daily OPD patients from Yashwant Ayurvedic Medical College PGT and RC Kodoli
Dist Kolhapur Maharashtra India Pin code 416114 |
|
|
Primary Sponsor
|
| Name |
Dr Dipali Vilas Katkar |
| Address |
Yashwant Ayurvedic College Kodoli Kolhapur Tal Panhala District
Kolhapur Maharashtra India Pin code 416114 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Dipali Vilas Katkar |
Yashwant Dharamartha Rugnalaya,Kodoli. |
Yashwant Ayurveda
Medical College PGT
and RC Kodoli OPD
no 5 ShalakyaTantra
Department
Kolhapur
MAHARASHTRA
Kolhapur
MAHARASHTRA |
9130896809
dipalikatkar2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Yashwant Ayurvedic Medical College PGT and RC Kodoli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K120||Recurrent oral aphthae. Ayurveda Condition: MUKHAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Daruharidra Raskriya , Reference: Yogratnakar Nighantu, Mukhrogchikitsa/7, Route: Topical, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kiratatiktkadi Kashaya yog , Reference: Gad Nigaraha khand 3,5/144, Route: Topical, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having sign and symptoms of Mukhapaka
2.Patients between 18 to 60 years of age group irrespective of Gender caste religion |
|
| ExclusionCriteria |
| Details |
1.Patients with malignancy of the oral cavity
2.Patients with any other disease of the oral cavity other than Mukhapaka
3.Patients having any systemic diseases which can interfere with the
study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the efficacy of Kiratatiktkadi kashaya yog pratisaran with madhu
in Mukhapaka |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To Evaluate the impact of the Kiratatiktkadi Kashaya yog pratisaran
with madhu on Ruja pain associated with stomatitis Mukhapaka |
15 days |
To Evaluate the impact of the Kiratatiktkadi Kashay yog Pratisaran with
madhu on Daha burning sensation in Mukhapaka |
15 days |
| To Determine the time taken for ulcers to heal completely |
15 days |
| To Evaluate the effect of the treatment on patients daily activities eating habits |
15 days |
| To assess the recurrence rate |
15 days |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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 3 |
|
Date of First Enrollment (India)
|
10/02/2026 |
| 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
|
This is Randomised Open Controlled clinical trial to study the efficacy of Kiratatiktkadi Kashaya yog Pratisaran with Madhu in Mukhapaka . Assessment of sign and symptoms will be done at regular intervals . Observation will be drawn from outcome of patient after 15 days. |