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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  
Dr.Devi Gopakumar 
 
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  
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 
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  
Status 
Not Applicable 
 
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.

 
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