| CTRI Number |
CTRI/2019/08/020856 [Registered on: 23/08/2019] Trial Registered Prospectively |
| Last Modified On: |
25/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study and compare the effect of aloe vera and turmeric in patients with oral lichen planus. |
|
Scientific Title of Study
|
Comparative Evaluation of Clinical Efficacy of Aloe Vera and Turmeric in Clinically Diagnosed Oral Lichen Planus Cases-A Randomized Clinical Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sarkate Priyadarshani Rustum |
| Designation |
Post Graduate Student |
| Affiliation |
MGM Dental College and Hospital |
| Address |
MGM Dental College and Hospital, Plot NO 01, Sector 01, Kamothe, Navi Mumbai, MH 410209
Plot NO 01, Sector 01, Kamothe, Navi Mumbai, MH 410209
Thane
MAHARASHTRA
410209
India |
| Phone |
7588847108 |
| Fax |
912227420320 |
| Email |
priyasarkate2605@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pathak Jigna |
| Designation |
Professor |
| Affiliation |
MGM Dental College and Hospital |
| Address |
MGM Dental College and Hospital, Plot NO 01, Sector 01, Kamothe, Navi Mumbai, MH 410209
Plot NO 01, Sector 01, Kamothe, Navi Mumbai, MH 410209
Thane
MAHARASHTRA
410209
India |
| Phone |
9819175805 |
| Fax |
|
| Email |
drjignapathak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sarkate Priyadarshani Rustum |
| Designation |
Post Graduate Student |
| Affiliation |
MGM Dental College and Hospital |
| Address |
MGM Dental College and Hospital, Plot NO 01, Sector 01, Kamothe, Navi Mumbai, MH 410209
Plot NO 01, Sector 01, Kamothe, Navi Mumbai, MH 410209
Thane
MAHARASHTRA
410209
India |
| Phone |
7588847108 |
| Fax |
912227420320 |
| Email |
priyasarkate2605@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM Dental College and Hospital |
|
|
Primary Sponsor
|
| Name |
Sarkate Priyadarshani Rustum |
| Address |
MGM Dental College and Hospital, Plot NO 01, Sector 01, Kamothe, Navi Mumbai, MH 410209 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Sarkate Priyadarshani Rustum |
MGM Dental College |
MGM Dental College and Hospital, Plot NO 01, Sector 01, Kamothe, Navi Mumbai, MH 410209
Thane
MAHARASHTRA |
7588847108
912227420320
priyasarkate2605@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Review Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aloe Vera and Turmeric |
Topical appilication of Aloe Vera Gel 3 times a day for 3 months, Turmeric powder with Glycerine topical application 3 times a day for 3 months |
| Comparator Agent |
Aloe Vera, Turmeric |
Topical appilication of Aloe Vera Gel 3 times a day for 3 months, Turmeric powder with Glycerine topical application 3 times a day for 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinically confirmed Oral lichen Planus and willing to take part in the study.
2. Patients willing to participate after he / she is made aware of all possible treatment modalities for lichen planus.
3. Patients who have received no treatment for OLP in the last 2 weeks in the case of topical treatments, or in the last 4 weeks in the case of systemic therapies. |
|
| ExclusionCriteria |
| Details |
1. Evidence of lichenoid reaction in clinical assessment.
2. Patients with other white lesions of oral cavity.
3. Patients with other mucocutaneous lesions of oral cavity.
4. Pregnancy, lactation
5. History of allergic reactions to Aloe Vera or Turmeric. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome is measured by VAS scale and modified oral mucositis index. |
Initial,1,2,and 3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The primary outcome is measured by VAS scale and modified oral mucositis index. |
Initial,1,2,and 3 month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
25/08/2019 |
| Date of Study Completion (India) |
18/09/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="23" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Pubmed journal, Journal of Oral and Maxilofacial Pathology, International journal of Oral and Maxilofacial Pathology, Journal of Oral Medicine, Oral Pathology, Oral Surgery and Oral Radiology. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Oral lichen planus (OLP) is a chronic inflammatory mucocutaneous disease. It affects 0.2–1.9% of the population. Clinically, the disease is characterized by different types of lesions – papular, reticular and in the form of plaques – that can alternate with erosive and ℠or ulcerative areas. The disease can produce considerable morbidity and alter patient quality of life, particularly in the presence of ulcerative lesions. Extensive research and numerous trials have been conducted to determine the most effictive and safe treatments for OLP, but currently there exists no definite treatment protocol for the management of OLP. In general, topical formulations are generally preferred as it has fewer adverse effects. From all the treatment modalities aloe vera and Curcumene (turmeric) shows good herbal modalities for OLP with no or minimal side effects so these study prompted us to evaluate and correlate the clinical efficacy of turmeric and aloe vera in the patients of OLP.
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