NCT07151261

Ashwagandha for Nighttime Waking

Effects of Daily Intake of Ashwagandha (Withania Somnifera) Root Extract Sustained Release (SR) Capsules 150mg on Disturbed Sleep: a Phase II, Randomized Placebo-controlled Trial With Wearable Device

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: National University of Natural Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research is to evaluate the effect of a sustained-release, lower-dosage (150mg) Ashwagandha supplement to reduce disturbed sleep. 54 participants, after randomization, will take either an Ashwagandha supplement or a placebo daily for 28 days (week 4) and wear an Oura ring. The Oura ring will measure waking after sleep onset (WASO). Questionnaires to evaluate quality of life and sleep will be administered at baseline and week 4.

Detailed description

Each participant will be in the study for about 5 weeks (1 preparation week and 4 weeks for the trial). Questionnaires consist of the Patient-Reported Outcomes Measurement Information System (PROMIS-29). Subjects will be screened for mild sleep disturbance using the PROMIS Sleep Disturbance questionnaire.

Conditions

• Disturbed Sleep

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Ashwagandha	Sustained-Release, lower-dosage (150mg) Ashwagandha Supplement, 1 capsule 1 time per day.
OTHER	Placebo	This placebo does not contain any of the interventional dietary supplement. The placebo consists of microcrystalline cellulose and is matched for shape, color, and smell. 1 capsule, 1 time per day.

Timeline

• Start date: 2025-10-20
• Primary completion: 2026-05-01
• Completion: 2026-05-11
• First posted: 2025-09-03
• Last updated: 2026-03-16

Locations

1 site across 1 country: United States