| CTRI Number |
CTRI/2024/06/069548 [Registered on: 26/06/2024] Trial Registered Prospectively |
| Last Modified On: |
20/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of 1 percent topical Spirulina gel as intervention in participants having Oral Lichen Planus |
|
Scientific Title of Study
|
Comparative evaluation of efficacy of topical application of Spirulina gel 1 percent and triamcinolone acetonide 0.1 percent 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 Nitika Aggarwal |
| Designation |
Post graduate student |
| Affiliation |
Government dental college and hospital, Mumbai |
| Address |
Room no. 23, Department of oral medicine and Radiology, government dental college and hospital, Mumbai
Mumbai
MAHARASHTRA
400001
India |
| Phone |
7206480337 |
| Fax |
|
| Email |
nitika9861@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijayalaxmi Nimma |
| Designation |
Associate professor |
| Affiliation |
Government dental college and hospital, Mumbai |
| Address |
ROOM NO.23, DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY, GOVERNMENT DENTAL COLLEGE AND HOSPITAL
Mumbai
MAHARASHTRA
400001
India |
| Phone |
9676557606 |
| Fax |
|
| Email |
drvijayaomr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nitika Aggarwal |
| Designation |
Post graduate student |
| Affiliation |
Government dental college and hospital, Mumbai |
| Address |
Room no. 23, Department of oral medicine and Radiology, government dental college and hospital, Mumbai
Mumbai
MAHARASHTRA
400001
India |
| Phone |
7206480337 |
| Fax |
|
| Email |
nitika9861@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room number 23, Department of Oral Medicine and Radiology,Government Dental College and Hospital, Mumbai (400001), Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Dr Nitika Aggarwal |
| Address |
Room no. 23, Department of oral medicine and Radiology, Government dental college and hospital, Mumbai |
| 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 Nitika Aggarwal |
Government dental college and hospital, Mumbai |
Room no. 23, Department of oral medicine and radiology, Government dental college and hospital, Mumbai
Mumbai
MAHARASHTRA |
7206480337
nitika9861@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Dental College and Hospital Mumbai, Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K121||Other forms of stomatitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Topical Spirulina 1% |
thrice daily for 4 weeks, after that thrice daily with 15 days follow up for 1 month |
| Comparator Agent |
Topical triamcinolone acetonide 0.1% |
thrice daily for 4 weeks, after that thrice daily with 15 days follow up for 1 month |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) All clinically Diagnosed cases with atrophic, erosive, reticular or any other form
of oral lichen Planus.
2) Patients above 21 years of age.
3) Patients with no contraindications or documented allergies to the
medications which are being used for study.
4) Patients willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
1) Previously treated patients of oral lichen planus in last 3 months or those
who have left treatment in-between, or undergoing any other
treatment modality.
2) Patients with co-existing systemic illness like diabetes mellitus, hypertension.
3) Pregnant and lactating mother. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Burning sensation
(Visual analog
scale),
Size of the lesion
(using vernier
caliper),
Clinical assessment
(Thongprasom
score) |
weekly for 4 weeks, after that 15 days for 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To record the adverse reactions, if any, with both the drugs in either of the two groups,
To record the recurrence of the lesion in any of the two groups |
weekly for 4 weeks, after that 15 days for 1 month |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/07/2024 |
| 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="10" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Oral lichen planus is chronic inflammatory muco-cutaneous immune mediated
disorder that affects skin and oral mucous membrane. It most commonly involves middle
aged patients with mean age between 30-60 years. Extensive research and numerous trials have been conducted to determine the most
efficacious and safe treatments for OLP. The treatment of oral lichen planus has always posed
a challenge to the dental surgeon. Steroids form the mainstay treatment modality for oral lichen planus. Amongst steroids,
triamcinolone acetonide forms the drug of choice owing to its intermediately acting nature
and ease of absorption from the oral mucous membrane. Necessity is the mother of invention. And hence to overcome the adverse effects newer
therapeutic agents have time and again been tried and tested. One such agent is the
commercially available superfood- Spirulina. Spirulina contains functional
compounds, such as phenolics, phycocyanins, and polysaccharides, with antioxidant, antiinflammatory, and immunostimulating effects.
This study aims to evaluate the efficacy of spirulina in the treatment of oral lichen planus and
compare it with corticosteroids.
|