| CTRI Number |
CTRI/2025/09/094674 [Registered on: 12/09/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive
Screening
Dentistry
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Role of resveratrol in oral Premalignant diseases |
|
Scientific Title of Study
|
Therapeutic potential of Natural polyphenol-Resveratrol in
Premalignant oral lesions-A Randomised Controlled Study”
|
| 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 nitin bhagat |
| Designation |
Professsor |
| Affiliation |
Manav rachna dental college |
| Address |
Sector 43, Faridabad, 121004, Haryana, India
Faridabad
HARYANA
121004
India |
| Phone |
99537 84571 |
| Fax |
|
| Email |
Nitinbhagat.sds@mrei.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Jiwyansh Sachdeva |
| Designation |
Student |
| Affiliation |
Manav rachna dental college |
| Address |
Mukherjee Park Tilak Nagar, Gangaram Vatika, Chaukhandi road
J7 ground floor
West
DELHI
110018
India |
| Phone |
08766338074 |
| Fax |
|
| Email |
Sachdevajiwyansh26@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jiwyansh Sachdeva |
| Designation |
Student |
| Affiliation |
Manav rachna dental college |
| Address |
Mukherjee Park Tilak Nagar, Gangaram Vatika, Chaukhandi road
J7 ground floor
West
DELHI
110018
India |
| Phone |
08766338074 |
| Fax |
|
| Email |
Sachdevajiwyansh26@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of oral surgery and maxillofacial,Manav rachna dental college |
|
|
Primary Sponsor
|
| Name |
Not applicable |
| Address |
Not applicable |
| 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 |
| Jiwyansh Sachdeva |
Manav rachna dental college |
Department of oral surgery and maxillofacial,room no 2 ,Q block , Manav rachna dental college
Faridabad
HARYANA |
8766338074
Sachdevajiwyansh26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee of MRDC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
For dental problem. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Male |
| Details |
1 Adults aged 18–70 years
2 Histologically confirmed OPLs (e.g.leukoplakia, oral epithelial dysplasia)
3 Lesion size should be more than or equal to 1cm
4 No prior treatment for the current lesion.
5 Willingness to comply with study procedures and provide informed consent. |
|
| ExclusionCriteria |
| Details |
1 Malignant oral lesions
2 Severe systemic conditions or immunocompromised status
3 Pregnancy or lactation
4 Known hypersensitivity to resveratrol
5 Concurrent use of other chemopreventive agents. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Change in lesion size and clinical appearance.
• Histopathological assessment of dysplasia grade.
|
Duration of study - 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Patient-reported pain & discomfort scores.
• Incidence of adverse events.
• Biomarker analysis for molecular mechanisms |
Duration of study -12 months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
22/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/09/2025 |
| 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)
|
Closed to Recruitment of Participants |
| 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
|
Title of the Study/Project : Therapeutic potential of resveratrol in PMD, a randomisedResveratrol , a natural polyphenol , exhibits anti-inflammatory , antioxidant and
wound healing properties by modulating cytokines and oxidative stress .
Preclinical studies support its role in enhancing tissue repair but clinical evidence i
oral surgery is limited .
clinical evidence supporting the use of Resveratrol in the treatment of oral
premalignant lesions remains limited, with few well-designed randomized controlle
trials evaluating its therapeutic potential.
This study aims to fill this gap by rigorously assessing the clinical and
histopathological effects of Resveratrol in patients with oral premalignant lesions
|