| CTRI Number |
CTRI/2024/05/068010 [Registered on: 28/05/2024] Trial Registered Prospectively |
| Last Modified On: |
22/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Compare The Efficacy Of a Creme Containing Coconut, Licorice And in patients suffering from Oral lichen planus with Topical Triamcinolone Acetonide Gel. |
|
Scientific Title of Study
|
Comparison Of Efficacy Of Topical Coconut, Licorice, Purslane Cream with Topical Triamcinolone Acetonide Gel for the Treatment 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 Disha Alhat |
| Designation |
PG Student |
| Affiliation |
Swargiya dadasaheb kalmegh smruti dental college and hospital, Nagpur |
| Address |
Room no 3, 1st floor Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Nagpur
Swargiya dadasaheb kalmegh smruti dental college and hospital
Nagpur
MAHARASHTRA
440001
India |
| Phone |
07820949794 |
| Fax |
|
| Email |
dralhat511@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ashish Lanjekar |
| Designation |
Doctor |
| Affiliation |
Swargiya dadasaheb kalmegh smruti dental college and hospital, Nagpur |
| Address |
ground floor, room no 3, Swargiya dadasaheb kalmegh smruti dental college and hospital, Nagpur
Swargiya dadasaheb kalmegh smruti dental college and hospital
Nagpur
MAHARASHTRA
440001
India |
| Phone |
9595052481 |
| Fax |
|
| Email |
ashish.lanjekar@sdk-dentalcollege.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Disha Alhat |
| Designation |
PG Student |
| Affiliation |
Swargiya dadasaheb kalmegh smruti dental college and hospital, Nagpur |
| Address |
Room no 3, 1st floor Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Nagpur
Swargiya dadasaheb kalmegh smruti dental college and hospital
Nagpur
MAHARASHTRA
440001
India |
| Phone |
7820949794 |
| Fax |
|
| Email |
dralhat511@gmail.com |
|
|
Source of Monetary or Material Support
|
| Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Nagpur-441110, India |
|
|
Primary Sponsor
|
| Name |
Disha Vijay Alhat |
| Address |
Behind Sai Shraddha Housing Society, Wagh Vasti, Shirdi-423109, India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Disha Alhat |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital |
ground floor, room no 3
Swargiya dadasaheb kalmegh smruti dental college and hospital, Waddhamna, Nagpur, state- Maharashtra, Country- India
Nagpur
MAHARASHTRA |
07820949794
dralhat511@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D829||Immunodeficiency associated with major defect, unspecified. Ayurveda Condition: CARMADALA-KUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Coconut-licorice-purslane cream, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(mg), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | 0.1% triamcinolone acetonide gel | It is a topical Corticosteroid.
will be applied 3 times a day on affected region for 3 months |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinically diagnosed oral lichen planus patients.
2. Healthy patients without any systemic diseases.
3. Patients who are ready to quit the habit if any present and accept regular follow up protocol.
4. Patients willing for inclusion under study with written consent and allow withdrawing anytime. |
|
| ExclusionCriteria |
| Details |
1. Patient with known history of hypersensitivity to Coconut cream, Licorice, pruslane and topical 0.1% triamcinolone acetonide gel.
2. Patient who will be diagnosed to have other intra oral lesions.
3. Pregnant women and lactating mothers.
4. Patient previously undergone treatment for oral lichen planus. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Topical coconut, licorice, purslane cream is efficacious in management of oral lichen planus. |
Baseline, 14th day, 30th day, 60th day and 90th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Topical coconut, licorice, purslane cream is more efficacious compared to topical triamcinolone acetonide gel. |
Baseline, 14th day, 30th day, 60th day & 90th day |
|
|
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)
|
03/06/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
A detailed case history will be taken from all the participants and will be recorded in the prepared proforma after patients written consent and approval from the Institutional Ethics Committee. Only those patients who are willing to participate will be considered in the study . Total 40 clinically diagnosed patients with Oral Lichen Planus will be enrolled in the study. Group A patients (20 subjects) will be instructed to apply Coconut, Licorice, Pruslane cream over the affected site 3 times a day, for 90 days. Patients will be ask to refrained from eating and drinking for 15 minutes post application of gel. Group B patients (20 subjects) will be instructed to apply topical triamcinolone acetonide gel over the affected site 3 times a day, for 90 days. Patients will be ask to refrained from eating and drinking for 15 minutes post application of gel. Pre-operative pain intensity will be measured. This clinical parameters will be measured and recorded at baseline before treatment and on days 14, 30, 60 and 90 days. Patients will be recalled for follow-up.
The intensity of pain will be recorded using a Visual Analogue Scale ranging from 0-10 where 0 denotes no pain and 10 denotes unbearable pain. |