CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Miconaz oral gel +4 moredrug
Likely dose
Rapid Release Capsules Melatonin, 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03833570
NCT03833570Phase 2Completed
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The Effectiveness of Melatonin in Prevention of Radiation-induced Oral Mucositis

Hams Hamed Abdelrahman·interventional·Posted Feb 7, 2019·Updated Jun 17, 2019

In Brief

A Phase 2 clinical trial evaluating Rapid Release Capsules Melatonin, 10 mg, Miconaz oral gel, and 3 other interventions for Oral Mucositis (Ulcerative) Due to Radiation. Completed, enrolled 40 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOral Mucositis (Ulcerative) Due to Radiation
CountriesEgypt
CollaboratorsAlexandria University

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedFeb 7, 2019
Enrollment StartJan 12, 2018
Primary CompletionNov 9, 2018
Study CompletionDec 1, 2018
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 7.4 years ago

Interventions

Rapid Release Capsules Melatonin, 10 mgdietary

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.

Miconaz oral geldrug

Antifungal agent

BBC oral spraydrug

Topical anesthetics and anti-inflammatory agent

Oracure geldrug

Topical analgesic gel

Alkamisr sachetsother

Sodium bicarbonate mouthwash