Effects of Bacopa monnieri herbal supplement on aging and neurocognitive functions, including neurophysiological assessments, in relation to constitution (Prakriti) in healthy adults: clinical trial protocol.

BACKGROUND: Aging is an irreversible process shaped by genetic and environmental factors. Beyond physical and mental decline, it involves complex biological mechanisms. Programmed theories propose aging follows a biological clock, while error theories attribute it to environmental damage. A key mechanism is telomere shortening; once critically shortened, cells enter senescence. Telomerase preserves telomeres, but its activity decreases with age. Aging also causes cognitive decline, measurable through tools like electroencephalography (EEG). STUDY DESIGN: This two-arm, double blind, placebo-controlled superiority randomized controlled trial evaluates the effects of Bacopa monnieri freeze-dried herbal decoction (BMFD) on aging and cognition. Elderly participants (MoCA ≥24) will be randomized to receive BMFD or placebo, administered as 120 mL twice daily for 45 days, with assessments at baseline, 45, and 90 days. Conducted at the Clinical Trial Center, Faculty of Indigenous Medicine, University of Colombo, the trial tests BMFD's ability to stabilize aging processes and enhance neurocognitive functions. OUTCOMES: Primary outcomes include telomerase activity and telomere length (qPCR). Secondary outcomes include neurocognitive function [validated MoCA for the Sri Lankan population], neurophysiological functions-nerve conduction test (NCT) for upper and lower limb nerves and brain electrical activity (EEG)-and assessing health-related quality of life (HRQoL) using a validated questionnaire. DISCUSSION: This trial will provide evidence on BMFD's potential to preserve telomere length, support cognitive functions, and slow aging processes. Integrating Ayurvedic principles, including constitution (Prakriti), it aims to enable early detection of cognitive decline and aging-related changes. Findings are expected to inform preventive and personalized strategies, contributing to evidence-based applications of Bacopa monnieri in healthy aging. CLINICAL TRIAL REGISTRATION: https://doi.org/10.1186/ISRCTN64126920, identifier ISRCTN64126920.