| CTRI Number |
CTRI/2025/11/096802 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
31/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study effect of two drugs Bhukharjaadi and Jati, in patients with Aphthous ulcer |
|
Scientific Title of Study
|
Comparative Evaluation of Efficacy of Bhukharjaadi (Lepidagathiscristata Wild.)
Gargles vs. Jati (Jasminumgrandiflorum Linn.) Gargles in the Management of Pittaj Mukhapak (Aphthous ulcer.)-Randomized Controlled Trial
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sonali Deshpande |
| Designation |
post graduate student |
| Affiliation |
Mahatma Gandhi Ayurved college Hospital and Research |
| Address |
Mahatma Gandhi Ayurved college Hospital and Research Center,Salod(H), Wardha,442001
Wardha, Mahashtra,442001, India
Wardha
MAHARASHTRA
442001
India |
| Phone |
08805369883 |
| Fax |
|
| Email |
deshpandesonali43@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sneha Vidhate |
| Designation |
associate professor |
| Affiliation |
Mahatma Gandhi Ayurved college Hospital and Research |
| Address |
Mahatma Gandhi Ayurved college Hospital and Research Center,Salod(H), Wardha,442001
Wardha, Mahashtra,442001, India
Wardha
MAHARASHTRA
442001
India |
| Phone |
8552838670 |
| Fax |
|
| Email |
sneha.vidhate@dmiher.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Sonali Deshpande |
| Designation |
PG student |
| Affiliation |
Mahatma Gandhi Ayurved college Hospital and Research |
| Address |
Mahatma Gandhi Ayurved college Hospital and Research Center,Salod(H), Wardha,442001
Wardha, Mahashtra,442001, India
Wardha
MAHARASHTRA
442001
India |
| Phone |
08805369883 |
| Fax |
|
| Email |
deshpandesonali43@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurved college Hospital and Research Center,Salod(H), Wardha,442001
Wardha, Mahashtra,442001, India |
|
|
Primary Sponsor
|
| Name |
MGACHRC |
| Address |
Mahatma Gandhi Ayurved college Hospital and Research Center,Salod(H), Wardha,442001
Wardha, Mahashtra,442001, India |
| 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 Sonali Deshpande |
Mahatma Gandhi Ayurved college Hospital and Research |
Dravyaguna vighvan department room no 3 Mahatma Gandhi Ayurved college Hospital and Research Center,Salod(H), Wardha,442001
Wardha, Mahashtra,442001, India
Wardha
MAHARASHTRA |
08805369883
deshpandesonali43@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe |
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: jati (jasminum grandflorum), Reference: PV Sharma dravyaguna, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -), Additional Information: Gargles will be prepared | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: bhukarjadi(lepadihathis cristata), Reference: ethanobotnical drug, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: gargles will be prepared |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patient having recurrent episodes of mukhapak
Patient having intolerance to eat spicy food.
patient having change in color of oral mucosa
Patient having history of burning sensation in oral cavity. |
|
| ExclusionCriteria |
| Details |
Known case of oral submucosal fibrosis.
2) Known case of gastritis.
3) Traumatic ulcers.
4) Oro-dental fistula.
5) Gingivitis. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduction of pain redness lesion and infection caused by aphthous stomatitis |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not avilable |
|
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/01/2026 |
| 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="2"
Months="5"
Days="1" |
|
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
|
Introduction : In Ayurveda, Mukhapak is a considered as a specific disease with its own specific Nidana, Purvarupa,Rupa, Samporapatiand Chikitsa which is correleated with Apthous stomatits in modern science,Modern treatment of mouth ulcer has lots of side effects, such as tooth and tongue staining, taste alteration, mouth irritation, so it is need to find alternative, safe and cost-effective herbal drug. epidagathis cristata is a traditionally used as treatment of mouth ulcer in various parts of Madhya Pradesh, Tamil Nadu, Melghat, M.S&dist. of Gadchiroli in Maharashtra.Jaati is also used traditionally in treatment of mukhapak(aphthous stomatitis).Gargles of above mentioned drug will be used in randamoized,single-blind,controlled trial,there is no clinical trial done on lipadihathis cristata therfore,pilot study of dosage will be conducted on 15 patients. Total 50 patient will be taken for study.The study aims to validate and compare there effectiveness,provide evidence based,affordable,and hostalic Ayurvedic options for aphthous stomatitis
|