| CTRI Number |
CTRI/2020/10/028529 [Registered on: 21/10/2020] Trial Registered Prospectively |
| Last Modified On: |
14/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparing the vitamin A Cream with drumstick plant extract gel in treatment of oral potentially malignant disorder-leukoplakia |
|
Scientific Title of Study
|
Comparison of effectiveness of Moringa oleifera leaves extract gel [2%] with Retino A (0.1%) cream for treatment of oral leukoplakia - A double blinded randomised control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrShivayogi Charantimath |
| Designation |
Reader |
| Affiliation |
dept.of OMDR KLE Vishwanath Katti Institute of dental sciences |
| Address |
Nehrunagar Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
|
| Fax |
|
| Email |
cshivayogi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrShivayogi Charantimath |
| Designation |
Reader |
| Affiliation |
Dept.of OMDR KLE Vishwanath Katti Institute of dental sciences |
| Address |
Nehrunagar Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
|
| Fax |
|
| Email |
cshivayogi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ansari Sulem Riyaz Ahmed |
| Designation |
Post graduate student OMDR |
| Affiliation |
Dept.of OMDR KLE Vishwanath Katti Institue of dental sciences |
| Address |
Nehrunagar Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
09773723359 |
| Fax |
|
| Email |
ansarisulem@gmail.com |
|
|
Source of Monetary or Material Support
|
| kLEs Dr.Prabhakar Kore basic science research center Belagavi |
|
|
Primary Sponsor
|
| Name |
DrAnsari Sulem Riyaz Ahmed |
| Address |
house no 4818 1st cross subhash nagar Belagavi 590010 |
| Type of Sponsor |
Other [post graduate thesis] |
|
|
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 |
| DrShivayogi Charantimath |
KLE VKIDS |
department of OMDR, Room no:01,Nehru nagar Belagavi-590010
Belgaum
KARNATAKA |
9739638971
cshivayogi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethics Committee KLE VK Institute of dental sciences,KLE University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C14||Malignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Moringa Oleifera leaves mucoadhesive gel |
Moringa Oleifera is rich in antioxidants.
The extraction of active ingredients such as quercetin will be done using the process of maceration(hydroalcohlic method).mucoadhesive gel will be prepared using HPMC.The concentration of Moringa Oleifera will be decided by MIC,MBC Values.
Route of administration - will be applied locally/topically in oral mucosa.
Dosage - 2-3 gms/application approximately.
The amount of gel will vary depending upon the size of lesion.
Duration of therapy- 3 months.
Application/day-thrice daily using sterile cotton bud. |
| Comparator Agent |
Retino-A 0.1% CREAM |
It is a cream which contains 1% tretinoin in a bland, hydrophilic base. Nonmedicinal ingredients: butylated hydroxytoluene, isopropyl myristate, polyoxyl (40) stearate, purified water, sorbic acid, stearic acid, stearyl alcohol, and xanthan gum. Each gram of gel contains 0.01% tretinoin.
Dosage - 2-3 gms/application approximately. The amount of cream will vary depending upon the size of lesion.
Duration of therapy- 3 months.
Application/day-thrice daily using sterile cotton bud. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Homogeneous leukoplakia of size range 2-6 cm in greatest dimension.
2.Patients above 18 years.
3.Patients who are willing to participate in this study.
|
|
| ExclusionCriteria |
| Details |
1.Non-homogenous leukoplakia.
2.Leukoplakia more than 6 cm in greatest dimension.
3.Leukoplakia involving tongue and floor of oral cavity.
4.Patients with any other potentially malignant disorders other than Oral leukoplakia and under treatment.
5.Pregnant and lactating females.
6.Patients who have already undergone treatment for Oral Leukoplakia (within 3 months)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the size of lesion of oral leukoplakia. |
1,2,3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in burning sensation |
1,2,3 months |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "65"
Final Enrollment numbers achieved (India)="65" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/12/2020 |
| Date of Study Completion (India) |
31/12/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil.
This is an interventional study. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Research summary Aim: The aim of the study is to evaluate & to compare the efficacy of Moringa oleifera leaf extract gel (2%) & Retino A cream (0.1%) in reduction of size of lesion in oral leukoplakia. Objectives : 1. To assess the efficacy of Moringa oleifera mucoadhesive gel in determining reduction in the size of the lesion in oral leukoplakia patient. 2. To assess the efficacy of Retino-A cream in determining reduction in size of the lesion in oral leukoplakia patient. 3. To compare the efficacy of Moringa oleifera mucoadhesive gel (2%) in determining the change in the size of the lesion in oral leukoplakia patient. Methodology : Clinically diagnosed cases of Oral Leukoplakia will be included in this study. The sample size is 72. 36 patients with lesion size ranging from 2- 4 cm and 36 patients with lesion size ranging from 4.1 – 6 cm will be equally distributed in case and control group using chit system. So case and control both group will be having 36 patients with equal number of size range lesions. The participants in case and control group will be advised topical application of the intervention and Retino-A respectively thrice-daily using sterile cotton bud. Outcome : The participants will recalled for review after 1, 2, 3 months for evaluation of change in size of the lesion. |