← Back to Search

Ashwagandha for Aging

Phase < 1

Recruiting

Led By Amala Soumyanath, PhD

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

Age 65 and older, male and female

Body Mass Index (BMI) greater than 17 and less than 35 at screening

Must not have

Serious health condition (i.e., illness, injury, impairment, or physical or mental condition which requires a) overnight hospitalization or b) continuing treatment that may cause episodic periods of incapacity of more than 3 consecutive days) within 30 days of screening

History of prostate cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up for each study period, prior to the pharmacokinetics visit and prior to the four-week follow-up visit

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if an herbal supplement is safe and effective for older adults.

Who is the study for?

This trial is for healthy adults aged 65 and older with a BMI between 17-35, good vision and hearing, no major health issues or psychiatric disorders, not currently pregnant or trying to conceive, non-smokers, and without allergies to nightshade plants. Participants must be willing to stop taking botanical supplements one week before the study.

What is being tested?

The study tests how well two doses (240 mg and 480 mg) of Shoden, an Ashwagandha extract supplement, are absorbed and processed in the body when taken orally by older adults. It aims to understand the bioavailability of its compounds.

What are the potential side effects?

While specific side effects aren't listed for this trial as it involves a generally considered safe herbal supplement, potential side effects may include mild digestive upset or allergic reactions in those sensitive to Withania somnifera ingredients.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 65 years old or older.

Select...

My BMI is between 17 and 35.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I haven't been hospitalized or needed ongoing treatment for a serious health issue in the last 30 days.

Select...

I have a history of prostate cancer.

Select...

I have sleep apnea, severe restless leg syndrome, major changes in my sleep/wake cycle, or narcolepsy.

Select...

I have a serious brain condition like a tumor or stroke.

Select...

I have been diagnosed with a major psychiatric disorder like depression or schizophrenia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ for each study period, a 48-hour post-administration period (15 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 5 hours, 6 hours, 9 hours, 12 hours, 24 hours, and 48 hours)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~for each study period, a 48-hour post-administration period (15 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 5 hours, 6 hours, 9 hours, 12 hours, 24 hours, and 48 hours)

This trial's timeline: 3 weeks for screening, Varies for treatment, and for each study period, a 48-hour post-administration period (15 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 5 hours, 6 hours, 9 hours, 12 hours, 24 hours, and 48 hours) for reporting.