Comparison of different mouth rinse for oral ulcer in head & neck cancer patients
Phase 3
- Conditions
- Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
- Registration Number
- CTRI/2020/01/022824
- Lead Sponsor
- Vardhman Mahavir Medical College and Safdarjung Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Head and neck cancer patients with oral mucositis ( World Health Organization grade 1-4)
Exclusion Criteria
. Patients with severe renal or hepatic insufficiency
. Patients with collagen vascular disorder
. Patients allergy to any ingredient of the mouth rinse
. Pregnancy
. Patients with active oral infection requiring antibiotics/antifungals
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Analgesic efficacy in terms of improvement in pain scores and doses of analgesicsTimepoint: 1st day, 3rd day, 1st, 2nd, 3rd and 4th week
- Secondary Outcome Measures
Name Time Method different side effectsTimepoint: 1st day, 3rd day, 1st, 2nd, 3rd and 4th week;Duration of pain relief following the use of different mouth rinseTimepoint: duration 30 minutes, 30 mins-1 hr or 1 hr;ECOG scoreTimepoint: 1st day, 3rd day, 1st, 2nd, 3rd and 4th week;Functional impairment scale(FIS)Timepoint: 1st day, 3rd day, 1st, 2nd, 3rd and 4th week;Patient satisfaction scoresTimepoint: 4th week;WHO grading of mucositisTimepoint: 1st day, 3rd day, 1st, 2nd, 3rd and 4th week