A Phase 2 interventional study of chamomile topical oral gel and Miconazole Topical Gel in Oral Mucositis Due to Chemotherapy, sponsored by Hams Hamed Abdelrahman. Status unknown at 1 site in Egypt. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-03-23.
Sponsored by Hams Hamed Abdelrahman · Phase 2, Interventional, and Prevention
the main aim of this study is to clinically assess the effectiveness of topical chamomile oral gel in the prevention of chemotherapy-induced oral mucositis.
The study was designed as a randomized, controlled, clinical trial. patients who were undergoing to receive chemotherapy were divided into three groups: Group I: was given conventional treatment. Group II: was given topical oral gel of chamomile. Group III: was given topical oral gel of chamomile in combination with the conventional treatment.
All patients have clinically evaluated at the start of the chemotherapy and three 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.
Counted across the registry records on this site, refreshed daily.
Males and females with an age of not less than 20 years and not exceeding 70 years.
Exclusion Criteria:
Topical oral chamomile gel three times daily for three weeks. Topical oral chamomile gel is prepared with the aid of Pharmacognosy and pharmaceutics departments, faculty of pharmacy, Alexandria University and mucoadhesive hydrogels (Carbopol® 970).
Drug: chamomile topical oral gel
Conventional therapy (symptomatic treatment) which included: Miconaz oral gel BBC oral spray Oracure gel Dose: Three times a day for three weeks
Drug: Miconazole Topical Gel · Drug: BBC oral spray · Drug: Oracure gel
Topical oral chamomile gel three times daily for three weeks in combination with the symptomatic treatment Symptomatic treatment which included: Miconaz oral gel BBC oral spray Oracure gel Symptomatic treatment dose: Three times a day for three weeks
Drug: chamomile topical oral gel · Drug: Miconazole Topical Gel · Drug: BBC oral spray · Drug: Oracure gel
Chemical constituents of chamomile, such as bisabolol, chamazulene, and the flavonoids apigenin and luteolin, possess anti-inflammatory properties.
topical anti fungal agent
Topical anesthetics and anti-inflammatory agent
Topical analgesic gel
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 week after the first chemotherapy session.
Time frame: Up to 3 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 first , second and third week after the chemotherapy session.
Time frame: Up to 3 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