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THE NEEM LEAF STUDY-TO FIND OUT WHETHER THE NEEM LEAF EXTRACT IS USEFUL IN REDUCING THE IMPACT OF RADIATION INDUCED MUCOSITIS IN ORAL CANCER PATIENTS

THE ROLE OF NEEM LEAF EXTRACT IN CONTROLLING RADIATION INDUCED MUCOSITIS IN ORAL CANCER PATIENTS-A PILOT STUDY

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/11/005163
Enrollment
40
Registered
2014-11-03
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- RADIATION INDUCED ORAL MUCOSITIS IN ORAL CANCER PATIENTS

Interventions

Intervention1: Topical Aqueous Azadiracta indica Leaf Extract-(TAAL) Mouth rinse: 10 gram leaf powder boiled in 1 liter of water-cooled and filtered.Extract used as mouth rinse at least 5 times a day

Sponsors

AMRITA INSTITUTE OF MEDICAL SCIENCE
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Radical,curative intend,post operative radiation treatment / post operative concurrent chemo-radiation treatment patients. 2.Patients with cancer in tongue and floor of mouth (requiring bilateral radiation) 3.Age 75 years or below 4.Male or Female 5.Patients fit for chemotherapy or radiation.

Exclusion criteria

Exclusion criteria: 1. Patients with cancer location other than tongue and floor of mouth. 2. Patients with secondary malignancy. 3. Non surgical patients. 4 . Patient requiring re-radiation in the same site.

Design outcomes

Primary

MeasureTime frame
To compare the onset in terms of days,progression and severity of oral mucositis in terms of RTOG Acute Radiation Morbidity Criteria in oral cavity cancer patients under different treatment plans. Timepoint: 1.Patient with grade 3 mucositis .

Secondary

MeasureTime frame
1 To compare the quality of life using FACT H&N criteria. 2 To compare infection control using clinical criteria alone.Timepoint: Until patient requires antibacterials antifungals steroids other mouth washes.

Countries

India

Contacts

Public ContactDR ANITHA GOPINATHAN

AMRITA INSTITUTE OF MEDICAL SCIENCES

anoopr@aims.amrita.edu984719518

Outcome results

None listed

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