Effects of Withania somnifera on Reproductive System: A Systematic Review of the Available Evidence

Table 1

Characteristics and results of human studies investigating effects of Withaniasomnifera on reproductive system.

Number	Author/year	Design	Participant	Intervention protocol	Duration; of study	Results	Place	Part/; compound
(1)	Mahdi et al., 2011 [12]	Controlled, prospective,; before and after clinical trial	Normozoospermic infertile men (); 3 groups; heavy smoker ), under psychological stress (), unknown etiology (), control fertile men ()	5 g/d/PO/single dose with milk	3 months	No marked change in semen volume, liquefaction time (, ), ↑ sperm concentration (, ), ↑ sperm motility in cigarette smokers and psychological stress groups (), ↑ LH, FSH, ↑ T, PRl, cortisol, LPO in seminal plasma and ↑ SOD in 3 groups (), ↑ CAT in psychological stress groups (), ↑ glutathione, ↑ ascorbic acid in psychological stress and unknown etiology groups (), ↑ vitamin E, ↑ vitamin A in 3 groups () after treatment compared to before treatment, ↑ 14% rate of success of pregnancy in the partners	India	Root powder
(2)	Ambiye et al., 2013 [20]	Double-blind, randomized, placebo-controlled clinical trial (a pilot study)	Oligospermic infertile male (); 2 groups: WS () and placebo ()	675 mg: 1 capsule of 225 mg/thrice a day/PO	90 days	↑ 53% semen volume, ↑ 167% sperm count, ↑ 57% sperm motility (), ↑ 17% serum T (), ↑ 34% LH () after 90 days of therapy compared to the baseline values on Day 0; GASE and GATE in WS-treated compared to placebo were excellent (68.75%)	India	Full spectrum; root extract
(3)	Dongre et al., 2015 [21]	Double-blind, randomized, placebo-controlled clinical trial (a pilot study)	Healthy married women (); WS (); placebo ()	Capsules of 300 mg/; twice daily/PO after food	8 weeks	↑ total score (FSFI) (), ↑ FSFI domain score for “arousal” (), “lubrication” (), “orgasm” (), “satisfaction” (), ↑ FSDS score (), ↑ number of successful sexual encounters () after treatment compared to placebo; PGART and PGATT in both groups were excellent, no toxic effect during 8 weeks in WS-treated group	India	High-concentration root water extract
(4)	Mamidi et al., 2014 [22]	Randomized, single-blind, placebo-controlled, parallel-group study	Men with ED (); 2 groups: WS; () and placebo ()	Four tablets 500 mg thrice a day (6 g)/PO after food	60 days	↑ 10.52% on EDSI, ↑ 4.18% on IMHQOL, ↑ 39.22 on QEQ in WS group, ↑ 11.20% on EDSI, ↑ 5.95% on IMHQOL, ↑ 45.74% on QEQ () in control group. No marked difference between two groups on all the scales (). No significant effect in length, circumference, angle of erection of penis after treatment between both groups	India	Root powder
(5)	Shukla et al., 2011 [23]	Controlled, prospective,; before and after clinical trial	Infertile men (); 3 groups: NZ (), OZ (), AZ () and control, healthy fertile men ()	5 g/day/single dose with milk	3 months	Sperms apoptosis in NZ and OZ men, ROS of spermatozoa in OZ and AZ infertile men (), ↑ metal ions concentration (Cu^2+, Zn^2+, Fe^2+, Au^2+) of seminal plasma in 3 groups () after treatment comparison to before treatment	India	Root powder
(6)	Gupta et al., 2013 [24]	Controlled, prospective, before and after clinical trial	Infertile men (); 3 groups: NZ (), OZ (), AZ () and control, healthy fertile men ()	5 g/day/PO/; single dose with milk	3 months	↑ sperm concentration, ↑ sperm motility, ↓ LPO, ↑ LH, ↑ T (), ↓ FSH, ↓ PRL, ↑ ALT, ↑ AST, ↑ LDH, ↑ IDH, ↑ alanine, ↑ glutamate, ↑ citrate, ↑ GPC, ↑ histidine, ↓ phenylalanine in seminal plasma, after treatment compared to before treatment in NZ, OZ, AZ groups ()	India	Root; powder
(7)	Ahmad et al., 2010 [25]	Controlled, prospective, before and after clinical trial	Infertile men (); 3 groups:; NZ (), OZ (), AZ () and control, healthy fertile men ()	5 g/day/PO with milk	3 months	↑ sperm concentration, ↑ sperm count (), ↑ sperm motility, LPO (), ↑ SOD, ↓ protein carbonyl groups in seminal plasma (), ↑ CAT (), ↑ glutathione (), ↑ vitamins A, E, and C (), ↑ seminal fructose (), ↑ T (), ↑ LH, ↓ FSH, ↓ PRL in all of the groups of infertile men after treatment compared to before treatment, ↑ semen volume in NZ and OZ groups after treatments compared to before treatments	India	Root; powder
(8)	Mamidi and Thakar, 2011 [26]	Randomized, single-blind, placebo-controlled, parallel-group study	Men with ED (); 2 groups: WS () and control ()	Four tablets 500 mg/PO/thrice a day after food	60 days	↑ 12.6% IIEF in WS-treated and ↑ 19.11% in placebo group (), no significant effect in the management of psychogenic erectile dysfunction and IIEF in WS-treated group compared to placebo group ()	India	Root powder

ND, not determined; WS, Withania somnifera; FSH, follicular stimulating hormone; LH, luteinizing hormone; ALP, alkaline phosphatase; Cd, cadmium; GSH, glutathione peroxidase; SOD, superoxide dismutase; CAT, catalase; MDA, malondialdehyde; STD, seminiferous tubules diameter; T, testosterone; PRL, prolactin; LPO, lipid peroxidation; GABAAg, amino butyric acid; TG, triglyceride; EDSI, erectile dysfunction severity index; FSFI, female sexual function index; FSDS, female sexual distress scale; IMHQOL, Internet mental health quality of life scale; QEQ, quality of erection questionnaire; NZ, normozoospermic; OZ, oligozoospermic; AZ, asthenozoospermic; IDH, isocitrate dehydrogenase; LDH, lactate dehydrogenase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; GPC, glycerophosphocholine; IIEF, international index of erectile function; PGART, patient’s global assessment of response to therapy; PGATT, patient’s global assessment of tolerability to therapy; GASE, global assessment scale for efficacy; GATE, global assessment scale for tolerability; ↑, increase; ↓, decrease.