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Coe ie Clinical Evaluation of Himplasia in the Management of Benign Prostate Hyperpla ay Agama! Pana Al? PaaS. ak Abstract Benign prostatic hyperplasin ie > nonmalignant enangemen ofthe poste pnd, commun xine In ‘er anime The preset sty was stn in eshte thelial etfcacy and aey af Hmplaca nbn pace ‘yperplas Matra and Methods: Tis ws an pen eal ‘el Undertaken In elderly ale pstmt ge 5 yeas tnd above dagnsed of benign prostatic hyperpana the Depart of Urls, Gavertment Medi Colles, implas was administered at a dow of 2 tes to 3 tens ie ay ora pono moni Wie ming 5 patie woe gen Kent loking pleco inthe sme dang. Al the patents were flliwed-up for nth tan Intra of eh They were evant by repel menue ANOVA followed By Bonforon'e maliple compris testorzairad tet albne with yoy snd noe the end a6 mothe, Resale and Concanon inp Signicamly rebeved he symptoms of BPH alongwith improvement im winery fw tae ad section in pos ‘oud mal urine and prtte volume Himpasia ak {ual mnde of atin wich sty ston Sa ete fenayne natn with alpha epi blocking actin Tee (were mo adverse vers reported or observed using the fice pra KEYWORDS: Hp, Big Pov eras Introduction Sen pipe A an leet eyes Ry ome ce Genes TMD, Ma fri). Exasvocle Plena Udon Goren Moa Clee, Sam Oars 1 EASE SES woo SSDS, Scorer oa Ladder‘ in fon of the rect. tf sounded by & ‘apie of Bros tieue ald the poste cape, The ‘tira pases though the prostate tote adr nck With ‘pblems ath urnson, becuse the la pine the tnd so the conden is clled benign prolate hypepla (arts, ko known niin prosaic Hypentophy oF nodular hyperplasia of the prostate Adenomatous prostatic roth is belived 9 begin at ppriatly age 3 year An elimated SO fre Pa Fsteoge even of BPH by age 0 gen and 75% by age tyes In USD fee pens BPH bce aly signifean! UTS reining eaten The Uraoae Dinas n Amerct BPH Pret examined the US prevalence of moderate severe LUTS define by an Americ Urs Associaton (AUA) Symptom Index Score Is expe i Annexure NO. Benign psa hyperpasla symptoms are casi os storage or voiding, Suraye symptoms inclade urinary trequeney npeny fompolirg nec! Wo vid tha crmot deter), ungeney Incontinence and voiding at night (vost) Vids sympoms ice wesk urs sm, Ieiteney (peeing 20 wait for the strat 0. bop inte) tring oo ye ug ent, fm the urava). and debi Thee storage and woking, mmmptoms are evalated sn. the nema! Pra Carempang Autor Dr Pred Pe HOD, Hesd- Mace! Seis & Ci Tl, RAD Cen, The Kins Dg Cargo, Tone, Para 94 862216905, Fax 9} OonaOT att, Ema dptcGhinasyansowe coe RU WEE 209K | Jy 0,108.0) hig & inl Bserch ‘ea een sins te arama oases ‘A phys examination pat hoy and evaluation o suplots provide the bor» dogo sf BPH. The Pipl exammaon nudes» dg rl examen {ORE and symptom evaluation fetal rom te ee Of the AUA Symptom Index Treat! tons or BPH inca tay Ganges wail walog. dg apy, ‘onsgcl proceed major sugey. Fe eames trewithutany vessel his pertetly {owathrenment of BPH whether a dese aang 1 betes the bereits ad dementf the teens Salute The sevens ren flowing esi! for BPH ‘Pekde pte ith 0% confidence ner for vrous sual procedures ranging fromm abot 4% to the inno pstnce ase ened al ae mel trerimets) incontinence tes incninence about Safer spay rah wy noe apeing eed nthe pt forthe ect manogeton Of seve progr 1 finda mend or BP tat safe ed fe fom Scrat even on praonged ve? nhs compound, Hires, ranted by The Hinalaya Dr Company, anglonda contains eta of vous at each as “nists Cann orn, ts, Ase rmenoats Ceca rare sn Aska pips a froved becca in robin the eymptore of prove Kerli, Ta clncal tal was planed osubsaninehs therapetc benatts and ovale the efency of Hinpein teva cin nd ronnie pores ip prot sh ‘im of the Study ‘To eualuate the saety and efficy of Himplasin in management of bein prolate hyperplasia Materials and Methods ‘Men aged 50 yrs an above wer nud inthe sty. All he consecutive pant f PHT atending the outpatient epariment of Coverment Modi Calls, Sorat Gan, Indi were screened fr this study, Those who opted for !nettnent were normed of wluntry nae of tal meses and wien consent wis obained. One hundred sod one patience wero enol from Fabranry 2002 t9 march 2008 Fimplain was evahsted foe its efenry informs of the folowing parameters f lrnroverent sn AUA symptom Scone 1 Reduction in poa-oid residual wine |ADA MEDCAL UREA mary 2010140) 4 Impioveent in riany How rate ‘9 Recction nthe teen of inary tention 1 Prostate weight # Improveront in the quality of Me Inclusion erteria Pacts having symptoms of benign pnstate hypertrophy ke weak seam, iterupted voiding, sense of incomplete voiding, inary feguency, urgency, nocturia were included In the study. Exclusion evteria Patients having carcinoma prostate, ake PSA (Proaate specific antigen) renal inifiency, tention of urine oF active urinay ret infection were eluded fr the tu. ‘The investigations dane were as flows Genera physical examination (© Abdominal examination and dita real examination 1 Serum PSA wa collated before DRE (© Abecminal ulrscund fui tet nd pote Pestle sre was ein on lensound (¢Tranecal ulrasound (TRUS) on sete patients (20r fl badder uflowenctey ‘© Complete bod counts, blood ure, serum eelinine [rosae specie antigen aneurin ritne Patents having lower usiary tat symp (LUTS) ‘wih presumed goes of BPH were further eve or purpose of his study Any urinary tat ection wasted nd patents reevsiate before esimation of yp sore 1 oid any anibiote ef No antibiones. or 5 aiphe relate ihbtors or alpha adrenergic locker ere ven to any pale ding the cg il Dosage “The patents were randomly eneized into Minas and placebo groups, comprising 50 and 51. patients seopetvey Th patients regen Himplaaao ltcabo i the dove of 2 tablets tice day, oe 6 months The age isto of patients sa in Tablet Follow-up and assessment All patients were Sllowed! for a pid of 6 months. At ech month follows wt, the ALA symptom scone and Cpl & hie tse ‘Table 1: Age distribution ‘Yeas | Wo of part ie | Wo pants Hinoiasa goup | Piccto group wan 3 7 70 15 7 7080 6 1s 3000 7 7 Toa! 50 51 ‘Teble 2: Prostate weight and grading Prostate walt (@rame) ‘Graaing 25 ons 7 = 50 gm 2 789m 3 > TBone 4 pact examination was peared and recorded in the ‘irucuved CRE Unlowmonyand sonography were done at the end of 38 and" month, A comple clnal end ached eamination wn rnin a andthe month Prete waa elated in fue freon gil al feamination as prade 1 ess than 25 grams) rade 2 (eae than 50 grams) grade 3 des than 73 grams) and grade + (ere than 75 grams) (Table 2 Primary and secondary endpoints ‘The proefned peimsry endpoints for wlcacy were ocr in he ttl AUA sone n thee & mea Gaerne in pratte zo and vone snd improvement i troflowmerry parameter. The predetined recondary tndpoins for sho! erm nd lantern sey wat uae by mene of adverse evenly pllent compliance tthe tag therapy, and improvement in haematlgiea) and ‘chemical promt ‘Adverse events Aller events eprte o oberve by patents wate rmcorded th information about severly, dale of nat ‘ution and action taker garding he say dug. Reon fof advene events to study mediation sens prefined ‘Uae (a wacton that does not foe & reason ie tempor sence frm the adminitation of the cg) "Rosie (lowe ncn esponee plier othe speed 2 Ce rain ars ts Mee es Prat iis rug bit could ave been preset by the patent nie State o other modes of therapy administered to the pln), ‘nd “Poable” lows 2 known response pater tthe suspect dg tha ould no He reaonably expe the own charset ofthe pte clini tt), ents wor alowed to wont ete fs the stad they had experince wero dicot during the ‘hid suaained serous cil events ulin epic trement For point ethaensing rm the sly, lots cemplnce (define a fk 0 fa les han of the median) ent regarded stent a, and ase foe mesumplane wire nit ‘Statistical Analysis The vues ate expend os Moan SD. Aly wae pevormod ung Repent! Messe of ANOVA fllwed by Bonfertn's Muliple Comparison tet pie! et od ‘util of rfene. The minim vel of gre os eat p05 Sasa! anal nr ou sng GraphPad prom sfewate (semion 8.0} Results ‘These wore 50 patents inthe Hips soup and 52 tions inthe pls group. The avernge ago the ants in Himplass group i 8 years ad hal of place 6.3 ears. The nbeatry svenetions before an afer etre ‘i exprened in Mean + SO ai tase in Table 3 Table 3 indicates that thewe veas 20 ekange sn eral HB, WC counts ee) ad lhe Hess (lod ures. eeatning ee) folowing Himpaia heapy srt ‘lacs were within nema Trentent with Hila se 1 deen tend im PA less thogh tiga’ sat ‘onthe other hand place group showed» manga ers in PSA kel, lagen to show symplomatic nie! by the at month of tnsiment ith Hinplasia anc tbr improve il parameters ws evident by the nd of 6 month kg wih poten alleviate in sypline. The average AUA Symptom sow reduced signa fom basins 1673 + 156 208 588 gD! compar plas gro at the end of months Table and Figure andthe dilerence Toten the cos as staistizlly sgt ot MEIC, JORMA eu 20101080) igi Gea Resear ‘ical Eaton of Hn inthe Manat of Base tt pep ‘Table 3 : Laboratory investigations Parameter ‘Himplasia (0=28) Placebo (n=33)_ Pretreatment | Posttreatment | Predreatment | Posttreatment Hesnogicin (ar 7) wena | tess 12s | tareaitzs | i2082 199 “otal eount (ou mm) roas = 1o7e | 7582+ 1305 | 7892 1717 | 7970. 1354 Polym (8) eoge27z2 | o5ts+7se | e3ass6a7 | esr sooo Lymphocytes (8) mares | sigizedo | a2teete | sp2tesar Monceyes (4) sassis2 | 173e176 | testes | 1582199 Eosinophils (%) aares2r | 2rzetat | asze2m | 2averod Basophis (%) orssosr | orzsoss | o0s6+024 | 0055 +024 Bcd urea (ng 4) w764643 | madseste | 29902600 | 29424539 Ccreateine (rg %) 1052023 | 1o7rsoze | 142029 | 1142020 Prostaty specie atizen (agin) | 247ateo | 2202145 | arreta7 | tanetis ‘ithe values aro expressed as Mean # 8D. AUA Symptoms Score Baseline mouth" 2aoothe Smomths ¢months " S months 6mouths ‘SCHimplasin Placebo "p00 ae compared to Baseline values Faure 1 AUR smsen so Hepa wr paso wou Postold resin urine volume Inet pesiod and rsdal not show signifies results with llssonographic and volume were raced sigificaly along withthe sigrfcantultaflowmetric findings except in incresse of Intent period rere in peo flow rae, voided volume, ane average flow (Table atthe end of Hinnplasn trentment. There was significant reduction in prose siae (pe. compare to the ple at the end of the teatment. Though not significant. TRE WS ap. Hmplasa growp 4 Incase inflow time, On the other hend, placebo group did Prostata size ‘of patents shoved reduetlon In INOW MEDICAL SOURUAL | may 200, 108) 2 Dil & inet Reach ha rai Hg te Magee of Brin Pi Hip Table 4 : AUA symptom score in Himplasia and placebo groups Parente Tesnet [avin [ Ynont | monde [3 nouie | «nome | Pens | moat] Aner [ tro [aes [smn [ro [rer | vawor [roar] Pro [ estes [875] eaves | wanran | sromrse | wave] esa "p-D0 as pared boarine vals ‘rosa sae on DRE as compared to only 4% in plasbo _soup. The rection in prostate sae as gee by DRE was igh signifeane in Hirplasin group (0.01) as compaved to placebo Cale 5. ‘Overall symptom score ‘The overall symptom scone was sgniiantly rece from 38116 2:7 e009) ot he vn of 9 smi. Ate ed ofthe study the score was 208 which is highly significant eduction (P<0.01) fom baseline core. On the oer hand ‘here was no significant change im placebo group (able 6 and Figure 3, Discussion In 169, Riolan cesribed for he it ime the enlargement ‘ofthe prostate and is most common clnssl manifestation the obstruction of the bladder outlet Sine then, much research has been focised on the etislgy and the cea ‘management of benign prose hyperpaia (BPED. Benn psate hyperplasia (BPH) sone ofthe most spent prosate normalities and an important cause of urinary difcuies inldely men It can be progresive nase, expecially Jett untieated Incomplete viding rests insta of bacteria Inthe blader mite ac an inert nay rt lnvetons. Urinary blader stones, are formed fom the ‘ysalsaton of ais a dhe residual rin. Uae retention, termed acute or conic 8 another form of progtession. ‘cate wiry retention isthe iabity wo vod, while in ‘chronic urinary retention the residyal urinay volume ‘gradually increases and the Bader disens Some patients ‘who suffer from ebranc urinary reterton may eventually progress to renal fre, 2 condition termed obsctive ropa. Table 5: Effect of Himpiasia on ultrasonography and uroflowmetry parameters Parameter Himpiasia Placebo Baseline | 2 month | 6% month | Baseline | a month | 6° month Prostate size (ar) 226881410 | 2600ei48 | 2068017 | seveeieat | avorioes| sesss2048 poor Peak tow rete (mimin) | 9480888 | t2vzea87 | 1206460 | aon20s | airos | @areaor pant ‘petot ‘ato pared fee) ‘siqaeet0 | yaiesee | saear23 | geataarer| abaaan7e| 2egvaaG2 pot pelos peas Flow tne 80) 4267237. | 44188708 | aazTan40| Gaaeizars| Sroose7| 20632605 Valdes vatur (mip ve52a1162 | zzoaatate | 2a77et0s4| 21@6a1450 | a0oeets04] Teo se1o7s peo0s | poo! Fesicusl volume im) | S8.8126084| a0.25ea207 | a7 geseots| Tar7eTos | 1sesi90.12| va7eune pot patos “average fw (ian) ‘4onza4 | ozreza | Ssea71 | seisiea | aaeiaze | somaa eons | pet ‘Siaifcance wit fepect to the baseline vals IND ICAL JOURNAL Jay 040,108) il eso fg erage of Bi Pra is 4s ‘Symptoms Score Baseline A month SHimplasia © Placebo Dig eat Beseeh 3 months 5 months 5p0.05, 0.001 as compared to baseline values Tigre 2 Oral yon sen ga ad peo pas Andiogans (estoserane ond related hormones) 30 consigned 0 play» permis loin BPH by mot capes “This means that angen have to be presen for BPH 10 occu, but donot necessary dielly cause the conto, “Ths is supported by the act that men eased before puberty 40 not develop SPH? ang, im men with ganic ‘Sse ht chit androgen procuctian of androgen actin, prostate growth is spied? when they ge, lke ner ren. Adeitonilly, adminitering exogenous tesastrone ‘ot absent wih 3 sigan ner i the sk of BPH symptoms, Dikydroestostrone (DHT), metabolite of testosterone eres! mastor of prostatic yth, T's symheze inthe prota fom eilating tesosterane by the action of the enzyme Selphaseductae, type 2. This fenayme losizad penepaly inthe stoal calls hence, these cls te the nisin ste forthe symbesie of OFT Dihyafotstoserone can ac in an autocrine fshon on the stromale eso in pancine lhion by sing ino nen (thelial cll fn both of these ell types, DHT binds t rudeas androgen receptor and sigals the tansripton of frouth factor that ae mitogenic to the epithe and ro fell DIT 1 ies more potent th eoterone bee It iasoctus from the andogen sceptor more sw. The impotiance of DHT in exusing nodular hyperplasia i supported by elscel observation in whch an inbitue of slphareuctine sven to men with this conden, Thetpy Table 6 : Overall symptom score ‘Group Ribassine | Ari month [AS monthe | ACS months Hinpisa | 9812080 | 2asass | ai7 nse | aoa vee Piaceba ‘aaszoae [ano | sia0ss | so720e "Values are expressed 6 Mean = 80. *peD05,"p<0001 we compared ‘basaine values. RON HEAL JOVIAL ery 200, 108 Diol & Cea esaeh Chal vat Hla he Meagan with Salphaseductse inhibitor markedly reduces the DHT ‘ontet ofthe prostate and in tar reduces prostate volume dad in many enn, BPH symptoms” ‘Experimental studios have shown the adrenoceptor antagonistic ad Sapa cerecase inhibitory activites of Flanpaoa, a8 ell ap ts efet in reducing the pttic ‘weight the epi! height and the stromal proliferation in cxperimentl prosntic Mypestophy i tts ‘The main herbs of Himplasininlude Tabula tert, Calpine bonds, Aneta, Aspragus rss and ‘irr roi ipsa es ere th Aka ps Trbnls termsrs poses ant nfammatory smooth mise relaxation and diuretic actions, which are useful im {genitourinary fectons, painful micturtion, ematti, slysun and bon prestae hyperplasia" The diuretic ct of Tinh tests helps eewe aan subcnl Trinary insufcency and also helps to reduce, post-oid ‘tine, Clinical tdi ave proved Crdace mare effete in the prosaic hyperropiyneurgenic binder are chronic urinary infections Cystometric stds have shown tha Craven surven improves Bluder tone and reves pos Pprosatectory atony ofthe Bladder. Crnaens mzalt as ‘ytopotectve acon and prevents urinary trac infections Cte nla etiellommatory and ons tom the smooth muse fee binder nthe othe rina oxgns © ‘This help the evacuation of the ladder andthe contol of inlectione: Crap lon ® has anise ation, which proventetrinary trict infection uewlly oasrved in BPH ete to stagnation of rine Herbs Ike Creare mule and Ana teh pases Salpha-edutse intbition with ‘eadrenergie blocking activity. Salphacrdctase nhbiion Blocks the conversion of etonteane to ditydrotestoseone, the major sex hormone inthe prostatic ells responsible for BPH, By ocking the aeecepors, Himplasia relaxes the smooth muslin the prostate tie and incre iy flow while shving the symptoms of uinry frequency, "urmary urgency and nocura. Aspeagus racemosa potent anuoxidant properties and. prevents ehrnicprostais™ Monover,Tibul titi, Caspinn tonto, Ae ‘aieh% posers antibacterial activity against susceptible ‘micrvonganiams and helps prevent symptoms of wetets dnd pecsaiis. The vazious herbs in Himplasia ac in 3 $ynoitic manner oreleve te ubseuctive symp long ‘vith contol of prostatic tise growth Conclusion ‘Currraly availble treatment options fo management of [BPH fave various imitations uch 2 low clink een or associated aceerse effects. Due to. these limitations, Dhyotherpy has been extensively rsenched and some % rsa Ms polyherbal formulations have been proven Benfica i the ‘mangement of BPH. This study i open cin tal and was planned to evaluate cinta elfeny and sstety of implasa a polyherbal formulation in BPH. Hinplasia has significant effects both subjectively ad objectisly over placebo in both srtntce and obstritioe Sumptows tn patents of BPH. Improvement ie abmeond a8 cary at ove month and the result i stained daring the treatment period in the study. No sde effects were obec i any patents daring the tial pero, which suggests that onli is safe for lomg-tamn amistrtion References 1. tice, Tensile Miowave Tormetharany of he Prosaie (TUNT) A ace by Jonathan Rubensiein. MD, Saf Physcian, Oeparment of Uragy,Unversyof Calta, ‘San Franceca and Kein T Mey, MD, Asoc Professor, Deparement of Urology, Nochwestem Unversity Medes! 2. Garry Mi, Fowler FJ J, Oley MP, eta. The American Logical Agsaiaton symptom do for enon prostatic yperplsia. The Messurament Commitee of ta Amencan Urological Acsociton. J. Ur 1990: 148(5 1642-1867. 3. Carraro JC, Raynaud JP, Koch G of at Compson of phieterpy (Peminon wis Sata inthe vesenant ‘benign prostate hyporraca: ranomice nrrationl sy of 1088 patents. Prostate 1088.29" 251-240. 4 Pauber 8M, Rinarston FO, Serant SN et a Ett of ‘Seronoe rape extra (Parc) on eeraelteseteone Induces expermaenal prostate enlangemeat in tho ra Pramas Raa 1896 9: 17-479, 4 lun Jk Opera Anatomica, velra; Rocopnta and ‘Actor, ed Luelae Parorum, 1649. pp, 874-90 1 LevttJM San KM, Prosate

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