Modi MB, Donga SB, Dei L. Clinical evaluation of Ashokarishta, Ashwagandha Churna, and Praval Pishti in the management of menopausal syndrome. AYU. 2012;33(4):511-516. doi:10.4103/0974-8520.110529

Publication Date: "Oct–Dec 2012"

Peer Reviewed: Yes

Study Design: "randomized open clinical trial"

Methodology: 52 patients randomly selected, given ASK (25 ml twice daily with water after food), ASW (3 g twice daily with milk half an hour before food), and PP (1 capsule of 250 mg twice daily with milk half an hour before food) for 3 months, assessed with MRS and MENQOL.

Sample Size: "52 patients were registered in the study, out of which 51 patients completed the study."

Controls Used: None stated.

Dose Used: "ASK (25 ml twice daily with equal quantity of water, after food, orally), ASW (3 g twice daily with milk, half an hour before food, orally) and PP (1 capsule of 250 mg twice daily with milk, half an hour before food, orally) for 3 months."

Statistical Significance Declared: "Statistically highly significant (P < 0.01)" for relief in MRS symptoms and MENQOL improvement.

Adverse Events due to Ashwagandha Supplementation: "No any adverse effect was noted during the study."

Conflict of Interest: None stated

Gopal S, Ajgaonkar A, Kanchi P, Kaundinya A, Thakare V, Chauhan S, Langade D. Effect of an ashwagandha (Withania somnifera) root extract on climacteric symptoms in women during perimenopause: A randomized, double-blind, placebo-controlled study. J Obstet Gynaecol Res. Published online September 22, 2021. doi:10.1111/jog.15030

Publication Date: "First published: 22 September 2021"

Peer Reviewed: Yes

Study Design: "randomized, double-blind, placebo-controlled study"

Methodology: 8-week study, 100 women, randomized to placebo or 300 mg Ashwagandha root extract twice daily, outcomes measured using MRS, MENQoL, hot flash score, and hormonal changes in estradiol, FSH, LH, and testosterone.

Sample Size: "100 participants"

Controls Used: "placebo"

Dose Used: "300 mg of an Ashwagandha root extract twice daily"

Statistical Significance Declared: "Statistically significant reduction in total MRS score (p < 0.0001)", "Significant reductions in the psychological (p = 0.0003), somato-vegetative (p = 0.0152), and urogenital (p < 0.0001) domains", "Statistically significant reduction in total MENQoL scores (p < 0.0001)", "Statistically significant increase in serum estradiol (p < 0.0001)", "Significant reduction in serum FSH (p < 0.0001) and serum LH (p < 0.05)"

Adverse Events due to Ashwagandha Supplementation: "Three participants in the ashwagandha group reported abdominal discomfort, abdominal pain, and nausea", "adverse events reported were mild and temporary"

Conflict of Interest: "None declared"

Dongre S, Langade D, Bhattacharyya S. Efficacy and Safety of Ashwagandha (Withania somnifera) Root Extract in Improving Sexual Function in Women: A Pilot Study. BioMed Research International. 2015;2015(1):284154. doi:10.1155/2015/284154.

Publication Date: "First published: 04 October 2015"

Peer Reviewed: Yes

Study Design: "randomized, double blind, and placebo-controlled"

Methodology: 50 study subjects were randomized to either HCARE-treated group or placebo group, consumed either HCARE or placebo capsules of 300mg twice daily for 8 weeks, assessed using FSFI and FSDS, and the number of total and successful sexual encounters.

Sample Size: "50 study subjects", "n = 25" per group

Controls Used: "placebo- (starch-) treated group"

Dose Used: "300mg twice daily for 8 weeks"

Statistical Significance Declared: "p < 0.001 for FSFI Total score, FSFI domain score for 'arousal' (p < 0.001), 'lubrication' (p < 0.001), 'orgasm' (p = 0.004), and 'satisfaction' (p < 0.001), and also FSDS score (p < 0.001) and the number of successful sexual encounters (p < 0.001)"

Adverse Events due to Ashwagandha Supplementation: "No adverse effects of therapy were observed in the HCARE group."

Conflict of Interest: "There is no conflict of interests."

Raut AA, Rege NN, Tadvi FM, et al. Exploratory study to evaluate tolerability, safety, and activity of Ashwagandha (Withania somnifera) in healthy volunteers.J Ayurveda Integr Med. 2012;3(3):111-114. doi:10.4103/0975-9476.100168

Publication Date: "July-September 2012"

Peer Reviewed: Yes

Study Design: "prospective, open-labeled, variable doses in volunteers"

Methodology: Volunteers received WS capsules in escalating doses every 10 days for 30 days; assessments included symptoms/signs, vital functions, hematological and biochemical organ function tests, muscle activity, exercise tolerance, body fat percentage, and lean body weight.

Sample Size: "Eighteen apparently healthy volunteers (12M:6F, age:18-30 years, and BMI: 19-30)"

Controls Used: No control group used.

Dose Used: "750 mg/day x10 days, 1000 mg/day x 10 days, 1250 mg/day x 10 days"

Statistical Significance Declared: "Repeated measures ANOVA, McNemar's test, and paired t test were employed. P <0.05 was considered significant."

Adverse Events due to Ashwagandha Supplementation: "One volunteer showed increased appetite, libido, and hallucinogenic effects with vertigo at the lowest dose and was withdrawn from study."

Conflict of Interest: None declared

Dongre S, Langade D, Bhattacharyya S. Efficacy and safety of Ashwagandha (Withania somnifera) root extract in improving sexual function in women: a pilot study. BioMed Res Int. 2015;2015:284154. doi:10.1155/2015/284154

Publication Date: "04 October 2015"

Peer Reviewed: Yes

Study Design: "Double blind, placebo-controlled, randomized"

Methodology: 50 subjects randomized to HCARE-treated group or placebo-treated group, consumed 300mg capsules twice daily for 8 weeks, sexual function assessed using FSFI and FSDS scales, and number of total and successful sexual encounters recorded.

Sample Size: "50 study subjects" (25 in HCARE group, 25 in placebo group)

Controls Used: "Placebo- (starch-) treated group"

Dose Used: "300mg twice daily"

Statistical Significance Declared: "FSFI Total score (p < 0.001), FSFI domain score for 'arousal' (p < 0.001), 'lubrication' (p < 0.001), 'orgasm' (p = 0.004), and 'satisfaction' (p < 0.001), and also FSDS score (p < 0.001) and the number of successful sexual encounters (p < 0.001)"

Adverse Events due to Ashwagandha Supplementation: "No adverse effects of therapy were observed in the HCARE group."

Conflict of Interest: "There is no conflict of interests."

Mikulska P, Malinowska M, Ignacyk M, Szustowski P, Nowak J, Pesta K, Szeląg M, Szklanny D, Judasz E, Kaczmarek G, et al. Ashwagandha(Withania somnifera)—Current Research on the Health-Promoting Activities: A Narrative Review.Pharmaceutics. 2023; 15(4):1057. https://doi.org/10.3390/pharmaceutics15041057

Publication Date: "24 March 2023."

Peer Reviewed: Yes.

Study Design: "narrative review."

Methodology: Literature review of current research on Ashwagandha's effects.

Sample Size: Various sample sizes depending on individual studies reviewed.

Controls Used: Placebo groups in various studies.

Dose Used: Various, including "300 mg of Withania somnifera root extract twice daily for eight weeks."

Statistical Significance Declared: "Significantly greater increases in muscle strength and power" and "Significant improvement in maximal aerobic capacity, time to exhaustion, and ventilatory threshold."

Adverse Events due to Ashwagandha Supplementation: "Liver damage is usually cholestatic or mixed with severe jaundice and pruritus, but is self-limiting, with normalisation of liver test results within 1–5 months."

Conflict of Interest: "The authors declare no conflict of interest."

Kulkarni P, Khobragade P. Phytoestrogens Medicinal Herbs - Safe and Effective Alternative to Hormone Replacement Therapy in Menopausal Syndrome. J Res Tradit Med. 2016;2(5). doi:10.21276/jrtm.2016/278

Publication Date: "Received: 28/11/2016 Revised: 4/1/2016 Accepted: 16/1/2017"

Peer Reviewed: No

Study Design: "Review Article"

Methodology: "Literatures such as Brihattrayee (Three major compendia of Ayurved), Nighantu (Lexicon), modern textbooks written in 21 century, and journals from year 2000 upto 2016 were critically reviewed to explore safety and efficacy of phytoestrogens in Ayurvedic herbs."

Sample Size: Not applicable

Controls Used: Not applicable

Dose Used: Not applicable

Statistical Significance Declared: Not applicable

Adverse Events due to Ashwagandha Supplementation: None mentioned

Conflict of Interest: None mentioned

POTOCKA Z, BORYCKA A, JĘDRZEJEWSKA B, KOTULSKA M, LASKUS P, LICHMAN M, LUBCZYŃSKA Z, PRZERADZKI J, RZĄD K. Potential clinical usage of ashwagandha root extract: A review. J Educ Health Sport. 2023;29(1):35-44. doi:10.12775/JEHS.2023.29.01.004

Publication Date: "2023"

Peer Reviewed: Yes

Study Design: "Review"

Methodology: Literature review conducted using PubMed and Google Scholar online databases.

Sample Size: Small sample studies

Controls Used: Placebo group

Dose Used: Not specified

Statistical Significance Declared: "Not statistically significant improvement in quality of life compared to placebo group"

Adverse Events due to Ashwagandha Supplementation: None directly linked to Ashwagandha supplementation

Conflict of Interest: Not stated

Rawat N, Roushan R. Ashwagandha (Withania Somnifera); A potential aphrodisiac drug in Ayurveda. Int J Basic Appl Res. 2019;8:1034-1041.

Publication Date: "August 2018"

Peer Reviewed: Yes

Study Design: "randomized, and placebo-controlled study"

Methodology: Evaluated efficacy of Ashwagandha root extract in enhancing cardiorespiratory endurance and improving quality of life in healthy athletic adults.

Sample Size: "50 healthy male/female athletic adults."

Controls Used: "placebo"

Dose Used: Not specified in the provided text.

Statistical Significance Declared: "P< 0.05"

Adverse Events due to Ashwagandha Supplementation: Not stated.

Conflict of Interest: Not declared.

Singh N, Bhalla M, de Jager P, Gilca M. An Overview on Ashwagandha: A Rasayana (Rejuvenator) of Ayurveda. Afr J Tradit Complement Altern Med. 2011;8(Suppl 5):9. doi:10.4314/ajtcam.v8i5S.9

Publication Date: "2011"

Peer Reviewed: Yes

Study Design: Review study, "Comparative studies on the biological model of animals."

Methodology: Animal studies involving swimming endurance tests, adrenal gland analysis, gastric ulcer prevention, tumor inhibition tests, neurodegenerative disease models, and various biochemical assays.

Sample Size: Not explicitly mentioned. (review study)

Controls Used: Various, including "Control group of mice," "non-swimmer group," and "untreated animals."

Dose Used: Various, including "An aqueous suspension of Ashwagandha root was used at 100 mg/kg/oral dosage."

Statistical Significance Declared: Various, including "The results indicate a significant increase in the plasma corticosterone level, phagocytic index and avidity index in rats subjected to cold swimming stress."

Adverse Events due to Ashwagandha Supplementation: No adverse events directly linked to Ashwagandha supplementation were declared.

Conflict of Interest: No conflicts of interest declared.

Umadevi M, Rajeswari R, Rahale CS, Selvavenkadesh S, Pushpa R, Sampath Kumar KP, Bhowmik D. Traditional And Medicinal Uses of Withania Somnifera. The Pharma Innovation. 2012;1(9):102. ISSN: 2277-7695. CODEN Code: PIHNBQ. ZDB-Number: 2663038-2. IC Journal No: 7725.

Publication Date: "2012"

Peer Reviewed: Yes

Study Design: Not specified in the provided text.

Methodology: Not specified in the provided text.

Sample Size: Not specified in the provided text.

Controls Used: Not specified in the provided text.

Dose Used: Not specified in the provided text.

Statistical Significance Declared: Not specified in the provided text.

Adverse Events due to Ashwagandha Supplementation: "Excessive doses of ashwagandha have been reported to cause abortions, so pregnant women should avoid this herb." "Large doses can cause diarrhea, stomach upset and vomiting."

Conflict of Interest: Not specified in the provided text.

Yadav P, Lamba A, Meena A, Tanwar R, Choudhary A, Choudhary A, Choudhary W. An Overview on Health Benefits of Withania somnifera (Ashwagandha) in Veterinary Medicine. Curr J Appl Sci Technol. 2023;42(22):10-16. doi:10.9734/cjast/2023/v42i224166

Publication Date: "29/07/2023"

Peer Reviewed: Yes

Study Design: "Review Article"

Methodology: Analysis of various pharmacological effects of Withania somnifera based on previously conducted studies.

Sample Size: Not applicable (Review article)

Controls Used: Not applicable (Review article)

Dose Used: Various doses mentioned for different studies within the review, such as "500 mg/kg thrice in a week for 8 consecutive weeks."

Statistical Significance Declared: Not applicable (review article).

Adverse Events due to Ashwagandha Supplementation: None declared in the review.

Conflict of Interest: "Authors have declared that no competing interests exist."

Ng QX, Loke W, Foo NX, Tan WJ, Chan HW, Lim DY, Yeo WS. A systematic review of the clinical use of Withania somnifera (Ashwagandha) to ameliorate cognitive dysfunction. Phytother Res. 2020;34(3):583-590. doi:10.1002/ptr.6552

Publication Date: "19 November 2019"

Peer Reviewed: Yes

Study Design: "systematic review"

Methodology: Comprehensive search of databases (PubMed, EMBASE, Medline, PsycINFO, Clinicaltrials.gov), title/abstract screening, manual review, PRISMA guidelines, English-language articles, cross-checking for accuracy, Cochrane Collaboration's tool for assessing risk of bias.

Sample Size: "Five clinical studies"

Controls Used: "Randomized, placebo-controlled, double-blind"

Dose Used: Various, such as "Two teaspoons of BR-16A (Mentat) thrice daily for 12 weeks", "Two teaspoons of BR-16A (Mentat) thrice daily for 1 year", "W. somnifera capsule (Sensoril) 250–500 mg/day for 8 weeks", "W. somnifera (Sensoril) 250 mg/day for 14 days", "W. somnifera root extract (300 mg twice daily) for 8 weeks", "W. somnifera (Sensoril) 1,000 mg/day for 12 weeks"

Statistical Significance Declared: Various, such as "Statistically significant (p < .05) improvement in Wechsler Memory Scale III subtest scores for logical memory, as well as improved executive function, sustained attention, and information-processing speed."

Adverse Events due to Ashwagandha Supplementation: "No major adverse events were reported in any of the trials"

Conflict of Interest: "The authors report no conflicts of interest."

Kumar MS, Banmali D, Purnendu P, Bhuyan GC, Rao MM. Uses of Withania somnifera (Linn) Dunal (Ashwagandha) in Ayurveda and its Pharmacological Evidences. Research Journal of Pharmacology and Pharmacodynamics. 2016;8(1):23-29. doi:10.5958/2321-5836.2016.00006.9

Publication Date: "Accepted on 21.02.2016"

Peer Reviewed: Yes

Study Design: "review"

Methodology: Literature review of pharmacological studies on Ashwagandha.

Sample Size: Not applicable (review study).

Controls Used: Not applicable (review study).

Dose Used: Varies across studies reviewed; specific doses not provided.

Statistical Significance Declared: Not provided (review study).

Adverse Events due to Ashwagandha Supplementation: "Ashwagandha is not recommended in case of hyperthyroidism or pregnancy and can in high doses provoke certain intestinal problems." "In strong doses, Ashwagandha can have a hypnotic effect."

Conflict of Interest: Not declared in the provided text.

Sandhir R, Sood A. Neuroprotective Potential of Withania somnifera (Ashwagandha) in Neurological Conditions. In: Kaul SC, Wadhwa R, eds. Science of Ashwagandha: Preventive and Therapeutic Potentials. Cham: Springer International Publishing; 2017:373-387. doi:10.1007/978-3-319-59192-6_18

Publication Date: "First Online: 12 September 2017"

Peer Reviewed: Yes

Study Design: "Chapter"

Methodology: Animal models, cell cultures, behavioral tests, biochemical assays.

Sample Size: Various studies with different models (exact sample sizes not specified).

Controls Used: "Haloperidol", "Reserpine", "Kainate", "Pentylenetetrazol (PTZ)", "6-hydroxydopamine", "Middle cerebral artery occlusion (MCAO)".

Dose Used: "WS root extract (100 mg/kg)", "WS root extract (50 mg/kg)", "WS root extract (200 mg/kg)", "Withanolide A".

Statistical Significance Declared: Various p-values and significance levels reported in different studies, exact values not specified.

Adverse Events due to Ashwagandha Supplementation: No adverse events directly linked to Ashwagandha supplementation stated.

Conflict of Interest: None stated.

Bonilla DA, Moreno Y, Gho C, Petro JL, Odriozola-Martínez A, Kreider RB. Effects of Ashwagandha (Withania somnifera) on Physical Performance: Systematic Review and Bayesian Meta-Analysis.Journal of Functional Morphology and Kinesiology. 2021; 6(1):20. https://doi.org/10.3390/jfmk6010020

Publication Date: "11 February 2021"

Peer Reviewed: Yes

Study Design: "Systematic review and Bayesian meta-analysis"

Methodology: PRISMA-based comprehensive systematic review; Bayesian hierarchical models for subgroup meta-analysis; estimation statistics analysis.

Sample Size: "A total of 13 studies met the requirements of this systematic review, although only 12 were included in the quantitative analysis."

Controls Used: Not Applicable. (review study)

Dose Used: Not Applicable. (review study)

Statistical Significance Declared: "The Bayesian models showed that future interventions might be at least in some way beneficial on the analyzed outcomes considering the 95% credible intervals for the meta-analytic effect size."

Adverse Events due to Ashwagandha Supplementation: "None of the clinical trials have found serious adverse effects from the consumption of Ashwagandha in the doses and length administered."

Conflict of Interest: “D.A.B. serves as Science Product Manager for MTX Corporation® in Europe, a company that sells a dietary product with Ashwagandha, has acted as a scientific consultant for MET-Rx in Colombia and is a current scientific affiliate to the “Creatine in Health” scientific advisory board for AlzChem (Tostberg, GmbH). R.B.K. has conducted a number of industry-sponsored studies on sport nutrition-related nutrients that include Ashwagandha, has served as a paid consultant and received honorariums to speak at conferences by industry, and currently serves as chair of the “Creatine in Health” scientific advisory board for AlzChem. The other authors declare no conflicts of interest.”