Endothelial DysfunctionNCT06472791
Centella Asiatica in Older Adults
A study testing Centella Asiatica in people with Endothelial Dysfunction, run by National University of Natural Medicine at 1 site in United States.
Trial summary
The purpose of this study is to determine the effects of a dietary supplement containing centella asiatica on on vascular endothelial function in older adults. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Endothelial Dysfunction
- What is being tested?
- Centella Asiatica
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ● Age 50 through 85, male or female
- Sufficient proficiency in English to understand study purpose and directions
- Willing and able to give informed consent
- Able to follow protocol and attend visits
Who cannot join
- History of myocardial infarction, known coronary or carotid disease, or heart failure
- History of stroke, Parkinson's disease, dementia, or other major CNS disorders
- History of hepatic disease (e.g. hepatitis, cirrhosis)
- Recent/recurring history of severe life-threatening medical conditions (e.g. cancer, except non-melanoma skin cancers)
- Active major infectious disease (e.g. pneumonia)
- Heavy alcohol use (15 drinks or more per week for men or 8 drinks or more per week for women) or substance use disorder
Show all 15Show fewer
- Current use of any medication typically used to treat hypertension or lower blood pressure (e.g. beta-blockers, ACE inhibitors)
- Current use of any medication typically used to prevent the coagulation of blood (e.g. warfarin (Coumadin))
- Chronic NSAID use (>3 times a week for more than 3 months)
- Current use of any medication or supplement typically used as a sedative (e.g. zolpidem (Ambien), benzodiazepines (Valium, Xanax), valerian root)
- Dietary supplements for improving nitric-oxide synthesis (e.g. L-arginine, L-citrulline)
- Current use of any medication typically used to control hypoglycemia (e.g. biguanides (Metformin))
- Current use of any medication typically used for erectile dysfunction (e.g. sildenafil (Viagra), tadalafil (Cialis))
- Pregnant, nursing, or planning a pregnancy within the next 6 weeks
- Open skin rashes and sores that may interfere with the placement of sensors
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Centella Asiatica on Vascular Endothelial Function in Older Adults
The purpose of this study is to determine the effects of a dietary supplement containing centella asiatica on on vascular endothelial function in older adults.
- Conditions
- Endothelial Dysfunction
- Being tested
- Centella Asiatica, Placebo Comparator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Centella AsiaticaDietary supplement
Also called gotu kola
Centella Asiatica is a perennial, herbaceous plant that is sold as a dietary supplement in the United States under the name Gotu Kola. It has been used for centuries in Ayurvedic and Chinese medicine. Evidence suggests it may help with resilience to aging and cognitive decline. The product for this study will be produced by Arjuna Natural.
Placebo ComparatorDietary supplement
The comparator will contain microcystalline cellulose in matched capsules. The comparator product for this study will be produced by Arjuna Natural.
| Study group | Role | What they receive |
|---|---|---|
| Centlla Asiatica | Experimental | 250 mg/day (1 capsules) for week 1. 500 mg/day (2 capsules) for week 2. 750 mg/day (3 capsules) for week 3. 1000 mg/ day (4 capsules) for week 4. Receives: Dietary Supplement: Centella Asiatica |
| Placebo | Placebo comparator | Matched number of capsules per week. Capsules will contain microcrystalline cellulose. Receives: Dietary Supplement: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial Function
Measured via EndoPAT device through a reactive hyperemia index (RHI).The device measures a signal based on arterial pulsatile volume changes from the fingertip. Blood flow to the brachial artery is temporarily occluded for 5 minutes using a blood pressure cuff. When the pressure is released, the arterial diameter increases, leading to increased flow. The EndoPat software calculates RHI using well-validated methods, by normalizing post-to-pre-occlusion signal ratio in the occluded arm to the same ratio in the control arm. The differences in endothelial function will be measured within groups from Baseline to Week 4. The between group differences will also be analyzed.
Measured: Baseline
Endothelial Function
Measured via EndoPAT device through a reactive hyperemia index (RHI).The device measures a signal based on arterial pulsatile volume changes from the fingertip. Blood flow to the brachial artery is temporarily occluded for 5 minutes using a blood pressure cuff. When the pressure is released, the arterial diameter increases, leading to increased flow. The EndoPat software calculates RHI using well-validated methods, by normalizing post-to-pre-occlusion signal ratio in the occluded arm to the same ratio in the control arm. The differences in endothelial function will be measured within groups from Baseline to Week 4. The between group differences will also be analyzed.
Measured: Day 1
Endothelial Function
Measured via EndoPAT device through a reactive hyperemia index (RHI).The device measures a signal based on arterial pulsatile volume changes from the fingertip. Blood flow to the brachial artery is temporarily occluded for 5 minutes using a blood pressure cuff. When the pressure is released, the arterial diameter increases, leading to increased flow. The EndoPat software calculates RHI using well-validated methods, by normalizing post-to-pre-occlusion signal ratio in the occluded arm to the same ratio in the control arm. The differences in endothelial function will be measured within groups from Baseline to Week 4. The between group differences will also be analyzed.
Measured: Week 4
Secondary outcomes (9)
Heart Rate Variability (HRV)
HRV will be measured continually at each visit via a wearable, wireless BodyGuard2.
Measured: Baseline
Heart Rate Variability (HRV)
HRV will be measured continually at each visit via a wearable, wireless BodyGuard2.
Measured: Day 1
Heart Rate Variability (HRV)
HRV will be measured continually at each visit via a wearable, wireless BodyGuard2.
Measured: Week 4
Blood Pressure
Blood pressure will be measured at each visit with an automatic sphygmomanometer.
Measured: Baseline
Blood Pressure
Blood pressure will be measured at each visit with an automatic sphygmomanometer.
Measured: Day 1
Blood Pressure
Blood pressure will be measured at each visit with an automatic sphygmomanometer.
Measured: Week 4
Body Mass Index (BMI)
BMI will be calculated each visit by measuring the participant's height and weight.
Measured: Baseline
Body Mass Index (BMI)
BMI will be calculated each visit by measuring the participant's height and weight.
Measured: Day 1
Body Mass Index (BMI)
BMI will be calculated each visit by measuring the participant's height and weight.
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start1 Feb 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial DysfunctionStudies of the same condition, open and under way.
- 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
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to take either a placebo or a Centella Asiatica-containing dietary supplement for four weeks
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Natural Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Zimmerman, National University of Natural Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06472791
- Sponsor's protocol ID
- BZCA
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2024
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Centella Asiatica on Vascular Endothelial Function in Older Adults
- ClinicalTrials.gov ID
- NCT06472791
- Acronym / sponsor ID
- BZCA
- Conditions
- Endothelial Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- National University of Natural MedicineUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effects of a dietary supplement containing centella asiatica on on vascular endothelial function in older adults.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to take either a placebo or a Centella Asiatica-containing dietary supplement for four weeks
| Arm | Type | Receives |
|---|---|---|
| Centlla Asiatica | Experimental | Dietary Supplement: Centella Asiatica250 mg/day (1 capsules) for week 1. 500 mg/day (2 capsules) for week 2. 750 mg/day (3 capsules) for week 3. 1000 mg/ day (4 capsules) for week 4. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo ComparatorMatched number of capsules per week. Capsules will contain microcrystalline cellulose. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ● Age 50 through 85, male or female
- Sufficient proficiency in English to understand study purpose and directions
- Willing and able to give informed consent
- Able to follow protocol and attend visits
Key exclusion criteria (15 listed)
- History of myocardial infarction, known coronary or carotid disease, or heart failure
- History of stroke, Parkinson's disease, dementia, or other major CNS disorders
- History of hepatic disease (e.g. hepatitis, cirrhosis)
- Recent/recurring history of severe life-threatening medical conditions (e.g. cancer, except non-melanoma skin cancers)
- Active major infectious disease (e.g. pneumonia)
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 |
|---|---|---|
| Centella AsiaticaAlso: gotu kolaCentella Asiatica is a perennial, herbaceous plant that is sold as a dietary supplement in the United States under the name Gotu Kola. It has been used for centuries in Ayurvedic and Chinese medicine. Evidence suggests it may help with resilience to aging and cognitive decline. The product for this study will be produced by Arjuna Natural. | Dietary supplement | Centlla Asiatica |
| Placebo ComparatorThe comparator will contain microcystalline cellulose in matched capsules. The comparator product for this study will be produced by Arjuna Natural. | Dietary supplement | Placebo |
Primary outcome
Endothelial Function
Time frame: Baseline
Measured via EndoPAT device through a reactive hyperemia index (RHI).The device measures a signal based on arterial pulsatile volume changes from the fingertip. Blood flow to the brachial artery is temporarily occluded for 5 minutes using a blood pressure cuff. When the pressure is released, the arterial diameter increases, leading to increased flow. The EndoPat software calculates RHI using well-validated methods, by normalizing post-to-pre-occlusion signal ratio in the occluded arm to the same ratio in the control arm. The differences in endothelial function will be measured within groups from Baseline to Week 4. The between group differences will also be analyzed.
Endothelial Function
Time frame: Day 1
Measured via EndoPAT device through a reactive hyperemia index (RHI).The device measures a signal based on arterial pulsatile volume changes from the fingertip. Blood flow to the brachial artery is temporarily occluded for 5 minutes using a blood pressure cuff. When the pressure is released, the arterial diameter increases, leading to increased flow. The EndoPat software calculates RHI using well-validated methods, by normalizing post-to-pre-occlusion signal ratio in the occluded arm to the same ratio in the control arm. The differences in endothelial function will be measured within groups from Baseline to Week 4. The between group differences will also be analyzed.
Endothelial Function
Time frame: Week 4
Measured via EndoPAT device through a reactive hyperemia index (RHI).The device measures a signal based on arterial pulsatile volume changes from the fingertip. Blood flow to the brachial artery is temporarily occluded for 5 minutes using a blood pressure cuff. When the pressure is released, the arterial diameter increases, leading to increased flow. The EndoPat software calculates RHI using well-validated methods, by normalizing post-to-pre-occlusion signal ratio in the occluded arm to the same ratio in the control arm. The differences in endothelial function will be measured within groups from Baseline to Week 4. The between group differences will also be analyzed.
9 secondary outcomes
Heart Rate Variability (HRV)
Time frame: Baseline
Heart Rate Variability (HRV)
Time frame: Day 1
Heart Rate Variability (HRV)
Time frame: Week 4
Blood Pressure
Time frame: Baseline
Blood Pressure
Time frame: Day 1
Blood Pressure
Time frame: Week 4
Body Mass Index (BMI)
Time frame: Baseline
Body Mass Index (BMI)
Time frame: Day 1
Body Mass Index (BMI)
Time frame: Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Centella Asiatica in people with Endothelial Dysfunction, run by National University of Natural Medicine 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 4 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: finished, as of the sponsor's last update on 1 Jul 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Endothelial Function (time frame: Baseline). 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?
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 1 Jul 2026; AzTrials last refreshed its copy on 29 Oct 2026.