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
Abstract
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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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