Ashwagandha for Cognitive Impairment

Overseen By Michele Guillen

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sutter Health

Must not be taking: Sedatives, Hypoglycemics

Disqualifiers: Hormone dependent cancer, Dementia, Autoimmune, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 9 weeks

80 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a 1:1 randomized double blinded placebo controlled trial. • To determine if ashwagandha can improve cognitive dysfunction when compared with placebo in patients undergoing chemotherapy for cancer.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, especially those that affect cognition, sedatives, certain supplements, and hypoglycemic medications. If you are on any of these, you may need to stop them to participate.

What evidence supports the effectiveness of the drug Ashwagandha for cognitive impairment?

There is some early clinical evidence from randomized, placebo-controlled, double-blind trials suggesting that Ashwagandha may improve cognitive tasks, executive function, attention, and reaction time in individuals with mild cognitive impairment and other mental health conditions. ^{1 2 3 4 5}

Is Ashwagandha safe for human use?

Ashwagandha appears to be generally safe for human use, with studies showing it is well tolerated and has minimal side effects. ^{1 4 6 7 8}

How is Ashwagandha unique for treating cognitive impairment?

Ashwagandha is unique for treating cognitive impairment because it is a natural herb used in Ayurvedic medicine that has shown early evidence of improving memory, attention, and reaction time in clinical studies, with minimal side effects. Unlike conventional drugs, it is derived from plant roots and contains active compounds like withanolides, which may offer cognitive benefits. ^{1 4 5 6 9}

Research Team

Deepti Behl

Principal Investigator

Sutter Health

Carol Parise, PhD

Principal Investigator

Sutter Health

Eligibility Criteria

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.

Inclusion Criteria

I can swallow pills.

You have experienced memory loss, trouble paying attention, or changes in your ability to think clearly during the first two cycles of chemotherapy, and your score on a specific memory and thinking test is less than 63.

I am currently on chemotherapy or had it within the last year.

Exclusion Criteria

I am currently being treated for a cancer that grows in response to hormones.

I have a history of low blood pressure.

You have a history of using drugs or alcohol in a harmful way.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ashwagandha 350 mg po BID or placebo for cognitive dysfunction associated with chemotherapy

9 weeks

Baseline visit, end of week 6 visit, end of treatment visit

Follow-up

Participants are monitored for cognitive function and use of ashwagandha after treatment

6 months

Online follow-up via REDCap database

Treatment Details

Interventions

• Ashwagandha
• Placebo

Trial Overview 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.

Participant Groups

Group I: ashwagandha Experimental Treatment 1 Intervention

Ashwagandha

Group II: placebo Placebo Group 1 Intervention

Placebo

Ashwagandha is already approved in India, United States for the following indications:

Approved in India as Ashwagandha for:

• Cognitive dysfunction
• Stress relief
• Anxiety
• Sleep improvement

Approved in United States as Ashwagandha for:

• Dietary supplement for stress relief and cognitive support

Who Is Running the Clinical Trial?

Sutter Health

Lead Sponsor

Trials

26

Recruited

68,900+

Findings from Research

A study using DNA barcoding on 103 market samples of Ashwagandha found that 77% were authentic, highlighting significant issues with botanical adulteration, especially in powdered forms.

Among the non-authentic samples, 82% were mixed with other plant species, indicating a need for stricter quality control to ensure the medicinal benefits of Ashwagandha are not compromised.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Authentication of the market samples of Ashwagandha by DNA barcoding reveals that powders are significantly more adulterated than roots. Amritha, N., Bhooma, V., Parani, M.[2021]

In a pilot study involving 50 adults with mild cognitive impairment, ashwagandha (300 mg twice daily) significantly improved memory and cognitive functions compared to a placebo over eight weeks.

Participants taking ashwagandha showed notable enhancements in immediate and general memory, as well as executive function and attention, indicating its potential as a beneficial treatment for cognitive decline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Ashwagandha (Withania somnifera (L.) Dunal) Root Extract in Improving Memory and Cognitive Functions. Choudhary, D., Bhattacharyya, S., Bose, S.[2018]

Withania somnifera, or Ashwagandha, is recognized for its potential benefits in promoting physical and mental health, particularly in treating various central nervous system disorders such as epilepsy, stress, and neurodegenerative diseases like Parkinson's and Alzheimer's.

The review highlights Ashwagandha's broad pharmacological activity, suggesting it may help rejuvenate the body and improve health in debilitated conditions, making it a valuable herb in traditional Ayurvedic medicine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Withania somnifera: an Indian ginseng. Kulkarni, SK., Dhir, A.[2022]

A systematic review of five clinical studies suggests that Withania somnifera (Ashwagandha) may improve cognitive function in various populations, including older adults with mild cognitive impairment and individuals with mental health disorders.

The studies indicate that Ashwagandha supplementation is well tolerated, showing good adherence and minimal side effects, making it a promising option for managing cognitive dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of the clinical use of Withania somnifera (Ashwagandha) to ameliorate cognitive dysfunction. Ng, QX., Loke, W., Foo, NX., et al.[2020]

The study found that Ashwagandha ghrita prepared using the murcchana process showed better antioxidant properties compared to plain ghee, indicating enhanced efficacy of the formulation.

Storage conditions significantly affected the quality of both plain ghee and Ashwagandha ghrita, with higher temperatures and longer storage times leading to more pronounced changes in their physical and chemical properties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Studies on Ashwagandha Ghrita with reference to murcchana process and storage conditions. Gurav, NS., Gurav, SS., Sakharwade, SN.[2021]

Ashwagandha contains several neuroprotective compounds, such as withanolides and sitoindosides, which have shown potential benefits in treating various brain disorders, including anxiety, Alzheimer's, and depression, based on preclinical studies.

There is currently no evidence of toxic effects from Ashwagandha, but more research is needed to fully understand its mechanisms of action and to support its use as a treatment in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ashwagandha in brain disorders: A review of recent developments. Zahiruddin, S., Basist, P., Parveen, A., et al.[2021]

Withania somnifera, or Ashwagandha, has been used for over 3,000 years in traditional Indian medicine and exhibits a wide range of biological effects, including anti-cancer, anti-inflammatory, and neuro-protective properties.

The active compound Withaferin-A in Ashwagandha contributes to its therapeutic effects by modulating mitochondrial function and reducing inflammation, making it a promising candidate for various health applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacological evaluation of Ashwagandha highlighting its healthcare claims, safety, and toxicity aspects. Mandlik Ingawale, DS., Namdeo, AG.[2021]

In a study of 14 Alzheimer's disease patients treated with Korean red ginseng (KRG) for 12 weeks, significant improvements were observed in cognitive function, particularly in the Frontal Assessment Battery score.

The treatment was associated with increased relative alpha power in the EEG, especially in the right temporal area, suggesting that KRG may enhance frontal lobe function in patients with Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Korean Red Ginseng on Cognitive Function and Quantitative EEG in Patients with Alzheimer's Disease: A Preliminary Study. Heo, JH., Park, MH., Lee, JH.[2016]

The study assessed the genetic diversity of 9 different ashwagandha cultivars using 20 ISSR primers, revealing that 86.1% of the genetic markers were polymorphic, indicating significant genetic variation among the varieties.

The findings suggest that ISSR molecular diversity assessments can help identify phylogenetic relationships among ashwagandha genotypes, which could be used to develop high-yielding varieties and improve desirable traits in this medicinal plant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Molecular characterization of India Ginseng Withania somnifera (L) using ISSR markers. Hiremath, C., Philip, R., Sundaresan, V.[2021]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Authentication of the market samples of Ashwagandha by DNA barcoding reveals that powders are significantly more adulterated than roots. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Ashwagandha (Withania somnifera (L.) Dunal) Root Extract in Improving Memory and Cognitive Functions. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Withania somnifera: an Indian ginseng. [2022]

4. England pubmed.ncbi.nlm.nih.gov

A systematic review of the clinical use of Withania somnifera (Ashwagandha) to ameliorate cognitive dysfunction. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Studies on Ashwagandha Ghrita with reference to murcchana process and storage conditions. [2021]

6. Ireland pubmed.ncbi.nlm.nih.gov

Ashwagandha in brain disorders: A review of recent developments. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Pharmacological evaluation of Ashwagandha highlighting its healthcare claims, safety, and toxicity aspects. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Effect of Korean Red Ginseng on Cognitive Function and Quantitative EEG in Patients with Alzheimer's Disease: A Preliminary Study. [2016]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Molecular characterization of India Ginseng Withania somnifera (L) using ISSR markers. [2021]