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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Giellepi SpA
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- clinical response at the end of treatment (day 6 ±2 days) and one month after the end of therapy.
研究概览
简要总结
A urinary tract infection (UTI) is a collective term for infections that involve any part of the urinary tract. It is one of the most common infections in local primary care. The incidence of UTIs in adult males aged less than 50 years is low, with adult women being 30 times more likely than men to develop a UTI. Increasing rates of antibiotic resistance and high recurrence rates threaten to greatly enhance the burden that these common infections place on society. Ideally, alternative therapies will be established that will be recalcitrant to the development of resistance. Many promising approaches are being developed, from leveraging what we have learned about the basic biology of UTI pathogenesis to specifically target virulence pathways. DAPAD COMPLEX for the treatment of urinary tract infections and improves the urinary tract functions. This trial will help us to evaluate safety and efficacy DAPAD COMPLEX dietary supplement in treatment of uncomplicated acute urinary tract infections (UTI). This can be used as an alternative therapy for treatment of uncomplicated acute urinary tract infections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Adult Female Fertile age Age ≥ 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): Dysuria Urgency (including nocturia) Frequency Suprapubic tenderness Urine culture positive for E.Coli ≥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: •A history of anatomical or functional abnormalities of the urogenital tract: •Congenital abnormalities •Polycystic kidney disease •Obstruction or stricture of renal pelvis, ureter or urethra •Kidney stones •Cystocele •Cystic diverticulae •Change of anatomical proportions (e.g. after ureter implantation) •Chronic vesico-urethral reflux •Neurogenic bladder 12.Severe chronic renal (creatinine clearance < 30 ml/min) or hepatic dysfunction 13.Diagnosis of diabetes 14.Immunosuppression: •Untreated infection with the human immunodeficiency virus (HIV) •Use of high-dose systemic corticosteroids or other immunosuppressive medication •Chemotherapy •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.
结局指标
主要结局
clinical response at the end of treatment (day 6 ±2 days) and one month after the end of therapy.
时间窗: (day 6 ±2 days) and one month after the end of therapy.
次要结局
- bacteriologic response at the end of therapy(day 6 ±2 days and one month after the end of therapy)