A Phase 2 interventional study of vitamin D oral gel and Miconazole Topical Gel in Oral Mucositis Due to Radiation, sponsored by Hams Hamed Abdelrahman. Status unknown at 1 site in Egypt. Open to participants aged 25 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-13.
Sponsored by Hams Hamed Abdelrahman · Phase 2, Interventional, and Prevention
The main aim of this study was to evaluate clinically the effect of topical oral vitamin D gel in comparison to conventional therapy in prevention of radiation - induced oral mucositis
The study was designed as randomized, controlled, clinical trial. patients who were undergoing to receive radiotherapy were divided into three groups: Group I: was given conventional treatment.Group II : was given topical oral gel of vitamin D. Group III: was given topical oral gel of vitamin D in combination with the conventional treatment.
All patients were clinically evaluated at the start the radiotherapy, three weeks and six weeks later for pain and oral mucositis severity.
488 studies on the registry are indexed under Mucositis; 70 are open to participants now.
This study's planned enrollment of 45 is close to the median of 50 across 394 interventional studies indexed under Mucositis.
Browse Mucositis studies →Hams Hamed Abdelrahman is the lead sponsor of 107 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
Topical oral vitamin D gel twice daily (Equivalent to 8000 I.U/day vitamin D) for six weeks. Topical oral Vitamin D gel is prepared with the aid of pharmaceutics department, faculty of pharmacy, Alexandria University. It is prepared by using Cholecalciferol 2ml ampoule (200.000 I.U.) within topical oral gel formulation.
Drug: vitamin D oral gel
Conventional therapy (symptomatic treatment) which included: * Miconaz oral gel * BBC oral spray * Oracure gel * Alkamisr sachets Dose: Three times a day for six weeks
Drug: Miconazole Topical Gel · Drug: BBC oral spray · Drug: Oracure gel · Other: Alkamisr sachets
Topical oral vitamin D gel twice daily (Equivalent to 8000 I.U/day vitamin D) for six weeks in combination with the symptomatic treatment Symptomatic treatment which included: * Miconaz oral gel * BBC oral spray * Oracure gel * Alkamisr sachets Symptomatic treatment dose: Three times a day for six weeks
Drug: vitamin D oral gel · Drug: Miconazole Topical Gel · Drug: BBC oral spray · Drug: Oracure gel · Other: Alkamisr sachets
vitamin D is a fat soluble vitamin which has important calcemic roles in the body regarding bone homeostasis and calcium/phosphorus balance. Recently, the non-calcemic roles of vitamin D as anti-inflammatory, anti-oxidant and immuno-regulatory functions have been widely reported.So, we tried to use it for prevention of radiation induced oral mucositis
topical anti fungal agent
Topical anesthetics and anti-inflammatory agent
Topical analgesic gel
Sodium bicarbonate mouthwash
Changes in severity of oral mucositis at different time points along the study
Oral mucositis will be evaluated by the World Health Organization (WHO) scale which record the extent and severity of oral mucositis at the third and sixth week after the first radiotherapy session.
Time frame: up to 3 and 6 weeks
Pain and discomfort severity at different time points along the study: Numeric Rating Scale
Discomfort and pain severity were reported by each patient using Numeric Rating Scale (NRS) at the third and sixth week after the first radiotherapy session.
Time frame: up to 3 and 6 weeks
Plan to share: No
This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Hams Hamed Abdelrahman