| CTRI Number |
CTRI/2025/01/078906 [Registered on: 17/01/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessing the role of stress in oral lichen planus patients through blood test |
|
Scientific Title of Study
|
Evaluation serum cortisol and questionnaire based assessment of stress levels and its correlation with clinical status of oral lichen planus |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hoglah S |
| Designation |
Post graduate |
| Affiliation |
Narayana dental college and hospital |
| Address |
Narayana dental college and hospital
Department of oral medicine and radiology room no.1
Chinthareddy palem nellore
Narayana dental college and hospital
Department of oral medicine and radiology room no.1
Chinthareddy palem nellore
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9849920652 |
| Fax |
|
| Email |
hoglahpaul@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kannan Natarajan |
| Designation |
PROFESSOR AND HEAD |
| Affiliation |
narayana dental college and hospital |
| Address |
Narayana dental college and hospital, department of oral medicine and radiology
Nellore-524003
Narayana dental college and hospital, department of oral medicine and radiology chinthareddypalem Nellore-524003
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9490471078 |
| Fax |
|
| Email |
dentkan1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Hoglah S |
| Designation |
Post graduate |
| Affiliation |
narayana dental college and hospital |
| Address |
Narayana dental college and hospital department of oral medicine and radiology chinthareddy palem ,nellore 524003
Narayana dental college and hospital department of oral medicine and radiology room chinthareddy palem nellore 524003
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
09849920652 |
| Fax |
|
| Email |
hoglahpaul@gmail.com |
|
|
Source of Monetary or Material Support
|
| Narayana dental college and hospital Nellore 524001 |
|
|
Primary Sponsor
|
| Name |
HOGLAH S |
| Address |
Narayana dental college and hospital department of oral medicine and radiology room no.1, chinthareddy palem , nellore |
| 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 HOGLAH |
Narayana hospital |
Narayana dental college and hospital, department of oral medicine and radiology room no.1, chinthareddy palem , nellore E-524003
Nellore
ANDHRA PRADESH |
9849920652
hoglahpaul@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L80-L99||Other disorders of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
patients in the age group of above 20yrs
patients diagnosed with OLP
patients willing to participate in this study. |
|
| ExclusionCriteria |
| Details |
smokers and tobacco users are excluded from this trial
pregnant and lactating mothers
patients with CNS and CVS disorders
patients with cancers
patients with renal and hepatic diseases |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To correlate the clinical status of oral lichen planus |
To correlate the clinical status of oral lichen planus |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Identify if there is any Correlation between the clinical status of oral lichen planus & the stress levels |
At the point of observation |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
28/01/2025 |
| 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="6"
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
|
40 patients diagnosed as having oral lichen planus will be recruited based on their voluntary willingness to participate in the study based on the the inclusion and exclusion criteria . Questionnaire will be administered for subjective assessment of stress levels followed by serum cortisol level assessment by CLIA method for objective assessment of stress levels. clinical grading of the oral lichen planus will be carried out .using Thongprasom scoring system .data will be tabulated and subjected to statistical analysis. |