An open-label randomised controlled trial protocol evaluating a Siddha add-on regimen for radiotherapy induced oral...

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 Thiripala Chooranam mouthwash and Gungiliya Vennai topical application three times daily in addition to SOC. Weekly assessments will be carried out by oncologists using validated tools including the Radiation Therapy Oncology Group (RTOG) Oral Mucositis Scale, WHO Oral Mucositis Scale, Visual Analogue Scale (VAS) for oral pain, and WHO three-step analgesic ladder. The primary outcome of the study is the assessment of RIOM severity using RTOG grading scale. Secondary outcomes include evaluation of mucositis severity using the WHO Oral Mucositis Scale, reduction in oral pain assessed by VAS (minimum 2-point reduction), analgesic usage based on the WHO three-step analgesic ladder, safety outcomes, and treatment interruptions. This study may provide evidence on the effectiveness and safety of an integrative Siddha-based approach in reducing RIOM severity and improving supportive care in patients undergoing radiotherapy for head and neck cancers.

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.