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Study of Mucoheal Rinse and Chocolate in Preventing and Reducing Mouth Ulcers During Exposure to Chemo-Radiation in Cancer Patients

Evaluation of Mucoheal Rinse and Mucoheal Chocolate in the Management of Chemo-Radiation Induced Mucocitis: An Exploratory Clinical Trial - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/102971
Enrollment
12
Registered
2026-02-04
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Health Condition 1: K137- Other and unspecified lesions of oral mucosa

Interventions

None listed

Sponsors

Dr.swapnali bandu naik
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Known case of any type of cancer receiving chemotherapy or radiation therapy irrespective of duration, aged 18 to 75 years, of any gender, and presenting with oral mucositis, assessed using standardized and validated grading systems, including World Health Organization Oral Toxicity Scale RTOG/EORTC Oral Toxicity Scale Oral Mucositis Assessment Scale NCI CTCAE National Cancer Institute Common Terminology Criteria for Adverse Events Scale

Exclusion criteria

Exclusion criteria: Patients with pre-existing oral lesions or infections example oral candidiasis, herpes simplex, leukoplakia prior to initiation of chemotherapy or radiotherapy. Patients with active systemic infections or febrile illness at the time of enrollment. Patients with autoimmune or inflammatory oral conditions example oral lichen planus, pemphigus vulgaris. Patients not willing to continue ongoing topical or systemic medications for oral mucosal conditions during the trial period.

Design outcomes

Primary

MeasureTime frame
Clinical improvement in chemo-radiation induced oral mucositis following intervention with Muco-heal chocolate and Muco-heal rinse , measured through change in mucositis grade from baseline to end of treatment.Timepoint: 4 weeks

Secondary

MeasureTime frame
Pain reduction associated with oral mucositisTimepoint: 4 weeks

Countries

India

Contacts

Public ContactDr Swapnali bandu naik

Dr. D. Y. Patil College of Ayurved and Research Centre

drswagata32@gmail.com7984956017

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026