A Single-center, Investigator-blinded, Randomized, 24-month, Parallel-group, Non-inferiority Study to Compare the Efficacy of Combination of Ayurvedic Therapy as Add-on treatment Versus Standard treatment in Oral Pre-malignant Lesions and Early Oral Cancer

(i)             Rationale -Medical and Surgical Interventions for premalignant lesions such as Leukoplakia, Erythroplakia and Oral submucous fibrosis have limited success. Few studies have explored the usefulness of Ayurveda medications in cancer. Newer drugs and targeted therapy to be explored to address this pressing problem in India.

(ii)           Novelty – The study is being planned to integrate traditional medicine with modern medicine for a common disease in India, with the aim to find an alternative method to meet the urgent need of the vulnerable population.

·      Objectives – To evaluate the effect of Ayurveda treatment on cell proliferation (Ki67) and  molecular targets (COX2, P53) in the target lesion in Oral Cancer.

·      To monitor the effect of Ayurveda treatment on symptom score (measured by Visual Analogue Scale) among the study groups at pre and post intervention

·      To evaluate the effect of Ayurveda treatment on mouth opening in Oral Submucous fibrosis.

·      To evaluate the effect of Ayurveda treatment on the appearance and size of  lesions with leukoplakia and erythroplakia.

 (iii)         Methods –

Study Design - This study will adopt a Randomized Controlled Assessor-Blinded Trial

Study Duration – 2 years

 Sample Size – The sample size estimated in each subgroup using Openepi v3.1 and G*Power software. The estimates are given below.

 Subgroup 1 - Premalignant Group– 86 in each group (Total N= 172)

Subgroup 2 – Submucous Fibrosis – 50 in each group (Total N= 100)

Subgroup 3 – Early Oral cancer– 33 in each group (Total N= 66)

 Study population –

The patients visiting the outpatient department with oral premalignant lesions and oral cancer will be prospectively enrolled in the study.

Recruitment and Participants –

·      After getting permission from the Institutional Ethics Committee, patients with oral premalignant and malignant lesions, will be recruited from ENT OPD after obtaining informed consent.

·      The patients will be grouped into two categories;

a) Receiving Standard Treatment - Betel Nut/Areca Nut/Quid and Tobacco cessation, Dietary Modification  for 3 months

b) Standard Treatment along with Ayurvedic treatment as add on therapy for 3 months

 (iv)          Expected outcome - The aim of this study is to develop a rationale for prevention of oral cancer from premalignant lesions by using traditional medicine and to generate evidence for the treatment of these lesions by Ayurveda drugs.