Cognitive ImpairmentEarly Phase 1NCT03937908

Pharmacokinetics Centella Asiatica Product (CAP) in Mild Cognitive Impairment

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

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 65 to 85 years
Conditions the study is for: Cognitive Impairment, 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: 5 participants
Where: 1 siteUnited States
Study dates: 31 Oct 2019to 21 Dec 2020
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
No healthy volunteers
Older adult

Who may be able to join

Age 65-85, male and female
Meet the National Institute of Aging - Alzheimer's Association core clinical criteria for mild cognitive impairment or probable Alzheimer's disease dementia with a Clinical Dementia Rating (CDR) score of 0.5-1 and MMSE score of 20-28
Report a history of subjective memory decline with gradual onset and slow progression over the last one year before screening; MUST be corroborated by an informant
On cholinesterase inhibitor therapy for Alzheimer's disease (AD) and must be on a stable dose for at least 12 weeks prior to baseline
Caregiver/study partner that can accompany participant to all study visits
Sufficient English language skills to complete all tests

Show all 13Show fewer

Sufficient vision and hearing to complete all tests
No known allergies to Centella asiatica or CAP excipients
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 <12)
Body Mass Index (BMI) greater than 17 and less than 35 at screening
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

Show all 15Show fewer

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)
Non-Alzheimer dementia such as vascular dementia, normal pressure hydrocephalus or Parkinson's disease
Mini Mental State Examination (MMSE) score of <20 or >28 or CDR score >1 or zero
Unwilling to maintain stable dosage of AD medications throughout study duration
Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
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 Product (CAP) in Elderly Participants With Mild Cognitive Impairment Receiving Cholinesterase Inhibitor Therapy

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.

Read the detailed description

PRIMARY OBJECTIVES:

To assess the bioavailability and rate of clearance of Centella asiatica derived compounds in mildly demented elders on cholinesterase inhibitor therapy through a pharmacokinetic study.
To determine the acute tolerability of a Centella asiatica product in mildly demented elders on cholinesterase inhibitor therapy.

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 10 hours after administration of each of the doses.

Conditions: Cognitive Impairment, Elderly
Being tested: 2g Centella asiatica water extract product, 4g Centella asiatica water extract product
Medical subject headings: Cognitive Dysfunction

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 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.
4g Centella asiatica water extract productDrug
Also called CAP 4g
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.

Study groups in NCT03937908
Study group	Role	What they receive
2g CAP	Experimental	Single administration of 2g of Centella asiatica water extract standardized product dissolved in 10-12 ounce of water and consumed by mouth once on an empty stomach. Receives: Drug: 2g Centella asiatica water extract product
4g CAP	Experimental	Single administration of 4g of Centella asiatica water extract standardized product dissolved in 10-12 ounce of water and consumed by mouth once on an empty stomach. Receives: Drug: 4g Centella asiatica water extract product

What is being measured

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

Peak Plasma Concentration of Centella Asiatica Bioactive Compounds (Cmax)
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 doses (2g and 4g).
Measured: A 10-hour post-administration period (15, 30, 45, 60, 90, 120, 150, 180, 240, 360, 480, and 600 minutes).
Time of Maximum Concentration (Tmax)
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 10-hour post-administration period (15, 30, 45, 60, 90, 120, 150, 180, 240, 360, 480 and 600 minutes).
Half-life (t1/2)
The half-life (t1/2) of the known bioactive compounds and their metabolites will be calculated from the plasma concentrations measured by high performance liquid chromatography tandem mass spectrometry to help determine dosage intervals.
Measured: A 10-hour post-administration period (15, 30, 45, 60, 90, 120, 150,180, 240, 360, 480, and 600 minutes).

Secondary outcomes (3)

Area Under the Curve (AUC) of the Concentration vs Time Profiles of Known 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 10 hour period, using high performance liquid chromatography tandem mass spectrometry in order to generate a pharmacokinetic curve, and determine pharmacokinetic parameters (area under the curve) for each of the two doses (2g and 4g).
Measured: A 10-hour post-administration period (15, 30, 45, 60, 90, 120, 150,180, 240, 360, 480 and 600 minutes).
Total Urinary Excretion
All urine produced over the 10 hours post-administration was collected into a single container. The concentration of bioactive compounds from Centella asiatica (triterpenes, caffeoylquinic acids, and their metabolites) was measured in the single total urine sample collected over 10 hours after CAP administration. Urine samples were treated with glucuronidase and sulfatase enzymes to release analyte from conjugated (Phase II metabolite) forms of the analyte. All samples were analyzed using high performance liquid chromatography tandem mass spectrometry. The concentrations obtained were multiplied by total urine volume to obtain the total amount of that analyte excreted. The total amount (free and conjugated forms) in micrograms of of each analyte in the 10h urine sample is reported.
Measured: Total 10 hours
NRF2 Expression
NRF2 gene expression was measured in peripheral blood mononuclear cells following consumption of 2g and 4g of Centella asiatica water extract product (CAP).
Measured: 0, 1, 2, 3, 4, and 6h following study intervention

Timeline

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

31 Oct 201921 Dec 2020

First posted6 May 2019
Study start31 Oct 2019
Primary completion21 Dec 2020
Study completion21 Dec 2020

Why it stopped: Participant study visits not possible during COVID-19 pandemic. Funder not able to support a continuation at some future date.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: This is an outpatient open-label clinical study using a blinded randomized crossover design of two doses.
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03937908
Sponsor's protocol ID: STUDY00017985
Other IDs: R61AT009628
Status last verified: Apr 2022
First submitted: 23 Apr 2019
Last updated: 4 May 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: ALL IPD that underlie results in a publication will be shared via a published journal article.

Publications

Wright KM, McFerrin J, Alcazar Magana A, Roberts J, Caruso M, Kretzschmar D, Stevens JF, Maier CS, Quinn JF, Soumyanath A. Developing a Rational, Optimized Product of Centella asiatica for Examination in Clinical Trials: Real World Challenges. Front Nutr. 2022 Jan 14;8:799137. doi: 10.3389/fnut.2021.799137. eCollection 2021.
PubMed 35096945
Wright KM, Bollen M, David J, Speers AB, Brandes MS, Gray NE, Alcazar Magana A, McClure C, Stevens JF, Maier CS, Quinn JF, Soumyanath A. Pharmacokinetics and Pharmacodynamics of Key Components of a Standardized Centella asiatica Product in Cognitively Impaired Older Adults: A Phase 1, Double-Blind, Randomized Clinical Trial. Antioxidants (Basel). 2022 Jan 23;11(2):215. doi: 10.3390/antiox11020215.
PubMed 35204098

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Cognitive Impairment trials

Study at a glance

From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pharmacokinetic Study of Centella Asiatica Product (CAP) in Elderly Participants With Mild Cognitive Impairment Receiving Cholinesterase Inhibitor Therapy
ClinicalTrials.gov ID: NCT03937908
Acronym / sponsor ID: STUDY00017985
Conditions: Cognitive Impairment, Elderly
Phase: Early Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Participant study visits not possible during COVID-19 pandemic. Funder not able to support a continuation at some future date.
Enrolment: 5 participants (actual)
Lead sponsor: Oregon Health and Science UniversityUniversity, hospital or other
Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Study start: 31 Oct 2019 (actual)
Primary completion: 21 Dec 2020 (actual)
Study completion: 21 Dec 2020 (actual)
First posted: 6 May 2019 (actual)
Results: Posted 4 May 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

To assess the bioavailability and rate of clearance of Centella asiatica derived compounds in mildly demented elders on cholinesterase inhibitor therapy through a pharmacokinetic study.
To determine the acute tolerability of a Centella asiatica product in mildly demented elders on cholinesterase inhibitor therapy.

OUTLINE:

Study design

Primary purpose: Screening
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: This is an outpatient open-label clinical study using a blinded randomized crossover design of two doses.

Arm	Type	Receives
2g CAP	Experimental	Drug: 2g Centella asiatica water extract productSingle administration of 2g of Centella asiatica water extract standardized product dissolved in 10-12 ounce of water and consumed by mouth once on an empty stomach.
4g CAP	Experimental	Drug: 4g Centella asiatica water extract productSingle administration of 4g of Centella asiatica water extract standardized product dissolved in 10-12 ounce of water and consumed by mouth once on an empty stomach.

Who may qualify

Ages: 65 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (13 listed)

Age 65-85, male and female
Meet the National Institute of Aging - Alzheimer's Association core clinical criteria for mild cognitive impairment or probable Alzheimer's disease dementia with a Clinical Dementia Rating (CDR) score of 0.5-1 and MMSE score of 20-28
Report a history of subjective memory decline with gradual onset and slow progression over the last one year before screening; MUST be corroborated by an informant
On cholinesterase inhibitor therapy for Alzheimer's disease (AD) and must be on a stable dose for at least 12 weeks prior to baseline
Caregiver/study partner that can accompany participant to all study visits

Key exclusion criteria (15 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
2g Centella asiatica water extract productAlso: CAP 2g2g 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	2g CAP
4g Centella asiatica water extract productAlso: CAP 4g4g 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 CAP

Primary outcome

Peak Plasma Concentration of Centella Asiatica Bioactive Compounds (Cmax)
Time frame: A 10-hour post-administration period (15, 30, 45, 60, 90, 120, 150, 180, 240, 360, 480, and 600 minutes).
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 doses (2g and 4g).
Time of Maximum Concentration (Tmax)
Time frame: A 10-hour post-administration period (15, 30, 45, 60, 90, 120, 150, 180, 240, 360, 480 and 600 minutes).
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
Half-life (t1/2)
Time frame: A 10-hour post-administration period (15, 30, 45, 60, 90, 120, 150,180, 240, 360, 480, and 600 minutes).
The half-life (t1/2) of the known bioactive compounds and their metabolites will be calculated from the plasma concentrations measured by high performance liquid chromatography tandem mass spectrometry to help determine dosage intervals.

3 secondary outcomes

Area Under the Curve (AUC) of the Concentration vs Time Profiles of Known Bioactives From Centella Asiatica
Time frame: A 10-hour post-administration period (15, 30, 45, 60, 90, 120, 150,180, 240, 360, 480 and 600 minutes).
Total Urinary Excretion
Time frame: Total 10 hours
NRF2 Expression
Time frame: 0, 1, 2, 3, 4, and 6h following study intervention

Results and safety

Results posted to the registry on 4 May 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental: 2g CAP Then 4g CAP	2	2
Experimental: 4g CAP Then 2g CAP	3	2

Primary outcome: Peak Plasma Concentration of Centella Asiatica Bioactive Compounds (Cmax)

Time frame: A 10-hour post-administration period (15, 30, 45, 60, 90, 120, 150, 180, 240, 360, 480, and 600 minutes).. Mean (Standard Error). Unit: ng/mL

Measure	2g CAP n = 4	4g CAP n = 4
Asiatic acid	124 (29)	259 (24)
Caffeic acid	0.3 (0.2)	1 (0.1)
Dihydrocaffeic acid	1 (0.4)	2 (0.2)
Dihydroferulic acid	11 (5)	20 (6)
Dicaffeoylquinic acids	18 (10)	3 (0.3)
Ferulic acid	1 (0.2)	1.4 (0.1)
3-(3-hydroxyphenyl)propionic acid	32 (18)	42 (18)
Isoferulic acid	0.9 (0.3)	2 (0.1)

2g CAP vs 4g CAP: p = 0.01, t-test, 2 sided
2g CAP vs 4g CAP: p = 0.23, t-test, 2 sided
2g CAP vs 4g CAP: p = 0.001, t-test, 2 sided

Population analysed: The pharmacokinetic parameter (Cmax) and time curves was calculated using non-compartmental analysis of plasma concentration versus time data using Excel software PK-solver (version 2.0).

Primary outcome: Time of Maximum Concentration (Tmax)

Time frame: A 10-hour post-administration period (15, 30, 45, 60, 90, 120, 150, 180, 240, 360, 480 and 600 minutes).. Mean (Standard Error). Unit: hours

Measure	2g CAP n = 4	4g CAP n = 4
Asiatic acid	2 (0.6)	2 (0.6)
Caffeic acid	4 (2)	4 (1)
Dihydrocaffeic acid	3.25 (0.5)	3.5 (0.5)
Dihydroferulic acid	3.4 (1)	3.5 (0.5)
Dicaffeoylquinic acids	6 (2)	0.6 (0.3)
Ferulic acid	5 (0.6)	5.5 (0.5)
3-(3-hydroxyphenyl)propionic acid	6 (1.4)	5.5 (1.7)
Isoferulic acid	1.3 (0.6)	1 (0.4)

2g CAP vs 4g CAP: p = 0.82, t-test, 2 sided
2g CAP vs 4g CAP: p = 0.40, t-test, 2 sided
2g CAP vs 4g CAP: p = 0.20, t-test, 2 sided

Primary outcome: Half-life (t1/2)

Time frame: A 10-hour post-administration period (15, 30, 45, 60, 90, 120, 150,180, 240, 360, 480, and 600 minutes).. Mean (Standard Error). Unit: hours

Measure	2g CAP n = 4	4g CAP n = 4
Asiatic acid	3.8 (1)	2.2 (0.5)
Caffeic acid	2.6 (1)	3.5 (1.2)
Dihydrocaffeic acid	4.8 (1.3)	1.1 (0.4)
Dihydroferulic acid	4.5 (1.6)	2.5 (0.3)
Dicaffeoylquinic acids	0 (0)	3 (2)
Ferulic acid	13.4 (5.3)	7 (1.2)
3-(3-hydroxyphenyl)propionic acid	2.3 (0.3)	1.8 (0.7)
Isoferulic acid	8.8 (5.7)	2.9 (0.6)

2g CAP vs 4g CAP: p = 0.34, t-test, 2 sided
2g CAP vs 4g CAP: p = 0.08, t-test, 2 sided
2g CAP vs 4g CAP: p = 0.23, t-test, 2 sided

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected during each study visit, 24 hours following study drug administration at each study visit, and 7 days after study visit two (end of study).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
2g CAP	0 of 4 (0%)	4 of 4 (100%)	0 of 4
4g CAP	0 of 4 (0%)	4 of 4 (100%)	0 of 4

Limitations and caveats (from the sponsor): Study was discontinued before the target number of participants were enrolled due to pandemic-related restrictions.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 35096945Wright KM, McFerrin J, Alcazar Magana A, Roberts J, Caruso M, Kretzschmar D, Stevens JF, Maier CS, Quinn JF, Soumyanath A. Developing a Rational, Optimized Product of Centella asiatica for Examination in Clinical Trials: Real World Challenges. Front Nutr. 2022 Jan 14;8:799137. doi: 10.3389/fnut.2021.799137. eCollection 2021.
Results publication: PubMed 35204098Wright KM, Bollen M, David J, Speers AB, Brandes MS, Gray NE, Alcazar Magana A, McClure C, Stevens JF, Maier CS, Quinn JF, Soumyanath A. Pharmacokinetics and Pharmacodynamics of Key Components of a Standardized Centella asiatica Product in Cognitively Impaired Older Adults: A Phase 1, Double-Blind, Randomized Clinical Trial. Antioxidants (Basel). 2022 Jan 23;11(2):215. doi: 10.3390/antiox11020215.
Individual participant dataSharing planned: Yes. ALL IPD that underlie results in a publication will be shared via a published journal article.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Amala Soumyanath, PhD principal investigator

OHSU Department of Neurology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 13 inclusion and 15 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: stopped early, as of the sponsor's last update on 4 May 2022. 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 4 May 2022). 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?

Peak Plasma Concentration of Centella Asiatica Bioactive Compounds (Cmax) (time frame: A 10-hour post-administration period (15, 30, 45, 60, 90, 120, 150, 180, 240, 360, 480, and 600 minutes).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03937908, which also lists 2 linked publications.

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 4 May 2022.