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

Influence of Bacopa monnieri on telomerase activity, telomere length and aging- related changes and neurocognitive functions, including neurophysiological assessments, in relation to constitution (Prakriti) in healthy adults

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN64126920

Enrollment

Registered

2025-01-28

Start date

2025-05-18

Completion date

Unknown

Last updated

2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The healthcare domain being studied is healthy aging and cognitive function enhancement, with a focus on the influence of Bacopa monnieri (L) Wettst on telomerase activity, telomere length, and prakriti (constitution) of healthy adults. Other

Interventions

Current interventions as of 06/10/2025: This will be a two-arm, double blind, exploratory, randomized control trial in healthy participants. A consecutive consenting sample method will be followed to

Eligibility

Sex/Gender

All

Age

60 Years to 64 Years

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 13/03/2025: 1. Healthy individuals aged 60 - 64 years 2. Both males and females 3. Nonsmokers and non-alcoholic 4. The MoCA score is 24 or above Previous inclusion criteria: 1. Healthy individuals aged 60 - 64 years 2. Both males and females 3. Nonsmokers and non-alcoholic 4. The MoCA score ranges between 0-30 and a score of 24 or above

Exclusion criteria

Exclusion criteria: 1. Healthy individuals below 60 and above 64 years 2. Individuals between 60 to 64 years old with CKD, CVD, Liver disorders, psychiatric illnesses, DM, cancers, Hypertension, hyperlipidemia etc 3. Those who have medically diagnosed diseases with reduced capacity to answer questions Added 18/07/2025: 4. Participants with dyspeptic symptoms

Design outcomes

Primary

Measure	Time frame
Current primary outcome(s) as of 10/03/2026: Telomerase activity and telomere length (qPCR) assessed at baseline, 45 and 90 days _____ Previous primary outcome(s): The following primary outcome measures are assessed at baseline, 45 and 90 days: 1. Cognitive impairment will be measured using the Montreal Cognitive Assessment (MoCA) validated for the Sri Lankan population 2. Telomerase activity and telomerase length of blood mononuclear cells of participants measured using qualitative polymerase chain reaction (QPCR) 3. Median nerve and Ulnar for upper limb function and Tibial and Common peroneal nerve for lower limb function measured using the nerve conduction test (NCT) 4. Electrical activity of the brain measured using electroencephalography (EEG)	—

Measure

Time frame

Current primary outcome(s) as of 10/03/2026: Telomerase activity and telomere length (qPCR) assessed at baseline, 45 and 90 days _____ Previous primary outcome(s): The following primary outcome measures are assessed at baseline, 45 and 90 days: 1. Cognitive impairment will be measured using the Montreal Cognitive Assessment (MoCA) validated for the Sri Lankan population 2. Telomerase activity and telomerase length of blood mononuclear cells of participants measured using qualitative polymerase chain reaction (QPCR) 3. Median nerve and Ulnar for upper limb function and Tibial and Common peroneal nerve for lower limb function measured using the nerve conduction test (NCT) 4. Electrical activity of the brain measured using electroencephalography (EEG)

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Secondary

Measure	Time frame
Current key secondary outcome(s) as of 10/03/2026: After 45 days, 90 days of follow-up: 1. Neurocognitive function [validated MoCA for the Sri Lankan population] 2. Neurophysiological functions—nerve conduction test (NCT) for upper and lower limb nerves and brain electrical activity (EEG) 3. Health-related quality of life (HRQoL) using a validated questionnaire _____ Previous key secondary outcome(s): Health-related quality of life (HRQoL) measured using an HRQoL questionnaire (Jankovic, Slobodan M., et al. 2021) at baseline and the end of the intervention (after 45 days, 90 days of follow-up)	—

Measure

Time frame

Current key secondary outcome(s) as of 10/03/2026: After 45 days, 90 days of follow-up: 1. Neurocognitive function [validated MoCA for the Sri Lankan population] 2. Neurophysiological functions—nerve conduction test (NCT) for upper and lower limb nerves and brain electrical activity (EEG) 3. Health-related quality of life (HRQoL) using a validated questionnaire _____ Previous key secondary outcome(s): Health-related quality of life (HRQoL) measured using an HRQoL questionnaire (Jankovic, Slobodan M., et al. 2021) at baseline and the end of the intervention (after 45 days, 90 days of follow-up)

—

Countries

Sri Lanka

Contacts

Public ContactPathirage Kamal Perera

kamalperera@fim.cmb.ac.lk+94 (0)716419072

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 3, 2026