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Herbal Supplement

Ashwagandha for Cognitive Impairment

Phase 2
Recruiting
Led By Deepti Behl, MD
Research Sponsored by Sutter Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to swallow pills
Currently undergoing chemotherapy or treatment with chemotherapy in the past year
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 weeks
Awards & highlights

Study Summary

This trial is testing whether the herb ashwagandha can help improve cognitive function in breast cancer patients undergoing chemotherapy, compared to those taking a placebo.

Who is the study for?
This trial is for English-speaking adults over 18 who are currently undergoing chemotherapy or have had it within the past year, experiencing cognitive issues like memory loss. They must be able to swallow pills and follow test instructions. People with hormone-dependent cancers, brain conditions, hypotension, autoimmune diseases, substance abuse history, stomach ulcers or gastritis aren't eligible.Check my eligibility
What is being tested?
The study tests if Ashwagandha can help with 'chemobrain'—cognitive problems after chemotherapy—compared to a placebo (a pill without active ingredients). Participants are randomly assigned to either the Ashwagandha group or placebo group in equal numbers without knowing which one they're getting.See study design
What are the potential side effects?
Ashwagandha may cause sedation and might interact with other medications causing drowsiness. It could also lower blood pressure and affect blood sugar levels. Stomach irritation is possible too.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can swallow pills.
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I am currently on chemotherapy or had it within the last year.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
FACT-Cog PCI

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ashwagandhaExperimental Treatment1 Intervention
Ashwagandha
Group II: placeboPlacebo Group1 Intervention
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ashwagandha
2017
Completed Phase 2
~140

Find a Location

Who is running the clinical trial?

Sutter HealthLead Sponsor
21 Previous Clinical Trials
156,820 Total Patients Enrolled
Deepti Behl, MDPrincipal InvestigatorSutter Health
Carol Parise, PhDStudy DirectorSutter Health
2 Previous Clinical Trials
44 Total Patients Enrolled

Media Library

Ashwagandha (Herbal Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT04092647 — Phase 2
Chemobrain Research Study Groups: ashwagandha, placebo
Chemobrain Clinical Trial 2023: Ashwagandha Highlights & Side Effects. Trial Name: NCT04092647 — Phase 2
Ashwagandha (Herbal Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04092647 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
~31 spots leftby Dec 2024