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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  
Name  Address 
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 
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  
Status 
Not Applicable 
 
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.
 
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