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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
Must not have
Undergoing treatment for any hormone dependent cancer
History of hypotension
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 weeks

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently being treated for a cancer that grows in response to hormones.
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I have a history of low blood pressure.
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I have a history of dementia, untreated depression, psychiatric disorder, or brain injury.
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I am not taking supplements that can make me sleepy.
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I am not on daily medication that affects my thinking.
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My cancer has spread to my brain.
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I have been diagnosed with a stomach ulcer or gastritis recently.
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I am currently taking medication to lower my blood sugar.
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I am currently taking sedatives or benzodiazepines.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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
2024
Completed Phase 2
~170

Find a Location

Who is running the clinical trial?

Sutter HealthLead Sponsor
23 Previous Clinical Trials
63,763 Total Patients Enrolled
Deepti Behl, MDPrincipal InvestigatorSutter Health
Stacy D'Andre, MDPrincipal InvestigatorSutter Health
1 Previous Clinical Trials
39 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
~3 spots leftby Dec 2024
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