Challenges and Strategies in Conducting a Randomized Controlled Trial of Herbal Medicine in Cancer Patients in Low-Resource Settings
Year: 2025
Type: preprint
Abstract: Introduction: Clinical trials are a type of scientific research conducted on humans to evaluate the pharmacological effects of an experimental drug. Clinical trials are classified into phases: Phase 1, 2, 3, and 4. Phase 3 is characterized as the final stage before registration for commercialization. In this phase, the clinical trial must be randomized and controlled. Clinical trials with natural products adhere to strict scientific standards to ensure that the phytotherapeutic agent is both effective and safe. The goal of this study is to enhance the management of clinical research involving natural products, with a particular focus on low-resource settings with cancer patients. Methods: This qualitative study outlines the challenges encountered during a clinical trial assessing the wound-healing effects of a mucoadhesive gel derived from an Amazonian plant species. Researchers conducted the trial at a specialized reference center for hematological diseases in Amazonas, Brazil. They collected data concurrently with the clinical trial, spanning the period from 2020 to 2025. This clinical trial was approved by the ethics committee Results: Our findings indicate that the success of randomized controlled trials in these settings is shaped not only by the objective characteristics of the institution but also by the subjective dynamics of both the research team and participants. Key challenges included limitations with relationship to research center’s infrastructure, research team cohesion, coupled to the natural product under study. Conclusion: Therefore, careful planning tailored to the study site’s unique conditions, along with effective promotion of the research proposal, can help mitigate challenges and enhance the likelihood of a successful trial.
Authors: Aline Sampaio Jamel, José Pereira de Moura Neto, Cleber Nunes Alexandre, Erich Vinícius de Paula, Lizete Karla Filgueiras de Souza, Genice Silva e Silva, Núbia de Cássia Almeida Queiroz, Mary Ann Foglio
Language: English
Subfield: Complementary and alternative medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Awards: Evaluation of the association of extracts of Pterodon pubescens Benth., Arrabidaea chica Verlot and Bixa orellana fruits in healing, antinociceptive and anti-inflammatory activities, Oncological Lesions Healing Project (Gel with Crajiru - Arrabidaea chica), G6438247056, G6756993358, G8013382317
OpenAlex ID: W4413411554