Early Phase 1
N=8
Pharmacokinetics of Centella Asiatica in the Elderly
Healthy · Elderly
Bottom Line
View on ClinicalTrials.gov: NCT03929250 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Maximum Human Plasma Concentration of Bioactives From Centella Asiatica. — 174; 372; 0.3; 0.5 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- 2g Centella asiatica water extract product (Drug); 4g Centella asiatica water extract product (Drug)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Oregon Health and Science University
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Human Plasma Concentration of Bioactives From Centella Asiatica. |
174; 372; 0.3; 0.5; 0.4; 0.5 | — |
| PRIMARY Total Plasma Concentration Over Time (Area Under the Curve) From Centella Asiatica Water Extract Product. |
48755; 91330; 1.8; 2.4; 1.7; 1.9 | — |
| PRIMARY Half-life |
4.1; 4.9; 8.4; 10.3; 1.8; 1.9 | — |
| PRIMARY Time of Maximum Concentration |
2.2; 2.8; 5.3; 4.5; 6.1; 3.2 | — |
| SECONDARY Urinary Excretion |
0; 0; 20.7; 18.6; 42.8; 48.7 | — |
| SECONDARY Oral Temperature |
98.2; 98.1 | — |
| SECONDARY Pulse Rate |
69; 64 | — |
| SECONDARY Seated Systolic Blood Pressure |
125; 119 | — |
| SECONDARY Body Mass Index |
28.4; 28 | — |
| SECONDARY Participants With Change in Electrocardiography |
0; 0 | — |
| SECONDARY Seated Diastolic Blood Pressure |
74; 69 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
- Absence of significant depression symptoms (Geriatric Depression Scale-15 score of 28
- General health status that will not interfere with the ability to complete the study
Exclusion Criteria
- 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 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
Data sourced from ClinicalTrials.gov (NCT03929250). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.