An Experimental Randomised Clinical Trial on Effectiveness of Capsicum annuum Glycerol in the management of Oral Mucositis assessed by Oral Mucositis Assessment Score

AIM : To evaluate the efficacy  of capsicum annuum glycerol in the management of oral mucositis through an experimental clinical trial. OBJECTIVE : 1)To assess the clinical effectiveness of Capsicum annum glycerol preparation for reducing erythema and ulcer size patients with oral mucositis using Oral Mucositis Assessment Scale. 2)To assess patient’s reported satisfaction and improvement in quality of life after treatment. HYPOTHESIS : 1. NULL HYPOTHESIS (H0):There is no significant reduction in Oral Mucositis Assessment score in oral mucositis treated with Capsicum annuum glycerol.        2. ALTERNATIVE HYPOTHESIS(H1) :There is a significant reduction in Oral Mucositis Assessment Score in oral mucositis treated with Capsicum annuum glycerol. METHODS OF DATA COLLECTION AND OUTCOME MEASUREMENT : Patients attending the Out-Patient Department of C.D.Pachchigar College of Homoeopathic Medicine And Hospital , peripheral outpatient units diagnosed with oral mucositis will be screened according to predefined inclusion and exclusion criteria. Eligible patients will be enrolled after obtaining written informed consent. Detailed case history including demographic data, medical history, duration, grade and clinical features of oral mucositis will be recorded in a specially designed Case Record Form (CRF). Baseline assessment of oral mucositis severity will be done using the Oral Mucositis Assessment Score (OMAS) prior to initiation of treatment. All enrolled participants will receive topical application of Capsicum annuum glycerol over the affected oral mucosa as per study protocol for the specified duration. Follow-up assessments will be conducted at predetermined intervals (e.g., Day 7, Day 14 and Day 21 / Day 28 as per protocol). At each follow-up visit, severity of oral mucositis will be reassessed using Oral Mucositis Assessment Score. Outcome Measurement : Reduction in Oral Mucositis Assessment Score (OMAS) from baseline to end of treatment. Effectiveness of the intervention will be evaluated by comparing pre-treatment (baseline) and post-treatment Oral Mucositis Assessment Scores. Adverse events, patient compliance and any additional treatment required will be recorded at each follow-up visit. Data obtained will be subjected to appropriate statistical analysis to determine the effectiveness of Capsicum annuum glycerol in the management of oral mucositis.

This research study will be started only after approved by ethical committee,registration in Veer Narmad South Gujarat University and registration under Clinical Trial Registry of India.