As more people seek natural remedies to improve their health and wellness, ashwagandha has gained attention for its potential benefits. This ancient herb has been used in traditional Ayurvedic medicine for centuries and is now widely available as a dietary supplement. However, with so much information out there, it can be overwhelming for consumers to navigate the world of ashwagandha. That’s why we’ve enlisted the expertise of a clinical pharmacist to provide an easy-to-understand overview of ashwagandha. In this blog post, we’ll explore the history and traditional uses of ashwagandha, review the clinical evidence for its use, and provide a breakdown of the top five commercial ashwagandha products on the market. Whether you’re new to ashwagandha or looking to deepen your understanding, this post is for you.
What is Ashwagandha?
Ashwagandha, also known as Withania Somnifera or Ayurvedic ginseng, is a powerful herb that has been used for thousands of years in traditional Ayurvedic medicine. It belongs to the Solanaceae family and the species name, somnifera, means “to induce sleep,” reflecting its traditional use in India as a sleep aid. It also goes by the name Asgand, Winter Cherry, and Indian Ginseng. Ashwagandha is a type of adaptogenic herb, which are herbal pharmaceuticals that help balance the body and mind, boost energy, and enhance physical and mental performance.
Ashwagandha is a 2 – 6 foot tall evergreen, straight, branching shrub that originates in drier parts of Western India and Mediterranean regions [Mukherjee et al 2020]. The root of the plant is considered the most useful part and is collected during the summer and winter months. The leafs and seeds have also been reported to be used for therapeutic and medicinal reasons. The dried root and the whole plant are used in the traditional medicine systems of Ayurveda, Siddha, Sowa-Rigpa (Amchi), and Unani.
The roots contain the main bioactive molecule, withanolides, which possess potential medicinal properties, including anti-inflammatory, antioxidant, antitumor, stress hormone lowering (e.g., cortisol), blood pressure lowering, blood glucose lowering, and anti-anxiety properties [Srivastava et al 2018]. Other parts of the plant, such as its stem and leaves, also contain other bioactive molecules such as sitoindosides, triethylene glycol, phenolic compounds and alkaloids [Kaushik et al 2017]. In the United States, Ashwagandha is considered a “botanical dietary supplement” as categorized the Food and Drug Administration (Speers et al 2021).
SUMMARY
Ashwagandha is an adaptogenic herb commonly used in traditional Ayurvedic medicine for its potential health benefits. It is known for its sedating and stress relieving properties and contains bioactive molecules like withanolides.
What uses of ashwagandha have the most scientific evidence?
Stress
Ashwagandha may be helpful in the management of stress due to its ability to enhance the levels of the brain chemical GABA (gamma aminobutyric acid) and its ability to reduce levels of the stress hormone cortisol.
A meta-analysis of 12 randomized clinical trials including a total of 1,002 adults (555 receiving ashwagandha and 445 control subjects) followed for 8 to 12 weeks suggested that ashwagandha reduced levels of stress and anxiety. The doses used ranged from 240mg to 1000mg per day. KSM-66 ashwagandha root extract or Shoden ashwagandha root and leaf extract were two commercial products included in this meta-analysis. However, the authors gave the evidence a low rating and that larger studies are needed to confirm these findings (Akhgarjand et al. 2022).
Insomnia
Ashwagandha may be helpful for the management of insomnia as well due to withanolides’ ability to increase levels of GABA and triethylene glycol’s (TEG) ability to enhance sleep as shown in mice.
A meta-analysis of 5 randomized clinical trials, including a total of 400 adults, suggested that patients taking KSM-66 ashwagandha root extract or Shoden ashwagandha root and leaf extract at doses in the range of 120mg to 600mg per day for 6 to 12 weeks improved overall sleep compared to placebo (Cheah et al. 2021). This study suggests that ashwagandha may be helpful for sleep, but larger studies are needed to confirm these findings.
A healthcare professional should be consulted to make sure your sleep hygiene is optimized before using ashwagandha to improve sleep quality.
Other potential uses of ashwagandha with less evidence
Smaller studies have suggested benefit of ashwagandha for the following uses:
Improved alertness in elderly people
Improved athletic performance
Improved cognitive performance in bipolar disorder
Improved balance in patients with cerebellar ataxia
Decreased chemotherapy related fatigue
Decreased blood glucose in patients with diabetes
Reduced anxiety in patients with generalized anxiety disorder
Reduced cholesterol levels
Improved male fertility
Reduced symptoms of obsessive compulsive disorder
Improved psychological well being in college students
Enhanced sexual function
SUMMARY
Ashwagandha may be helpful in managing stress and anxiety by enhancing GABA levels and reducing cortisol levels. It may also improve sleep quality due to its withanolides and TEG content, according to a meta-analysis of randomized clinical trials, but further research is needed to confirm these findings.
What is the most common dose of ashwagandha?
It has been most often used in doses of 120mg per day up to 1200mg per day for up to 12 weeks in randomized clinical trials. The dose used in studies varies depending on the type of extract (KSM-66, Sensoril, Shoden, Prolanza, and NooGandha ashwagandha, see below for more information).
What are the adverse effects?
Ashwagandha is generally considered safe when taken in recommended doses. However, some individuals may experience adverse effects, including:
Upset stomach: Ashwagandha may cause nausea, diarrhea, and other digestive symptoms in some individuals.
Allergic reactions: Some people may be allergic to Ashwagandha, resulting in skin rashes, itching, and difficulty breathing.
Hormonal changes: Ashwagandha may affect hormone levels in some individuals, particularly in women. This can result in menstrual irregularities, changes in libido, and other related symptoms. It has also been shown to increase the level of thyroid hormones so caution should be taken in people with underlying thyroid issues.
Liver: There have been several case reports of liver injury with ashwagandha. If you experience yellowing of skin or eyes, pain in upper abdomen, a swollen belly, or disorientation or confusion while taking ashwagandha, stop taking it immediately and seek medical attention.
Anhedonia: People experiencing this have a reduce ability to experience pleasure. We have heard anecdotal reports of this in people taking ashwagandha. We recommend to stop taking ashwagandha.
SUMMARY
Ashwagandha is generally considered safe, but some individuals may experience adverse effects such as upset stomach, allergic reactions, hormonal changes, and liver injury, and caution should be taken in people with underlying thyroid issues.
Are there important interactions with prescription medications?
Ashwagandha may interact with certain medications: such as blood thinners, thyroid hormones, digoxin, and anti-anxiety drugs.
Limited evidence suggests ashwagandha may decrease blood sugar levels; therefore, it may have an additive effect when used with prescription medications for diabetes.
Limited evidence suggests ashwagandha may decrease blood pressure; therefore, it may have an additive effect when used with prescription medications for high blood pressure.
Ashwagandha has been shown to increase levels of the neurotransmitter GABA (gamma amino butyric acid); therefore, it may have an additive effect when used with benzodiazepines such as Xanax, Ativan, and Valium, which also increase GABA, and may result in over sedation.
Ashwagandha has been shown to increase levels of thyroid hormones; therefore, it may have additive effects with prescription thyroid medications such as Synthroid or generic levothyroxine.
Finally, ashwagandha may falsely elevate levels of the prescription medication digoxin.
SUMMARY
Ashwagandha may interact with certain medications: blood thinners, thyroid hormones, digoxin, anti-anxiety drugs, as well as mediciations for diabetes and high blood pressure. Ashwagandha may falsely elevate levels of the prescription medication digoxin.
How do I choose which ashwagandha product to take?
When choosing an Ashwagandha product, it is important to look for high-quality, reliable products that have been manufactured under strict quality control standards. Here are some factors to consider when selecting an Ashwagandha product:
Standardization: Look for products that are standardized to a specific concentration of the active compounds in Ashwagandha, such as withanolides. This helps ensure consistent potency and efficacy.
Third-party testing: Choose products that have been tested by independent third-party labs to verify the purity and potency of the product. USP verified mark is an example (https://www.usp.org/verification-services/verified-mark). NSF certified content is another example (https://www.nsf.org/knowledge-library/who-is-nsf-international).
Brand reputation: Consider the reputation of the brand and look for products from well-established, reputable companies with a track record of producing high-quality products.
Manufacturing practices: Look for products that have been manufactured in a GMP (Good Manufacturing Practice) certified facility, which follows strict quality control standards.
Dosage: Make sure the product you choose provides the desired dosage of Ashwagandha, based on your individual needs and the recommendations of your healthcare professional.
We will cover 5 commercially available ashwagandha extracts including KSM-66, Sensoril, Shoden, Prolanza, and NooGandha.
What is KSM-66 Ashwagandha?
KSM-66 Ashwagandha is a unique product manufactured exclusively by Ixoreal, a company based in India. It is derived solely from the root of the plant as opposed to the leaves, which Ixoreal maintains is the only part of the ashwagandha plant that is supported by the ancient ayurvedic texts and by the government of India, and that the leaves should be used as compost to replenish the organic content of the soil.
It is considered a “full spectrum extract”, which means that it contains all the various phytochemical compounds of the root in a natural balance, not just the widely recognized active ingredient of ashwagandha, withanolides. KSM-66 is standardized to a > 5% concentration of withanolides. KSM-66 also has a neutral taste and good solubility making it suitable for food and beverage applications.
Ixoreal does not outsource any part of the manufacturing process of KSM-66 by owning its own farms, production facilities, lab, research center, and distribution facilities.
Ixoreal sources its ashwagandha roots from the state of Rajasthan in India. The herb requires well-drained, sand loamy, or light red soils with a pH of 7.5-8.0, and areas receiving 650-750 mm rainfall are best suited for its cultivation. The roots of ashwagandha are cultivated organically, and only special or High A-grade root pieces are used for the extraction, ensuring a solid and bright root up to 7 centimeters long and with a diameter of 1 to 1.5 centimeters.
Ixoreal uses sustainable methods in its agricultural practices within the guidelines of the Sustainability Assessment of Food and Agriculture Systems (SAFA) of the Food and Agriculture Organization of the United Nations (FAO). It also uses traceability methods by partnering with TagOne, which is a company that develops traceability management systems, and this helps the company capture and validate all parts of the manufacturing process of KSM-66.
Ixoreal’s manufacturing process uses a “green chemical” method that mimics the ancient ayurvedic tradition of using cow’s milk, without the use of harsh chemicals. There is also a cow’s milk free version. Ixoreal also strictly adheres to WHO and US-FDA guidelines on GMP (good manufacturing practice) in their state-of-the-art facility, ensuring a high-quality and safe product.
KSM-66 and its manufacturing process have gone through very extensive inspections and safety assessments in the industry, resulting in the highest number of certifications for any botanical. These include GMP (USP, NSF, NPA-UL, WHO), 100% USDA Organic, Non-GMO Project Verified, Gluten-Free (by GFCO), BSCG-drug free, Kosher, Halal, HACCP, and many others for a total of 41 certifications.
KSM-66 has been the subject of 24 clinical trials published in peer-reviewed scientific journals with 26 more trials planned or ongoing (direct communication from Ixoreal representative). The dose of KSM-66 used in these studies ranged from 250mg to 600mg per day. As mentioned above, KSM-66 has shown some benefit for insomnia and stress, but further study is required to confirm these results.
Overall, KSM-66 Ashwagandha is a highly regarded and extensively tested product, rooted in ancient traditions and manufactured using modern methods. Per Ixoreal, it can be found in over 1500 commercially available products from major supplement companies across the globe (e.g. Nature’s Bounty, GNC, CVS, and Costco). The company says that one billion doses of KSM-66 were sold worldwide in 2021. Its “full spectrum extract” and adherence to strict quality standards make it an excellent choice for those seeking the potential health benefits of ashwagandha. To find products containing KSM-66, visit https://ksm66ashwagandhaa.com/ksm-66/products-with-ksm-66/.
SUMMARY
KSM-66 Ashwagandha is a branded version of ashwagandha, derived only from the root, and manufactured by Ixoreal, an Indian-based company. It is a “full spectrum extract,” and uses a “green chemical” process that mimics ancient ayurvedic methods.
What is Sensoril Ashwagandha?
Sensoril Ashwagandha, manufactured by Natreon, is derived from a blend of both leaves and roots of the ashwagandha plant using a completely aqueous (water soluble) extraction process. This proprietary extract has been extensively studied in more than ten randomized, double-blind, placebo-controlled human clinical trials.
Sensoril Ashwagandha is known for its applications in supplements, foods, beverages, and personal care products. It is also noteworthy that the ashwagandha plants are harvested from organic farms in Madra Pradesh, India, providing a sustainable sourcing method that Natreon boasts has benefits for local farmers.
The bioactive level specifications of Sensoril Ashwagandha are withanolide glycosides ≥10%, oligosaccharides ≥32%, and withaferin A ≤0.5%, a patented composition that is quality control tested using HPLC and UPLC. Withaferin A, one of the most studied withanolides, is known to support heart health, brain health, and a healthy immune response. Oligosaccharides are another bioactive component of Ashwagandha that are critical for normal cellular function, including cell adhesion and cellular recognition. They also contribute to the soluble fiber content, which supports digestion and heart health. Sensoril is vegan, GRAS affirmed, non-GMO project verified, and organic certified.
SUMMARY
Sensoril Ashwagandha, a proprietary extract manufactured by Natreon, is derived from both the leaves and roots of the ashwagandha plant using a water-soluble extraction process.
What is Shoden Ashwagandha?
Shoden is a high-potency extract derived from the leaves and roots of the ashwagandha plant with 35% withanolides (as measured by HPLC). Shoden® is part of an exclusive portfolio of proprietary ingredients from NutriScience Innovations LLC, and is a registered trademark of Arjuna Natural Pvt. Ltd.
The ashwagandha plant used in Shoden® is grown, harvested, and processed in Karnataka, India, through Madya Pradesh. The harvesting of the crop is mostly done by hand, with natural fertilizers and pesticides being used to ensure sustainability. Each incoming lot of ashwagandha plants are tested for purity and authenticity to ensure that there is no adulteration or contamination.
The manufacturing facility itself is modern and clean, using only food-grade ethanol and purified potable water in the extraction process. Ethanol is recovered and purified, and a high percentage is reused. The facility has also invested in harnessing solar power to help with sustainability and reduce its carbon footprint.
Shoden is self-affirmed GRAS (Generally Recognized As Safe) and has been tested in several studies with a recommended dose of 120mg per day.
As mentioned above, Shoden ashwagandha has shown some benefit for insomnia and stress, but further study is required to confirm these results.
SUMMARY
Shoden® is a high potency ashwagandha extract with 35% withanolides, grown and harvested sustainably in India using natural fertilizers and pesticides.
What is Prolanza Ashwagandha?
Prolanza is a long-acting Ashwagandha root extract-based ingredient that contains a unique composition of 20 withanolides, with 10 of them being USP compliant. Prolanza has a 4-5% concentration of withanolides.
An interesting feature of Prolanza is its innovative release pattern (proprietary information), which enables it to exert its clinical benefits for a prolonged duration with just a single daily dose. This makes it easier for consumers to incorporate Prolanza into their daily routine. A single small dose of 300mg/day is sufficient due to the long-acting biological action and high bioavailability offered by Prolanza.
The manufacturer of Prolanza conducted in-vivo toxicity studies compliant with OECD guidelines, which showed no signs of toxicity at the doses tested. A self-affirmed GRAS dossier is also available for Prolanza. Additionally, Prolanza uses food sourced excipients, is non-GMO, and is GMP compliant.
Prolanza 300mg per day has shown some benefit in one study in reducing perceived stress score and cortisol levels in adults reporting moderate to high levels of stress (Gopukumar et al. 2021).
An example product that contains Prolanza ashwagandha is Primal Stress from Primal Harvest (https://primalharvest.com/products/primal-stress-relief).
SUMMARY
Prolanza is a long-acting Ashwagandha extract that contains a unique composition of 20 withanolides, with 10 of them being USP compliant and 10 additionally identified. With an innovative release pattern, Prolanza offers a convenient one-a-day dosage and uses food-sourced excipients.
What is NooGandha Ashwagandha?
NooGandha by Specnova is an ashwagandha root and leaf (offered in root only as well) extract specific for cognitive function. Specnova, the manufacturer for NooGandha, claims that it is a specialized cognitive-enhancing nootropic (enhances memory and cognition and minimizes stress) focused ashwagandha that still retains anti-stress/cortisol benefits, but is not sedating or relaxing like traditional types of ashwagandha extracts.
Specnova boasts that it uses clean processing and extraction technologies in its manufacturing process. The company also boasts that its novel manufacturing processes identifies and selects only compounds with elevated nootropic bioactivity and bioavailability, while reducing compounds that are overly sedating. We queried Specnova about their extraction process and selection of nootropic compounds, but the company declined to offer further details citing proprietary concerns.
NooGandha contains withanolides (3.5 – 4% as validated by USP-HPLC), but also includes other classes of bioactive compounds, such as alkaloids. Furthermore, NooGandha utilizes ashwagandha’s natural plant matrix components for stability and absorption.
A small study of NooGandha 225mg to 400mg once daily in adults with perceived stress demonstrated improvements in self reported anxiety, stress, and depression when compared to a placebo group (Remenapp et al. 2022).
The recommended dose for NooGandha is 225-400mg taken once daily for improved cognitive performance and nootropic benefits. NooGandha is a clean label supplement, which means it contains no carriers, dairy, excipients, or maltodextrin.
SUMMARY
Specnova, the manufacturer of NooGandha, claims that it is a specialized cognitive-enhancing ashwagandha with anti-stress/cortisol benefits, but without sedative effects.
Which Ashwagandha Extract is The Best?
The five ashwagandha extracts mentioned, KSM-66, Sensoril, Shoden, Prolanza, and NooGandha, vary in percentage of withanolides, extraction process, dosage, disclosure of manufacturing process, and clinical trials (see table below). Specifically, with regards to the percentage of withanolides, there is no good evidence to support a high concentration product like Shoden (35%) over the other products that contain lower percentages.
There is no direct comparison between products in a clinical trial of insomnia, anxiety, depression, and stress. The decision to choose one product over another should consider the proven safety of the product, transparency in manufacturing, quality and purity of the extract, and scientific research in human clinical trials supporting its use for a particular ailment (see table below for product comparison).
In our opinion, KSM-66 ashwagandha should be considered first over the other 4 products because of the transparency of the harvesting and manufacturing process readily available on the website, green and sustainable extraction process, various certifications from trusted organizations, and clinical trial research supporting its use for stress and insomnia.
Pharmacist’s Recommendations
Ashwagandha is safe to take at doses of up to 1200mg per day and it may have benefits in managing stress and improving sleep, but further studies are needed to confirm safety and efficacy.
It is important to note that the exact mechanisms by which Ashwagandha works are not fully understood and require further research. Additionally, the effects of Ashwagandha may vary based on individual factors such as age, health status, and dosage.
Some of the commercial products reviewed above include KSM-66, Sensoril, Shoden, NooGandha, and Prolanza ashwagandha extracts, which have varied transparency of the manufacturing process as well as different withanolides concentration (see comparison table above). In our view, KSM-66 ashwagandha may be preferred since it has the most clinical studies supporting its use in patients, and it is produced by a reliable company, Ixoreal, with the most GMP certifications and highest level of transparency.
If you have any medical conditions or take prescription medications, you should consult with a healthcare professional before trying ashwagandha. We also suggest exploring non-medication-based ways to manage stress and anxiety, such as tai-chi, yoga, meditation, and professional counseling. If you are pregnant or breast-feeding, do not take ashwagandha.
REFERENCES
- Natural medicines comprehensive database. Ashwagandha professional monograph. Accessed February 2023.
- Akhgarjand et al. Does Ashwagandha supplementation have a beneficial effect on the management of anxiety and stress? A systematic review and meta-analysis of randomized controlled trials Phytother Res. 2022 Nov;36(11):4115-4124.
- Mukherjee PK, Banerjee S, Biswas S, Das B, Kar A, Katiyar C. Withania somnifera (L.) Dunal-Modern perspectives of an ancient Rasayana from Ayurveda. J Ethnopharmacol. 2020; 264:113157.
- Srivastava A, Gupta AK, Shanker K, Gupta MM, Mishra R, Lal RK. Genetic variability, associations, and path analysis of chemical and morphological traits in Indian ginseng [Withania somnifera (L.) Dunal] for selection of higher yielding genotypes. Journal of ginseng research. 2018; 42(2):158–64.
- Kaushik MK, Kaul SC, Wadhwa R, Yanagisawa M, Urade Y. Triethylene glycol, an active component of Ashwagandha (Withania somnifera) leaves, is responsible for sleep induction. PLoS One. 2017; 12(2): e0172508.
- Gopukumar K, Thanawala S, Somepalli V, Rao TSS, Thamatam VB, Chauhan S. Efficacy and safety of ashwagandha root extract on cognitive functions in healthy, stressed adults: a randomized, double-blind, placebo-controlled study. Evid Based Complement Alternat Med. 2021 Nov 30;2021:8254344.
- Remenapp A, Coyle K, Orange T, et al. Efficacy of Withania somnifera supplementation on adult’s cognition and mood. J Ayurveda Integr Med. 2021 Nov 25;13(2):100510.
- Speers AB, Cabey KA, Soumyanath A, Wright KM. Effects of Withania somnifera (Ashwagandha) on Stress and the Stress- Related Neuropsychiatric Disorders Anxiety, Depression, and Insomnia. Curr Neuropharmacol. 2021;19(9):1468-1495.
Disclaimer: The information provided in this blog post is for educational purposes only and should not be considered as a substitute for professional medical advice, diagnosis, or treatment. As a clinical pharmacist, I strive to provide accurate and up-to-date information, but the field of herbal supplements is constantly evolving. Individual responses to herbal supplements may vary, and it is important to consult with a qualified healthcare professional before starting any new herbal supplement regimen. Additionally, it is crucial to carefully read and follow the instructions, warnings, and precautions provided by the manufacturers of herbal supplements. The author and the website disclaim any liability for any adverse effects or consequences resulting from the use or misuse of the information contained in this blog post.
