| CTRI Number |
CTRI/2024/11/076160 [Registered on: 01/11/2024] Trial Registered Prospectively |
| Last Modified On: |
23/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluating the usefulness of Stressnil oral spray in treating patients with oral lichen planus |
|
Scientific Title of Study
|
Therapeutic evaluation of Stressnil oral spray in the management of oral lichen planus- A randomized controlled trial |
| 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 Fathima Mohammed Abdul Majeed |
| Designation |
Postgraduate resident Department Of Oral Medicine And Radiology |
| Affiliation |
Yenepoya Dental College And Hospital |
| Address |
Department Of Oral Medicine And Radiology, Room number 1, Yenepoya Dental College, Deralakatte,
Dakshina Kannada
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9663637193 |
| Fax |
|
| Email |
fathimamajeed102@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashanth Shenoy |
| Designation |
Professor and head of Department Of Oral Medicine And Radiology |
| Affiliation |
Yenepoya Dental College And Hospital |
| Address |
Department Of Oral Medicine And Radiology, Room number 1, Yenepoya Dental College, Deralakatte,
Dakshina Kannada
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9845082753 |
| Fax |
|
| Email |
prashanthshenoy4@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prashanth Shenoy |
| Designation |
Professor and head of Department Of Oral Medicine And Radiology |
| Affiliation |
Yenepoya Dental College And Hospital, Mangalore |
| Address |
Department Of Oral Medicine And Radiology, Room number 1, Yenepoya Dental College, Deralakatte, Mangalore, Karnataka 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9845082753 |
| Fax |
|
| Email |
prashanthshenoy4@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Oral Medicine And Radiology, Room number 1, Yenepoya Dental College, Deralakatte,
Dakshina Kannada
|
|
|
Primary Sponsor
|
| Name |
Dr Fathima Mohammed Abdul Majeed |
| Address |
Department Of Oral Medicine And Radiology, Room number 1, Yenepoya Dental College, Deralakatte,
Mangalore
Karnataka 575018 |
| 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 Fathima Mohammed Abdul Majeed |
Yenepoya Dental College And Hospital |
Department Of Oral Medicine And Radiology
Room no 1
Derlakatte
Mangalore 575018
Dakshina Kannada
KARNATAKA |
9663637193
fathimamajeed102@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| YENEPOYA ETHICS COMMITTE-1 E |
Approved |
| YENEPOYA ETHICS COMMITTE-1 E |
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 |
Stressnil Anti-Antistress Oral spray |
Stressnil oral spray is sprayed 5-6 times sublingually equivalent to 1 ml of the spray. The ingredients of the spray include Indian valerian 30mg, Melatonin 3mg, L-theanine 3 mg, and Tryptophan 5mg. It has to be sprayed one hour before bed at night along with applying triamcinolone acetonide 0.1% paste on the affected site.
The application of stressnil oral spray and triamcinolone acetonide 0.1% paste will continue for 1 month. |
| Comparator Agent |
Triamcinolone acetonide 0.1% paste |
Triamcinolone acetonide paste 0.1% is applied to the oral lichen planus affected site in the oral mucosa 3 times a day. This application has to be continued for one month. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1) Biopsy confirmed Oral lichen planus cases.
2) Age > 18 years. |
|
| ExclusionCriteria |
| Details |
1. Patient < 18 years.
2. Patients who are pregnant and lactating.
3. Medically compromised patients undergoing treatment for all systemic conditions except for blood pressure and diabetes (COPD patients, chronic kidney disease patients, liver disorder patients, etc will be excluded from the study)
4. Patients with lichenoid drug reactions(caused by drugs like ACE inhibitors, beta-blockers, diuretics, etc) and that arise due to heavy
metal restorations or any drugs.
5. Histologic signs of dysplasia. (participants who have malignancy/cancer and are under treatment for the same will be excluded from the study). |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in the size of oral lichen planus lesion by visual assessment and photographic documentation.
Reduction in symptoms/ burning sensation using NRS(numeric rating scale) |
Baseline, 1 week, 2 weeks, 3 weeks, and 4 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in the progression of lesion. |
2 weeks & 4 weeks. |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/11/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
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 randomised controlled trial titled" therapeutic evaluation of Stressnil oral spray in the management of Oral Lichen planus" will be conducted in the department of oral medicine and radiology in Yenepoya dental college. the study has a total of 34 patients 17 in each group was estimated as sample size. All the participants in this study will be clinically and histologically confirmed cases of oral lichen planus. group A will be prescribed Stressnil oral spray along with routine triamcinolone acetonide 0.1%. this spray has to be spayed 5-6 times sublingual one hour prior to going to bed at night for a span of one month. group b will be prescribed triamcinolone acetonide 0.1% alone. patients will be recalled every week for a month to assess the reduction in size and pain of the patient. all the participants will be given standard modality of treatment and informed consent and will be taken from all the participants. oral lichen planus is a chronic inflammatory condition associated that has various etiology and predisposing factors, stress is found to be one of the factors hence we are trying to treat stress using this spray as it claims to reduce stress ,modulate sleep and provide relaxation in patients. |