Effects of Bacopa monnieri herbal supplement on aging and neurocognitive functions with relation to constitution (Prakriti) in healthy adults. Clinical trial protocol

Background: Aging is an irreversible process influenced by both internal (genetic) and external (environmental) factors. These factors contribute to differences in how individuals age. Aging is not just about a decline in physical and mental abilities but involves complex biological mechanisms. Two main theories explain aging: 1. Programmed Theories: Suggest that aging follows a biological clock; and 2. Error Theories Propose that aging is caused by environmental damage to cells, leading to DNA damage and the accumulation of harmful substances. Telomere shortening is a major contributing element to aging. With every cell division, the protecting telomeres at the ends of chromosomes get shorter. When they become too short, cells stop dividing, a process known as cellular senescence. Telomere length is maintained by an enzyme called telomerase, but its activity decreases with age. Aging is also associated with changes in the brain, including a decline in cognitive abilities like memory and decision-making. These changes can be observed through brain activity using techniques like EEG (electroencephalography). This study aims to explore whether an Bacopa monerri freeze dried herbal decoction can help slow aging-related changes, maintain telomere length, and improve cognitive functions. Study design: This is a two-arm, open-label, non-inferiority, randomized controlled clinical trial enrolling participants (The MoCA score of 24 or above). This study aims to assess the potential of BMFD- Bacopa monerri freeze-dried decoction -the interventional dosage) in stabilizing the aging process and influencing cognitive functions in the elderly Participants. Participants will be allocated randomly into the two arms and consider testing dosage form (BMFD), which has the highest anti-aging activity and the highest anti-lipase activity and placebo to evaluate if the BMFD dosage form is better at stabilizing the process of aging and aging-related neurocognitive functions as compared to placebo. The duration of the BMFD dosage form or placebo administration will be 45 days. It will be given as 120 ML twice a day. They will be requested to take a daily dose of 120 ml of BMFD twice a day before meals. The total duration of BMFD administration is 45 days. The follow-up duration for this study is set to 45 days. Participants will be recruited from a single-center clinical trial at the Clinical Trial Center, Faculty of Indigenous Medicine, University of Colombo, Sri Lanka. The study aims to evaluate the effects of BMFD decoction on neurocognitive functions and aging-related changes in the elderly. The primary outcomes will be assessed at baseline, 45 days, and 90 days. These include: neurocognitive functions, measured using the Montreal Cognitive Assessment (MoCA) validated for the Sri Lankan population. telomerase activity and telomere length of blood mononuclear cells, assessed using qualitative polymerase chain reaction (QPCR). Peripheral nerve conduction: Upper limbs -Median nerve and Ulnar nerve and lower limbs: Tibial and Common peroneal nerve, assessed using the nerve conduction test (NCT). Electrical activity of the brain, measured through electroencephalography (EEG). Secondary outcomes include the assessment of Health-Related Quality of Life (HRQoL) using a HRQoL questionnaire (Janković, Slobodan M., et al., 2021), evaluated at baseline, 45 days, and 90 days. This trial utilizes a product (BMFD decoction) already tested for efficacy in other contexts, ensuring its safety for use in this population. The outcomes will provide valuable insights into how BMFD can stabilize neurocognitive functions and aging-related changes, enabling early interventions and personalized preventive strategies. Discussion : This clinical trial will provide evidence-based scientific data on the effectiveness of Bacopa monnieri and its Ayurvedic dosage form, BMFD, in the aging process and neurocognitive enhancement concerning individual constitution ( Prakriti ). This trial is expected to contribute to the early detection of cognitive impairment and aging-related neurophysiological changes in relation to individual constitution ( Prakriti ). Trial registration: ISRCTN64126920 https://doi.org/10.1186/ISRCTN64126920