| CTRI Number |
CTRI/2018/08/015563 [Registered on: 31/08/2018] Trial Registered Prospectively |
| Last Modified On: |
21/09/2021 |
| 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
|
Benefits of neem for Oral lichen planus patients. |
|
Scientific Title of Study
|
Evaluation of the effectiveness of neem extracts mouthwash as an adjuvant therapeutic modality 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 |
Dr Ashita Kalaskar |
| Designation |
Associate Professor |
| Affiliation |
Government Dental College and hospital, Nagpur |
| Address |
Dept. Oral Medicine and radiology, Government Dental College and hospital, Government medical college campus, medical square,Nagpur
Nagpur
MAHARASHTRA
440003
India |
| Phone |
8550928585 |
| Fax |
|
| Email |
kalaskarashita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashita Kalaskar |
| Designation |
Associate Professor |
| Affiliation |
Government Dental College and hospital, Nagpur |
| Address |
Dept. Oral Medicine and radiology, Government Dental College and hospital, Government medical college campus, medical square,Nagpur
Nagpur
MAHARASHTRA
440003
India |
| Phone |
8550928585 |
| Fax |
|
| Email |
kalaskarashita@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashita Kalaskar |
| Designation |
Associate Professor |
| Affiliation |
Government Dental College and hospital, Nagpur |
| Address |
Dept. Oral Medicine and radiology, Government Dental College and hospital, Government medical college campus, medical square,Nagpur
Nagpur
MAHARASHTRA
440003
India |
| Phone |
8550928585 |
| Fax |
|
| Email |
kalaskarashita@gmail.com |
|
|
Source of Monetary or Material Support
|
| For procuring and formulating clobetasol propionate and nystatin mouthwash: Sain medicaments pvt. Ltd, Hyderabad, Telangana, India |
| For procuring and formulating neem extract mouthwash: dept of Rashshastra, Mahatma Gandhi Ayurved College Hospital and Research centre, Salod, Wardha |
| 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 sponsor] |
|
|
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 Kalaskar |
Sharad Pawar Dental College and hospital |
Department of oral medicine and radiology, Datta Meghe Institute of medical sciences (Deemed University), Sawangi, (Meghe), Wardha
Wardha
MAHARASHTRA |
8550928585
kalaskarashita@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| datta meghe institute of medical sciences institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D898||Other specified disorders involving the immune mechanism, not elsewhere classified, Symptomatic Oral Lichen Planus patients coming to the OPD of Oral Medicine and Radiology Department of S.P.D.C. DMIMS Sawangi, Wardha and fulfilling the inclusion criteria. , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Clobetasole nystatin mouthwash |
Clobetasole (0.05%) nystatin ( 100 000 IU/cc) 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 nystatin mouthwash and neem leaves extract mouthwash. |
Clobetasole (0.05%) nystatin ( 100 000 IU/cc) 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 leaves extract mouth wash |
Neem leaves mouthwash (5-20%) will be given to symptomatic oral lichen planus patients (20 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 |
70.00 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
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator 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. |
Burning sensation and
The severity of lesions on each side will be evaluated on 1st day, 3rd day, 7th day, 2nd week, 3rd week, 4th week, 2nd month, 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. |
2nd and 3rd month folow-up |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
17/09/2018 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/12/2020 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="20" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Publication of the study under process |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Lichen planus is a chronic mucocutaneous disease with variable etiologies. As there is no established cure variable treatment modalities are available most of which provide symptomatic relief only to recur later. Neem has been considered wonder drug exhibiting various properties like antiinflammatory, immnomodulating, antifungal etc. hence this study is planned to evaluate the effectiveness of neem in oral lichen planus patients.
|