CTRI Number |
CTRI/2019/01/017246 [Registered on: 25/01/2019] Trial Registered Prospectively |
Last Modified On: |
23/11/2019 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda Dentistry |
Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
Public Title of Study
|
Neem for oral lichen planus patients. |
Scientific Title of Study
|
Evaluation of the efficacy of topical neem extract in the management of Oral lichen planus. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Ashita Kalaskar |
Designation |
Associate Professor |
Affiliation |
Government Dental College and Hospital, Nagpur |
Address |
Government Dental College and Hospital, Government Medical Campus, Medical Square, Nagpur
Nagpur MAHARASHTRA 440003 India |
Phone |
8550928585 |
Fax |
|
Email |
kalaskarashita@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Ashita Kalaskar |
Designation |
Associate Professor |
Affiliation |
Government Dental College and Hospital, Nagpur |
Address |
Government Dental College and Hospital, Government Medical Campus, Medical Square, Nagpur
MAHARASHTRA 440003 India |
Phone |
8550928585 |
Fax |
|
Email |
kalaskarashita@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Ashita Kalaskar |
Designation |
Associate Professor |
Affiliation |
Government Dental College and Hospital, Nagpur |
Address |
Government Dental College and Hospital, Government Medical Campus, Medical Square, Nagpur
MAHARASHTRA 440003 India |
Phone |
8550928585 |
Fax |
|
Email |
kalaskarashita@gmail.com |
|
Source of Monetary or Material Support
|
For procuring and formulating clobetasol propionate mouthwash: Gurunank college of Pharmacy, Nagpur |
For procuring and formulating neem extract mouthwash: Shri Ayurvedic College, Nagpur |
monetary support is by self. address: government dental college and hospital, government
medical campus, medical square, Nagpur-440003 |
|
Primary Sponsor
|
Name |
Dr Ashita Kalaskar |
Address |
Dept. Oral Medicine and radiology,Gov Dental college and hospital,
Nagpur |
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 |
Ashita Kalskar |
Government dental college and hospital, Nagpur |
Dept. Oral Medicine and radiology, Government medical college campus, medical
square,Nagpur
Nagpur
MAHARASHTRA
440003 Nagpur MAHARASHTRA |
8550928585
kalaskarashita@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional ethics committee, Govt. Dental College and Hospital, Nagpur |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: D899||Disorder involving the immune mechanism, unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
clobetasole propionate 0.05% |
Clobetasole (0.05%) is given to
symptomatic oral lichen planus
patients to be rinsed for 15 min
and then spit. This has to be
done three times daily. The
patients are subsequently
evaluated for reduction in
symptoms and lesions. |
Intervention |
Clobetasole propionate and neem leaves
extract mouthwash. |
Clobetasole (0.05%) mouthwash and
neem leaves extract mouthwash
(5-20%)are give to symptomatic
oral lichen planus patients to be
rinsed for 15 min and then spit.
This has to be done three times
daily. After an interval of one
hour after using Clobetasole+
nystatin mouthwash, neem
leaves extract mouthwash has
to be used. The patients are
subsequently evaluated for
reduction in symptoms and
lesions. |
Intervention |
Neem extract mouth
wash |
Neem leaves mouthwash
(10%) will be given to
symptomatic oral lichen planus
patients. They have to use it thrice daily and
will be evaluated in subsequent
follow up visits for the reduction
in symptoms or lesions. |
|
Inclusion Criteria
|
Age From |
16.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1.Symptomatic Patients with any clinical types and manifestations of
OLP and those confirmed histopathologically will be included in the
study.
2.Patients who have discontinued previous treatment for OLP for last
six months. |
|
ExclusionCriteria |
Details |
1.Patients younger than 16 years old.
2.Patients with skin lesions.
3.Patients with non symptomatic OLP lesions
4.Patients with lesions showing malignant or dysplasic changes.
5.Patients undergoing any other treatment for oral lichen planus.
Pregnant and nursing woman.
Patients having systemic problems or under any medications for the
same.
Patients having habit of chewing tobacco and betelnut or smoking |
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
Method of Concealment
|
Pre-numbered or coded identical Containers |
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Burning sensation will be evaluated by visual analog scale.
The severity of lesions on each side will be
evaluated by Thongprasom criteria. |
1st day, 3rd day, 7th day, 2nd week, 3rd week, 4th week, 2nd month and 3rd month |
|
Secondary Outcome
|
Outcome |
TimePoints |
Acceptability of neem mouthwash.
Total duration required to decrease the
symptoms.
Recurrence of the lesions in two months
follow-up. Clinical improvement.Adverse effects if any. |
1st day, 3rd day, 7th day, 2nd
week, 3rd week, 4th week, 2nd month, 3rd
month. |
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
|
20/02/2019 |
Date of Study Completion (India) |
Date Missing |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="6" Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
Study will be published once completed |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Oral lichen planus (OLP) is a chronic mucocutaneous disease with variable etiologies. Literature shows weak evidence of effectiveness of variable treatment options available. Also most of them show complications after chronic use. Hence an alternative and safe approach like herbal therapy should be encouraged. Neem, considered as a wonder drug, exhibits properties which could be benificial for oral lichen planus. Hence this study is planned to evaluate the efficacy of 10% neem mouthwash in OLP. |