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Head and Neck Cancer Studies / Oral Health in Cancer Treatment · Journal article
Frontiers in Medicine · September 4, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a protocol for an ongoing open-label Phase II randomised controlled trial comparing a Siddha add-on regimen (Thiripala Chooranam mouthwash and Gungiliya Vennai topical application plus standard of care) versus benzydamine mouthwash alone for radiation-induced oral mucositis in head and neck cancer patients. No outcome data are available; the study is at the enrolment stage and does not yet provide evidence of efficacy or safety.
Open-label randomised controlled Phase II trial. Patients with head and neck cancer undergoing radiotherapy or concurrent chemoradiotherapy who are at risk of developing radiation-induced oral mucositis.. Intervention: Siddha formulations: Thiripala Chooranam mouthwash and Gungiliya Vennai topical application, three times daily, in addition to standard of care benzydamine mouthwash.. Compared with: Benzydamine mouthwash six times daily (standard of care alone).. n = 160. Not stated in the provided text..
Planned enrolment of 160 participants (80 per arm) in a Phase II superiority trial Primary outcome: RIOM severity assessed using RTOG Oral Mucositis Scale Secondary outcomes include WHO Oral Mucositis Scale severity, oral pain reduction (minimum 2-point VAS reduction target), analgesic usage, safety, and treatment interruptions
Secondary outcomes include WHO Oral Mucositis Scale severity, oral pain reduction (minimum 2-point VAS reduction target), analgesic usage, safety, and treatment interruptions
This protocol outlines a planned comparative evaluation of integrative Siddha medicine as an adjunct to standard symptomatic care for RIOM. Pending completion and results, it may inform whether traditional medicine formulations reduce mucositis severity and pain in this population; currently it provides no clinical guidance as enrolment is ongoing and no efficacy or safety data are available.
This is a protocol paper for an ongoing Phase II trial with no results reported; it describes planned methodology and endpoints only, representing preliminary evidence generation in progress.
As stated by the source record.
Quoted from the source exactly as published.
This protocol outlines a planned comparative evaluation of integrative Siddha medicine as an adjunct to standard symptomatic care for RIOM. Pending completion and results, it may inform whether traditional medicine formulations reduce mucositis severity and pain in this population; currently it provides no clinical guidance as enrolment is ongoing and no efficacy or safety data are available.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
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. 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.
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