| CTRI Number |
CTRI/2024/09/073385 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
03/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
The Study Aimed To See If Adding Zinc Acetate To Triamcinalone Acetonide Would Help To Treat Patients With Oral Lichen Planus |
|
Scientific Title of Study
|
Assessment of efficacy of zinc acetate as an adjuvant to triamcinalone acetonide in patients with oral lichen planus: A randomized clinical trail. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Surasura venkata padmini |
| Designation |
Post graduate |
| Affiliation |
narayana dental college and hospital |
| Address |
Room no- 1 Narayana dental college and hospital, chintharedddypalem, nellore -524002
Room no-1 Narayana dentalcollege and hospital ,chinthareddypalem nellore-524002
Nellore
ANDHRA PRADESH
524002
India |
| Phone |
7780697515 |
| Fax |
|
| Email |
chikkipaddu96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Swapna sridevi beeraka |
| Designation |
Reader |
| Affiliation |
NARAYANA DENTAL COLLEGE AND HOSPITAL |
| Address |
NARAYANA DENTAL COLLEGEAND HOSPITAL,CHINTHAREDDYPALEM NELLORE-524002
Room no-1 Narayana dentalcollege and hospital ,chinthareddypalem,nellore
Nellore
ANDHRA PRADESH
524002
India |
| Phone |
9441788440 |
| Fax |
|
| Email |
chikkipaddu96@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Surasura venkata padmini |
| Designation |
Post graduate |
| Affiliation |
narayana dental college and hospital |
| Address |
Narayana dental college and hospital, chinthareddypalem- nellore -524002
Roomno-1 narayana dentalcollegeND hospital , chinthareddypalem,nellore
Nellore
ANDHRA PRADESH
524002
India |
| Phone |
7780697515 |
| Fax |
|
| Email |
chikkipaddu96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Narayana dental college and hospital chinthareddypalem, nellore, andhrapradesh ,india ,ANDHRAPRADESH, INDIA |
|
|
Primary Sponsor
|
| Name |
Surasura venkata padmini |
| Address |
ORAL MEDICINE AND RADIOLOGY ROOM NO 1 Narayana dental college and hospital,chinthareddypalem- nellore, andhra pradesh , 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 Surasura venkata padmini |
narayana dental college and hospital , |
Roomno-1, narayana dental college and hospital, chinthareddypalem,nellore -524002
Nellore
ANDHRA PRADESH |
7780697515
chikkipaddu96@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: L089||Local infection of the skin and subcutaneous tissue, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Triamcinolone Acetonide |
Ointment Triamcinolone Acetonide twice a day for two months |
| Intervention |
Zinc Acetate |
TAB. Zinc Acetate 15MG Twice a day for two months will be given for the patients |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
69.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Symptomatic Oral Lichen Planus
Patients willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
Patients with Asymptomatic Oral Lichen Planus
Pregnant and lactating females
Patient with history of CNS, CVS, Renal or Hepatic diseases except hypertension
Patients with Cancers
Patients under active treatment for lichen planus
Patients on steroids, immunomodulators for other conditions
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PAIN SCORE USING VISUAL ANALOUGE SCALE |
1ST,7TH,14TH,21ST |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| PAIN SCORE USING THONGPRASOM SCALE |
1ST,7H,14TH,21ST |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
18/10/2024 |
| 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="6"
Days="0" |
|
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
|
My aim of the study is to determine whether zinc acetate is useful as an adjuvant therapy in the management of patients with oral lichen planus.A total of 40 patients with symptomatic oral lichen planus will be randomly assigned into two groups based on computer generated randomization table. GROUP A ( Control Group ) compromise of 20 participants to who 0.1%Triamcinolone acetonide topical application will be given twice a day for two months along selfcare instructions . Group B (Study Group )comprises of 20 participants to whom zinc acetate 15mg supplementation along with 0.1% Triamcinolone acetonide topical application will be given twice a day for 2 months along with self care instructions |