drugset / Trial / NCT05693597

Evaluation of the Effect of Nigella Sativa for the Prophylaxis to Radiation Induced Dermatitis in Breast Cancer Patients

NCT05693597

RandomizedParallel-groupOpen-labelPrevention

Summary

Radiation induced dermatitis (RID) is one of the leading adverse events of radiation therapy, and if occurred could alter the course of therapy. The main pathways of RID is inflammation and oxidative stress on local and systemic bases. Nigella sativa is an herbal medicine whose anti-inflammatory and antioxidant activities have been proven in several clinical trials. Thus, the aim of the present study is to evaluate the efficacy of Nigella sativa as a prophylactic method against the development of RID.

Timeline

Start
2023-01-24
Primary completion
2024-02-20
Completion
2024-02-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Nigella sativa Traditional medicine (herbal / TCM) 1.5 ml Topical
Subject Nigella sativa Traditional medicine (herbal / TCM) 40 mg/kg Oral
Subject Nigella sativa Traditional medicine (herbal / TCM) 80 mg/kg Oral

Indications