Carica papaya L. Leaf: A Systematic Scoping Review on Biological Safety and Herb-Drug Interactions

Table 1

Population, Intervention, Comparison, and Outcomes (PICO) framework.

Elements	Details
Population	1. Human patients of all ages and diseases, healthy and unhealthy; 2. Animal models in toxicity studies; 3. Animal models, cell models, or assays in herb-drug interaction studies
Intervention	C. papaya leaf as a single herb, in any form of any formulation. Only studies utilizing the leaf part of the plant were included
Comparator	Placebo, no treatment, or control treatment
Outcome	Primary outcome: 1. Safe dosage range and formulations documented; 2. Intrinsic toxicity data including adverse events and serious adverse events reported in clinical trials or studies which may or may not be related to treatment; 3. Toxicity findings from animal toxicity studies; 4. Reports on herb-drug interaction; Secondary outcome: Reporting quality of randomised controlled and quasiexperimental trials specific to quality of herbal medicine interventions (Consolidated Standards of Reporting Trials (CONSORT) extension for herbal trials, item No. 4 [29]), an indirect indicator of extrinsic toxicity of the test item