Effects of Tribulus terrestris saponins on proliferation and invasion of A549 cells

Objective:Tribulus terrestris saponin is a traditional Chinese medicine in China.This experiment was designed to investigate the effects of tribulus terrestris saponin on the proliferation and invasion ability of non-small cell lung cancer A549 cells.Methods:A549 cells were divided into normal control and experimental groups(Tribulus terrestris saponin 250μg/mL group,Tribulus terrestris saponin 200μg/mL group,Tribulus terrestris saponin 150μg/mL group,Tribulus terrestris saponin 100μg/mL group,Tribulus terrestris saponin 50μg/mL group).The proliferation viability of the cells in each group was detected by CCK8,the invasion of tumor cells was detected by Transwell model.The mRNA expression of MMP9 and caspase-3 in each group of cells was detected by RT-PCR.Immunofluorescence staining was used to observe the fluorescence intensity of caspase-3 in each group of cells.Results:Compared with the normal control group,tribulus terrestris saponin significantly inhibited the proliferation activity and invasion ability of A549 cells,which was statistically significant(P<0.01).In the invasion assay,compared with the control group,MMP9 expression was significantly reduced and caspase-3 expression was significantly increased in the tribulus terrestris saponin group,and both were concentration-dependent,with statistically significant differences(P<0.01).By cellular immunofluorescence staining experiments,it was found that the fluorescence expression of caspase-3 was enhanced in the experimental group compared with the normal control group,in which the high concentration saponin group was significantly higher than the low concentration group.Conclusion:Tribulus terrestris saponin can inhibit the invasive ability of A549 cells by down-regulating the expression of MMP9,and induce irreversible apoptosis by up-regulating the activation of caspase-3 expression to form caspase-3.

Modulatory effects of the fruits of Tribulus terrestris L. on the function of atopic dermatitis-related calcium channels,Orai1 and TRPV3

Objective: To examine the effects of Tribulus terrestris L.(T. terrestris) extract on the modulation of calcium channels to evaluate its use in topical agents for treatment of atopic dermatitis.Methods: The 70% methanol extract of T. terrestris was prepared. Human HEK293 T cells with over-expressed calcium release-activated calcium channel protein 1(Orai1),transient receptor potential vanilloid 1, or transient receptor potential vanilloid 3(TRPV3)were treated with T. terrestris extract. Modulation of ion channels was measured using a conventional whole-cell patch-clamp technique.Results: T. terrestris extract(100 mg/m L) significantly inhibited Orai1 activity in Orai1-stromal interaction molecule 1 co-overexpressed HEK293 T cells. In addition, T. terrestris extract significantly increased the TRPV3 activity compared with 2-Aminoethyl diphenylborinate(100 mmol/L), which induces the full activation of TRPV3.Conclusions: Our results suggest that T. terrestris extract may have a therapeutic potential for recovery of abnormal skin barrier pathologies in atopic dermatitis through modulating the activities of calcium ion channels, Orai1 and TRPV3. This is the first study to report the modulatory effect of a medicinal plant on the function of ion channels in skin barrier.

Two new furostanol saponins from Tribulus terrestris L.

Two new furostanol glycoside,26-O-β-D-glucopyranosyl-(25S)-5α-furost-3β,22α,26-triol-3-O-β-D-rhamnopyranosyl-(1→2)-[β-D-glucopyranosyl-(1→4)]-β-D-galactopyranoside(1) and 26-O-β-D-glucopyranosyl-(25S)-5α-furost-20(22)-en-2α,3β,26-triol-3-O-β-D-glucopyranosyl-(1→2)-O-β-D-glucopyranosyl-(1→4)-β-D-galactopyranoside(2) were isolated fromthe fruits of Tribulus terrestris L.The structures of two new furostanol saponins were elucidated by spectroscopic methods.

Tribulus terrestris extracts alleviate muscle damage and promote anaerobic performance of trained male boxers and its mechanisms： Roles of androgen, IGF-1, and IGF binding protein-3

Purpose: To investigate the effects of Tribulus terrestris(TT) extracts on muscle mass, muscle damage, and anaerobic performances of trained male boxers and its mechanisms: roles of plasma androgen, insulin growth factor 1(IGF-1), and IGF-1 binding protein-3(IGFBP-3).Methods: Fifteen male boxers were divided into exercise group(E, n = 7) and exercise plus TT group(E + TT, n = 8). The 2 groups both undertook3-week high-intensity and 3-week high-volume trainings separated by a 4-week rest. TT extracts(1250 mg/day) were orally administered by boxers in E + TT group. TT extract compositions were detected by UHPLC–Q-TOF/MS. Before and at the end of the 2 trainings, muscle mass, anaerobic performance, and blood indicators were explored.Results: Compared with E group, decreases of plasma CK(1591.5 ± 909.6 U/L vs. 2719.9 ± 832.5 U/L) and IGFBP-3(3075.5 ± 1072.5 ng/m L vs. 3950.8 ± 479.3 ng/m L) as well as increases of mean power(MP, 459.4 ± 122.3 W vs. 434.6 ± 69.5 W) and MP/body weight(MP/BW, 7.5 ± 0.9 W/kg vs. 7.1 ± 1.1 W/kg) were detected in E + TT group after a high-intensity training. For high-volume training, reduction of IGFBP-3(2946.4 ± 974.1 ng/m L vs. 3632.7 ± 470.1 ng/m L) and increases of MP(508.7 ± 103.2 W vs. 477.8 ± 49.9 W) and MP/BW(8.2 ± 0.3 W/kg vs.7.5 ± 0.9 W/kg) were detected in E + TT group, compared with E group. Muscle mass, blood levels of testosterone, dihydrotestosterone(DHT),and IGF-1 were not signifiantly changed between the 2 groups.Conclusion: Taking 1250 mg capsules containing TT extracts did not change muscle mass and plasma levels of testosterone, DHT, and IGF-1 but significantly alleviated muscle damage and promoted anaerobic performance of trained male boxers, which may be related to the decrease of plasma IGFBP-3 rather than androgen in plasma.

Use of a Natural Compound Made of Ecklonia bicyclis Seaweed, Tribulus terrestris and Water-Soluble Chitosan Oligosaccharide, in Male Sexual Asthenia with Mild or Mild-Moderate Erectile Dysfunction and Serum Testosterone Levels at the Lower Limit of Normal

Objectives: to evaluate the effectiveness of a natural compound made of Ecklonia bicyclis Seaweed, Tribulus terrestris and water-soluble chitosan oligosaccharide, in the male sexual asthenia with mild or mild-moderate erectile dysfunction and serum testosterone levels between 280 and 350 ng/dl. Materials and Methods: 84 male patients affected by reduced libido and serum testosterone levels at the lower limit of normal, were recruited. We have separated patients in three different age groups: group A (18 - 45 years), group B (45 - 59 years), group C (>60 years). All subjects answered the International index of erectile function questionnaire (IIEF-5) and underwent determination of serum total testosterone before and after 30 days of treatment. Results: Before treatment, the group A showed mean (± standard deviation) total testosterone 321.9 ± 19.2 ng/dl and mean IIEF-5 18.6 ± 1.97, in the group B it was 318.5 ± 18.1 ng/dl and 16.3 ± 2.66, and finally in the group C it was 305.4 ± 13.1 ng/dl and 14.2 ± 1.95 respectively. After treatment mean total testosterone and mean IIEF-5 were respectively: group A (448 ± 111.46 ng/dl and 21.84 ± 3.41);group B (453.8 ± 105.23 ng/dl and 20.4 ± 3.81);group C (385.8 ± 87.29 ng/dl and 16.7 ± 3.84). Conclusions: The treatment with Ecklonia bicyclis, Tribulus terrestris and water-soluble chitosan oligosaccharide might represent a safe and effective option on the improvement of libido and erectile function in man with testosterone level at the lower limit of normal.

Steroidal saponins with anti-inflammatory activity from Tribulus terrestris L.

Objective:Tribulus terrestris L.(T.terrestris)is a highly valuable traditional Chinese medicine used to treat stroke,inflammation,pulmonary fibrosis,liver cancer,and urolithiasis.To identify the basic substance responsible for the anti-inflammatory effect of TST(total saponins of Tribulus),its chemical composition was systematically studied,and its effect of inhibiting nitric oxide generation and the expression of related inflammatory factors were determined.Methods:To separate chemical constituents from T.terrestris by column chromatography.Spectroscopic methods,including 1D and 2D nuclear magnetic resonance spectroscopy(NMR)and mass spectrometry(MS)techniques,were used to elucidate the isolated compounds.The anti-inflammatory activities of TST and several compounds were evaluated in vitro.Results:Fifteen steroidal saponins,including 9 furostanol steroidal saponins(1,2,3,4,5,6,7,8,and 15)and 6 isospirostanol steroidal saponins(9,10,11,12,13,and 14),were isolated from T.terrestris.TST significantly decreased the expression of tumor necrosis factor-a(TNF-a)and interleukin-6(IL-6)in RAW 264.7 cells stimulated by lipopolysaccharides.Compounds 13 and 15 evidently reduced TNF-a expression.Compounds 6,10,12,13,and 15 markedly reduced IL-6 expression.Conclusions:Compounds 1 was a novel furostanol steroidal saponin,named 26-O-b-D-glucopyranosyl-(25R)-5afurostan-12-carbonyl-20(22)-en-3b,26-diol-3-O-{b-D-xylopyranosyl-(1→2)-[b-D-xylopyranosyl-(1→3)]-b-D-glucopyranosyl-(1→4)-[a-L-rhamnopyranosyl-(1→2)]-b-D-galactopyranoside}.Compounds 2 was isolated from the family Zygophyllaceae for the first time,and 5 and 6 were isolated from the Tribulus genus.TST and compounds 6,10,12,13,and 15 exerts antiinflammatory activity.

Chromatographic finger print analysis of anti-inflammatory active extract fractions of aerial parts of Tribulus terrestris by HPTLC technique

Objective:To develop HPTLC fingerprint profile of anti-inflammatory active extract fractions of Tribulus terrestris(family Zygophyllaceae).Methods:The anti-inflammatory activity was tested for the methanol and its fractions(chloroform,ethyl acetate,n-butanol and aqueous)and chloroform extract of Tribulus terrestris(aerial parts)by injecting different groups of rats(6 each)with carrageenan in hind paw and measuring the edema volume before and 1,2 and 3 h after carrageenan injection.Control group received saline i.p.The extracts treatment was injected i.p.in doses of 200 mg/kg 1 h before carrageenan administration.Indomethacin(30 mg/kg)was used as standard.HPTLC studies were carried out using CAMAG HPTLC system equipped with Linomat IV applicator.TLC scanner 3.Reprostar 3,CAMAG ADC 2 and WIN CATS-4 software for the active fractions of chloroform fraction of methanol extract.Results:The methanol extract showed good antiedematous effect with percentage of inhibition more than 72%,indicating its ability to inhibit the inflammatory mediators.The methanol extract was re-dissolved in 100 mL of distilled water and fractionated with chloroform,ethyl acetate and n-butanol.The four fractions(chloroform,ethyl acetate,n-butanol and aqueous)were subjected to anti-inflammatory activity.Chloroform fraction showed good anti-inflammatory activity at dose of 200 mg/kg.Chloroform fraction was then subjected to normal phase silica gel column chromatography and eluted with petroleum ether-chloroform,chloroform-ethyl acetate mixtures of increasing polarity which produced 15 fractions(F1-F15).Only fractions F1,F2,F4,F5,F7,F9,F11 and F14 were found to be active,hence these were analyzed with HPTLC to develop their finger print profile.These fractions showed different spots with different R_f values.Conclusions:The different chloroform fractions F1,F2,F4,F5,F7,F9,F11 and F14 revealed 4,7,7,8,9,7,7 and 6 major spots,respectively.The results obtained in this experiment strongly support and validate the traditional uses of this Sudanese medicinal plant.

Optimization of Extraction of Saponins from Tribulus terrestris L.

To promote the recovery of saponins from Tribulus terrestris L.,the water dissolution and ethanol precipitation method was adopted to extract saponins from the powder prepared from T.terrestris fruit.The optimal process was to extract with 9 fold of the extracting water at the ethanol concentration of 85 for 3 times,each time 3.5 h.The effects of the factors ranked as the extracting water quantity > treatment time > treatment times > ethanol concentration.Under these optimal conditions,the recovery of saponins was 2.81%.After these crude saponins were purified by D101 macroporous adsorptive resin,the purity was found to be promoted through the UV scanning method,and the recovery of the refined saponins was up to 1.53%.Both of the recovery values were higher than that of the existing process.

Elastosonographic Changes in Patients with Peyronie's Disease, before and after Treatment with a Compound Based on <i>Ecklonia bicyclis</i>, <i>Tribulus terrestris</i>, and Water-Soluble Chitosan

Several diagnostic techniques have been proposed during the time for the diagnostic evaluation of Induratio Penis Plastica (IPP), due to poor sensitivity and specificity of standard B-Mode Ultrasonography. Shear-Wave elastosonography (SWE) is a relative new ultrasound technique, already used for several organs, which allows evaluating the rigidity of the tissues. Furthermore, we used a compound consisting of Ecklonia bicyclis, Tribulus terrestris, and Biovis (water-soluble Chitosan) with antifibrotic and antioxidant properties and analyzed the elastosonographic variations following the assumption of the compound. From March 2016 to April 2017, 40 patients were recruited with a mean age of 62. All patients underwent elastosonographic measurements at the start of treatment. Subsequently each patient took 1 tablet of the compound of Ecklonia bicyclis, Tribulus terrestris, and Biovis (water-soluble Chitosan) for 6 months. All patients underwent elastosonographic investigation at the end of treatment. The elastosonographic measurement prior treatment, showed that the average of the three measurements (proximal, medial and distal), was 37.05 KPa ± 7.76 SD and 38.8 KPa ± 10.11 SD for the left and right cavernous body, respectively. The examination at the end of the six months of treatment, with the compound showed that the average values of fibrosity were 31.07 KPa ± 7.5 SD and 30.86 KPa ± 11.4 SD for the left and right cavernous body respectively, demonstrating a decrease in fibrosity that was statistically significant (P < 0.01). Our data demonstrate that taking the compound for six months reduces the stiffness of the corpora cavernosa.

Protective Effects of Tribulus terrestris,Avena sativa,and White Ginseng Powder on Bone Mineral Density in Hypercholesterolemic Rats

This study investigated the effects of the herbal compounds Tribulus terrestris(TT),Avena sativa(AS),white ginseng(WG),and a triple combination(TC)powder on the serum total cholesterol,low-density lipoprotein cholesterol(LDL-C),high-density lipoprotein cholesterol(HDL-C),triglyceride,and the tibial bone mineral density(BMD)levels in rats fed a high-cholesterol diet.This study comprised Group I(normal pellet feed),Group II(pellet feed with 2%cholesterol),Group III(2%cholesterol plus 15%TT),Group IV(2%cholesterol plus 7.5%AS),Group V(2%cholesterol plus 5%WG)and Group VI(2%cholesterol plus 7.5 TT%+3.75%AS,2.5%WG).The serum total cholesterol,LDL-C,HDL-C,triglyceride,and tibial BMD(g/cm2)levels were measured.Significant decrease in the serum HDL-C levels in Group II than Group I,and significant increase in the serum LDL-C levels in Group II than Groups I and VI were determined.The tibial BMD levels were significantly lower in Groups II and IV than Group I.It was determined that WG and TC significantly prevented the serum total cholesterol increase;TC significantly prevented the serum LDL-C increase;and TT,WG,and TC were non-significantly effective in the improvement of tibial BMD levels.

Vascular protective effects of aqueous extracts of Tribulus terrestris on hypertensive endothelial injury

Angiotensin Ⅱ(Ang Ⅱ) is involved in endothelium injury during the development of hypertension. Tribulus terrestris(TT) is used to treat hypertension, arteriosclerosis, and post-stroke syndrome in China. The present study aimed to determine the effects of aqueous TT extracts on endothelial injury in spontaneously hypertensive rats(SHRs) and its protective effects against Ang Ⅱ induced injury in human umbilical vein endothelial cells(HUVECs). SHRs were administered intragastrically with TT(17.2 or 8.6 g·kg^(-1)·d^(-1)) for 6 weeks, using valsartan(13.5 mg·kg^(-1)·d^(-1)) as positive control. Blood pressure, heart rate, endothelial morphology of the thoracic aorta, serum levels of Ang Ⅱ, endothelin^(-1)(ET^(-1)), superoxide dismutase(SOD) and malonaldehyde(MDA) were measured. The endothelial injury of HUVECs was induced by 2 × 10–6 mol·L^(-1) Ang Ⅱ. Cell Apoptosisapoptosis, intracellular reactive oxygen species(ROS) was assessed. Endothelial nitric oxide synthase(eN OS), ET^(-1), SOD, and MDA in the cell culture supernatant and cell migration were assayed. The expression of hypertension-linked genes and proteins were analyzed. TT decreased systolic pressure, diastolic pressure, mean arterial pressure and heart rate, improved endothelial integrity of thoracic aorta, and decreased serum leptin, Ang Ⅱ, ET^(-1), NPY, and Hcy, while increased NO in SHRs. TT suppressed Ang Ⅱ-induced HUVEC proliferation and apoptosis and prolonged the survival, and increased cell migration. TT regulated the ROS, and decreased mR NA expression of Akt1, JAK2, PI3Kα, Erk2, FAK, and NF-κB p65 and protein expression of Erk2, FAK, and NF-κB p65. In conclusion, TT demonstrated anti-hypertensive and endothelial protective effects by regulating Erk2, FAK and NF-κB p65.

Protection by the gross saponins of Tribulus terrestris against cerebral ischemic injury in rats involves the NF-κB pathway

The aim of this study was to investigate whether the gross saponins of Tribulus terrestris(GSTT),a traditional Chinese herbal medicine,have neuroprotective effects on rats subjected to middle cerebral artery occlusion(MCAO),through nuclear factor-κB(NF-κB)pathway and inflammatory mediators.Cerebral ischemia was produced by MCAO in either untreated(control)or GSTT-pretreated rats,and the animals were examined for infarct volume,cerebral edema,neuro-behavioral abnormality and pathological changes.Meanwhile,the expression of NF-kB protein in brain tissue was analyzed on Western blots and the serum levels of TNF-α and IL-1 were determined by ELISA.The experimental results demonstrated that,compared with the control MCAO group,GSTT-pretreated MCAO group had significantly reduced infarct volume,brain edema and neuro-behavioral abnormality,and lesser degree of pathologic changes in the brain,as well as had lower levels of serum TNF-α and IL-1β,and higher levels of brain NF-κB(Po0.05).Furthermore,treatment with an NF-κB inhibitor pyrrolidine dithiocarbamate(PDTC)abolished the protective effects of GSTT against MCAO-induced cerebral ischemic injury.These results indicated that GSTT’s ability to protect against cerebral ischemic injury was mediated through the NF-κB signaling pathway,and that GSTT may act through inhibition of the production of inflammatory mediators.

Antiglycation and antioxidant activities of the crude extract and saponin fraction of Tribulus terrestris before and after microcapsule release

Objective:The present study investigated antiglycation and antioxidant activities of crude dry extract and saponin fraction of Tribulus terrestris.It also developed a method of microencapsulation and evaluated antiglycation and antioxidant activities of crude dry extract and saponin fraction before and after microcapsule release.Methods:Antiglycation activity was determined by relative electrophoretic mobility(REM),free amino groups and inhibition of advanced glycation end-product(AGE)formation.Antioxidant activity was determined by 2,2-diphenyl-1-picrylhydrazyl(DPPH),ferric ion-reducing antioxidant power(FRAP),nitric oxide(NO)and thiobarbituric acid reactive species(TBARS)tests.Microcapsules were prepared using maltodextrin as wall material and freeze-drying as encapsulation technique.Morphological characterization of microcapsules was evaluated by scanning electron microscopy,and encapsulation efficiency and microcapsule release were determined by total saponins released.Antiglycation and antioxidant assays were performed using crude dry extract and saponin fraction of T.terrestris before and after release.Results:Saponin fraction showed an increase of 32.8%total saponins.High-performance liquid chromatography-mass spectrometry analysis showed the presence of saponins in the obtained fraction.Antiglycation evaluation by REM demonstrated that samples before and after release presented antiglycation activity similar to bovine serum albumin treated with aminoguanidine.Additionally,samples inhibited AGE formation,highlighting treatment with saponin fraction after release(89.89%).Antioxidant tests demonstrated antioxidant activity of the samples.Crude dry extract before encapsulation presented the highest activities in DPPH(92.00%)and TBARS(32.49%)assays.Saponin fraction before encapsulation in FRAP test(499μmol Trolox equivalent per gram of dry sample)and NO test(15.13μmol nitrite formed per gram of extract)presented the highest activities.Conclusion:This study presented antiglycation activity of crude dry extract and saponin fraction of T.terrestris,besides it demonstrated promising antioxidant properties.It also showed that the encapsulation method was efficient and maintained biological activity of bioactive compounds after microcapsule release.These results provide information for further studies on antidiabetic and antiaging potential,and data for new herbal medicine and food supplement formulations containing microcapsules with crude extract and/or saponin fraction of T.terrestris.

What is the effect of Tribulus terrestris on testicular morphology and sperm production?An experimental study in the rat model

The objective of this study was to investigate whether treatment with Tribulus terrestris(Tt)has any impact on the testicular morphology and function in a rodent model.Twenty male rats were divided into a control group and a group receiving 100 mg kg^(-1) body weight of Tt supplementation.After 4o days of experiment,the animals were submitted to euthanasia;epididymal tail spermatozoa were collected;and spermatozoa concentration,motility,and viability were analyzed.In addition,testicles were collected and processed for histomorphometrical analyses.Data were compared using the Student's t-test and considered significant when P<O.05.Spermatozoa concentration,motility,and viability showed no difference between the groups.Further,testicular weight and volume,seminiferous tubule diameter,tunica propria surface density,seminiferous epithelium surface density,and intertubular compartment surface density were statistically similar between the groups.However,seminiferous epithelium height and tubular lumen surface density were augmented in animals treated with Tt.Treatment with Tt does not cause a major impact on testicular morphology,promoting only subtle modifications.No difference on spermatozoa parameters was observed.

大孔吸附树脂纯化蒺藜总皂苷的工艺研究

[目的]通过对10种大孔吸附树脂筛选,寻求适用于纯化蒺藜总皂苷类成分的大孔吸附树脂。[方法]比较不同种大孔吸附树脂对蒺藜总皂苷的静态吸附率和解吸率;用不同浓度的乙醇进行洗脱并计算总皂苷回收率和纯度。[结果]HPD-300大孔吸附树脂的回收率为87%,纯度可以达到68%。[结论]HPD-300树脂综合性能最好,适宜于蒺藜总皂苷的分离纯化。

An overview of benign prostatic hyperplasia and its appreciation in Greco-Arab (Unani) system of medicine

Objective:Conventional treatments for benign prostatic hyperplasia(BPH)like 5alpha-reductase inhibitors and invasive surgery are associated with some obvious side effects.Conversely,evidence,though limited,has shown that alternative medicines are safer and have potential to improve the lower urinary tract symptoms(LUTS)and quality of life in addition to improving sexual dysfunction in patients with BPH.The current article aimed to include an overview of BPH,different ways of its management,and particularly its appreciation in Greco-Arab(Unani)system of medicine,one of the alternative medicinal systems.Methods:PubMed,Scopus,ScienceDirect,Web of Sciences,Google Scholar databases and classical texts of Greco-Arab medicine were searched for data collection.Results:In Unani system of medicine,BPH,traced under the headings of Waram unuq al-mathana(bladder neck swelling)and Insidad majra-i-mathana(bladder outlet obstruction),has been managed for centuries with herbal medicines yet demanding a comprehensive scientific validation.Among the herbs,Cucurbita pepo,Tribulus terrestris,Urtica dioica,and Linum usitatissimum are worth mentioning.Conclusion:For achieving the goal of LUTS-free ageing men,and safer and cost-effective future management of BPH,Unani herbal medicine could hopefully prove beneficial.

“Tradamixina TP” Compound in Monotherapy for Three Months in Patients with LUTS: Observational Study on Improvement of Urinary Symptoms and Sexual Function in Men

Introduction: Benign Prostatic Hypertrophy (BPH) and Lower Urinary Tract Symptoms (LUTS) frequently affect the male population after the age of 50. Moreover, it is well known that there is a correlation of these symptoms with Erectile Dysfunction (ED) that can reach a frequency of roughly 52% in men aged between 40 and 70 years old. In this study, we aimed at evaluating the effect of a new natural compound “Tradamixina TP” (composed of 80 mg of the algae Ecklonia Bicyclis, 100 mg of Tribulus terrestris and 100 mg of Chitosan Water-soluble oligosaccharide 320 mg of Serenoa repens) in the improvement of Lower Urinary Tract Symptoms (LUTS). Materials & Methods: One-hundred patients with an average age of 64 years old and who were not taking any medication or phytotherapy for prostatic hypertrophy or erectile dysfunction were recruited in the study. All participants were subjected to serum prostate antigen (PSA) and uroflowmetry measuring maximal urine flow/sec (Qmax), at baseline and after 12 weeks. In addition, patients were asked to take the Tradamixina TP for 3 months and to complete at the beginning and end of the treatment the following questionnaires: 1) the IPSS investigating the level of LUTS, and 2) the IIEF-15 investigating the erectile dysfunction. Results: After the treatment, the IPSS scores were lower than those before the treatment. Moreover, a significant effect was found for the IIEF erectile subdomain with scores that were significantly higher at 12 weeks than at baseline. A similar result was found for the IIEF overall subdomain. A decrease of total serum PSA was also observed. Conclusions: After 3 months of daily treatment, the new compound “Tradamixina TP” improved patients’ sexual function, LUTS and led also to a decrease in serum PSA levels.