| CTRI Number |
CTRI/2024/11/076144 [Registered on: 01/11/2024] Trial Registered Prospectively |
| Last Modified On: |
27/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Trial on effectiveness of omega-3 fatty acid supplements compared to Steroids in treating Lichen Planus of mouth |
|
Scientific Title of Study
|
Trial on effectiveness of omega 3 fatty acid supplements compared to Topical Steroids in Oral Lichen Planus Management |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Medona Antony |
| Designation |
Postgraduate |
| Affiliation |
Kannur Dental College |
| Address |
First year postgraduate
Department of Oral Medicine and Radiology,Room No 1
Kannur Dental College
Anjarakandy Integrated Campus
Anjarakandy 670611
Kannur Dt, Kerala state, India.
Kannur
KERALA
670611
India |
| Phone |
8139045701 |
| Fax |
|
| Email |
mariaantomedona@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prathima Sreenivasan |
| Designation |
Professor and Head |
| Affiliation |
Kannur Dental College, Anjarakandy, Kannur. |
| Address |
Department of Oral Medicine and Radiology, Room No.1, Kannur Dental College
Anjarakandy Integrated Campus
Kannur
KERALA
670611
India |
| Phone |
9447780310 |
| Fax |
|
| Email |
prathimasumal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prathima Sreenivasan |
| Designation |
Professor and Head |
| Affiliation |
Kannur Dental College, Anjarakandy, Kannur. |
| Address |
Department of Oral Medicine and Radiology, Room No.1, Kannur Dental College
Anjarakandy Integrated Campus
Kannur
KERALA
670611
India |
| Phone |
9447780310 |
| Fax |
|
| Email |
prathimasumal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of Oral Medicine and Radiology,Room No.1, Kannur Dental College, Anjarakandy, Kannur (District), Kerala, India |
|
|
Primary Sponsor
|
| Name |
Medona Antony |
| Address |
Department of Oral Medicine and Radiology, Room No 1,
Kannur Dental College
Anjarakandy Integrated Campus
Anjarakandy , 670611
Kannur Dist,Kerala State, India.
|
| Type of Sponsor |
Other [Self] |
|
|
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 Prathima Sreenivasan |
Kannur Dental College |
Department of Oral Medicine and Radiology, Room No.1, Kannur Dental College, Anjarakandy, Kannur(District), Kerala(State), India. Pin-670611
Kannur
KERALA |
94477080310
prathimasumal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Kannur Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L439||Lichen planus, unspecified, (2) ICD-10 Condition: K137||Other and unspecified lesions of oral mucosa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Omega -3 Fatty acid supplements |
1000 mg omega-3 fatty acids with 180 mg EPA and 120mg DHA once daily, oral route of administration, for 4 weeks. |
| Comparator Agent |
Topical Corticosteroids |
Triamcinolone topical oralpaste (0.1% buccal paste) topical intra-oral application over the lesion, thrice daily for 2 weeks , twice for next 2 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Clinically diagnosed oral lichen planus patients according to WHO 2003 criteria.
2.Patients in the age group of 18 years and above. |
|
| ExclusionCriteria |
| Details |
1.Patients having HIV infection and other immunocompromised diseases.
2. Patients on immune suppressant medication for other reasons, cancer chemotherapy, radiotherapy.
3.Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the effectiveness of omega3 fatty acid supplements in the resolution of symptoms of Oral Lichen Planus. |
Baseline- 0 day , 1st assessment -2nd week, 2nd assessment- 4th week
3rd assessment - 8th week
4th assessmet - 12th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Determine the rapidity of resolution of Oral Lichen Planus using Omega 3 fatty acids supplements. |
Baseline- 0 day , 1st assessment -2nd week, 2nd assessment- 4th week
3rd assessment - 8th week
4th assessmet - 12th week |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
10/11/2024 |
| 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
|
This study is a Randomized Control Trial to evaluate the Effectiveness of Omega-3 fatty acid supplements in the patients with Oral Lichen Planus.This is a hospital based study, conducting in the Department of Oral Medicine and Radiology, Kannur Dental College. The study duration will be 1 year. Patients in the age group of 18 years and above and clinically diagnosed Oral Lichen Planus patients according to WHO 2003 criteria will be the inclusion criteria.Exclusion criteria include, the patients having HIV infection and other immuno compromised diseases. Patients on immune suppressant medication for other reasons, cancer chemotherapy, radiotherapy and pregnant and lactating women. All participants will be explained about the study and written informed consent will be obtained. Participants in the study will be randomly allocated using computer software program into intervention and control group , having 21 participants in each group. Group1 will be the control group with 21 participants they will be administered with Topical Corticosteroids and Group 2 will be the intervention group with 21 participants and they will be administered with Topical corticosteroids and 1000mg of Omega-3 fatty acid with 180mg EPA and 120mg DHA. Baseline measurements will be taken using the following outcome measures- VAS score and REU score. At every followup visits on 2nd, 4th, 8th and 12th week the same measures will be used to assess the outcome. Total duration will be 3 months.
|