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HealthyEarly Phase 1NCT03929250

Pharmacokinetics of Centella Asiatica in the Elderly

A Early Phase 1 study testing 2g Centella asiatica water extract product and 4g Centella asiatica water extract product in people with Healthy and Elderly, run by Oregon Health and Science University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will measure the oral bioavailability and pharmacokinetics of known bioactive compounds from a standardized Centella asiatica water extract (CAW) product (CAP) in cognitively healthy elders. Read more about this study

Who is it for?
Ages 65 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Healthy, Elderly
What is being tested?
2g Centella asiatica water extract product and 4g Centella asiatica water extract product
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
5 Jul 2019to 3 Jan 2024
Phase
Early Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Age 65-85, male and female
  • Sufficient English language skills to complete all tests
  • Sufficient vision and hearing to complete all tests
  • No known allergies to Centella asiatica or CAP components
  • Willingness to discontinue all botanical dietary supplements for one week prior to and during each study visit
  • Willingness to comply with a 48-hour low plant diet for each study visit
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  • Absence of significant depression symptoms (Geriatric Depression Scale-15 score of <12)
  • Body Mass Index (BMI) greater than 17 and less than 35 at screening
  • Non-demented, defined as Clinical Dementia Rating (CDR) score of zero and Mini Mental State Examination (MMSE) score >28
  • General health status that will not interfere with the ability to complete the study

Who cannot join

  • Current smoking, alcohol or substance abuse according to DSM-V criteria
  • Women who are pregnant, planning to become pregnant or breastfeeding
  • Men who are actively trying to conceive a child or planning to within three months of study completion
  • Severe aversion to venipuncture
  • Abnormal laboratory evaluation indicating asymptomatic and untreated urinary tract infection
  • Cancer within the last five years, with the exception of localized prostate cancer (Gleason Grade <3) and non-metastatic skin cancers
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  • Comorbid conditions such as diabetes mellitus, kidney failure, liver failure, hepatitis, blood disorders, clinical symptomatic orthostatic hypotension, and unstable or significantly symptomatic cardiovascular disease
  • Significant disease of the central nervous system such as brain tumor, seizure disorder, subdural hematoma, cranial arteritis, or clinically significant stroke
  • Major depression, schizophrenia, or other major psychiatric disorder defined by DSM-V criteria
  • Medications: sedatives (except those used occasionally for sleep), central nervous system active medications that have not been stable for two months (including beta blockers, cimetidine, SSRIs, SNRIs), anticoagulants (i.e. Warfarin), investigational drugs used within five half-lives of baseline visit, systemic corticosteroids, neuroleptics, anti-Parkinsonian agents, narcotic analgesics, nicotine (tobacco, patches, gum, lozenges, etc.), Cannabis sativa (herb or edibles)
  • Diseases associated with dementia such as Alzheimer's disease, vascular dementia, normal pressure hydrocephalus or Parkinson's disease with a CDR score >0.5 and MMSE score <28
  • Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Oregon Health and Science University Department of Neurology

    Portland, Oregon, 97239

Other trials in United States

About this study

Official title: A Pharmacokinetic Study of Centella Asiatica in the Elderly

This study will measure the oral bioavailability and pharmacokinetics of known bioactive compounds from a standardized Centella asiatica water extract (CAW) product (CAP) in cognitively healthy elders.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To assess the bioavailability and rate of clearance of Centella asiatica derived compounds in the plasma and urine of cognitively healthy elders over 12 hours.
  2. To determine the acute tolerability of a Centella asiatica product in cognitively healthy elders.

OUTLINE:

Participants will orally consume a single administration of a standardized Centella asiatica water extract product (CAP). Two doses (2g and 4g CAW) will be administered on separate occasions, at least two weeks apart. The levels of known bioactive compounds present in Centella asiatica will be measured in human plasma and urine over 12 hours after administration of each of the doses.

Conditions
Healthy, Elderly
Being tested
2g Centella asiatica water extract product, 4g Centella asiatica water extract product

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 2g Centella asiatica water extract productDrug

    Also called CAP 2g

    2g Centella asiatica water extract product is a powder containing Centella asiatica water extract (CAW) and excipients to improve palatability, color matching and dispersability in water. It will be consumed on an empty stomach orally suspended in 10-12 ounces of water.

  • 4g Centella asiatica water extract productDrug

    Also called CAP 4g

    4g Centella asiatica water extract product is a powder containing Centella asiatica water extract (CAW) and excipients to improve palatability, color matching and dispersability in water. It will be consumed on an empty stomach orally suspended in 10-12 ounces of water.

Study groups in NCT03929250
Study groupRoleWhat they receive
2g CAW Dose, then 4g CAW DoseExperimentalParticipants first receive a single dose of a product containing 2g CAW, then after a minimum washout period of 2 weeks, they receive a single dose of a product containing 4g CAW.
Receives: Drug: 2g Centella asiatica water extract product; Drug: 4g Centella asiatica water extract product
4g CAW Dose, then 2g CAW DoseExperimentalParticipants first receive a single dose of a product containing 4g CAW, then after a minimum washout period of 2 weeks, they receive a single dose of a product containing 2g CAW.
Receives: Drug: 2g Centella asiatica water extract product; Drug: 4g Centella asiatica water extract product

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Human Plasma Concentration of Bioactives From Centella Asiatica.

    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 12 hour period, using high performance liquid chromatography tandem mass spectrometry in order to generate a pharmacokinetic curve, and determine pharmacokinetic parameters (maximum concentration and area under the curve) for each of the two doses (2g and 4g).

    Measured: A 12-hour post-administration period (15, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, and 720 minutes).

  2. Total Plasma Concentration Over Time (Area Under the Curve) From Centella Asiatica Water Extract Product.

    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 12 hour period, using high performance liquid chromatography tandem mass spectrometry in order to generate a pharmacokinetic curve, and determine pharmacokinetic parameters (maximum concentration and area under the curve) for each of the two doses (2g and 4g).

    Measured: A 12-hour post-administration period (15, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, and 720 minutes).

  3. Half-life

    The half-life (t1/2) of the known bioactive compounds was calculated from the plasma concentrations measured by high performance liquid chromatography tandem mass spectrometry to help determine dosage intervals.

    Measured: A 12-hour post-administration period (15, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, and 720 minutes).

  4. Time of Maximum Concentration

    The time of maximum concentration (tmax) of the known bioactive compounds and their metabolites will be calculated from the concentrations measured by high performance liquid chromatography tandem mass spectrometry in order to help determine dosage intervals

    Measured: A 12-hour post-administration period (15, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, and 720 minutes).

Secondary outcomes (7)
  1. Urinary Excretion

    The concentration of bioactive compounds from Centella asiatica (triterpenes, caffeoylquinic acids, and their metabolites) will be measured in a pooled urine sample collected over 12 hours after CAP administration and analyzed using high performance liquid chromatography tandem mass spectrometry.

    Measured: Over 12 hours post-administration

  2. Oral Temperature

    Oral temperature will be measured in degrees Fahrenheit by means of a thermometer.

    Measured: 720 minutes after administration

  3. Pulse Rate

    Pulse rate will be measured peripherally over one minute.

    Measured: 720 minutes after administration

  4. Seated Systolic Blood Pressure

    Seated blood pressure will be measured in millimeters mercury.

    Measured: 720 minutes after administration

  5. Body Mass Index

    Height in centimeters and weight in kilograms will be measured and aggregated to measure body mass index in kilograms per meter squared (kg/m2).

    Measured: 720 minutes after administration

  6. Participants With Change in Electrocardiography

    Resting electrocardiography will be measured for up to five minutes using a five lead mobile electrocardiogram. The investigators will determine the number of participants who develop changes in electrocardiography compared to the zero minute timepoint following CAP administration.

    Measured: 0, 360 and 720 minutes after administration

  7. Seated Diastolic Blood Pressure

    Seated blood pressure will be measured in millimeters mercury.

    Measured: 720 minutes after administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2019
  2. Study start5 Jul 2019
  3. Primary completion30 Nov 2019
  4. Study completion3 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Screening
Allocation
Randomised
Intervention model
Crossover
Model description
Randomization will use an arm equivalence design to promote equal numbers of participants for each order schema.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03929250
Sponsor's protocol ID
STUDY00017697
Status last verified
Jul 2025
First submitted
21 Apr 2019
Last updated
6 Aug 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All IPD that underlie results reported in a publication after de-identification.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing 2g Centella asiatica water extract product and 4g Centella asiatica water extract product in people with Healthy and Elderly, run by Oregon Health and Science University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Human Plasma Concentration of Bioactives From Centella Asiatica. (time frame: A 12-hour post-administration period (15, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, and 720 minutes).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.

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