| CTRI Number |
CTRI/2025/08/092827 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
08/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Mukharogahar Taila for oil pulling versus chlorhexidine gargle which works more better for tobacco induced mouth ulcers |
|
Scientific Title of Study
|
Evaluation of Comparative Efficacy of Mukharogahar Taila Gandusha (Oil Pulling) Versus Chlorhexidine Gargle in Tobacco Chewing Induced 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 |
Anamika jain |
| Designation |
PG Scholar |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Wardha |
| Address |
Room number 20 Department of Agadtantra and Vidhi Vaidyaka Mahatma Gandhi Ayurved College Hospital and Research centre Salod Wardha Maharashtra Pincode 442001
Datta Meghe Institute of Higher Education and Research deemed to be University Sawangi Wardha Maharashtra Pincode 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
6264511074 |
| Fax |
|
| Email |
anamika.aj001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anamika jain |
| Designation |
PG Scholar |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Wardha |
| Address |
Room number 20 Department of Agadtantra and Vidhi Vaidyaka
Mahatma Gandhi Ayurved College Hospital and Research Centre
Salod Wardha Maharashtra
India
pinocde 442001
Datta Meghe Institute of Higher Education and Research deemed to be University Sawangi Wardha Maharashtra Pincode 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
6264511074 |
| Fax |
|
| Email |
anamika.aj001@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Minakshi Urkude |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Wardha |
| Address |
Room number 20 Department of Agadtantra and Vidhi Vaidyaka
Mahatma Gandhi Ayurved College Hospital and Research Centre
Salod Wardha Maharashtra
India
pinocde 442001
Datta Meghe Institute of Higher Education and Research deemed to be University Sawangi Wardha Maharashtra Pincode 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
9421727976 |
| Fax |
|
| Email |
minakshi.urkude@dmiher.edu.in |
|
|
Source of Monetary or Material Support
|
| Room number 20 Department of Agadtantra and Vidhi Vaidyaka
Mahatma Gandhi Ayurved College Hospital and Research Centre
Salod Wardha Maharashtra
India
pinocde 442001 |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Ayurved College Hospital and Research Centre DMIHER Salod Wardha |
| Address |
Department of Agadtantra and Vidhi Vaidyaka
Mahatma Gandhi Ayurved College Hospital and Research Centre
Salod Wardha Maharashtra
India
pinocde 442001 |
| 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 |
| Anamika jain |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Wardha |
Department of Agadtantra and Vidhi Vaidyaka
Mahatma Gandhi Ayurved College Hospital and Research Centre
Salod Wardha Maharashtra
India
pinocde 442001
Wardha
MAHARASHTRA |
06264511074
anamika.aj001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Ayurved College Hospital and Research Centre Institutional Ethics Committee Salod Wardha |
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 | Classical | | (1) Medicine Name: Mukharogahar Taila, Reference: Rasaratna samuccaya 31/104, Route: Topical, Dosage Form: Taila, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Chlorhexidine Gargle | Chlorhexidine ia an antiseptic agent, it works by killing harmful microorganisms and cleans the affected area |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having a history of chewing tobacco and its related products.
|
|
| ExclusionCriteria |
| Details |
1.Disease is most advanced with premalignant and malignant changes
2.Generalized fibromatosis
3.Chronic debilitating conditions such as uncontrolled DM, uncontrolled HT, HIV, etc.
4.Pregnant and lactating females.
5.Patients on Oral topical medications |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in redness, burning sensation, pain, number and size of ulcerations and recurrence rate. |
at baseline, 3rd day, 7th day, 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ORAL INTAKE WILL BE INCREASED |
15 DAYS |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
11/11/2025 |
| 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="2"
Months="0"
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
|
The volunteers will be informed about study protocol. willing participants will be randomly selected as per computer generated table. the clinical research format will be prepared and validated. before the study approval will be taken IEC, MGACRC ,salod Wardha and CTRI registration will be done. after selection each participant will be tested individually and selected according to selection criteria. They are divided into two groups. The trial is a randomized,open - label standard control equivalent clinical trial. it will include 15 days treatment period and follow up |