Clinical evaluation of a standardized botanical formulation in type 2 diabetes using a unified incretin therapeutic index

Background

Botanical formulations enriched with polyphenols, bitter phytoconstituents, dietary fibers, and alkaloids have traditionally been used for the management of metabolic disorders. However, standardized clinical evaluation frameworks capable of integrating multisystem therapeutic responses remain limited.

Aim

To evaluate the clinical efficacy of a standardized, multi-component botanical formulation in adults with type 2 diabetes mellitus under routine care conditions and to develop and apply the Unified Incretin Therapeutic Index (UITI) as a composite multidomain assessment tool for integrative evaluation of therapeutic response.

Methods

In this 24-week, non-randomized controlled clinical study, 180 adults with type 2 diabetes were allocated to either a standardized botanical intervention group (n = 90) or a standard care control group (n = 90). The UITI was constructed by integrating four domain-specific indices: Incretin Response Composite Score, Metabolic Burden Score, Musculoskeletal Damage Index, and Renal Safety Index using effect size–weighted standardization. Clinical, metabolic, inflammatory, musculoskeletal, and renal biomarkers were evaluated at baseline and study completion.

Results

The botanical intervention demonstrated significant improvements across all evaluated domains compared with control (all p < 0.0001). Large effect sizes were observed for incretin-related response (d = 2.84), metabolic burden (d = 2.68), musculoskeletal damage (d = 1.49), and renal safety (d = 3.48). Significant reductions were observed in HbA1c (-29.91%), HOMA-IR (-77.25%), hs-CRP (-63.67%), body adiposity indices, and muscle injury biomarkers, accompanied by improvement in eGFR (+ 102.85%). The UITI effectively differentiated multidomain therapeutic responses and provided an integrated assessment of clinical improvement.

Conclusion

The standardized botanical formulation demonstrated coordinated improvements across glycemic, inflammatory, metabolic, musculoskeletal, and renal domains in adults with type 2 diabetes within the context of a pragmatic, non-randomized study design. The Unified Incretin Therapeutic Index may provide a useful composite framework for evaluating multidomain responses to botanical interventions in metabolic disorders. Further randomized controlled studies with mechanistic validation are warranted.

Clinical trial number

Not applicable.