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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: CTRI
Last refreshed on: 9 October 2017
Main ID:  CTRI/2016/10/007415
Date of registration: 27-10-2016
Prospective Registration: Yes
Primary sponsor: Dr Sharmila S
Public title: Comparative study on Oak gall oil and Triphala oil in the treatment of oral leukoplakia and erythroplakia
Scientific title: Comparison of effectiveness of Oak gall oil and Triphala oil as an adjuvant in the reversal of oral leukoplakia and erythroplakia รข??A double blinded randomized clinical trial
Date of first enrolment: 02-05-2016
Target sample size: 40
Recruitment status: Open to Recruitment
URL:  http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=14799
Study type:  Interventional
Study design:  Randomized, Parallel Group, Active Controlled Trial Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant and Investigator Blinded  
Phase:  Phase 3
Countries of recruitment
India
Contacts
Name: Dr MB Aswath Narayanan   
Address:  Room no 4,department of public health dentistry,Tamilnadu Government Dental College and Hospital,Chennai,Tamilnadu 600003 Chennai, TAMIL NADU India
Telephone: 9840127997
Email: mban1965@yahoo.com
Affiliation:  Tamilnadu Government Dental College and Hospital,Chennai
Name: Dr Sharmila S   
Address:  Room no 4,department of public health dentistry,Tamilnadu Government Dental College and Hospital,Chennai,Tamilnadu 600003 Chennai, TAMIL NADU India
Telephone: 9840127997
Email: mban1965@yahoo.com
Affiliation:  Tamilnadu Government Dental College and Hospital,Chennai
Key inclusion & exclusion criteria
Inclusion criteria: Outpatients who are current tobacco users and are diagnosed with either leukoplakia and erythroplakia

Histologically mild or moderate epithelial dysplasia


Exclusion criteria: Subjects with malignant tumours of oral cavity

Subjects with any systemic diseases

Subjects who are pregnant or lactating

Subjects who are physically and mentally challenged

Subjects with known hypersensitivity to toluidine blue

Subjects with dental conditions such as orthodontic appliances or prostheses that may interfere with the examination

Subjects who are currently receiving any type of cessation, alcohol or illicit drug treatment at the time of recruitment

Subjects who are under medication for systemic illness

Leukoplakia with p2 grading of histopathological evaluation by vanderwaal et al 2000



Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
oral leukoplakia and erythroplakia
Intervention(s)
Intervention1: oak gall oil: Arm A - oak gall powder is mixed with coconut oil in equal parts and patients are instructed to apply 2ml of the oil topically over the lesion four times a day after food for a period of six weeks
Control Intervention1: Triphala oil: Arm B - triphala powder is mixed with coconut oil in equal parts and patients are instructed to apply 2ml of the oil topically over the lesion four times a day after food for a period of six weeks
Primary Outcome(s)
Assessment of reversal of oral leukoplakia and erythroplakia both clinically and histologically.------Timepoint: At baseline,sixth week and at the end of third month
Secondary Outcome(s)
Self -reported abstinence from the tobacco habit

------Timepoint: At baseline, sixth week and third month
Secondary ID(s)
nil
Source(s) of Monetary Support
Department of Public health Dentistry, Tamilnadu Government Dental college and hospital,Chennai
Secondary Sponsor(s)
Results
Results available:
Date Posted:
URL:
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