CTRI Number |
CTRI/2013/09/004029 [Registered on: 27/09/2013] Trial Registered Retrospectively |
Last Modified On: |
18/09/2013 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Dentistry |
Study Design |
Single Arm Study |
Public Title of Study
|
Use of aloevera in oral pruritic skin disease treatment |
Scientific Title of Study
|
EFFICACY OF TOPICAL ALOEVERA IN THE TREATMENT OF ORAL LICHENPLANUS - A CLINICAL TRIAL WITH QUASI EXPERIMENTAL DESIGN |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Devi Gopakumar |
Designation |
MDS student |
Affiliation |
PMS College of Dental Science and Research, Trivandrum, Kerala |
Address |
Sougandhikam, JNS 5, Jainagar, Medical College. P.O, Trivandrum, Kerala
Thiruvananthapuram KERALA 695011 India |
Phone |
|
Fax |
|
Email |
deviomr@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Vivek V |
Designation |
Professor & Head |
Affiliation |
PMS College of Dental Science and Research, Trivandrum, Kerala |
Address |
Dept. of Oral Medicine & Radiology, PMS College of Dental Science & Research, Vattappara, Trivandrum- 695028
Thiruvananthapuram KERALA 695028 India |
Phone |
9447341035 |
Fax |
|
Email |
vivekv@rediffmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Devi Gopakumar |
Designation |
MDS student |
Affiliation |
PMS College of Dental Science and Research, Trivandrum, Kerala |
Address |
Sougandhikam, JNS 5, Jainagar, Medical College. P.O, Trivandrum, Kerala
KERALA 695011 India |
Phone |
|
Fax |
|
Email |
deviomr@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
PMS College of Dental Sciences and research |
Address |
Vattappara
Trivandrum
Kerala |
Type of Sponsor |
Research institution and hospital |
|
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 |
Vivek V |
Dept. of Oral Medicine & Radiology Room No 1 PMS College of Dental Sciences |
Vattappara
Trivandrum 695028 Thiruvananthapuram KERALA |
9447341035
vivekv@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee, PMS College of Dental Sciences |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Oral Lichenplanus, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Aloe vera gel |
Patients with oral lichen planus will be treated with topical aloe vera
Aloe vera gel will be used here which contains about 70% concentration of aloe vera .It is applied topically on the affected oral mucosa, three times daily, for one minute and advised to spit out.It is applied for three months |
Comparator Agent |
Not applicable |
Not applicable as this is a single arm study |
|
Inclusion Criteria
|
Age From |
10.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
Patients willing to undergo treatment and participate in the study.Patients clinically and histopathologically diagnosed with oral lichenplanus |
|
ExclusionCriteria |
Details |
Patients above 70 yrs. Pregnancy and lactating mothers. Mentally challenged patients. Allergic patients. Patients taking drugs capable of producing lichenoid reactions. Presence of dysplasia in histopathologic examination. Patients with other dermatologic lesions. Patients with renal and hepatic problems |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Case Record Numbers |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
It is measured as yes or no on the basis of reduction in size of the lesion clinically and by comparing pre and post treatment photographs. Assessing reduction in burning sensation/ pain using Visual Analog Scale |
Patients are reviewed weekly for three months. |
|
Secondary Outcome
|
Outcome |
TimePoints |
There will be reduction in pain which will be assessed by the VAS. |
Patients are reviewed weekly for 3 months and follow up for 6 months |
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
10/01/2013 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="0" Months="10" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Introduction: Oral lichen planus[ OLP] is a chronic inflammatory mucocutaneous disease characterized by outbreaks or flares.1 It affects 0.2-1.9%of the population.2,3Although etiology is unknown, pathogenesis of oral lichenplanus is known to involve an immune disorder,with epithelial damage caused by cytotoxic CD8+lymphocytes1,2,3,4.The disease can produce considerable morbidity and alter patient quality of life,particularly in the presence of ulcerative lesions4,5. A variety of treatments have been proposed for Oral lichen planus:topical or systemic corticosteroids,cyclosporine,retinoids,azathioprine,tacrolimus, pimecrolimus,photochemotherapy and surgery4,5.The main inconvenience of these treatments is represented by the sideeffects they usually produce.3,4 Aloe vera(AV) (Aloe barbadensis miller) is a member of the liliaceae family6 It is widely used as a natural alternative therapy for various types of diseases, and several studies have suggested the healing ,cosmetic & nutritional benefits of this plant6 .Aloe vera exerts anti-inflammatory effects through the reduction of leucocyte adhesion &TNF- levels7,8,9 and the effect of topical aloe vera in Oral lichen planus has been studied and reported by Hayes 10 and Choonhakarn et al.11
Objectives: To observe the efficacy of topical aloe vera in oral lichen planus by,
1) assessing the reduction in size of the lesion by clinical examination
2)assessing the reduction in burning sensation using visual analog scale
Materials and Methods: Patients who are diagnosed clinically and histopathologically as having oral lichen planus will be treated with topical aloe vera .Duration of this study will be approximately 1 yr from (june 2012- june 2013) Aloe vera gel will be used here which contains about 70% concentration of aloe vera .It is mainly the leaf pulp of this plant.Instructions should be given to relieve stress by patient councelling & reassuarance after informed consent.Biopsy will be done under local anesthesia in patients who are clinically diagnosed as having Oral Lichen planus in Department of Oral Medicine & Radiology .Pre treatment photographs will be taken as well as size of the lesion will be measured every week.Biopsy specimen will be send to the Department of Oral pathology & Microbiology for histopathological investigations.After confirming the diagnosis, treatment of Oral lichen planus will be carried out in Oral Medicine department by topical aloe vera preparation .Aloe vera gel of 70% concentration will be used [ from Hiran Agroceuticals Pvt Ltd, Madurai, India ].Duration of study/treatment is approximately 1yr.Method of application is topical by using a gauze spatula thrice daily for 12 weeks.It is allowed to remain in the mouth for 1 minute.After 1minute patient is asked to swish & spit.Patients will be reviewed on a weekly basis.On every recall visits size of lesion will be measured clinically which will be well supported by pre & post treatment photographs .Degree of burning sensation will be measured using the Visual analog scale. |