NCT07008300

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

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-07-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2025-06-06
• Last updated: 2025-12-17

Locations

1 site across 1 country: United States