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The Effect of Violet Flower on Fatigue

Investigating the Effect of Viola odorata L. Tablets on Radiotherapy-induced Fatigue in Breast Cancer

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20241026063503N1
Enrollment
70
Registered
2025-07-03
Start date
2025-07-12
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer-related fatigue. Neoplastic (malignant) related fatigue

Interventions

Intervention 1: Intervention group: Each violet tablet contains 500 mg of aqueous extract of Viola odorata and one tablet is taken every 12 hours for 4 weeks. Intervention 2: Control group: The placeb

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
25 Years to 65 Years

Inclusion criteria

Inclusion criteria: 25 - 65 years old women Breast Cancer Patients Radiation Treatment in Progress Fatigue Score above 37 based on FSS questionnaire Hemoglobin at least 10 g/dl Hematocrit at least 30% SGOT less than 3 folds of normal limit Bilirubin less than 2 mg/dl Creatinine less than 2 mg/dl Normal TSH

Exclusion criteria

Exclusion criteria: Bilateral breast involvement History of asthma Uncontrolled pain History of severe heart disease History of allergy to violet

Design outcomes

Primary

MeasureTime frame
Score of Fatigue Severity "Visual Analogue Fatigue Scale". Timepoint: The beginning of the study and 4 weeks later. Method of measurement: Using Visual Analogue Fatigue Scale questionnaire.;Score of "Fatigue Severity". Timepoint: The beginning of the study and 4 weeks later. Method of measurement: Fatigue Severity Scale questionnaire.;Score of "The Cancer Fatigue Scale". Timepoint: The beginning of the study and 4 weeks later. Method of measurement: The Cancer Fatigue Scale questionnaire.

Secondary

MeasureTime frame
Score of "Quality of life". Timepoint: The beginning of the study and 4 weeks later. Method of measurement: Quality of life questionnaire.;Score of "Treatment Satisfaction". Timepoint: After the Intervention completion. Method of measurement: Treatment Satisfaction questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Khancherli

Shahid Beheshti University of Medical Sciences

f.khancherli@sbmu.ac.ir+98 21 8877 3521

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026