Qualitative Exploration of Ethical and Regulatory Review of Herbal Remedy Trials in Tanzania: A Case Study of the Maytenus Senegalensis Clinical Trial

Abstract

Background: Herbal remedies are vital worldwide and 80% of Africans rely on them. However, the limited number of well-designed clinical trials in Tanzania emphasizes the necessity for specific ethical and regulatory guidance. This research article examines the M. senegalensis clinical trial as case study to highlight ethical and regulatory review process in Tanzania.

Methods: A single intrinsic case study design was employed to gain insight into the ethical and regulatory review process of the M. senegalensis trial in Tanzania. A qualitative desk review was utilized, and searches were conducted using PubMed, ScienceDirect, Google Scholar databases, and gray literature. Thematic analysis was used for the data analysis.

Results: The document screening identified valuable sources, including three regulatory authority guidelines, five peer-reviewed journal articles, one organizational report and guideline, and five submission packages for the M. senegalensis trial protocol. It also included responses from ethics committees and regulatory authorities. The study found that the essential information for the ethical and regulatory review of herbal remedy trials in Tanzania encompasses nonclinical and clinical studies, anecdotal and ethnomedical evidence, study design, population, endpoints, scientific name, plant extraction details, product type (e.g., raw (fresh or dry), extract), extraction solvent, moisture content, identification of raw material, chemical profile, dose determination, and adverse event monitoring.

Conclusions: The majority of essential information identified focuses on the standardization and quality assurance of the tested herbal product to ensure its verifiability and reproducibility. The findings can guide the review process and create specific herbal trial guidelines in Tanzania and beyond.