A study to see if adding Siddha treatment to regular care can improve radiotherapy-related mouth sores in head and neck cancer patients

An Open label randomized controlled trial to evaluate the efficacy and safety of a Siddha regimen as an add-on to standard care in the management of Radiotherapy- Induced Oral Mucositis (RIOM) among individuals with head and neck cancer treated at a Regional Cancer Centre - NIL

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/12/098832

Enrollment

160

Registered

2025-12-10

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K123- Oral mucositis (ulcerative)

Interventions

Intervention1: Thiripala chooranam mouth wash Gungiliya vennai: Thiripala chooranam Volume: 60 ml per time. Frequency of rinse: 3 times a day Duration of rinse/time: 30 seconds Gungiliyavennai-10 gm

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosed Head and Neck Cancers with involvement of the Oral cavity and oropharynx scheduled for 6-7 weeks of RT with 60-66 Gy radiation dose Participants who are willing to provide informed consent.

Exclusion criteria

Exclusion criteria: Known hypersensitivity to any component of the Siddha formulation Presence of active oral infections unrelated to radiotherapy Known case of Severe systemic illness deemed not fit by the Investigator Concurrent participation in another clinical trial Those using dentures Cases of Re- Radiation and palliative Radiation

Design outcomes

Primary

Measure	Time frame
The proportion of participants who develop Radiation-Induced Oral Mucositis (RIOM) of RTOG grade more than or equal to 3 at any time during radiotherapy and upto 6 weeks following completion of radiotherapy, compared between the two arms.Timepoint: baseline, 8weeks (end of RT), 14 weeks (end of post RT follow-up)	—

Secondary

Measure	Time frame
The proportion of reduction in the occurrence of severity of oral mucositis according to the WHO grading scale at any time during radiotherapy & upto 6 weeks following completion of radiotherapy.Timepoint: baseline, 8weeks (end of RT), 14 weeks (end of post RT follow-up);Proportion of participants with minimum 2point reduction of pain intensity assessed by Visual Analogue Scale (VAS) in both the arms.Timepoint: baseline, 8weeks (end of RT), 14 weeks (end of post RT follow-up);Percentage of Analgesic use among study groups, evaluated according to the WHO Analgesic Step-LadderTimepoint: baseline, 8weeks (end of RT), 14 weeks (end of post RT follow-up);Number of Adverse Events reported in both groupsTimepoint: baseline, 8weeks (end of RT), 14 weeks (end of post RT follow-up);Proportion of participants with more than 1 radiotherapy interruption due to severe RIOM & total number of days of missed RT due to interruptions during the radiotherapy period between groups.Timepoint: baseline, 8weeks (end of RT)	—

Measure

Time frame

The proportion of reduction in the occurrence of severity of oral mucositis according to the WHO grading scale at any time during radiotherapy & upto 6 weeks following completion of radiotherapy.Timepoint: baseline, 8weeks (end of RT), 14 weeks (end of post RT follow-up);Proportion of participants with minimum 2point reduction of pain intensity assessed by Visual Analogue Scale (VAS) in both the arms.Timepoint: baseline, 8weeks (end of RT), 14 weeks (end of post RT follow-up);Percentage of Analgesic use among study groups, evaluated according to the WHO Analgesic Step-LadderTimepoint: baseline, 8weeks (end of RT), 14 weeks (end of post RT follow-up);Number of Adverse Events reported in both groupsTimepoint: baseline, 8weeks (end of RT), 14 weeks (end of post RT follow-up);Proportion of participants with more than 1 radiotherapy interruption due to severe RIOM & total number of days of missed RT due to interruptions during the radiotherapy period between groups.Timepoint: baseline, 8weeks (end of RT)

—

Countries

India

Contacts

Public ContactDr P Shanmugapriya

Cancer Institute (WIA) Adyar

doctorsowmiyapgi@gmail.com7042811034

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026