[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100481608":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":44,"centralContacts":49,"locations":55,"responsibleParty":149,"collaborators":43,"id":151,"slug":152,"hasResults":153,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":153,"sex":159,"minAge":160,"maxAge":161,"enrollmentInfo":162,"targetDuration":43,"studyType":165,"phases":166,"briefSummary":168,"conditions":169,"keywords":171,"overallStatus":74,"whyStopped":43,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":184},{"fullName":5,"class":6},"Xintian Pharmaceutical","INDUSTRY",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Tamsulosin Hydrochloride Capsules combine with Ningmitai Capsules placebo","ACTIVE_COMPARATOR","Patients take tamsulosin hydrochloride capsules (1 tablet each time, once daily) and Ningmitai capsules placebo (0.38 g\u002Fcapsule, 4 capsules\u002Ftime, tid.)",[13],"Drug: Tamsulosin",{"label":15,"type":16,"description":17,"interventionNames":18},"Silodosin Capsules combine with Ningmitai Capsules placebo","EXPERIMENTAL","Patients take Silodosin Capsules ( Qianweitai®, 4mg\u002Fcapsule, 1 capsule\u002Ftime, bid, after breakfast and dinner) and Ningmitai capsules placebo (0.38 g\u002Fcapsule, 4 capsules\u002Ftime, tid).",[19],"Drug: Silodosin Capsules",{"label":21,"type":16,"description":22,"interventionNames":23},"Silodosin Capsules combine with Ningmitai Capsules","Patients take Silodosin Capsules ( Qianweitai®, 4mg\u002Fcapsule, 1 capsule\u002Ftime, bid, after breakfast and dinner) and Ningmitai capsules (Ningmitai®, 0.38 g\u002Fcapsule, 4 capsules\u002Ftime, tid).",[19,24],"Drug: Ningmitai capsule",[26,33,39],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Silodosin Capsules","Silodosin is a α1A-adrenergic receptor antagonist which can relax the smooth muscle of bladder and prostate, relieves the dynamic obstruction of bladder outlet, and improves the lower urinary tract symptoms caused by BPH. The instruction of Silodosin Capsule (Qianweitai®) is 4mg\u002Fcapsule，1 capsule\u002Ftime, bid, after breakfast and dinner.",[21,15],[32],"Qianweitai",{"type":27,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"Ningmitai capsule","Ningmitai Capsule (Ningmitai®) is Traditional Chinese Medicine which has already used in treatment of urinary system disease (eg. CPPS, BPH) in China for more than twenty years. The instruction of Ningmitai Capsule is 0.38g\u002Fcapsule, 4 capsule\u002Ftime, tid.",[21],[38],"Ningmitai",{"type":27,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"Tamsulosin","Tamsulosin is α1A-adrenergic receptor which has used in treatment of BPH for few years. The instruction of Tamsulosin Capsule is 1 tablet at a time, 1 time a day.",[9],null,[45],{"name":46,"affiliation":47,"role":48},"Zhongguo Chen, MD","employee","STUDY_CHAIR",[50],{"name":51,"role":52,"phone":53,"phoneExt":43,"email":54},"Peiling Shi","CONTACT","+8619821240029","lc-spl@xtyyoa.com",[56,72,83,95,106,118,126,138],{"facility":57,"status":58,"city":59,"state":60,"zip":43,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Beijing Tiantan Hospital, Capital Medical University","NOT_YET_RECRUITING","Beijing","Beijing Municipality","China","CN",{"type":64,"coordinates":65},"Point",[66,67],116.39723,39.9075,{"lat":67,"lon":66},[70],{"name":71,"role":52,"phone":43,"phoneExt":43,"email":43},"Yong Zhang, MD",{"facility":73,"status":74,"city":59,"state":60,"zip":43,"country":61,"countryCode":62,"cosmosGeoPoint":75,"geoPoint":77,"contacts":78},"Beijing Tongren Hospital, Capital Medical University","RECRUITING",{"type":64,"coordinates":76},[66,67],{"lat":67,"lon":66},[79],{"name":80,"role":52,"phone":81,"phoneExt":43,"email":82},"Shan Chen, MD","+8613611257388","shanchentr@gmail.com",{"facility":84,"status":58,"city":85,"state":86,"zip":43,"country":61,"countryCode":62,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"The First Affiliated Hospital of Guangzhou Medical University","Guangzhou","Guangdong",{"type":64,"coordinates":88},[89,90],113.25,23.11667,{"lat":90,"lon":89},[93],{"name":94,"role":52,"phone":43,"phoneExt":43,"email":43},"Zhigang Zhao, MD",{"facility":96,"status":58,"city":97,"state":86,"zip":43,"country":61,"countryCode":62,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Peking University Shenzhen Hospital","Shenzhen",{"type":64,"coordinates":99},[100,101],114.0683,22.54554,{"lat":101,"lon":100},[104],{"name":105,"role":52,"phone":43,"phoneExt":43,"email":43},"Shangqi Yang",{"facility":107,"status":58,"city":108,"state":109,"zip":43,"country":61,"countryCode":62,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"The Central Hospital Of WUHAN","Wuhan","Hubei",{"type":64,"coordinates":111},[112,113],114.26667,30.58333,{"lat":113,"lon":112},[116],{"name":117,"role":52,"phone":43,"phoneExt":43,"email":43},"Yonglian Guo, MD",{"facility":119,"status":58,"city":108,"state":109,"zip":43,"country":61,"countryCode":62,"cosmosGeoPoint":120,"geoPoint":122,"contacts":123},"Wuhan No.1 Hospital",{"type":64,"coordinates":121},[112,113],{"lat":113,"lon":112},[124],{"name":125,"role":52,"phone":43,"phoneExt":43,"email":43},"Chuanhua Zhang, MD",{"facility":127,"status":58,"city":128,"state":129,"zip":43,"country":61,"countryCode":62,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"The Second Affiliated Hospital of Soochow University","Suzhou","Jiangsu",{"type":64,"coordinates":131},[132,133],120.59538,31.30408,{"lat":133,"lon":132},[136],{"name":137,"role":52,"phone":43,"phoneExt":43,"email":43},"Boxin Xue, MD",{"facility":139,"status":58,"city":140,"state":129,"zip":43,"country":61,"countryCode":62,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Wuxi No.2 People's Hospital","Wuxi",{"type":64,"coordinates":142},[143,144],120.28857,31.56887,{"lat":144,"lon":143},[147],{"name":148,"role":52,"phone":43,"phoneExt":43,"email":43},"Ninghan Feng, MD",{"type":150,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR","100481608","phase-4-the-efficacy-and-safety-of-silodosin-singly-or-combined-with-ningmitai-capsules-in-the-treatment-of-benign-prostatic-hyperplasia-100481608",false,"NCT05551221","The Efficacy and Safety of Silodosin Singly or Combined With Ningmitai Capsules in the Treatment of Benign Prostatic Hyperplasia","The Efficacy and Safety of Silodosin Singly or Combined With Ningmitai Capsules in the Treatment of Benign Prostatic Hyperplasia (BPH) Complicated With Lower Urinary Tract Symptoms (LUTS) -A Multicenter, Prospective, Randomized, Double-blind, Positive Controlled Study","NQTIPS","Inclusion Criteria:\n\n1. Male Subjects aged 60 ～ 80 years, clinically diagnosed as benign prostatic hyperplasia.\n2. Has an IPSS score ≥ 8 points at Screening and Baseline.\n3. Has a 4 ≤ Qmax ≤ 15 ml\u002Fs when urination volume \\> 150 ml.\n4. Has a prostate volume (PV) ≥ 30 ml by ultrasound examination.\n5. Subjects who can read, understand, and complete the research questionnaire.\n6. Subjects willing to participate voluntarily in this clinical trial, give informed consent and sign informed consent.\n\nExclusion Criteria:\n\n1. Subjects with prostate cancer or other malignant tumors.\n2. Subjects have serum tPSA \\> 10ng\u002Fml, or 4 ≤ tPSA ≤ 10ng\u002Fml while fPSA\u002FtPSA \\\u003C 0.16 times.\n3. Subjects suffered from other diseases causing dysuria, such as bladder neck spasm, urethral stricture, neurogenic bladder dysfunction, etc.\n4. Subjects have suffered from acute urinary retention, or complicated with gross hematuria, urinary tract infection, bladder stones, secondary upper urinary tract hydronephrosis, urinary incontinence, renal insufficiency and other Subjects that researchers believe meet the surgical indications.\n5. Subjects have undergone prostate surgery, microwave therapy, urethral dilatation or acute urinary retention catheterization or other invasive procedures.\n6. Subjects have residual urine volume (PVR) \\> 100ml, or those who may have urinary retention and need catheterization.\n7. Subjects who took α receptor blockers, traditional Chinese medicine or botanical drugs for treating BPH within two weeks before participating this clinical trial.\n8. Subjects who take 5α reductase inhibitor or other antiandrogen therapy drugs within half a year before participating this clinical trial.\n9. Subjects who need to take drugs prohibited in this study or adopt prohibited treatment methods during treatment.\n10. Subjects who Complicated with severe cardiovascular and cerebrovascular diseases, respiratory diseases, blood diseases, liver and kidney diseases.\n11. There are significant abnormalities in clinical or laboratory examination indexes of patients, such as ALT and AST ≥ 2.5 times of the upper limit of reference value, creatinine (Scr) \\> 1.5 times of the upper limit of reference value, or poor blood glucose control (fasting blood glucose FPG ≥ 10 mmol\u002FL).\n12. Subjects who are allergic to the drugs or ingredients used in the test definitely.\n13. Any otherSubjects in the opinion of researchers is not suitable for inclusion.","MALE","60 Years","80 Years",{"count":163,"type":164},312,"ESTIMATED","INTERVENTIONAL",[167],"PHASE4","Objective: To evaluate the efficacy and safety of Ningmitai Capsules and Silodosin Capsules in the treatment of Benign Prostatic Hyperplasia (BPH) with Lower Urinary Tract Symptoms (LUTS) compared with Tamsulosin Hydrochloride Sustained Release Capsules.\n\nStudy design: A multicenter, prospective, randomized, double-blind, positive controlled clinical study.\n\nInterventions:\n\nGroup A: Oral Tamsulosin Hydrochloride Capsules and Ningmitai Capsules placebo for 12 weeks.\n\nGroup B: Oral l Silodosin Capsules and Ningmitai Capsules placebo for 12 weeks. Group C: Oral l Silodosin Capsules and Ningmitai Capsules for 12 weeks.",[170],"Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms",[172,173,174],"Benign Prostatic Hyperplasia Silodosin Capsules","Ningmitai Capsule","Silodosin","2022-09-21",{"date":177,"type":178},"2022-09-23","ACTUAL",{"date":180,"type":178},"2022-07-18",{"date":182,"type":164},"2026-12-31",{"name":5,"class":6},8]