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Chamomile Gel for Chemotherapy-Induced Oral Mucositis
NCT04317183Phase 2
Key facts
- Status
- Unknown
- Start
- May 2019
- Primary completion
- Mar 2020
- Countries
- 1
- Modality
- Hydrogel Systems, Transdermal Patches
- Drugs
- Chamomile cream
- Conditions
- oral mucositis (OM)
01
Overview
Phase 2, randomised trial of Chamomile cream in oral mucositis (OM) (3 arms). Primary endpoint: Changes in severity of oral mucositis at 3 weeks. Status: unknown.
02
Design
3 arms- Study design
- Randomized
Chamomile Gel
Topical chamomile oral gel 3x daily
Conventional Therapy
Miconazole gel, BBC spray, Oracure gel 3x daily
Combination Therapy
Chamomile gel + Conventional therapy 3x daily
03
Who it enrols
Patients aged 20-70 receiving 5-FU based chemotherapy, excluding those with uncontrolled systemic diseases (diabetes, cardiovascular, liver, renal) or pregnancy.
04
Endpoints
Primary
Changes in severity of oral mucositis
Secondary
Pain and discomfort severity
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