An open-label randomised controlled trial protocol evaluating a Siddha add-on regimen for radiotherapy induced oral mucositis in head and neck cancer patients.

Radiation-induced oral mucositis (RIOM) is a common and clinically significant complication in patients undergoing radiotherapy or concurrent chemoradiotherapy for head and neck cancers. It can cause severe oral pain, dysphagia, nutritional compromise, secondary infections, and treatment interruptions, thereby affecting treatment compliance and oncological outcomes. Since the current standard of care (SOC) mainly focuses on symptomatic relief, there is a need for integrative treatment approaches that may improve overall patient outcomes. The present study is designed as a randomised controlled Phase II superiority trial involving 160 participants, with 80 participants allocated to each study arm. Participants in the control arm will receive benzydamine mouthwash six times daily as SOC, while those in the intervention arm will receive Siddha formulations such as Clinical Trial Registration: https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MTQ2MTYw&Enc=&userName=, Registered in Clinical Trial Registry, India (CTRI/2025/12/098832- registered on 10-12-2025). Participant enrolment for the trial has commenced, and the study is currently ongoing.