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NCT03937908 · ClinicalTrials.gov registry record · Early Phase 1

Pharmacokinetics Centella Asiatica Product (CAP) in Mild Cognitive Impairment

A Early Phase 1 study, sponsored by Oregon Health and Science University.

Terminated
Registry status
Early Phase 1
Development phase
5
Enrollment target

NCT03937908: Clinical Trial Early Phase 1 study, sponsored by Oregon Health and Science University.

NCT03937908 is a Early Phase 1 study that was terminated before completion, run by Oregon Health and Science University. The registered enrollment target is 5 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03937908, a Early Phase 1 study, was terminated before completion, sponsored by Oregon Health and Science University.

TERMINATED
Registry status
Early Phase 1
Development phase
5 participants
Enrollment target

Study Summary

This study will measure the oral bioavailability and pharmacokinetics of known bioactive compounds from a standardized Centella asiatica water extract product (CAP) in mildly demented elders on cholinesterase inhibitor therapy. Compound levels will be measured in human plasma and urine over 10 hours after acute oral administration of two doses of the botanical extract product. The dose giving maximum plasma levels (Cmax)closest to those observed in the investigator's mouse studies, the area under the curve (AUC0-12), as well as the rate of clearance (t ½) of the known compounds and time of maximum concentration (tmax), will be identified. These data will be used to inform decisions on the dosage and dosing frequency for future clinical trials.

Primary Outcome

Following oral administration of a product made from a water extract of Centella asiatica (CAP), the plasma concentration of Centella asiatica derived bioactive compounds (triterpenes, caffeoylquinic acids, and their metabolites) will be measured in blood samples obtained over a 10 hour period, using high performance liquid chromatography tandem mass spectrometry in order to generate a pharmacokinetic curve, and determine pharmacokinetic parameters (maximum concentration) for each of the two dos

Interventions

  • DRUG 2g Centella asiatica water extract product
  • DRUG 4g Centella asiatica water extract product

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2019-10-31
Est. Completion 2020-12-21
Phase Early Phase 1

Why NCT03937908 stopped before completion

NCT03937908 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (91% lower).

The record links to 0 conditions, and to 2 interventions - of which 2g Centella asiatica water extract product is the first listed.

NCT03937908 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03937908 about?

NCT03937908 is a clinical study titled "Pharmacokinetics Centella Asiatica Product (CAP) in Mild Cognitive Impairment". This study will measure the oral bioavailability and pharmacokinetics of known bioactive compounds from a standardized Centella asiatica water extract product (CAP) in mildly demented elders on cholinesterase inhibitor therapy. Compound levels will be measured in human plasma and urine over 10 hours...

What is the current status of trial NCT03937908?

This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 5 participants. The study started on 2019-10-31. Estimated completion is 2020-12-21.

What interventions are being tested in trial NCT03937908?

The interventions under investigation include: 2g Centella asiatica water extract product (DRUG), 4g Centella asiatica water extract product (DRUG).

Who is sponsoring clinical trial NCT03937908?

This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03937908's enrollment target sits among peer trials

5 1887th of 2000 higher than 80 of 2,000 other Early Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03937908, the US trial registry maintained by the National Library of Medicine. NCT03937908 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.