Effect of Bacillus clausii Spores in the relief of mouth ulcers in Cancer Patients Undergoing Radiation Therapy

Efficacy of Bacillus clausii Spores in the Amelioration of Oral Mucositis in Cancer Patients Undergoing Radiation Therapy

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/12/016748

Enrollment

Registered

2018-12-20

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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: Bacillus clausii spores as add on to sodium bicarbonate gargle, benzdamine gargle.: 2 million spores per dose, alternate day from the first day of radiation therapy untill completion of

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with head and neck cancer receiving RT dose around 6000-7000 cGy with or without concomitant chemotherapy. 2. Patients willing to give written informed consent

Exclusion criteria

Exclusion criteria: 1. Severe oral fibrosis or stomatitis at the time of screening. 2. Other comorbidities like hepatic, renal impairment and cardiac failure.

Design outcomes

Primary

Measure	Time frame
1. Time taken for appearance of mucositis in each group 2. Time for resolution of mucositis. 3. Severity of mucositis in each group. Timepoint: day 0, 7, 14, 21,28, 35, 42, 49 from onset of RT	—

Secondary

Measure	Time frame
1. Time taken for appearance of mucositis in each group 2. Time for resolution of mucositis.Timepoint: day 0, 7, 14, 21,28, 35, 42, 49 from onset of RT	—

Countries

India

Contacts

Public ContactMehdi Ali Mirza

NIZAMS INSTITUTE OF MEDICAL SCIENCES

mehdialimirza@gmail.com9160368850

Outcome results

None listed

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