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Pharmacokinetics Centella Asiatica Product (CAP) in Mild Cognitive Impairment

NCT03937908 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2022-05-04

Study results available
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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.

Conditions

Interventions

DRUG

2g Centella asiatica water extract product

2g of Centella asiatica water extract (CAW) in a standardized product containing excipients to improve palatability, color matching and dispersability. The product (CAP) is a powder which will be dissolved in 10-12 ounce of water and consumed by mouth once on an empty stomach.

DRUG

4g Centella asiatica water extract product

4g of Centella asiatica water extract (CAW) in a standardized product containing excipients to improve palatability, color matching and dispersability. The product (CAP) is a powder which will be dissolved in 10-12 ounce of water and consumed by mouth once on an empty stomach.

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Amala Soumyanath, PhD · OHSU Department of Neurology

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
65 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-31
Primary Completion
2020-12-21
Completion
2020-12-21
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03937908 on ClinicalTrials.gov