| CTRI Number |
CTRI/2024/07/069828 [Registered on: 02/07/2024] Trial Registered Prospectively |
| Last Modified On: |
22/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study to evaluate the effect of local application of Tulsi plant derived ointment comparing it with numbing gel Lidocaine in the management of mouth ulcers. |
|
Scientific Title of Study
|
A Comparative study to assess the efficacy of topical Tulsi (Ocimum sanctum) and topical Lidocaine in the management of recurrent aphthous stomatitis (minor). |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anu M |
| Designation |
Postgraduate student |
| Affiliation |
Best Dental Science College |
| Address |
Department of Oral Medicine and Radiology,
Best Dental Science College,
69/1 ultra nagar,
Madurai Chennai Highway,
Madurai.
Madurai
TAMIL NADU
625104
India |
| Phone |
8608044701 |
| Fax |
|
| Email |
pappu.anu246@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sudarshan.R |
| Designation |
Professor and Head of the Department |
| Affiliation |
Best Dental Science College |
| Address |
Department of Oral Medicine and Radiology,
Best Dental Science College,
69/1 ultra nagar,
Madurai Chennai Highway,
Madurai.
Madurai
TAMIL NADU
625104
India |
| Phone |
9444498736 |
| Fax |
|
| Email |
sudarshanr093@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anu M |
| Designation |
Postgraduate student |
| Affiliation |
Best Dental Science College |
| Address |
Department of Oral Medicine and Radiology,
Best Dental Science College,
69/1 ultra nagar,
Madurai Chennai Highway,
Madurai.
Madurai
TAMIL NADU
625104
India |
| Phone |
8608044701 |
| Fax |
|
| Email |
pappu.anu246@gmail.com |
|
|
Source of Monetary or Material Support
|
| Best Dental Science College
69/1, ultra nagar,
Madurai - chennai highway,
Madurai- 625104
Tamil nadu, India. |
|
|
Primary Sponsor
|
| Name |
Anu M |
| Address |
3/987, N.G.O Colony,
Dindigul - 624005
Tamil nadu, 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 Anu M |
Best Dental Science College |
Ground floor room No
1,Department of Oral
Medicine and Radiology
Madurai
TAMIL NADU |
8608044701
pappu.anu246@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Best Dental Science College - Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K120||Recurrent oral aphthae, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
topical Lidocaine |
Subjects are prescribed with 10g of topical Lidocaine and instructed to applied at the site of ulcer 4times/day, using cotton buds, for a duration of 7 days. |
| Intervention |
topical Tulsi |
Subjects are prescribed with 10g of topical Tulsi and instructed to applied at the site of ulcer 4times/day,using cotton buds to form a thin smear over the ulcer, for a duration of 7 days.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Subjects giving a history of recurrent aphthous stomatitis-minor(ulcers that measure less
then 10 mm, and heal within 4 to 14 days without scarring) with a minimum of two episodes in a year.
Subjects with 1to 3 minor recurrent aphthous ulcers of less than 48 hours duration. |
|
| ExclusionCriteria |
| Details |
Subjects with any systemic disorders.
Subjects with the habit of smoking or alcoholism.
Subjects undergoing orthodontic therapy.
Subjects who had undergone tooth extraction or any dental surgical
procedure in the past 2 weeks.
Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in size of the ulcer, intensity of pain
and degree of erythema
|
Day 1,4 and 7 of using topical Tulsi and topical Lidocaine
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in recurrences of the ulcer |
Day 30 and 60 |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/07/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
This study is a randomized, parallel group trial comparing the efficacy of topical Tulsi and topical Lidocaine in the management of recurrent aphthous stomatitis that will be conducted in Best Dental Science College in India. The primary outcome will be reduction in size of the ulcer, intensity of pain and degree of erythema which will be followed in day 1, 4 and 7 of using topical Tulsi and Lidocaine. |