What large, registered randomized trials of Bacopa monnieri are planned or ongoing, and where can their protocols and registries be accessed?
Executive summary
There are several registered randomized trials of Bacopa monnieri that have completed or reported results and a few recent registrations accessible via public registries, but no single large, definitive multi‑center randomized trial (for example, a head‑to‑head trial versus an approved cognitive drug) is described as ongoing in the provided sources. Systematic reviews and meta‑analyses explicitly call for larger, well‑designed randomized trials and point readers to registry entries (ClinicalTrials.gov, ANZCTR) and published trial protocols as the primary places to find ongoing‑trial information [1] [2] [3].
1. What registered randomized trials currently surface in the public record and where to read their protocols
Recent randomized, double‑blind, placebo‑controlled trials of specific Bacopa extracts have registry identifiers and published reports that include protocol details; for example, a 12‑week randomized trial of Bacopa (Bacumen®) lists its Australian New Zealand Clinical Trials Registry registration ACTRN12623000475640 and is indexed on PubMed with study design and outcomes summarized in the abstract [4]. ClinicalTrials.gov also hosts entries related to Bacopa interventions (for instance study NCT06355167 is listed on ClinicalTrials.gov), and trial pages there typically provide registration records and protocol summaries where available [5]. Peer‑reviewed publications that report randomized trials—available via PubMed and PMC—contain methods sections that function as protocol summaries for completed studies; representative examples include elderly‑participant randomized trials and trials using Bacognize® or Bacopa extracts reported on PMC and PubMed [6] [7].
2. How large are the trials found in the literature and what gaps do registries reveal
Most randomized trials identified in systematic reviews and meta‑analyses remain modest in size and duration—commonly 12‑week interventions with sample sizes in the tens to low hundreds—which is why meta‑analysts call for a large, well‑designed “head‑to‑head” trial to provide definitive efficacy data [8] [1]. Reviews and evidence summaries note 22 clinical trials aggregated in recent reviews but emphasize heterogeneity in extract composition, doses (typically 300–450 mg/day), and outcomes, and they explicitly recommend larger randomized trials across varied populations to confirm cognitive and safety signals [9] [10].
3. Where to look for planned or ongoing large trials (registry guidance)
Public registries are the authoritative sources for planned and ongoing randomized trials: ClinicalTrials.gov and the Australian New Zealand Clinical Trials Registry (ANZCTR) are specifically cited in trial reports and reviews as locations where registration numbers and protocol information appear [4] [5] [1]. For investigators seeking protocol documents or full statistical analysis plans, individual registry records sometimes link to sponsor‑posted protocols or to journal protocol publications; when a registry record lacks a full protocol, the corresponding PubMed/PMC article or the trial’s sponsor webpage is the next best source [6] [4].
4. Why no single large, definitive registered trial is visible in these sources and what that implies
Multiple sources flag the absence of large multi‑center randomized comparisons versus approved cognitive drugs and attribute the gap to variable extract formulations, small sample sizes, and limited pharmacokinetic data—problems that complicate large trial design and standardization [2] [1]. Systematic reviews and expert summaries therefore recommend standardized extract characterization and larger trials to resolve efficacy and safety questions rather than claiming such a trial is already under way in the public registries cited here [1] [2].
5. Caveats, competing perspectives and how commercial interests shape the landscape
Published overviews and LiverTox summaries report primarily benign safety signals but note gastrointestinal adverse events and recommend larger safety datasets; they also highlight variability in extract composition that can bias outcomes across industry‑sponsored versus academic trials [11] [2]. Alternative viewpoints appear in the literature—some meta‑analyses find promising effects on attention and memory speed while others call results tentative—so readers should interpret registry entries and sponsor claims with awareness of potential publication bias and commercial agendas [1] [12].