Ashwagandha Supplementation for Prevention of Muscle Damage | NCT06900569

Studies
Ashwagandha Supplementation for Prevention of Muscle Damage

NCT06900569

Sponsor

University of Saskatchewan

Status

Completed

Last Update Posted

Feb 23, 2026Actual

Enrollment

19Actual

Phase

Not Applicable

Conditions

Muscle Damage

Interventions

Ashwagandha
Placebo

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 22, 2025Actual

Primary Completion Date

Apr 30, 2025Actual

Completion Date

May 15, 2025Actual

First Submitted Date

Mar 15, 2025

First Submission Date that Met QC Criteria

Mar 21, 2025

First Posted Date

Mar 28, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 19, 2026

Last Update Posted Date

Feb 23, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Ashwagandha is an herbal supplement that has a wide range of benefits related to exercise when supplemented for about 8-12 weeks. This study aims to investigate whether short-term Ashwagandha supplementation can enhance muscle recovery following exercise by measuring muscle strength recovery, swelling, and soreness in the biceps.

Detailed Description

The purpose of the study is to determine the effects of Ashwagandha supplementation on recovery from muscle-damaging exercise. Ten to twenty participants will be randomized to receive Ashwagandha supplementation (600 mg/d) or placebo for 10 days. On day 7, participants will perform a muscle damaging exercise session (six sets of concentric and emphasized eccentric repetitions with the biceps). Before and after exercise and at 24, 48, and 72 hours after exercise, isometric muscle strength, muscle swelling (ultrasound), and muscle soreness will be assessed. The investigators hypothesize the Ashwagandha will alleviate symptoms of muscle damage (swelling and soreness) and enhance strength recovery after a bout of muscle-damaging exercise.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	600 mg/d placebo for 10 days	Dietary Supplement: Placebo
Ashwagandha	Experimental	600 mg/d Ashwagandha	Dietary Supplement: Ashwagandha

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ashwagandha	Dietary Supplement	600 mg/d Ashwagandha	Ashwagandha
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in isometric biceps strength measured with a dynamometer (Nm)		72 hours

Secondary Outcomes

Measure	Description	Time Frame
Change in muscle thickness measured with ultrasound (cm)		72 hours
Change in muscle soreness measured with a visual analog scale with scores ranging from 0 (no soreness) to 10 (maximal soreness)		72 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: male or female, aged 18-35y

Exclusion Criteria:

Conditions that may be affected by exercise (determined by "yes" answers to the "Get Active Questionnaire") Pregnant Breastfeeding

Allergies to:

Dicalcium Phosphate
Cellulose
Vegetable magnesium stearate
Silica

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Saskatchewan		Saskatoon	Saskatchewan	S7K 2X2	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C030693	Ashwagandha

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided