NCT06171724

Ashwagandha Pharmacokinetics Study in Older Adults

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

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 11 (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 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.

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: 2024-04-08
• Primary completion: 2024-11-01
• Completion: 2024-12-09
• First posted: 2023-12-15
• Last updated: 2026-04-09
• Results posted: 2026-04-09

Locations

1 site across 1 country: United States