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Melatonin for Prevention of Radiation Induced Oral Mucositis

NCT03833570 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-06-17

No results posted yet for this study

Summary

The main aim of this study was to evaluate the effectiveness of melatonin in prevention of radiation induced oral mucositis clinically and biochemically.

Conditions

  • Oral Mucositis (Ulcerative) Due to Radiation

Interventions

DIETARY_SUPPLEMENT

Rapid Release Capsules Melatonin, 10 mg

Melatonin is a dietary supplement which is naturally produced in the body and closely involved in the natural sleep cycle. recently topical and systemic melatonin supplements. have been proposed as a new therapeutic modality for oral mucositis due to its anti-cancer, anti-inflammatory, and anti-oxidant effects.

DRUG

Miconaz oral gel

Antifungal agent

DRUG

BBC oral spray

Topical anesthetics and anti-inflammatory agent

DRUG

Oracure gel

Topical analgesic gel

OTHER

Alkamisr sachets

Sodium bicarbonate mouthwash

Sponsors & Collaborators

  • Alexandria University

    collaborator OTHER

  • Hams Hamed Abdelrahman

    lead OTHER

Principal Investigators

  • Hossam H Abdelaziz Elsabbagh, BDS · Alexandria University

  • Eglal M Moussa, Phd · Alexandria University

  • Sabah AH Mahmoud, Phd · University of Alexandria

  • Rasha O Elsaka, Phd · University of Alexandria

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-12
Primary Completion
2018-11-09
Completion
2018-12-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03833570 on ClinicalTrials.gov