Formulation of Viola odorata L. Tablet and Evaluation of The Product Effect on Breast Cancer-Related Fatigue: A Randomized, Controlled Pilot Trial

Ghazaleh  Heidarirad; Homa  Hajimehdipoor; Sadegh  Rajabi; Haniyeh  Kashafroodi; Fatemeh  Khancherli; Mona Malekzadeh  Moghani; Behnaz  Keramatian; Fatemeh  Ghorbannejad; Fatemeh  Ghorbannejad

doi:10.18502/tim.v10i3.19759

Ghazaleh Heidarirad Department of Traditional Medicine, School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran
Homa Hajimehdipoor Department of Traditional Pharmacy, School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran
Sadegh Rajabi Traditional Medicine and Materia Medica Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
Haniyeh Kashafroodi Traditional Medicine and Materia Medica Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
Fatemeh Khancherli Department of Traditional Medicine, School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran
Mona Malekzadeh Moghani Medical School, Shahid Beheshti University of Medical Sciences, Tehran, Iran
Behnaz Keramatian Traditional Medicine and Materia Medica Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
Fatemeh Ghorbannejad Traditional Medicine and Materia Medica Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
Fatemeh Ghorbannejad Traditional Medicine and Materia Medica Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran

DOI: https://doi.org/10.18502/tim.v10i3.19759

Keywords: Viola odorata; Formulation; Breast cancer; Cancer-related fatigue; Pilot study

Abstract

This study was designed to formulate a Viola odorata L. tablet (VOT) and evaluate its efficacy in managing cancer-related fatigue (CRF) in breast cancer patients undergoing radiotherapy. The tablet was formulated and subjected to quality control tests. The pilot study was conducted as a randomized, double-blind trial. A total of 18 breast cancer patients were enrolled and randomly assigned to two groups. The intervention and control groups received VOT/bis in die (Bid) and placebo, respectively, for 4 weeks. All the patients completed the visual analog fatigue scale (VAFS), fatigue severity scale (FSS), and cancer fatigue scale (CFS) questionnaires before and after the intervention. The best tablet formulation contained V. odorata extract 486 mg, PVPK30 50 mg, lactose 450 mg, Avicel PH102 100 mg, SiO₂ 14 mg, and magnesium stearate 20 mg. Dimensions, disintegration time, hardness, friability, weight, and total phenolics as pyrogallol were 7.1×9.9×30.3 mm, 28 min, 9.5 kp, 0.37%, 1120mg, 22.8 mg/tab, respectively. More than 80% of the phenolics in the tablets were dissolved during the dissolution test in 30 min. In the pilot study, only VOT treatment significantly decreased the VAFS (p = 0.02), FSS (p = 0.08), and CFS (p=0.03) scores. The results indicated desirable VOT physicochemical characteristics and suggested it as an herbal product for managing CRF in breast cancer patients.