[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100211363":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":18,"locations":32,"responsibleParty":45,"collaborators":18,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":18,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":18,"studyType":62,"phases":63,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":6,"whyStopped":18,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":85},{"fullName":5,"class":6},"PIMERIndia","UNKNOWN",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention 'Sildenafil'.","EXPERIMENTAL","MHE patient receiving Sildenafil. Intervention: Sildenafil Drug Dosage: 25 mg once a day for one week followed by 25 mg twice daily for two weeks then 25 mg thrice daily for one week.",[13],"Drug: Sildenafil.",{"label":15,"type":16,"description":17,"interventionNames":18},"'No sildenafil'","NO_INTERVENTION","Control Arm: MHE patients not receiving SIldenafil Intervention.Followed up for 4 weeks.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Sildenafil.","Arm 1 :Sildenafil Drug Dosage: 25 mg once a day for one week followed by 25 mg twice daily for two weeks then 25 mg thrice daily for one week.",[9],[26],"Suhagra.",[28],{"name":29,"affiliation":30,"role":31},"Radha K Dhiman, MD, DM, FACG","PGIMER Chandigarh","PRINCIPAL_INVESTIGATOR",[33],{"facility":34,"status":18,"city":35,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":18},"Postgraduate Institute of Medical Education & Research Chandigarh","Chandigarh","160012","India","IN",{"type":40,"coordinates":41},"Point",[42,43],76.7884,30.73629,{"lat":43,"lon":42},{"type":31,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":48,"oldNameTitle":18,"oldOrganization":18},"Radha K Dhiman","Professor","Post Graduate Institute of Medical Education and Research, Chandigarh","100211363","phase-1-efficacy-of-sildenafil-in-the-improvement-of-cognition-and-quality-of-life-in-patients-with-cirrhosis-of-liver-a-proof-of-concept-study-100211363",false,"NCT02028429","Efficacy of Sildenafil in the Improvement of Cognition and Quality of Life in Patients With Cirrhosis of Liver. A Proof of Concept Study.","To Study The Proof of Concept in The Improvement of Cognition and Quality of Life in Cirrhotic Patients With Minimal Hepatic Encephalopathy by Means of a Pharmacological Intervention With Sildenafil (A Phosphodiesterase-5 Inhibitor).","Inclusion Criteria: • Male patients aged 18-70 years diagnosed to have cirrhosis of liver at Liver Clinic of Department of Hepatology, PGIMER Chandigarh by means of clinical, biochemical and ultrasonographical\u002FCT or liver biopsy.\n\n* MHE will be defined by PHES ≤-5 and normal MMSE score of ≥24.\n\nExclusion Criteria:\n\n* Patients unable to give informed consent.\n* H\u002FO alcohol intake during last 12 weeks.\n* Significant comorbid illness such as heart disease, respiratory disease, or renal failure.\n* Any neurological disease such as Alzheimer disease, Parkinson's disease, stroke, non- hepatic metabolic encephalopathy's.\n* Any anatomical deformities or disease of the penis such as Peyronie's disease.\n* Patients having psychiatric illness and taking treatment with antidepressant, sedative or neuroleptics.\n* Patients who start taking alcohol during the study period will be excluded.\n* Patients taking vasodilators such as nitrates.\n* Hepatocellular carcinoma.\n* Recent history of upper GI bleed in last 6 weeks.\n* Active ongoing infection.\n* Electrolyte abnormality precipitating MHE.\n* Color vision abnormalities.","MALE","18 Years","70 Years",{"count":60,"type":61},50,"ACTUAL","INTERVENTIONAL",[64,65],"PHASE1","PHASE2","The study is being conducted to evaluate the efficacy of Sildenafil (a 5-phosphodiesterase inhibitor) as a means to improve the cognitive impairment encountered in patients of minimal hepatic encephalopathy (MHE) as proposed in different studies.\n\nThis study would also assess the role of improvement of cognition as a means of improvement in quality of life.The patients will receive Sildenafil or no treatment for 4 weeks.\n\nThis study may prove and provide important therapeutic strategy for cognition impairment in patients with MHE.",[68],"Hepatic Encephalopathy.",[70,71,72,73,74],"Minimal Hepatic Encephalopathy (MHE)","Psychometric Hepatic Encephalopathy Score (PHES)","Sickness Impact Profile (SIP)","Model for End-stage Liver Disease (MELD)","Child-Turcotte-Pugh score (CTP)","2014-01-03",{"date":77,"type":78},"2014-01-07","ESTIMATED",{"date":80,"type":18},"2012-07",{"date":82,"type":78},"2014-01",{"name":48,"class":84},"OTHER",1]