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Comparison of the effect of Two Mouthwashes on Radiation induced Mouth Ulcers

Comparison of the effectiveness of Curcumin and Benzydamine mouthwash on oral mucositis in head and neck cancer patients scheduled for radiotherapy â?? A Double Blinded Randomised Controlled Clinical Trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/04/013362
Enrollment
60
Registered
2018-04-19
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: null- Head and neck cancer patients scheduled to receive radiation therapy

Interventions

Intervention1: Curcumin: It is an extract of turmeric of which a mouth wash is made. In the mouthwash sodium benzoate (preservative) and clove oil is added. 0.1% curcumin mouthwash was administered o

Sponsors

DR SWIKANT SHAH
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patient histo-pathologically confirmed to have head and neck cancer scheduled for Radio therapy. 2.Minimum period of radiotherapy - 4-6 weeks with radiation dose 0f >=50Gy 3.Patients who are able to use mouthwash. 4.Patient with KARNOFSKY PERFORMANCE STATUS SCALE more than 60%

Exclusion criteria

Exclusion criteria: 1.Any physically handicapped condition which can affect the use of mouthwash 2.Patients who are on any other oral related medicine/mouthwash 3.Pregnant patients

Design outcomes

Primary

MeasureTime frame
1.To assess the oral mucosal status prior to the onset of Radiotherapy using various scales for assessing Oral Mucositis. 2.To assess the change in Oral Mucositis in both study groups at 1st week, 2nd week, 3rd week,4th week, 5th week and 6th week of radiotherapy after using the mouthwash. Timepoint: baseline, 1st week, 2nd week, 3rd week, 4th week, 5th week, 6th week

Secondary

MeasureTime frame
To check patient compliance with the mouthwashes for both the study groups at 1st week, 2nd week, 3rd week,4th week,5th week and 6th week.Timepoint: 1st week, 2nd week, 3rd week, 4th week, 5th week, 6th week

Countries

India

Contacts

Public ContactDR HEMAMALINI RATH

S.C.B DENTAL COLLEGE & HOSPITAL

hema_hr@rediffmail.com9437225245

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 19, 2026