| CTRI Number |
CTRI/2022/12/048473 [Registered on: 26/12/2022] Trial Registered Prospectively |
| Last Modified On: |
24/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Curcumin vs retinoic acid topical application in treatment of oral
premalignant lesions |
|
Scientific Title of Study
|
Comparative Evaluation of efficacy of Topical Application
of curcumin and Retinoic acid in treatment of oral
premalignant lesions |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Geetika Gupta |
| Designation |
Intern |
| Affiliation |
Sri Rajiv Gandhi College of dental sciences and hospital |
| Address |
Dept of oral and maxillofacial surgery,Sri Rajiv Gandhi College of dental sciences,Bangalore
Bangalore
KARNATAKA
560032
India |
| Phone |
7892035651 |
| Fax |
|
| Email |
gitikagupta2611@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hemavathi U |
| Designation |
Senior Lecturer,Dept of Oral and maxillofacial surgery |
| Affiliation |
Sri Rajiv Gandhi College of Dental Sciences |
| Address |
Room no.9,first floor,Dept of oral and maxillofacial surgery,Sri Rajiv Gandhi College of dental sciences,Bangalore
Bangalore
KARNATAKA
560032
India |
| Phone |
9663906416 |
| Fax |
|
| Email |
drhemau85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hemavathi U |
| Designation |
Senior Lecturer,Dept of Oral and maxillofacial surgery |
| Affiliation |
Sri Rajiv Gandhi College of Dental Sciences |
| Address |
Room no 9,first floor,Dept of oral and maxillofacial surgery,Sri Rajiv Gandhi College of dental sciences,Bangalore
Bangalore
KARNATAKA
560032
India |
| Phone |
9663906416 |
| Fax |
|
| Email |
drhemau85@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Rajiv Gandhi College of Dental Sciences
|
|
|
Primary Sponsor
|
| Name |
Sri Rajiv Gandhi College of dental Sciences and hospital |
| Address |
Sri Rajiv Gandhi College of dental Sciences and hospital,Bangalore |
| Type of Sponsor |
Research institution |
|
|
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 Hemavati U |
Sri Rajiv Gandhi College of dental Sciences |
Room 9.first floor,Dept of oral and maxillofacial surgery,Sri Rajiv Gandhi College of Dental Sciences and Hospital,Sri Rajiv Gandhi College of dental Sciences and hospital,Bangalore
Bangalore
KARNATAKA |
9663906416
drhemau85@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical committee,Sri Rajiv Gandhi College of dental Sciences and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L988||Other specified disorders of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Capsule Curcumin 500 mg |
Capsule form-Content punctured and applied by patient.
Route of administration- Topical
Frequency - 3 times a day
Duration - 3 months |
| Comparator Agent |
Retinoic acid gel |
A-Ret 1%w/w Gel 20 gm
Route of administration- Topical
Frequency- 3 times a day
Duration - 3 months |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age > 20 years
Patient with cessation of habit 1 month
before intervention.
Patients reporting to the department of oral
and maxillofacial surgery with clinical
sign and histologically proven
premalignant lesions.
Patients with early stage lesion
Patients willing to be a part of the study
and giving consent for the same |
|
| ExclusionCriteria |
| Details |
1)Patient with h/o topical therapy to oral
lesion.
2)Patients with hypersensitivity to drug
3)Patients reporting to the department of oral
and maxillofacial surgery with clinical
sign and histologically proven
premalignant lesions.
4)Pregnancy
5)Patients with advanced stage lesion
6)Patients with h/o reported adverse effects
to treatment with retinoic acid and
curcumin. |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Pain- Visual analog scale
2)Burning sensation of the lesion
3)Change in size of lesion |
1)Baseline
2)During application period-
15 days once- upto 1 month
Every month once- upto 3 months
3)During followup-
Every month once- upto 3 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse effects |
Single visit |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
31/12/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Potentially malignant lesions (PML) are oral mucosal lesions that are at enhanced danger of malignant transformation compared to healthy mucosal lesions.They account for 17% to 35% of all new cases of oral cavity cancer and undergo malignant transformation between 0.7% and 2.9% annually.The most commonly described premalignant oral lesions are leukoplakia,erythroplakia,oral lichen planus, and submucous fibrosis.
The early detection and therapeutic management of these lesions are very much essential to prevent malignant transformation.
Although many medicinal agents have been tried in the past,there is no gold standard which has been established for treating these conditions.We are using topical application of curcumin and retinoic acid in the treatment of these lesions.
Curcumin is a yellow color plant derivative obtained from the root of Curcuma longa (Turmeric) which belongs to the ginger family,with anti-inflammatory, antifibrotic, antioxidant, and anticarcinognic property.Retinoic acid is a metabolite of vitamin A) which has significant role in cell growth,differentiation and apoptosis, anti inflammatory,and anti oxidant property. |