| CTRI Number |
CTRI/2017/11/010321 [Registered on: 01/11/2017] Trial Registered Retrospectively |
| Last Modified On: |
18/08/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study and compare the effects of two medications; corticosteroids (Clobetasol Propionate) and Aloe Vera in the treatment of Oral Lichen Planus. |
|
Scientific Title of Study
|
A Randomised Parallel Clinical Trial To Compare The Efficacy Of Topical Application Of 97% Aloe Vera Gel Along With 94.7% Aloe Vera Juice Versus 0.05% Clobetasol Propionate Topical Application In The Treatment 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 Aniket Uday Vaidya |
| Designation |
M.D.S. Student |
| Affiliation |
Goa Dental College and Hospital |
| Address |
Oral Medicine and Radiology Dept.
Goa Dental College and Hospital
Bambolim, Goa (403 202)
INDIA.
North Goa
GOA
403202
India |
| Phone |
8390541605 |
| Fax |
|
| Email |
draniketvaidya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manisha Khorate |
| Designation |
Assistant Professor |
| Affiliation |
Goa University |
| Address |
OPD 1-A,Oral Medicine and Radiology Dept.
Goa Dental College and Hospital, Rajiv Gandhi Medical Complex,
Bambolim, Goa (403 202)
INDIA.
North Goa
GOA
403202
India |
| Phone |
9823213773 |
| Fax |
|
| Email |
khoratemanisha@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aniket Uday Vaidya |
| Designation |
M.D.S. Student |
| Affiliation |
Goa Dental College and Hospital |
| Address |
Oral Medicine and Radiology Dept.
Goa Dental College and Hospital
Bambolim, Goa (403 202)
INDIA.
GOA
403202
India |
| Phone |
8390541605 |
| Fax |
|
| Email |
draniketvaidya@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD 1-A, Oral Medicine and Radiology Department,Goa Dental College And Hospital, Rajiv Gandhi Medical Campus, Bambolim - Goa 403202 |
|
|
Primary Sponsor
|
| Name |
Dr Aniket Uday Vaidya |
| Address |
Oral Medicine and Radiology Dept.
Goa Dental College and Hospital
Bambolim, Goa (403 202)
INDIA. |
| Type of Sponsor |
Other [Dr. Aniket Vaidya] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Ajit D Dinkar |
Professor and Head
Oral Medicine and Radiology Dept.
Goa Dental College and Hospital
Bambolim, Goa (403 202)
INDIA. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aniket Uday Vaidya |
Goa Dental College and Hospital |
OPD No. 1 -A, Ground Floor,
Oral Medicine and Radiology Dept.
North Goa
GOA |
8390541605
8390541605
draniketvaidya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D899||Disorder involving the immune mechanism, unspecified, Oral Lichen Planus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.05% Clobetasol Propionate Ointment |
0.05% Clobetasol Propionate ointment local intraoral topical application on the affected area BD for 2 months |
| Intervention |
Aloe vera gel, Aloe vera juice |
97% pure Aloe vera gel local intraoral topical application on the affected area BD for 2 months
94.7% pure Aloe vera juice 10 ml BD on empty stomach for 2 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with clinically diagnosed and histologically confirmed Oral Lichen Planus lesions will be included.
2. Age group above 18 years.
3. Patient willing to participate in the study and sign the informed consent.
4. Patients given medical clearance by General Medicine Dept., Goa Medical College for being included in the trial in spite of of the medical conditions like hypertension, diabetes mellitus and hyperthyroidism etc
5. If patient is under any other systemic medications or topical treatment for oral lichen planus then in such cases the patients will be included in this study three months after cessation of the current systemic steroidal treatment or one month after cessation of non-steroidal systemic treatment or steroidal / non-steroidal topical treatment if the lesions have still persisted. |
|
| ExclusionCriteria |
| Details |
1. Patients who were clinically diagnosed as OLP but thereafter not confirmed histologically or histologically diagnosed as lichenoid reaction.
2. History of allergy to 0.05% Clobetasol Propionate Ointment or 97 % pure Aloe Vera gel and 94.7% pure Aloe Vera juice.
3. Medically compromised patients who could not be put on topical steroids or Aloe Vera as advised by the General Medicine Dept., Goa Medical College, Bambolim-Goa.
4. Pregnant or Lactating females. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Difference in the size of the lesion
2. Difference in the VAS score
3. Number of sites involved
4. Lesion characteristics; reticular, plaque, papular, erosive, atrophic or ulcerative
5. Extraoral site involvement, if any |
1. Difference in the size of the lesion
2. Difference in the VAS score
3. Number of sites involved
4. Lesion characteristics; reticular, plaque, papular, erosive, atrophic or ulcerative
5. Extraoral site involvement, if any |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Histological characteristics before and after treatment
2. Recurrence rate
3. Safety of the drugs / adverse reactions |
1. Histological characteristics before and after treatment
2. Recurrence rate
3. Safety of the drugs / adverse reactions |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
09/09/2016 |
| Date of Study Completion (India) |
31/01/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
under review process |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is a randomized, parallel group, clinical trial comparing the efficacy topical application of 97% Aloe vera gel and 94.7% Aloe vera juice versus 0.05% Clobetasol Propionate Ointment topical application for 2 months in 60 patients with Oral lichen Planus. This study will include the patients attending the Oral Medicine and Radiology Dept. Out Patient Dept., Goa Dental College and Hospital, Bambolim, Goa. All the patients will be followed up on monthly basis for a period of 6 months. The primary outcome measures will be difference in the size of the lesion, difference in the VAS score, number of sites involved, lesion characteristics; reticular, plaque, papular, erosive, atrophic or ulcerative, extra-oral site involvement, if any. The secondary outcomes will be changes histological characteristics before and after treatment, recurrence rate and safety of the drugs / adverse reactions. |