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

NCT05693597 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2024-02-23

No results posted yet for this study

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.

Conditions

  • Radiation Dermatitis

Interventions

DRUG

Imtenan Oil

Cold Press Oil

DRUG

Baraka Capsules

Soft Gelatin Capsules

Sponsors & Collaborators

  • Ain Shams University

    collaborator OTHER

  • German University in Cairo

    lead OTHER

Principal Investigators

  • Mayar Waleed Salaheldin Aly, M.Sc. · German University in Cairo

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05693597 on ClinicalTrials.gov