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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
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
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 moreOther 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 moreTrial 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.
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Who is running the clinical trial?
Oregon Health and Science UniversityLead Sponsor
985 Previous Clinical Trials
7,385,676 Total Patients Enrolled
Alzheimer's AssociationOTHER
93 Previous Clinical Trials
40,943 Total Patients Enrolled
Amala Soumyanath, Ph.DPrincipal InvestigatorOregon Health and Science University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have conditions like diabetes, kidney or liver failure, hepatitis, blood disorders, low blood pressure when standing, or heart disease.I am a man not planning to father a child within three months after the study ends.I haven't had cancer in the last 5 years, except for low-grade prostate or non-spreading skin cancer.I do not have significant symptoms of depression.I have a serious brain condition like a tumor or severe stroke.I can see and hear well enough to do all required tests.My condition is a type of dementia, but not Alzheimer's.I am between 65 and 85 years old.I have been on a steady dose of Alzheimer's medication for at least 12 weeks.I am not willing to keep my Alzheimer's medication dose the same during the study.I have mild cognitive impairment or early Alzheimer's with specific test scores.My BMI is between 17 and 35.I am not currently using any restricted medications or substances listed.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Centella asiatica water extract product (CAP) 4g
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