HealthyEarly Phase 1NCT06171724
Ashwagandha Pharmacokinetics Study 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.
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
- 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
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2024to 9 Dec 2024
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
About this study
Official title: Safety, Tolerability, and Pharmacokinetics of an Oral Withania Somnifera Product in Older Adults
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 randomized, double-blind, crossover trial evaluating (a) the pharmacokinetics of withanolides from two doses (240 and 480 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. Participants will be randomized to one of two dose sequence groups. 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 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 (240 or 480 mg) for four weeks, at which time they will return for a follow-up visit.
- 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 group | Role | What they receive |
|---|---|---|
| Shoden 240 mg | Experimental | Participants will receive a single dose of 240 mg Shoden, administered as two 120 mg capsules, at pharmacokinetics visit 1 or 2 depending on their sequence group. Forty-eight hours later, participants will receive a 35-day supply of Shoden at a dose of 240 mg per day. Receives: Dietary Supplement: Shoden |
| Shoden 480 mg | Active comparator | Participants will receive a single dose of 480 mg Shoden, administered as two 240 mg capsules, at pharmacokinetics visit 1 or 2 depending on their sequence group. Forty-eight hours later, participants will receive a 35-day supply of Shoden at a dose of 480 mg per day. Receives: Dietary Supplement: Shoden |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax) of Withanolides After Shoden Administration
After oral administration of Shoden (240 or 480 mg), plasma concentrations of withanolides will be measured in plasma samples obtained over a 48-hour period, using liquid chromatography coupled to multiple reaction monitoring mass spectrometry (LC-MRM-MS) to determine pharmacokinetic parameters.
Measured: 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)
Secondary outcomes (19)
Time of Maximum Concentration of Withanolides After Shoden Administration
The time of maximum (tmax) of withanolides over the first 48 hours post-Shoden administration will be calculated using liquid chromatography coupled to multiple reaction monitoring mass spectrometry (LC-MRM-MS).
Measured: 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)
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, 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)
Steady-state Concentration of Selected Withanolides in Plasma
Concentration (ng/ml) of selected withanolides in plasma after four weeks' use
Measured: For each study period, steady state concentration will be collected during week 4 following four weeks' daily use of Shoden.
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.
Measured: For each study period, urine collected over the first 12 hours post-Shoden administration.
Number of Participants With Abnormal ECG Readings (7 Hours)
Resting electrocardiography will be measured using a ten-lead electrocardiogram at the zero-minutes timepoint and 7 hours post-Shoden administration. Electrocardiogram changes will be assessed and alternative clinical explanations considered, in order to determine if any changes are attributable to the study intervention. The number of participants with abnormal ECG readings at 7 hours compared to baseline will be reported.
Measured: For each study period, electrocardiography will be assessed at 0 and 7 hours post-Shoden administration. For pharmacokinetics visits that were halted early, ECG was collected at 24 hours.
Number of Participants With Abnormal ECG Readings (4 Weeks)
Resting electrocardiography will be measured using a ten-lead electrocardiogram at the zero-minutes timepoint and 4-weeks post-Shoden administration. Electrocardiogram changes will be assessed and alternative clinical explanations considered, in order to determine if any changes are attributable to the study intervention. The number of participants with abnormal ECG readings at 4 weeks compared to baseline will be reported.
Measured: For each study period, electrocardiography will be assessed at 0 and 4 weeks post-Shoden administration.
Mean Change in ALT (10 Hours)
A comprehensive metabolic panel will measure alanine aminotransferase and in units per liter as a marker of liver function. Enzyme levels falling outside the normal range will be compared to baseline levels, and alternative clinical explanations considered, in order to determine if elevations are attributable to the study intervention. Changes in laboratory outcomes from the baseline visit to the four-week follow-up visit for each study period will be presented using descriptive statistics (e.g., means and standard deviations, frequency and percent).
Measured: For each study period, liver function will be assessed at 0 and 10 hours post-Shoden administration. For pharmacokinetics visits that were halted early, safety labs were collected at 24 hours.
Mean Change in ALT (4 Weeks)
A comprehensive metabolic panel will measure alanine aminotransferase and in units per liter as a marker of liver function. Enzyme levels falling outside the normal range will be compared to baseline levels, and alternative clinical explanations considered, in order to determine if elevations are attributable to the study intervention. Changes in laboratory outcomes from the baseline visit to the four-week follow-up visit for each study period will be presented using descriptive statistics (e.g., means and standard deviations, frequency and percent).
Measured: For each study period, liver function will be assessed at 0 and 4 weeks post-Shoden administration.
Mean Change in AST (10 Hours)
A comprehensive metabolic panel will measure aspartate aminotransferase and in units per liter as a marker of liver function. Enzyme levels falling outside the normal range will be compared to baseline levels, and alternative clinical explanations considered, in order to determine if elevations are attributable to the study intervention. Changes in laboratory outcomes from the baseline visit to the four-week follow-up visit for each study period will be presented using descriptive statistics (e.g., means and standard deviations, frequency and percent).
Measured: For each study period, liver function will be assessed at 0 and 10 hours post-Shoden administration. For pharmacokinetics visits that were halted early, safety labs were collected at 24 hours.
Mean Change in AST (4 Weeks)
A comprehensive metabolic panel will measure aspartate aminotransferase and in units per liter as a marker of liver function. Enzyme levels falling outside the normal range will be compared to baseline levels, and alternative clinical explanations considered, in order to determine if elevations are attributable to the study intervention. Changes in laboratory outcomes from the baseline visit to the four-week follow-up visit for each study period will be presented using descriptive statistics (e.g., means and standard deviations, frequency and percent).
Measured: For each study period, liver function will be assessed at 0 and 4 weeks post-Shoden administration.
Mean Change in Creatinine (10 Hours)
A comprehensive metabolic panel will measure creatinine as a marker of kidney function. Each parameter falling outside the normal range (0.5 to 1.2 milligrams per deciliter) 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. Changes in laboratory outcomes from the baseline visit to 10-hours post-Shoden administration for each study period will be presented using descriptive statistics (e.g., means and standard deviations, frequency and percent).
Measured: For each study period, liver function will be assessed at 0 and 10 hours post-Shoden administration. For pharmacokinetics visits that were halted early, safety labs were collected at 24 hours.
Mean Change in Creatinine (4 Weeks)
A comprehensive metabolic panel will measure creatinine as a marker of kidney function. Each parameter falling outside the normal range (0.5 to 1.2 milligrams per deciliter) 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. Changes in laboratory outcomes from the baseline visit to the four-week follow-up visit for each study period will be presented using descriptive statistics (e.g., means and standard deviations, frequency and percent).
Measured: For each study period, liver function will be assessed at 0 and 4 weeks post-Shoden administration.
Mean Change in Thyroid-stimulating Hormone (4 Weeks)
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. Changes in laboratory outcomes from the baseline visit to the four-week follow-up visit for each study period will be presented using descriptive statistics (e.g., means and standard deviations, frequency and percent).
Measured: For each study period, thyroid-stimulating hormone will be assessed at 0 minutes post-Shoden administration and four weeks post-Shoden administration.
Mean Change in Testosterone (4 Weeks)
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. Changes in testosterone will be analyzed by sex, by dose.
Measured: For each study period, testosterone will be assessed at 0 minutes post-Shoden administration and four weeks post-Shoden administration.
Mean White Blood Cell Count (4 Weeks)
White 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. Changes in laboratory outcomes from the baseline visit to the four-week follow-up visit for each study period will be presented using descriptive statistics (e.g., means and standard deviations, frequency and percent).
Measured: For each study period, white blood cells will be assessed at 0 minutes post-Shoden administration and four weeks post-Shoden administration.
Mean Change in Red Blood Cell Count (4 Weeks)
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. Changes in laboratory outcomes from the baseline visit to the four-week follow-up visit for each study period will be presented using descriptive statistics (e.g., means and standard deviations, frequency and percent).
Measured: For each study period, red blood cells will be assessed at 0 minutes post-Shoden administration and four weeks post-Shoden administration.
Mean Change in Hemoglobin (4 Weeks)
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. Changes in laboratory outcomes from the baseline visit to the four-week follow-up visit for each study period will be presented using descriptive statistics (e.g., means and standard deviations, frequency and percent).
Measured: For each study period, hemoglobin will be assessed at 0 minutes post-Shoden administration and four weeks post-Shoden administration.
Mean Change in Hematocrit (4 Weeks)
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. Changes in laboratory outcomes from the baseline visit to the four-week follow-up visit for each study period will be presented using descriptive statistics (e.g., means and standard deviations, frequency and percent).
Measured: For each study period, hematocrit will be assessed at 0 minutes post-Shoden administration and four weeks post-Shoden administration.
Percentage of REDCap Surveys Completed
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, prior to the pharmacokinetics visit and prior to the four-week follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start8 Apr 2024
- Primary completion1 Nov 2024
- Study completion9 Dec 2024
Why it stopped: Amended study protocol was not reapproved in time for completion of study activities.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Alex Speers, ND, Oregon Health and Science University
- Investigators
- Alex Speers, ND, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06171724
- Sponsor's protocol ID
- 26055
- Other IDs
- KL2TR002370
- Status last verified
- Mar 2026
- First submitted
- 5 Dec 2023
- Last updated
- 9 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, and Pharmacokinetics of an Oral Withania Somnifera Product in Older Adults
- ClinicalTrials.gov ID
- NCT06171724
- Acronym / sponsor ID
- 26055
- Keywords
- Withania, Herbal Medicine, Dietary Supplements
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Amended study protocol was not reapproved in time for completion of study activities.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 9 Dec 2024 (actual)
- First posted
- 15 Dec 2023 (actual)
- Results
- Posted 9 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will measure the oral bioavailability and pharmacokinetics of known compounds from a standardized Withania somnifera botanical dietary supplement in healthy older adults.
Detailed description
This is a randomized, double-blind, crossover trial evaluating (a) the pharmacokinetics of withanolides from two doses (240 and 480 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. Participants will be randomized to one of two dose sequence groups. 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 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 (240 or 480 mg) for four weeks, at which time they will return for a follow-up visit.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shoden 240 mg | Experimental | Dietary Supplement: ShodenParticipants will receive a single dose of 240 mg Shoden, administered as two 120 mg capsules, at pharmacokinetics visit 1 or 2 depending on their sequence group. Forty-eight hours later, participants will receive a 35-day supply of Shoden at a dose of 240 mg per day. |
| Shoden 480 mg | Active comparator | Dietary Supplement: ShodenParticipants will receive a single dose of 480 mg Shoden, administered as two 240 mg capsules, at pharmacokinetics visit 1 or 2 depending on their sequence group. Forty-eight hours later, participants will receive a 35-day supply of Shoden at a dose of 480 mg per day. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (16 listed)
- 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
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 |
|---|---|---|
| ShodenShoden® 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. | Dietary supplement | Shoden 240 mg, Shoden 480 mg |
Primary outcome
Maximum Plasma Concentration (Cmax) of Withanolides After Shoden Administration
Time frame: 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)
After oral administration of Shoden (240 or 480 mg), plasma concentrations of withanolides will be measured in plasma samples obtained over a 48-hour period, using liquid chromatography coupled to multiple reaction monitoring mass spectrometry (LC-MRM-MS) to determine pharmacokinetic parameters.
19 secondary outcomes
Time of Maximum Concentration of Withanolides After Shoden Administration
Time frame: 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)
Half-life of Withanolides After Shoden Administration
Time frame: 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)
Steady-state Concentration of Selected Withanolides in Plasma
Time frame: For each study period, steady state concentration will be collected during week 4 following four weeks' daily use of Shoden.
Urine Concentration of Withanolides After Shoden Administration
Time frame: For each study period, urine collected over the first 12 hours post-Shoden administration.
Number of Participants With Abnormal ECG Readings (7 Hours)
Time frame: For each study period, electrocardiography will be assessed at 0 and 7 hours post-Shoden administration. For pharmacokinetics visits that were halted early, ECG was collected at 24 hours.
Number of Participants With Abnormal ECG Readings (4 Weeks)
Time frame: For each study period, electrocardiography will be assessed at 0 and 4 weeks post-Shoden administration.
Mean Change in ALT (10 Hours)
Time frame: For each study period, liver function will be assessed at 0 and 10 hours post-Shoden administration. For pharmacokinetics visits that were halted early, safety labs were collected at 24 hours.
Mean Change in ALT (4 Weeks)
Time frame: For each study period, liver function will be assessed at 0 and 4 weeks post-Shoden administration.
Mean Change in AST (10 Hours)
Time frame: For each study period, liver function will be assessed at 0 and 10 hours post-Shoden administration. For pharmacokinetics visits that were halted early, safety labs were collected at 24 hours.
Mean Change in AST (4 Weeks)
Time frame: For each study period, liver function will be assessed at 0 and 4 weeks post-Shoden administration.
Mean Change in Creatinine (10 Hours)
Time frame: For each study period, liver function will be assessed at 0 and 10 hours post-Shoden administration. For pharmacokinetics visits that were halted early, safety labs were collected at 24 hours.
Mean Change in Creatinine (4 Weeks)
Time frame: For each study period, liver function will be assessed at 0 and 4 weeks post-Shoden administration.
Mean Change in Thyroid-stimulating Hormone (4 Weeks)
Time frame: For each study period, thyroid-stimulating hormone will be assessed at 0 minutes post-Shoden administration and four weeks post-Shoden administration.
Mean Change in Testosterone (4 Weeks)
Time frame: For each study period, testosterone will be assessed at 0 minutes post-Shoden administration and four weeks post-Shoden administration.
Mean White Blood Cell Count (4 Weeks)
Time frame: For each study period, white blood cells will be assessed at 0 minutes post-Shoden administration and four weeks post-Shoden administration.
Mean Change in Red Blood Cell Count (4 Weeks)
Time frame: For each study period, red blood cells will be assessed at 0 minutes post-Shoden administration and four weeks post-Shoden administration.
Mean Change in Hemoglobin (4 Weeks)
Time frame: For each study period, hemoglobin will be assessed at 0 minutes post-Shoden administration and four weeks post-Shoden administration.
Mean Change in Hematocrit (4 Weeks)
Time frame: For each study period, hematocrit will be assessed at 0 minutes post-Shoden administration and four weeks post-Shoden administration.
Percentage of REDCap Surveys Completed
Time frame: For each study period, prior to the pharmacokinetics visit and prior to the four-week follow-up visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: 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.
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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.
Alex Speers, ND principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
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: stopped early, as of the sponsor's last update on 9 Apr 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. 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?
Yes. Results are posted in the registry (first posted 9 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Maximum Plasma Concentration (Cmax) of Withanolides After Shoden Administration (time frame: 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)). 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 9 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.