Studies.

All studies are product-specific, which means that they are done exactly on the extract contained in KSM66. In all studies, the dose 2x300 mg has been used - i.e. one capsule morning and evening. Experience in combination with safety studies shows that in case of increased need, the dose can be doubled.

ALL ASHWAGANDHA IS NOT THE SAME
When talking about Ashwagandha, it is important to understand that not all Ashwagandha is the same. What determines efficacy and safety is the plant part and the extraction method used. The current discussion about the possible risks of taking Ashwagandha is a result of this ignorance. Side effects when using leaves, berries and stem have been assumed to also apply to the root of ashwagandha - which is as wrong as assuming that potatoes are toxic, because the potato leaf is (Ashwagandha is part of the potato family). In traditional Indian medicine (Ayurveda), only root is used internally - precisely because the leaves contain high levels of cytotoxic substances such as Withaferin A and Withanone - substances that are not found in KSM66, which is a pure organic water/milk extract of root. Using leaves internally is something we in the West have figured out. Leaves cost only a fraction of root because leaves are normally used for fertilizer.

Below is a safety assessment and a selection of relevant studies on KSM66. Some of the studies are done on indications that go beyond the health claims registered with EFSA. However, since the studies also support the permitted health claims regarding function, safety and absorption, we have nevertheless chosen to make them available. If you are interested in further studies, please contact us.

The EFSA registered health claims are: KSM66, full spectrum extract of Ashwagandha (Withania somnifera) contributes to increased stress resilience, physical and mental capacity, emotional balance, easier falling asleep, relaxation, recovery and coping. In addition, Ashwagandha supports the sexual function of men and the reproductive organs of women and contributes to energy, endurance and increased muscle mass during exercise. Through its antioxidant capacity, Ashwagandha also contributes to maintaining general health.

KSM66 - a safety evaluation

After an incorrect risk assessment by the Danish National Food Administration regarding the safety of ashwagandha root - where, based on mainly small animal studies on leaves and stems, they incorrectly concluded that ashwagandha root can have negative effects, we have chosen to publish a complete safety assessment of KSM66. The most used and clinically studied ashwagandha in the world. For more information, contact Tom Johnsson, head of R&D: +46705949195, tom@medicinegarden.se

KSM66 - a safety assessment

This safety report has been prepared in light of the directly erroneous conclusions of a Danish risk assessment of ashwagandha (May 2020(DTU DOCX. No. 19/1030299). The safety report clearly shows that the Danish risk assessment of ashwagandha is not applicable to KSM66. The world's most widely used and well-documented ashwagandha. For more information contact Tom Johnsson, 0705 949195, tom@medicinegarden.se

Improved recovery after exercise and normalized (higher) testosterone values (2023)

Effect of Ashwagandha Root Extract on Serum Testosterone and Muscle Recovery in Strength Training, a prospective, randomized, double-blind, placebo-controlled study. The aim was to investigate the effects of Ashwagandha root extract on serum testosterone and inflammatory markers in healthy adults following resistance training Narsingh Verma, Sandeep Kumar Gupta, Shashank Tiwari, Ashok Kumar Mishra, Vaishali Thakare, Shirish Patil International Journal of Medical and Pharmaceutical Research, Volume: 4 Issue:5 2023

Improved training results and greater muscle growth and increased VO2 Max (2023)

Effects of Ashwagandha (Withania somnifera) standardized root extract on physical endurance and VO2max in healthy adults preforming resistance training: An eight-week, prospective, randomized, double-blind, placebo-controlled study Narsingh Verma, Sandeep Kumar Gupta, Sayali Patil, Shashank Tiwari, Ashok Kumar Mishra F1000Research 2023, 12:335

Improving sexual health in healthy but stressed women (2022)

Efficacy and Safety of Ashwagandha (Withania somnifera) Root Extract for Improvement of Sexual Health in Healthy Women: A Prospective, Randomized, Placebo-Controlled Study Ashutosh Ajgaonkar , Mukta Jain , Khokan Debnath Cureus 14(10): e30787. DOI 10.7759/cureus.30787

Improving sexual performance in healthy but stressed men (2022)

Effect of standardized root extract of ashwagandha (Withania somnifera) on well-being and sexual performance in adult males: A randomized controlled trial Chauhan, S., Srivastava, M. K., & Pathak, A. K. Health science reports, 5(4), e741.

Improvement of mild menopausal symptoms in healthy women (2021)

Effect of an ashwagandha (Withania somnifera) root extract on climacteric symptoms in women during perimenopause: A randomized, double-blind, placebo-controlled study Sriram Gopal, Ashutosh Ajgaonkar, Padmaja Kanchi, Aditi Kaundinya, Vaishali Thakare, Sanjaya Chauhan and Deepak Langade Japan Society of Obstetrics and Gynecology. 2021 Dec;47(12):4414-4425

Fitness (VO2max), recovery and stress management improved (2021)

A double-blind, randomized, placebo-controlled trial on the effect of Ashwagandha (Withania somnifera dunal.) root extract in improving cardiorespiratory endurance and recovery in healthy athletic adults

The worse the sleep quality - the better the effect. Both sleep onset and sleep quality improved (2021)

Clinical evaluation of the pharmacological impact of ashwagandha root extract on sleep in healthy volunteers and insomnia patients: A double-blind, randomized, parallel-group, placebo-controlled study

Improving the health, quality of life and sleep of older people (2020)

Efficacy and Tolerability of Ashwagandha Root Extract in the Elderly for Improvement of General Well-being and Sleep: A Prospective, Randomized, Doubleblind, Placebo-controlled Study.

Less stress and anxiety and better quality of sleep (2019)

Adaptogenic and Anxiolytic Effects of Ashwagandha Root Extract in Healthy Adults: A Double-blind, Randomized, Placebo-controlled Clinical Study Jaysing Salve , Sucheta Pate , Khokan Debnath , Deepak Langade Published 12/25/2019, DOI: 10.7759/cureus.6466

Easier falling asleep and better sleep quality (2019)

Efficacy and Safety of Ashwagandha (Withania somnifera) Root Extract in Insomnia and Anxiety: A Double-blind, Randomized, Placebo-controlled Study. Langade D, Kanchi S, Salve J, et al (September 28, 2019) Cureus 11(9): e5797. DOI 10.7759/cureus.5797

Normalization of thyroid function in subclinical hypothyroidism (2017)

Efficacy and Safety of Ashwagandha Root Extract in Subclinical Hypothyroid Patients: A Double-Blind, Randomized Placebo-Controlled Trial. Sharma, A. K., Basu, I., & Singh, S. (2017). The Journal of Alternative and Complementary Medicine.

Reducing stress and body weight (2017)

Body Weight Management in Adults Under Chronic Stress Through Treatment With Ashwagandha Root Extract: A Double-Blind, Randomized, Placebo-Controlled Trial Choudhary, D., Bhattacharyya, S., & Joshi, K. (2017). Journal of evidence-based complementary & alternative medicine, 22(1), 96-106. pub med

Better memory, concentration and focus (2017)

Efficacy and Safety of Ashwagandha (Withania somnifera (L.) Dunal) Root Extract in Improving Memory and Cognitive Functions Choudhary, D., Bhattacharyya, S., & Bose, S. (2017). Journal of Dietary Supplements, 1-14. Chicago.

Increased muscle growth and strength, less body fat (2015)

Examining the effect of Withania somnifera supplementation on muscle strength and recovery: a randomized controlled trial Wankhede, S., Langade, D., Joshi, K., Sinha, S. R., & Bhattacharyya, S. (2015). Journal of the International Society of Sports Nutrition, 12(1), 43. pub med

Increasing fitness and improving physical and mental health (2015)

Efficacy of Ashwagandha (Withania somnifera [L.] Dunal) in improving cardiorespiratory endurance in healthy athletic adults Choudhary, B., Shetty, A., & Langade, D.. G. (2015) Ayu, 36(1), 63

Increasing female sexual desire and function (2015)

Efficacy and Safety of Ashwagandha (Withania somnifera) Root Extract in Improving Sexual Function in Women: A Pilot Study Dongre, S., Langade, D., & Bhattacharyya, S. (2015). BioMed research international, 2015

Increased sex drive, function and testosterone levels (2013)

Clinical Evaluation of the Spermatogenic Activity of the Root Extract of Ashwagandha (Withania somnifera) in Oligospermic Males: A Pilot Study Ambiye. V. R., Langade, D., Dongre, S., Aptikar, P., Kulkarni, M., & Dongre, A. (2013). Evidence-Based Complementary and Alternative Medicine.

Reduces stress, anxiety and depression (2012)

A prospective, randomized double-blind, placebo-controlled study of safety and efficacy of a high-concentration full-spectrum extract of Ashwagandha root in reducing stress and anxiety in adults. Chandrasekhar, K., Kapoor, J., & Anishetty, S. (2012). Indian journal of psychological medicine, 34(3), 255.

The world's most well-documented ashwagandha - both in terms of efficacy and safety.
- 22 published double-blind, placebo-controlled and randomized studies, done on healthy but stressed people.
- 9 completed double-blind, placebo-controlled, randomized studies (under publication).
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Side effects
In total, 1888 people have been included in these 31 studies of which 968 have received KSM66, 600 mg per day while the rest have received identical placebo. In the KSM66 group 3.4% adverse events were recorded and in the placebo group 4.13%. All adverse events were mild and transient.
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Safety studies
In addition to the clinical studies, 12 preclinical safety studies have been conducted, the majority of which have been published. Acute toxicity, mutagenicity and reproduction have been studied. The preclinical studies include a long-term study and a reproduction study using a dose of 2000 mg/kg, which is 200 times the normal dose. No adverse changes compared to placebo have been noted in any of the studies

The world's most certified plant extracts

The quality work with production, environment and safety has meant that KSM66 is the world's most certified dietary supplement. Among other things, KSM66 is certified by BSCG (Banned Substances Control Group), one of the USA's leading anti-doping organizations.