Bioadhesive herbal mouthwashes for management of radiation induced oral mucositis in Head & Neck cancer patients.

Comparative effectiveness of benzydamine against the bioadhesive mouthwashes of Centella asiatica & Solanum nigrum Linn in the management of oral mucositis. A Double Blinded Randomized controlled trial.

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/06/054012

Enrollment

Registered

2023-06-16

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-04

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

Conditions

Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx

Interventions

Intervention1: Bioadhesive mouthwash containing Centella asiatica: 5mL of Centella asiatica mouthwash to be used thrice daily, morning, afternoon, and night. The patient is asked to swish the mouthwas

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with histologically confirmed diagnosis of carcinoma of the oral cavity undergoing radiotherapy 5 times/week for 6-7 weeks. 2. Mucositis affecting any oral anatomical structures diagnosed according to WHO criteria.

Exclusion criteria

Exclusion criteria: 1. Patients with oral mucositis and undergoing radiotherapy for cancers other than head and neck. 2. Patients receiving other prophylactic interventions for oral mucositis. 3. Patients who does not give consent for participation or refuse to follow up

Design outcomes

Primary

Measure	Time frame
1) Reduction in severity of oral mucositis assessed using the WHO grading system 2) Reduction in pain associated with oral mucositis assessed using the VAS scale.Timepoint: Visit 1- At the end of the 2nd week/ Day 1 (±1day) Visit 2- At the end of the 3rd week/ Day 8 (±1day) Visit 3- At the end of the 4th week/ Day 15 (±1day) Visit 4- At the end of the 5th week/ Day 22 (±1day) Visit 5- At the end of the 6th week/ completion of radiotherapy Day 29 (±1day) Visit 6- 1 week Post radiotherapy Day 36	—

Measure

Time frame

1) Reduction in severity of oral mucositis assessed using the WHO grading system 2) Reduction in pain associated with oral mucositis assessed using the VAS scale.Timepoint: Visit 1- At the end of the 2nd week/ Day 1 (±1day) Visit 2- At the end of the 3rd week/ Day 8 (±1day) Visit 3- At the end of the 4th week/ Day 15 (±1day) Visit 4- At the end of the 5th week/ Day 22 (±1day) Visit 5- At the end of the 6th week/ completion of radiotherapy Day 29 (±1day) Visit 6- 1 week Post radiotherapy Day 36

—

Secondary

Measure	Time frame
Adverse effects if any.Timepoint: Visit 1- At the end of the 2nd week/ Day 1 (±1day) Visit 2- At the end of the 3rd week/ Day 8 (±1day) Visit 3- At the end of the 4th week/ Day 15 (±1day) Visit 4- At the end of the 5th week/ Day 22 (±1day) Visit 5- At the end of the 6th week/ completion of radiotherapy Day 29 (±1day) Visit 6- 1 week Post radiotherapy Day 36 (±1day)	—

Countries

India

Contacts

Public ContactDr Vaishali Keluskar

KAHER’s KLE Vishwanath Katti Institute of Dental Sciences

jayapriyathirupathii13@gmail.com7708444396

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026