| CTRI Number |
CTRI/2025/02/080455 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
12/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic gel for pain managment in mouth ulcers |
|
Scientific Title of Study
|
Development and Analytical evaluation of an Ayurvedic herbal gel for 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 |
Srishti Kumari |
| Designation |
Second Professional Under Graduate |
| Affiliation |
SDM College of Ayurveda and Hospital Hassan |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka
Hassan
KARNATAKA
573201
India |
| Phone |
9798489297 |
| Fax |
|
| Email |
srishti.sriu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bargale Sushant Sukumar |
| Designation |
Associate Professor Department of Swasthavritta |
| Affiliation |
SDM College of Ayurveda and Hospital Hassan |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka
Hassan
KARNATAKA
573201
India |
| Phone |
9036524877 |
| Fax |
|
| Email |
dr.sushant99@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bargale Sushant Sukumar |
| Designation |
Associate Professor Department of Swasthavritta |
| Affiliation |
SDM College of Ayurveda and Hospital Hassan |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka
KARNATAKA
573201
India |
| Phone |
9036524877 |
| Fax |
|
| Email |
dr.sushant99@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM College of Ayurveda and Hospital Hassan Karnataka 573201 |
|
|
Primary Sponsor
|
| Name |
SDM College of Ayurveda and Hospital Hassan |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka |
| Type of Sponsor |
Private medical college |
|
|
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 Srishti Kumari |
SDM College of Ayurveda and Hospital Hassan |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka
Hassan
KARNATAKA |
9798489297
srishti.sriu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan |
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 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Ayurvedic Herbal Gel, Reference: NA, Route: Oral, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged 18-60 years with clinical symptoms of stomatitis.
2. Selection is inclusive of all genders, castes, religions, and occupations.
|
|
| ExclusionCriteria |
| Details |
1. Those with oral carcinoma or leukoplakia.
2. Non-healing ulcers persisting over 14 days. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of ayurvedic herbal gel as topical application in the pain management of stomatitis. |
7 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To develop Ayurvedic herbal gel for pain management in stomatitis.
|
1 Month |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
25/02/2025 |
| 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="3"
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 study focuses on developing and evaluating an Ayurvedic herbal gel for stomatitis (mouth ulcers). The gel formulation includes herbs like Yastimadhu, Triphala, Manjistha, Ela, Haridra, Aloe vera, and Jati, known for their anti-inflammatory and wound-healing properties. The research follows traditional Arka preparation,followed by malahara preparation, phytochemical screening, and analytical tests for consistency, pH, and spreadability. A clinical study on 10 patients will assess its efficacy in pain relief using the Visual Analog Scale. The study aims to provide a natural alternative to chemical-based treatments, aligning with modern preferences for herbal solutions. |