Ashwagandha for Cognitive Impairment

Recruiting in Palo Alto (17 mi)

Overseen by Stacy D'Andre, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Sutter Health

Must not be taking: Sedatives, Hypoglycemics

Disqualifiers: Hormone dependent cancer, Dementia, Autoimmune, others

Prior Safety Data

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.

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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.

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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.

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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.

Trial 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

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Sutter Cancer Center Sacramento, CA

Who Is Running the Clinical Trial?

Sutter Health Lead Sponsor

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] Ashwagandha, also known as Indian Ginseng, is a highly traded medicinal plant, which is used in Ayurveda, Siddha and Unani systems of medicine to improve cognitive function, decrease inflammation, and to counter the ill-effects of aging. Withanolide A and Withaferin A from Ashwagandha were shown to improve immunity and have anti-cancer property, respectively.

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] Cognitive decline is often associated with the aging process. Ashwagandha (Withania somnifera (L.) Dunal) has long been used in the traditional Ayurvedic system of medicine to enhance memory and improve cognition.

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

Withania somnifera: an Indian ginseng. [2022] Withania somnifera, popularly known as Ashwagandha is widely considered as the Indian ginseng. In Ayurveda, it is classified as a rasayana (rejuvenation) and expected to promote physical and mental health, rejuvenate the body in debilitated conditions and increase longevity. Having wide range of activity, it is used to treat almost all disorders that affect the human health. The present review discusses the pharmacological basis of the use of W. somnifera in various central nervous system (CNS) disorders, particularly its indication in epilepsy, stress and neurodegenerative diseases such as Parkinson's and Alzheimer's disorders, tardive dyskinesia, cerebral ischemia, and even in the management of drug addiction.

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

A systematic review of the clinical use of Withania somnifera (Ashwagandha) to ameliorate cognitive dysfunction. [2020] Many developed countries are experiencing a rapidly "greying" population, and cognitive decline is common in the elderly. There is no cure for dementia, and pharmacotherapy options to treat cognitive dysfunction provide limited symptomatic improvements. Withania somnifera (Ashwagandha), a popular herb highly valued in Ayurvedic medicine, has often been used to aid memory and cognition. This systematic review thus aimed to evaluate the clinical evidence base and investigate the potential role of W. somnifera in managing cognitive dysfunction. Using the following keywords [withania somnifera OR indian ginseng OR Ashwagandha OR winter cherry] AND [brain OR cognit* OR mental OR dementia OR memory], a comprehensive search of PubMed, EMBASE, Medline, PsycINFO and Clinicaltrials.gov databases found five clinical studies that met the study's eligibility criteria. Overall, there is some early clinical evidence, in the form of randomized, placebo-controlled, double-blind trials, to support the cognitive benefits of W. somnifera supplementation. However, a rather heterogeneous study population was sampled, including older adults with mild cognitive impairment and adults with schizophrenia, schizoaffective disorder, or bipolar disorder. In most instances, W. somnifera extract improved performance on cognitive tasks, executive function, attention, and reaction time. It also appears to be well tolerated, with good adherence and minimal side effects.

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

Studies on Ashwagandha Ghrita with reference to murcchana process and storage conditions. [2021] Withania somnifera (L.) (family-Solanaceae), known as 'Indian ginseng' or 'Ashwagandha' is acclaimed as an effective adaptogen, immunomodulator, aphrodisiac and sedative. Ashwagandhaghrita is a recognized ghee based Ayurvedic formulation. Few ancient texts suggest murcchana process for preparation of Ashwagandha ghrita.

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

Ashwagandha in brain disorders: A review of recent developments. [2021] Withania somnifera (Family: Solanaceae), commonly known as Ashwagandha or Indian ginseng is distributed widely in India, Nepal, China and Yemen. The roots of plant consist of active phytoconstituents mainly withanolides, alkaloids and sitoindosides and are conventionally used for the treatment of multiple brain disorders.

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

Pharmacological evaluation of Ashwagandha highlighting its healthcare claims, safety, and toxicity aspects. [2021] Withania somnifera, commonly known as "Ashwagandha" or "Indian ginseng" is an essential therapeutic plant of Indian subcontinent regions. It is regularly used, alone or in combination with other plants for the treatment of various illnesses in Indian Systems of Medicine over the period of 3,000 years. Ashwagandha (W. somnifera) belongs to the genus Withania and family Solanaceae. It comprises a broad spectrum of phytochemicals having wide range of biological effects. W. somnifera has demonstrated various biological actions such as anti-cancer, anti-inflammatory, anti-diabetic, anti-microbial, anti-arthritic, anti-stress/adaptogenic, neuro-protective, cardio-protective, hepato-protective, immunomodulatory properties. Furthermore, W. somnifera has revealed the capability to decrease reactive oxygen species and inflammation, modulation of mitochondrial function, apoptosis regulation and improve endothelial function. Withaferin-A is an important phytoconstituents of W. somnifera belonging to the category of withanolides been used in the traditional system of medicine for the treatment of various disorders. In this review, we have summarized the active phytoconstituents, pharmacologic activities (preclinical and clinical), mechanisms of action, potential beneficial applications, marketed formulations and safety and toxicity profile of W. somnifera.

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] Korean red ginseng (KRG) has a nootropic effect. This study assessed the efficacy of KRG on cognitive function and quantitative electroencephalography (EEG) in patients with Alzheimer's disease (AD).

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

Molecular characterization of India Ginseng Withania somnifera (L) using ISSR markers. [2021] Ashwagandha (Withania somnifera (L.) Dunal), popularly known as Indian ginseng or winter cherry is a multipurpose plant of immense therapeutic value in the ayurvedic and indigenous medicine system and distributed in wide geographic locations and exhibiting extensive phenotypic and chemical variability.