| CTRI Number |
CTRI/2025/09/094012 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
01/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Clinical Study To Evaluate The Efficacy Of
Tila Kwatha Gandusha And Triphala (Bibhitaki Aamlaki Haritaki) Kwatha Gandusha
In Mukhapaka With Special Reference To Stomatitis
|
|
Scientific Title of Study
|
Comparative Clinical Study To Evaluate The Efficacy Of
Tila Kwatha Gandusha And Triphala Kwatha Gandusha
In Mukhapaka With Special Reference 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 Teaswini Suresh Makode |
| Designation |
Pg Scholar |
| Affiliation |
SVNHT Ayurved Mahavidyalaya And Chikitsalaya, Shrishivajinagar Rahuri Factory |
| Address |
Department of Shalakyatantra SVNHT Ayurved Mahavidyalaya And Chikitsalaya Shrishivajinagar Rahuri Factory Maharashtra India 413706
Ahmadnagar
MAHARASHTRA
413706
India |
| Phone |
8830215455 |
| Fax |
|
| Email |
makodetejal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandee Nimase |
| Designation |
Associate Professor |
| Affiliation |
SVNHT Ayurved Mahavidyalaya And Chikitsalaya,Shrishivajinagar Rahuri Factory |
| Address |
Department of Shalakyatantra SVNHT Ayurved Mahavidyalaya And Chikitsalaya Shrishivajinagar Rahuri Factory Maharashtra India 413706
Ahmadnagar
MAHARASHTRA
413706
India |
| Phone |
8421534177 |
| Fax |
|
| Email |
snimase85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tejaswini Suresh Makode |
| Designation |
Pg Scholar |
| Affiliation |
SVNHT Ayurved Mahavidyalaya And Chikitsalaya,Shrishivajinagar Rahuri Factory |
| Address |
Department of Shalakyatantra, SVNHT Ayurved Mahavidyalaya And Chikitsalaya, Shrishivajinagar Rahuri Factory,Maharashtra,India
Ahmadnagar
MAHARASHTRA
413706
India |
| Phone |
8830215455 |
| Fax |
|
| Email |
makodetejal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Shalakyatantra, SVNH Ayurved Mahavidyalaya And Chikitsalaya, Shrishivajinagar Rahuri Factory,
413706 Maharashtra, India. |
|
|
Primary Sponsor
|
| Name |
Dr Tejaswini Suresh Makode |
| Address |
Department Of Shalakyatantra SVNHT Ayurved Mahavidyalaya And Chikitsalaya Shrishivajinagar Rahuri Factory 413706 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 Tejaswini Suresh Makode |
SVNHT Ayurved Mahavidyalaya And Chikitsalaya Shrishivajinagar Rahuri Factory |
Department Of SVNHT Ayurved Mahavidyalaya And Chikitsalaya Shrishivajinagar Rahuri Factory Maharashtra India 413706
Ahmadnagar
MAHARASHTRA |
8830215455
makodetejal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICAL COMMITTEE OF SVNH AYURVED MAHAVIDYALAYA AND CHIKITSALAYA RAHURI FACTORY 413706 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K137||Other and unspecified lesions of oral mucosa. Ayurveda Condition: MUKHAROGAH, (2) ICD-10 Condition:R52||Pain, unspecified. Ayurveda Condition: MUKHAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Tila Kwatha Gandusha , Reference: Pandit suryaprasad Tripathi Bhaishajya Ratnavali satik kaviraj pandit gopalprasad Sharma kaushik prakashan Mumbai shloka no 62 page no 812, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Triphala Kwatha Gandusha, Reference: Aacharya Trivedi Astang Sangrah Uttarsthan Adhyay no 26 sholka no 164, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Abhakta, 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 |
Patients having Lakshana of Mukhapaka
Patients with age group of 18-60 years
Patients willing for trial with written consent
Patients having recurrent Mukhapaka
|
|
| ExclusionCriteria |
| Details |
unconscious, poisoned, weak, krisha person,
patient suffering from bleeding disorders
Patient having chronic or carcinogenic ulcers in oral cavity
Patient age below 18 years and above 60 years
Patients suffering from any other systemic disorder Patients with oral candidiasis
Patients with diagnosed oral malignancy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the EFFICACY OF
TILA KWATHA GANDUSHA AND TRIPHALA KWATHA GANDUSHA
IN MUKHAPAKA
|
30 days
IN MUKHAPAKA
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
TO EVALUATE THE EFFICACY OF
TILA KWATHA GANDUSHA
IN MUKHAPAKA |
At the end of
30 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 3 |
|
Date of First Enrollment (India)
|
13/09/2025 |
| 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="2"
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
|
A consecutive samples of 60 patients who are seeking treatment and care at the study hospital who fullfil the eligibility (inclusion and exclusion) criteria and who consent to participant will be selected by convenience sampling method from the study setting (ie. the OPD/Ward/Hospital) The sample will be then randomly and equally allocated to two groupsThe selected sample of 60 subjects will be randomly allocated to two groups using Simple block randomization method A predetermined computer generated random allocation plan will be utilised where in 15 blocks of size 4 each will be used for equal assignment of subjects in to two comparison groups First group will recieve TILA KWATHA GANDUSHA and second group will recieve TRIPHALA KWATHA GANDUSHA |