CTRI/2021/03/032136已完成未知
A randomized double blind, two arms, parallel assignment, placebo controlled study to evaluate the efficacy and safety of DAPAD COMPLEX dietary supplement as an adjuvant therapy in treatment of uncomplicated acute urinary tract infections (UTI) - none
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- Giellepi SpA
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Adult Female Fertile age
- •Age ââ?°Â¥ 18 years to 45 years
- •Written informed consent
- •At least one of four key UTI symptoms that could be attributed to an uncomplicated UTI, and no alternative explanation (i.e. symptoms suggestive of STI or vulvo-vaginitis):
- •Urgency (including nocturia)
- •Suprapubic tenderness
- •Urine culture positive for E.Coli ââ?°Â¥105 cfu/mL
排除标准
- •1.Male sex
- •2.Urine culture positive to uropathogens different from E. coli
- •3.Pregnancy or planned pregnancy
- •4.Concomitant antimicrobial therapy at the time of screening
- •5.Use of any antibiotics in the past 7 days
- •6.Use of dietary supplements (such as cranberry, probiotics, etc) during the month before recruitment
- •7.Known or suspected hypersensitivity or allergy to any ingredient of Investigational product
- •8.Active upper UTI (e.g. pyelonephritis, urosepsis: fever > 38.0, flank pain, chills)
- •9.Symptoms/signs suggestive of vaginitis or sexually transmitted infection
- •10.Indwelling catheter, nephrostomy, ureter stent or other foreign material
- •11.Otherwise complicated UTI:
- •Ã¢â?¬Â¢A history of anatomical or functional abnormalities of the urogenital tract:
- •Ã¢â?¬Â¢Congenital abnormalities
- •Ã¢â?¬Â¢Polycystic kidney disease
- •Ã¢â?¬Â¢Obstruction or stricture of renal pelvis, ureter or urethra
- •Ã¢â?¬Â¢Kidney stones
- •Ã¢â?¬Â¢Cystocele
- •Ã¢â?¬Â¢Cystic diverticulae
- •Ã¢â?¬Â¢Change of anatomical proportions (e.g. after ureter implantation)
- •Ã¢â?¬Â¢Chronic vesico-urethral reflux
- •Ã¢â?¬Â¢Neurogenic bladder
- •12.Severe chronic renal (creatinine clearance < 30 ml/min) or hepatic dysfunction
- •13.Diagnosis of diabetes
- •14.Immunosuppression:
- •Ã¢â?¬Â¢Untreated infection with the human immunodeficiency virus (HIV)
- •Ã¢â?¬Â¢Use of high-dose systemic corticosteroids or other immunosuppressive medication
- •Ã¢â?¬Â¢Chemotherapy
- •Ã¢â?¬Â¢Treatment with radiation
- •15.Critical illness requiring intensive care
- •16.Planned surgery within the next 6 weeks
- •17.Pelvic or gynecological surgery during the 6 months before recruitment
- •18.Inability to take oral drugs
- •19.Participation in another prospective clinical trial
- •20.Previous enrolment in the proposed study
- •21.Inability to understand or to follow the study protocol
研究者
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