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HealthyEarly Phase 1NCT07008300

Safety, Tolerability, and Pharmacokinetics of an Oral Withania Somnifera Product in Older Adults

A Early Phase 1 study testing Shoden in people with Healthy and Aging, run by Oregon Health and Science University at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study will measure the oral bioavailability and pharmacokinetics of known compounds from a standardized Withania somnifera botanical dietary supplement in healthy older adults. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy, Aging
What is being tested?
Shoden
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
1 Jul 2025to 1 Dec 2025
Phase
Early Phase 1
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 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Age 65 and older, male and female
  • Body Mass Index (BMI) greater than 17 and less than 35 at screening
  • Sufficient vision and hearing to complete all tests
  • Willingness to discontinue all botanical supplementation for one week prior to and throughout study
  • No known sensitivity to Withania somnifera or any of its derivatives
  • Normal or clinically not significant 12-lead electrocardiogram (ECG) recording
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  • Hepatic (ALT, AST, bilirubin), renal (creatinine, estimated GFR), and TSH parameters within normal range
  • Hemoglobin ≥13.0 g/dL or hematocrit ≥39% (males) OR hemoglobin ≥12.5 g/dL or hematocrit ≥38% (females), per FDA recommendations on blood donation
  • General health status that will not interfere with the ability to complete the study
  • Willingness to attend all study visits
  • Willingness to avoid caffeine and xanthine-containing foods or beverages (e.g., coffee, tea, chocolate, caffeine-containing sodas, colas, etc.), as well as grapefruit juice and poppy-containing foods for 48 hours prior to baseline visits
  • Willingness to adhere to special diet (no dairy, grapefruit products, poppy-containing foods, high-fat meals, caffeine, or xanthine-containing foods or beverages) during baseline visits and until after 24-hour visit
  • Mini-Mental State Exam (MMSE) score ≥26

Who cannot join

  • Current smoking, alcohol, or substance abuse according to DSM-V criteria
  • Participants who are currently pregnant, actively trying to conceive a child, or planning to within three months of study completion
  • Severe aversion to venipuncture
  • Donation of blood within 90 days of screening
  • Participation in drug research study within 90 days of screening
  • 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
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  • Allergy to nightshade plants (Solanaceae family)
  • Abnormal labs indicating symptomatic and untreated urinary tract infection
  • History of prostate cancer
  • History of kidney transplant
  • Cancer within the last five years, with the exception of non-metastatic skin cancers
  • Comorbid conditions requiring medication such as diabetes, kidney failure, liver failure, hepatitis, blood disorders, hypotension, thyroid disease, respiratory disorders, or cardiovascular disease
  • Presence of sleep apnea, moderate to severe restless leg syndrome, major circadian rhythm changes, or narcolepsy
  • Significant disease of the Central Nervous System (CNS) such as brain tumor, seizure disorder, subdural hematoma, cranial arteritis, or clinically significant stroke
  • Diagnosis of major depression, schizophrenia, bipolar disorder, or other major psychiatric disorder as defined by DSM-V criteria
  • Diseases associated with dementia such as Alzheimer's disease, vascular dementia, normal pressure hydrocephalus or Parkinson's disease

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Oregon Health & Science University

    Portland, Oregon, 97239

Other trials in United States

About this study

This study will measure the oral bioavailability and pharmacokinetics of known compounds from a standardized Withania somnifera botanical dietary supplement in healthy older adults.

Read the detailed description

This is a single-blind, crossover trial evaluating (a) the pharmacokinetics of withanolides from two doses (120 and 240 mg) of a commercially available Withania somnifera root and leaf extract (Shoden®), (b) the safety and tolerability of these doses over four weeks' use and (c) the feasibility of remotely measuring sleep- and stress-related outcomes in older adults. There will be two four-week study periods separated by a two-week washout period. During each study period, participants will attend a 13-hour pharmacokinetics study visit, where they will receive a single dose of either 120 or 240 mg Shoden®, and return for 24- and 48-hour blood and urine collections. After the 48-hour visit, they will continue taking Shoden® at the administered dose (120 or 240 mg) for four weeks, at which time they will return for a follow-up visit.

Conditions
Healthy, Aging
Being tested
Shoden
Keywords
Withania, Herbal Medicine, Dietary Supplements

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ShodenDietary supplement

    Shoden® powder is a commercial, dried 70% ethanolic extract of Withania somnifera (ashwagandha, WS) root and leaf, standardized to 35% withanolide glycosides. Shoden® powder is manufactured by Arjuna Natural Pvt Ltd, based in Kochi, Kerala, India.

Study groups in NCT07008300
Study groupRoleWhat they receive
Shoden 120 mgExperimentalShoden, administered as a single 120 mg capsule, once at the pharmacokinetics visit and once daily for four weeks following the 48 hour visit.
Receives: Dietary Supplement: Shoden
Shoden 240 mgExperimentalShoden, administered as a single 240 mg capsule, once at the pharmacokinetics visit and once daily for four weeks following the 48 hour visit.
Receives: Dietary Supplement: Shoden

What is being measured

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

  1. Plasma concentration of withanolides after Shoden administration

    After oral administration of Shoden (120 or 240 mg), plasma concentrations of eleven withanolides (withanolide A, withanolide B, withaferin A, withanone, withanoside IV, withanoside V, 12-deoxywithastramonolide, sominone, viscosalactone B, 4-oxo withaferin A, and 2,3-dihydro-3β-methoxy withaferin-A) will be measured in blood samples obtained over a 48-hour period, using liquid chromatography coupled to multiple reaction monitoring mass spectrometry (LC-MRM-MS) to determine pharmacokinetic parameters (maximum concentration, area under the curve(0-t), and area under the curve(0-infinity)).

    Measured: For each study period, collected over a 48-hour post-administration period (0 minutes, 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)

Secondary outcomes (15)

  1. Time of maximum concentration of withanolides after Shoden administration

    The time of maximum (tmax) of withanolides will be calculated using liquid chromatography coupled to multiple reaction monitoring mass spectrometry (LC-MRM-MS).

    Measured: For each study period, collected over a 48-hour post-administration period (0 minutes, 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)

  2. Half-life of withanolides after Shoden administration

    The half-life (t1/2) of withanolides will be calculated using liquid chromatography coupled to multiple reaction monitoring mass spectrometry (LC-MRM-MS).

    Measured: For each study period, collected over a 48-hour post-administration period (0 minutes, 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)

  3. Steady-state concentration of selected withanolides in plasma

    Concentration (ng/ml) of selected withanolides in plasma after four weeks' use

    Measured: At four weeks for each study period

  4. Urine concentration of withanolides after Shoden administration

    The concentration (ng/ml) of withanolides in urine will be measured in a pooled urine sample over 12 hours post-Shoden administration, at 24 and 48 hours post-administration, and after four weeks' use.

    Measured: For each study period, collected from 0-12 hours, 24 hours, and 48 hours of each pharmacokinetics visit, and at four weeks

  5. Adverse events

    A multi-system questionnaire will record the type and severity (range 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = fatal) of any adverse events. Adverse events will be assessed to determine if any changes are attributable to the study intervention. The proportion of participants who report each type of adverse event will be reported.

    Measured: For each study period, baseline and 12 hours of each pharmacokinetics visit, and at 2 weeks and 4 weeks. Also collected at 2 weeks post-study completion.

  6. Number of participants with abnormal ECG readings

    Resting electrocardiography will be measured using a ten-lead electrocardiogram. Electrocardiogram changes from the zero-minute (baseline) timepoint will be measured, and alternative clinical explanations considered, in order to determine if any changes are attributable to the study intervention. The investigators will also determine the proportion of all participants who develop changes in electrocardiography compared to the zero-minute timepoint following Shoden administration.

    Measured: For each study period, baseline (0 hours) and 7 hours of each pharmacokinetics visit, and at 4 weeks.

  7. Liver function

    A comprehensive metabolic panel will measure alanine aminotransferase and aspartate aminotransferase in units per liter as markers of liver function. Enzyme levels falling outside the normal range (0-35 Units per liter for alanine aminotransferase and 17-59 Units per liter for aspartate aminotransferase) will be compared to baseline levels, and alternative clinical explanations considered, in order to determine if elevations are attributable to the study intervention. The investigators will aggregate the measures by using an elevation in either enzyme function as a reflection of overall liver function. The investigators will also determine the proportion of all participants who develop abnormal laboratory values following Shoden administration

    Measured: For each study period, baseline (0 hours) and at 10 hours of each pharmacokinetics visit, and at 4 weeks

  8. Kidney function

    A comprehensive metabolic panel will measure creatinine and blood urea nitrogen levels in milligrams per deciliter as markers of kidney function. Each parameter falling outside the normal range (0.5 to 1.2 milligrams per deciliter for creatinine and 7 to 20 milligrams per deciliter for blood urea nitrogen) will be compared to baseline values. If elevations are observed, alternative clinical explanations will be considered to determine if elevations are attributable to the study intervention. The investigators will aggregate the measures by using an elevation in either blood urea nitrogen or creatinine as a reflection of overall kidney function. The investigators will also determine the proportion of all participants who develop abnormal laboratory values following Shoden administration

    Measured: For each study period, baseline (0 hours) and at 10 hours of each pharmacokinetics visit, and at 4 weeks

  9. Thyroid-stimulating hormone

    Thyroid-stimulating hormone will be measured in units of milli-international units per liter as a marker of thyroid function. Any changes in hormone levels will be compared to baseline levels. Alternative clinical explanations will be considered in order to determine if any changes in hormone levels are attributable to the study intervention. The investigators will also determine the proportion of all participants who have observed changes in thyroid-stimulating hormone following Shoden administration.

    Measured: For each study period, baseline and at 4 weeks

  10. Testosterone

    Testosterone will be measured in units of nanograms per deciliter. Any changes in hormone levels will be compared to baseline levels. Alternative clinical explanations will be considered in order to determine if any changes in testosterone levels are attributable to the study intervention. The investigators will also determine the proportion of all participants who have observed changes in testosterone following Shoden administration.

    Measured: For each study period, baseline and at 4 weeks

  11. White blood cell count

    White blood cells will be measured in units of cells per cubic millimeter. Any changes in white blood cell levels will be compared to baseline levels. Alternative clinical explanations will be considered in order to determine if any changes in white blood cells are attributable to the study intervention. The investigators will also determine the proportion of all participants who have observed changes in white blood cells following Shoden administration.

    Measured: For each study period, baseline and at 4 weeks

  12. Red blood cell count

    Red blood cells will be measured in units of cells per cubic millimeter. Any changes in red blood cell levels will be compared to baseline levels. Alternative clinical explanations will be considered in order to determine if any changes in red blood cells are attributable to the study intervention. The investigators will also determine the proportion of all participants who have observed changes in red blood cells following Shoden administration.

    Measured: For each study period, baseline and at 4 weeks

  13. Hemoglobin

    Hemoglobin will be measured in grams per deciliter. Any changes in hemoglobin will be compared to baseline levels. Alternative clinical explanations will be considered in order to determine if any changes in hemoglobin are attributable to the study intervention. The investigators will also determine the proportion of all participants who have observed changes in hemoglobin following Shoden administration.

    Measured: For each study period, baseline and at 4 weeks

  14. Hematocrit

    Hematocrit will be measured in percent. Any changes in hematocrit will be compared to baseline levels. Alternative clinical explanations will be considered in order to determine if any changes in hematocrit are attributable to the study intervention. The investigators will also determine the proportion of all participants who have observed changes in hematocrit following Shoden administration.

    Measured: For each study period, baseline and at 4 weeks

  15. Feasibility of administering REDCap surveys

    The feasibility of administering REDCap surveys will be assessed by calculating the percentage of administered questionnaires that are returned and fully completed by participants, with feasibility defined as at least 80% of all administered questionnaires returned and completed.

    Measured: For each study period, baseline and at 4 weeks

Timeline

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

  1. First posted6 Jun 2025
  2. Study start1 Jul 2025 (estimated)
  3. Primary completion1 Dec 2025 (estimated)
  4. Study completion1 Dec 2025 (estimated)

Why it stopped: Enrollment never started due to time and budgetary constraints

Resources

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
Basic science
Allocation
Non-randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07008300
Sponsor's protocol ID
STUDY00026055
Other IDs
KL2TR002370
Status last verified
Dec 2025
First submitted
27 May 2025
Last updated
17 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The individual coded participant data that support the published results will be available to be shared for research purposes. Data, plasma, and urine specimens will be stored for future research in a repository. All data/specimens will be coded with each participant's identification code, visit number, and date of collection. Data will be available four months after publication ending five years post article publication. For repository requests, the repository guardian Alex Speers (speers@ohsu.edu) or designee will review the requestor's institutional review board approval memo, protocol, and repository sharing agreement before samples/data are released. Separate institutional review board approval/determination will be required for each specific human subject research activity that uses coded data/specimens from the repository.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Shoden in people with Healthy and Aging, run by Oregon Health and Science University 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 13 inclusion and 16 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: withdrawn, as of the sponsor's last update on 17 Dec 2025. 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Plasma concentration of withanolides after Shoden administration (time frame: For each study period, collected over a 48-hour post-administration period (0 minutes, 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)). 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 NCT07008300.

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 17 Dec 2025.

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