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Herbal Medicine

Centella Asiatica for Cognitive Impairment

Phase 1

Recruiting

Led By Amala Soumyanath, Ph.D

Research Sponsored by Oregon Health and Science University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and six weeks

Awards & highlights

Study Summary

This trial will test if a natural extract is safe and if it can help with a medical issue.

Who is the study for?

This trial is for people aged 65-85 with mild cognitive impairment or early Alzheimer's, who can speak English and have good vision and hearing. They must not be allergic to Centella asiatica, have a BMI of 17-35, no severe depression or suicidal thoughts, stable health, and agree to stop taking botanical supplements. Participants need an informant to confirm memory decline and a caregiver for visits.Check my eligibility

What is being tested?

The study tests if a water extract of Centella asiatica taken orally for six weeks shows biological signs of improving cognition compared to placebo. It also checks the safety and how well participants tolerate the treatment. The trial includes multiple MRI scans.See study design

What are the potential side effects?

While specific side effects are not listed here, the trial will monitor how safe the Centella asiatica product is and how well participants can tolerate it over the course of six weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks and 10 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks and 10 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks and 10 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline in brain N-acetylaspartate (NAA) to creatine (Cr) metabolite ratio (NAA/Cr) after 6 weeks on intervention.

Secondary outcome measures

Interventional procedure

Change from baseline in body mass index after 6 weeks on intervention.

Change from baseline in electrocardiography signals after 6 weeks on intervention.

+7 more

Other outcome measures

Change from baseline in cortical and hippocampal levels of Adenosine triphosphate (ATP)/total phosphate after 6 weeks on intervention.

Change from baseline in cortical and hippocampal levels of inorganic phosphate (Pi)/total phosphate after 6 weeks on intervention.

Change from baseline in cortical and hippocampal levels of phosphocreatine (PCr)/total phosphate after 6 weeks on intervention.

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Centella asiatica water extract product (CAP) 4gExperimental Treatment1 Intervention

A sachet of containing 4g dried hot water extract (CAW) of Centella asiatica combined with inactive ingredients (excipients) will be dissolved in water and orally consumed daily as a drink for six weeks. Assessments will be collected at baseline and after six weeks of daily intervention.

Group II: PlaceboPlacebo Group1 Intervention

A sachet of inactive ingredients (excipients) identical in composition to those found in the active arm will be be dissolved in water and orally consumed daily for six weeks. Assessments will be collected at baseline and after six weeks of daily intervention.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor

974 Previous Clinical Trials

7,385,864 Total Patients Enrolled

Alzheimer's AssociationOTHER

91 Previous Clinical Trials

40,790 Total Patients Enrolled

Amala Soumyanath, Ph.DPrincipal InvestigatorOregon Health and Science University

Media Library

Centella asiatica product (Herbal Medicine) Clinical Trial Eligibility Overview. Trial Name: NCT05591027 — Phase 1

Mild Cognitive Impairment Research Study Groups: Placebo, Centella asiatica water extract product (CAP) 4g

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor open to individuals aged thirty and over?

"Those aged between 65 and 85 years old can partake in this clinical trial."

Answered by AI

Is admission to the study still open?

"According to the clinicaltrials.gov listing, this medical trial is still enrolling patients. It was announced on December 1st 2022 and updated most recently on March 30th 2023."

Answered by AI

Is the Centella asiatica water extract product (CAP) 4g accepted by the FDA?

"Safety evaluations suggest that the Centella asiatica water extract product (CAP) 4g has a low risk, rating at 1 on our scale. This is because this Phase 1 trial lacks sufficient evidence to confirm its efficacy and safety."

Answered by AI

How many participants are currently included in this clinical trial?

"Affirmative. According to clinicaltrials.gov, the trial initially made available on December 1st 2022 is currently welcoming participants. As of March 30th 2023, it seeks 48 patients from a single medical site."

Answered by AI

Does this research project offer opportunities for me to get involved?

"This clinical trial seeks 48 elderly individuals, aged 65-85, with a mild cognitive impairment. To be eligible for the study, patients must possess sufficient English and auditory/visual capabilities. Additionally, the patient should not suffer from any allergies to Centella asiatica or have depression symptoms (Geriatric Depression Scale-15 score of < 5) nor suicidal ideation (as measured by subscale scores 3,7 11 12 14). Furthermore they need to maintain a BMI between 17 and 35 and agree to discontinue taking all dietary supplements one week before and during the course of the experiment as well as cooperate in undergoing multiple magnetic resonance imaging"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Target Engagement of Centella Asiatica in Cognitive Impairment

Amala Soumyanath 2022. "Safety and Target Engagement of Centella Asiatica in Cognitive Impairment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05591027.