Home » Trials » SLCTR/2026/022
Influence of Bacopa monnieri on safety, tolerability, telomere and neurophysiological functions in healthy older adults in relation to prakriti
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SLCTR Registration Number
SLCTR/2026/022
Date of Registration
The date of last modification
Aug 13, 2026
Scientific Title of Trial
Influence of Bacopa monnieri on safety, tolerability, telomere and neurophysiological functions in healthy older adults in relation to prakriti
Public Title of Trial
Effects of Brahmi (Bacopa monnieri) on memory, brain function, wellbeing, healthy ageing and safety in healthy older adults with different body constitutions (Prakriti).
Disease or Health Condition(s) Studied
Healthy ageing, cognitive function, neurophysiological function, and telomere biology in healthy older adults.
Scientific Acronym
BRAIN-AGE Study (Bacopa Research on Aging, Neurophysiology and Genomic Effects)
Public Acronym
BRAIN-AGE (Brahmi Research on Aging, Neurophysiology and Genomic Effects)
Brief title
Effects of Bacopa monnieri on healthy ageing and neurophysiological functions in older adults.
Universal Trial Number
UTN: U1111-1345-3186
Any other number(s) assigned to the trial and issuing authority
EC-26-013- Ethics Review Committee Faculty of Medicine University of Colombo
What is the research question being addressed?
What is the optimal dose of Bacopa monnieri freeze-dried decoction (BMFD) that provides maximal improvement in telomerase activity and preservation of telomere length, while ensuring acceptable safety and tolerability in healthy older adults?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Dose comparison
Assignment
Parallel
Purpose
Health services research
Study Phase
Phase 0 (exploratory trials)
Intervention(s) planned
Clinical Trial Centre – Professorial Unit, National Ayurveda Teaching Hospital, Borella, Sri Lanka, Traditional Medicine Consultation Unit (TMCU) / Clinical Trial Centre, Faculty of Indigenous Medicine, University of Colombo and Neuro science research Centre- Department of Physiology, Faculty of Medicine, University of Colombo, Sri Lanka
Eligible participants will be individually randomized into three parallel intervention groups in a 1:1:1 ratio after completion of baseline assessments. A computer-generated randomization sequence will be used for allocation of participants. The unit of randomization will be the individual participant. Allocation will be performed after confirming eligibility and baseline assessments.
As this is an open-label dose-finding study, blinding is not applicable. The allocation sequence will be securely maintained, and participants will be assigned according to the generated randomization schedule.
a. Method of randomization into study arms: Computer-generated randomization with equal allocation (1:1:1 ratio) into three parallel intervention groups.
b. Unit of randomization: Individual participant.
c. Method of sequence generation: Computer-generated randomization sequence.
d. Method of allocation concealment: Allocation will be performed after confirmation of eligibility and completion of baseline assessments according to the generated randomization sequence.
Group I (High-dose BMFD): 180 mL twice daily (total 360 mL/day) Group II (Medium/test-dose BMFD): 120 mL twice daily (total 240 mL/day) Group III (Low-dose BMFD): 60 mL twice daily (total 120 mL/day)
The intervention will be administered orally, twice daily, for 45 days. Following completion of the intervention period, participants will be followed up until Day 90 for assessment of safety, tolerability, aging-related parameters, and neurophysiological functions.
This study does not include a control arm receiving standard therapy.
Primary and secondary outcome assessments related to aging-associated parameters and neurophysiological functions will be conducted at baseline, midpoint, and endpoint visits. Safety and tolerability assessments will also be performed throughout the study period.
Inclusion criteria
1.Age between 60 - 64 2.Both male and females 3.Nonsmokers and non-alcohol user 4.The Montreal Cognitive Assessment (MoCA) score of 26 or above
Exclusion criteria
Primary outcome(s)
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1.
Incidence of treatment emergent adverse events Metric Number and proportion of participants experiencing one or more adverse events, graded according to CTCAE Methods of aggregation- Frequency and percentage of participants by dose group. |
[ Baseline, Week 6, Week 12 ] |
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2.
Safety laboratory parameters Variable Hematological and biochemical safety parameters (e.g., FBC, AST, ALT, serum creatinine, fasting blood glucose, urine analysis) Metric Absolute values and change from baseline Methods of aggregation Mean ± SD and mean change from baseline by dose group |
[ Time point Baseline, Week 6, Week 12 ] |
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3.
Tolerability Variable Tolerability score based on investigator-administered checklist and participant symptom diary Metric Total tolerability score and frequency of treatment-related symptoms Methods of aggregation Mean score and proportion of participants reporting symptoms Time point |
[ Baseline, Week 6, Week 12 ] |
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4.
Telomerase activity Variable Telomerase activity in PBMCs Metric Relative telomerase activity measured by laboratory assay Methods of aggregation Mean change from baseline by dose group |
[ Baseline, Week 6, Week 12 ] |
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5.
Telomere length Variable Relative telomere length in PBMCs Metric T/S ratio measured using quantitative PCR (qPCR) Methods of aggregation Mean change from baseline by dose group Time point Baseline, Week 6, Week 12 |
[] |
Secondary outcome(s)
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1.
Cognitive function Variable Montreal Cognitive Assessment (MoCA) score Metric Total MoCA score (0–30) Methods of aggregation Mean ± SD and mean change from baseline by dose group Time point |
[ Baseline, Week 6, Week 12 ] |
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2.
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[ Baseline, Week 6, Week 12 ] |
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[ Baseline, Week 6, Week 12 ] |
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[ Baseline, Week 6, Week 12 ] |
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[ Baseline, Week 6, Week 12 ] |
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[ Baseline, Week 6, Week 12 ] |
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[ Baseline, Week 6, Week 12 ] |
Target number/sample size
24
Countries of recruitment
Sri Lanka
Anticipated start date
2026-06-01
Anticipated end date
2027-08-30
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Funding source under discussion and The first stage of the research was initiated through the University of Colombo Small Research Grant (Grant No. AP/3/2024/SG/10).
Regulatory approvals
“Not applicable – Ayurvedic pharmacopeial preparation.”
Status
Approved
Date of Approval
2026-04-23
Approval number
EC-26-013
Details of Ethics Review Committee
| Name: | Ethics Review Committee Faculty of Medicine University of Colombo |
| Institutional Address: | Faculty of Medicine University of Colombo P O Box 271, Kynsey Road, Colombo 8, Sri Lanka |
| Telephone: | +94-11-2695300 ext 240 Fax: +94-11-2691581 |
| Email: | erc@med.cmb.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Dr.HLNR.Pradeep
Lecturer -Probationary
Faculty of indigenous Medicine University of Colombo, Sri Lanka
0112789950
0711723286
ranganapradeep@fim.cmb.ac.lk
Contact Person for Public Queries
Prof.Dilshnai Dissanyake
Professor in Physiology
Faculty of Medicine University of Colombo, Sri Lanka
+94 112 695 300
0718232420
dilshanid@physiol.cmb.ac.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
Yes
Protocol version and date
Protocol URL
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
