Assessing the effectiveness of Propolis and Curcumin mouthwash in the management of Radiotherapy, Chemotherapy or combined modality induced Oral Mucositis - A Randomised Clinical Trial
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- 1) Reduction in WHO grading of Oral Mucositis
Study Overview
Brief Summary
This study evaluates the effectiveness of a novel combination mouthwash containing propolis and curcumin in managing oral mucositis among postoperative oral cancer patients undergoing radiotherapy and/or chemotherapy. Oral mucositis severity will be assessed using WHO grading criteria at regular intervals to compare outcomes between those receiving the propolis-curcumin mouthwash and those on standard care. The research aims to determine whether this natural, cost-effective combination offers superior therapeutic benefits compared to conventional management, potentially providing a safer alternative for this distressed patient population.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 90.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •80 years of age. 2) Histopathologically confirmed oral squamous cell carcinoma cases who underwent surgery for oral cancer. 3) Patients undergoing conventional or intensity-modulated radiation therapy with cumulative dose of more than or equal to 50 Gy to oral cavity/oropharynx region. 4) No pre existent oral mucositis.
Exclusion Criteria
- •Age less than 18 years of age 2) Previous history of Radiotherapy or chemotherapy to the head and neck region.
- •Allergic to propolis, beeswax or any other component of mouthwash.
- •Systemic severe diseases.
Outcomes
Primary Outcomes
1) Reduction in WHO grading of Oral Mucositis
Time Frame: Until the radiotherapy/chemotherapy/both is going on with review once in 15 days upto 45 days.
2) Reduction in VAS score
Time Frame: Until the radiotherapy/chemotherapy/both is going on with review once in 15 days upto 45 days.
Secondary Outcomes
- 1) severity of oral mucositis(2) duration of oral mucositis)
Investigators
Dr Ruhjaan Bhagat
SAVEETHA INSTITUTE OF MEDICAL AND TECHNICAL SCIENCES