| CTRI Number |
CTRI/2025/03/082156 [Registered on: 11/03/2025] Trial Registered Prospectively |
| Last Modified On: |
10/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of panchashireesh agad churna in tobacco chewing induced Oral Submucosal fibrosis Grade 2 |
|
Scientific Title of Study
|
Clinical evaluation of panchashireesh Agad churna pratisaran in tobacco chewing induced Sarvasar Mukhapaka (Oral Submucosal Fibrosis Grade 2) |
| 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.Uday Dipak Shelar |
| Designation |
PG Scholar |
| Affiliation |
Bharati Vidyapeeth (Deemed To Be University)college Of Ayurved,Pune |
| Address |
Bharati Vidyapeeth (Deemed to be university) college of Ayurveda
and Hospital Department of Agad tantra OPD no-26,Katraj-
Dhanakawadi,Pune
Pune
MAHARASHTRA
411043
India
Pune
MAHARASHTRA
411043
India |
| Phone |
8652204073 |
| Fax |
|
| Email |
uday.shelar-ayurved@bvp.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasad Namewar |
| Designation |
HOD Associate Professor |
| Affiliation |
Bharati Vidyapeeth (Deemed To Be University)college Of Ayurved,Pune |
| Address |
Bharati Vidyapeeth (Deemed To Be University) College Of Ayurved
Department Of Agad Tantra Katraj Dhankwadi Campus Pune
Pune
MAHARASHTRA
411043
India
Pune
MAHARASHTRA
411043
India |
| Phone |
9226269869 |
| Fax |
|
| Email |
Prasad.namewar@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prasad Namewar |
| Designation |
HOD Associate Professor |
| Affiliation |
Bharati Vidyapeeth (Deemed To Be University)college Of Ayurved,Pune |
| Address |
Bharati Vidyapeeth (Deemed To Be University) College Of Ayurved
Department Of Agad Tantra Katraj Dhankwadi Campus Pune
Pune
MAHARASHTRA
411043
India
Pune
MAHARASHTRA
411043
India |
| Phone |
9226269869 |
| Fax |
|
| Email |
Prasad.namewar@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
| Bharati ayurved college and Hospital Dept of agad tantra Dhankawadi Pune Maharashtra 411043 India |
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
Bharati Vidyapeeth (Deemed To Be University)College Of ayurved
and hospital Department Of Agad Tantra Katraj dhankawadi Pune Maharashtra 411043 India |
| Type of Sponsor |
Other [Research institution and hospital Bharti vidyapeeth pune] |
|
|
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 |
| DrUday D Shelar |
Bharati Vidyapeeth Deemed To be University College of Ayurveda Katraj Dhankawadi Pune |
Bharati Vidyapeeth
College of Ayurveda
and Hospital
Department
of Agadtantra OPD
no.26 and IPD second ground
floor
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
8652204073
uday.shelar-ayurved@bvp.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth Deemed to be University Pune India College of Ayurved Pune Satara Road Pune 411043 ETHICS COMMITTEE [BV(DU)COA EC] |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K135||Oral submucous fibrosis. Ayurveda Condition: MUKHAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Panchashireesh agad churna, Reference: Bhavaprakash nighantu madhyam khand 67-79, Route: Topical, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: -), Additional Information: - | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Triamcinolone acetonide, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Tobacco chewing since 2-3 years
Patient having clinical symptoms of OSMF 2 |
|
| ExclusionCriteria |
| Details |
Patient with recurrent stomatitis due to nuetritional deficiency
Patient diagnosed with oral squamous cell carcinoma |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.The reduction in the gradation of symptoms or complete alleviation in
symptoms of OSMF will reveal the efficacy of Panchashireesh Agad churna in OSMF Grade II
caused by Tobacco chewing. |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Worsening in the OSMF grade II symptoms will be measured as
secondary end point. |
28 days |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
21/03/2025 |
| 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="1"
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 study will conducted after obtaining permission from institutional ethical committee and will be registered ctri India as per inclusion criteria.patient will be selected and screening done at OPD and IPD of Agadtantra |