An Early Phase 1 interventional study of Shoden in Healthy and Aging, sponsored by Oregon Health and Science University. Terminated at 1 site in United States. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-09.
Sponsored by Oregon Health and Science University · Early Phase 1, Interventional, and Basic science
This study will measure the oral bioavailability and pharmacokinetics of known compounds from a standardized Withania somnifera botanical dietary supplement in healthy older adults.
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.
Oregon Health and Science University is the lead sponsor of 676 studies on the registry; 136 are open to participants now.
Of its 49 completed or terminated interventional studies of FDA-regulated products, 36 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Dietary Supplement: Shoden
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.
Dietary Supplement: Shoden
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.
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.
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)
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).
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
The half-life (t1/2) of withanolides will be calculated using liquid chromatography coupled to multiple reaction monitoring mass spectrometry (LC-MRM-MS).
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
Concentration (ng/ml) of selected withanolides in plasma after four weeks' use
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
The concentration (ng/ml) of withanolides in urine will be measured in a pooled urine sample over 12 hours post-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)
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.
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)
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.
Time frame: 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).
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)
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).
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)
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).
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)
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).
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)
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).
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)
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).
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)
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).
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)
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.
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)
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).
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)
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).
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)
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).
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)
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).
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
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.
Time frame: For each study period, prior to the pharmacokinetics visit and prior to the four-week follow-up visit
Participants were recruited from April 2024 until September 2024.
| Milestone | Shoden 240 mg First, Then Shoden 480 mg | Shoden 480 mg First, Then Shoden 240 mg |
|---|---|---|
| Started | 3 | 4 |
| Completed | 1 | 1 |
| Not completed | 2 | 3 |
| Withdrew: Adverse event | 1 | 1 |
| Withdrew: Mild anemia noted on baseline labs at pharmacokinetics visit 1. | 1 | 1 |
| Withdrew: Mild anemia noted on baseline labs at pharmacokinetics visit 2 | 0 | 1 |
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.
| ng/ml | Shoden 240 mg | Shoden 480 mg |
|---|---|---|
| Withaferin A | 3.02 ± 0.76 | 13.69 ± 7.36 |
| Isomer of 4-oxo Withaferin A | 46.82 ± 1.66 | 187.62 ± 120.77 |
| Sominone | 10.24 ± 6.48 | 33.45 ± 14.42 |
| Isomer of 2,3-Didehydrosomnifericin | 19.62 ± 16.04 | 35.28 ± 17.60 |
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).
| hours | Shoden 240 mg | Shoden 480 mg |
|---|---|---|
| Withaferin A | 0.88 ± 0.18 | 1.25 ± 0.66 |
| Isomer of 4-oxo Withaferin A | 3.25 ± 0.35 | 2.83 ± 0.58 |
| Sominone | 5.50 ± 0.71 | 5.67 ± 0.58 |
| Isomer of 2,3-Didehydrosomnifericin | 0.75 ± 0.35 | 2.00 ± 0.50 |
The half-life (t1/2) of withanolides will be calculated using liquid chromatography coupled to multiple reaction monitoring mass spectrometry (LC-MRM-MS).
| hours | Shoden 240 mg | Shoden 480 mg |
|---|---|---|
| Withaferin A | 2.0 ± 0.0 | 5.0 ± 3.1 |
| Isomer of 4-oxo withaferin A | 18.1 ± 4.8 | 24.1 ± 12.3 |
| Sominone | 4.7 ± 2.4 | 7.7 ± 4.9 |
| Isomer of 2,3-didehydrosomnifericin | 6.2 ± 6.1 | 10.3 ± 3.1 |
Concentration (ng/ml) of selected withanolides in plasma after four weeks' use
| ng/ml | Shoden 240 mg | Shoden 480 mg |
|---|---|---|
| Withaferin A | 1.13 ± 0.60 | 2.35 ± 1.07 |
| Isomer of 4-oxo Withaferin A | 24.11 ± 7.13 | 41.94 ± 19.36 |
| Sominone | 14.93 ± 10.89 | 23.40 ± 2.67 |
| Isomer of 2,3-Didehydrosomnifericin | 13.35 ± 1.84 | 36.91 ± 19.50 |
The concentration (ng/ml) of withanolides in urine will be measured in a pooled urine sample over 12 hours post-Shoden administration.
| micrograms excreted in 12 hours | Shoden 240 mg | Shoden 480 mg |
|---|---|---|
| Free withaferin A | 133.5 ± 115.3 | 172.9 ± 151.1 |
| Free isomer of 4-oxo-withaferin A | 95.8 ± 17.9 | 230.3 ± 73.7 |
| Isomer of 4-oxo-withaferin A as Phase II conjugates | 25.5 ± 0.8 | 24.0 ± 86.2 |
| Sominone as Phase II conjugates | 61.7 ± 29.2 | 76.8 ± 25.2 |
| Free isomer of 2,3-didehydrosomnifericin | 234.8 ± 139.9 | 663.1 ± 222.6 |
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.
| Participants | Shoden 240 mg | Shoden 480 mg |
|---|---|---|
| Number of Participants With Abnormal ECG Readings (7 Hours) | 0 | 0 |
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.
| Participants | Shoden 240 mg | Shoden 480 mg |
|---|---|---|
| Number of Participants With Abnormal ECG Readings (4 Weeks) | 0 | 0 |
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).
| U/L | Shoden 240 mg | Shoden 480 mg |
|---|---|---|
| Mean Change in ALT (10 Hours) | 0 ± 2.2 | -1 ± 1.7 |
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).
| U/L | Shoden 240 mg | Shoden 480 mg |
|---|---|---|
| Mean Change in ALT (4 Weeks) | 5.3 ± 8.5 | -0.4 ± 3.6 |
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).
| U/L | Shoden 240 mg | Shoden 480 mg |
|---|---|---|
| Mean Change in AST (10 Hours) | -0.8 ± 2.1 | -1.2 ± 1.6 |
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).
| U/L | Shoden 240 mg | Shoden 480 mg |
|---|---|---|
| Mean Change in AST (4 Weeks) | 3 ± 3 | 0.8 ± 1.3 |
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).
| mg/dL | Shoden 240 mg | Shoden 480 mg |
|---|---|---|
| Mean Change in Creatinine (10 Hours) | 0.02 ± 0.04 | 0.002 ± 0.06 |
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).
| mg/dL | Shoden 240 mg | Shoden 480 mg |
|---|---|---|
| Mean Change in Creatinine (4 Weeks) | 0.05 ± 0.07 | 0.10 ± 0.07 |
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).
| mIU/L | Shoden 240 mg | Shoden 480 mg |
|---|---|---|
| Mean Change in Thyroid-stimulating Hormone (4 Weeks) | -0.3 ± 1.4 | -0.3 ± 0.3 |
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.
| ng/dL | Male Participants - 240 mg | Female Participants - 240 mg | Male Participants - 480 mg | Female Participants - 480 mg |
|---|---|---|---|---|
| Mean Change in Testosterone (4 Weeks) | 113 ± NA | -1.5 ± 3.5 | 179 ± NA | -1.5 ± 2.9 |
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).
| 10^3 cells/microliter | Shoden 240 mg | Shoden 480 mg |
|---|---|---|
| Mean White Blood Cell Count (4 Weeks) | -0.5 ± 0.5 | 0.0 ± 1.3 |
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).
| 10^6 cells/µL | Shoden 240 mg | Shoden 480 mg |
|---|---|---|
| Mean Change in Red Blood Cell Count (4 Weeks) | 0.1 ± 0.2 | -0.5 ± 1.0 |
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).
| g/dL | Shoden 240 mg | Shoden 480 mg |
|---|---|---|
| Mean Change in Hemoglobin (4 Weeks) | 0.3 ± 0.6 | 0.04 ± 0.7 |
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).
| percentage of total blood volume | Shoden 240 mg | Shoden 480 mg |
|---|---|---|
| Mean Change in Hematocrit (4 Weeks) | 1.1 ± 1.8 | 1.2 ± 2.2 |
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.
| percentage of questionnaires completed | Shoden 240 mg | Shoden 480 mg |
|---|---|---|
| Percentage of REDCap Surveys Completed | 88.9 | 90.9 |
Collected over For each study period (240 or 480 mg Shoden), an adverse events questionnaire was administered at baseline, 12 hours, 48 hours, 2 weeks, and 4 weeks. An adverse events questionnaire was also administered at the exit phone call, which was conducted two weeks after the final clinic visit (final clinic visit occurred up to 12 weeks post baseline of first study period).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Shoden 240 mg | 0/5 (0%) | 0/5 (0%) | 5/5 (100%) |
| Shoden 480 mg | 0/6 (0%) | 0/6 (0%) | 6/6 (100%) |
| Event | Shoden 240 mg | Shoden 480 mg |
|---|---|---|
| DiarrheaGastrointestinal disorders | 2/5 | 5/6 |
| IndigestionGastrointestinal disorders | 1/5 | 3/6 |
| Muscle achesMusculoskeletal and connective tissue disorders | 2/5 | 1/6 |
| FatigueGeneral disorders | 2/5 | 2/6 |
| NauseaGastrointestinal disorders | 1/5 | 2/6 |
| VomitingGastrointestinal disorders | 0/5 | 2/6 |
| HeadacheNervous system disorders | 1/5 | 2/6 |
| DrowsinessGeneral disorders | 1/5 | 2/6 |
| Abdominal crampsGastrointestinal disorders | 1/5 | 2/6 |
| Dry skinSkin and subcutaneous tissue disorders | 0/5 | 2/6 |
Total number of participants enrolled and randomized to a sequence group.
| Age, Continuous(years) | All Study Participants |
|---|---|
| Mean | 69.7 ± 3.8 |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 5 |
| Male | 2 |
| Ethnicity (NIH/OMB)(Participants) | All Study Participants |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 7 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | All Study Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 7 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | All Study Participants |
|---|---|
| United States | 7 |
| Body Mass Index(kg/m^2) | All Study Participants |
|---|---|
| Mean | 23.9 ± 2.7 |
| Systolic Blood Pressure(mmHg) | All Study Participants |
|---|---|
| Mean | 134.6 ± 14.7 |
| Diastolic Blood Pressure(mmHg) | All Study Participants |
|---|---|
| Mean | 73.0 ± 5.5 |
1 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
Supporting information: Study protocol, Sap, Icf, Analytic code
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