Multicenter, Randomized, Double-blind, Placebo-controlled Parallel Group Trial to Evaluate the Efficacy and Tolerability of a Phytotherapy Combination (Aqualibra) in Patients With Uncomplicated Cystitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 主要终点
- microbiologic response
研究概览
简要总结
This randomized, placebo-controlled, double-blind study investigated the efficacy and safety of the herbal medicinal product containing a combination of extracts of restharrow root (Ononidis radix), Java tea (Orthosiphonis folium) and goldenrod herb (Solidaginis herba) in women with acute lower uUTI.
详细描述
This randomized, placebo-controlled, double-blind study investigated the efficacy and safety of the herbal medicinal product containing a combination of extracts of restharrow root (Ononidis radix), Java tea (Orthosiphonis folium) and goldenrod herb (Solidaginis herba) in the treatment of acute lower uUTI. The herbal medicinal product represent a multi-target therapy that includes diuretic, anti-inflammatory and antimicrobial aspects.
Patients were randomized to one of the two treatment groups and treated with the phytotherapeutic agent or matching placebo for seven days.
The primary endpoint was microbiologic response defined as reduction in bacterial urine culture counts by at least 10*2 CFU/ml.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female outpatients aged 18-75 years
- •Diagnosis of acute lower uUTI occurring for the first time or acute relapse of chronic recurrent uUTI
- •Typical symptoms of cystitis (pollakisuria, dysuria and urgency)
- •Bacterial count of 10*4 - 10*6 colony forming units (CFU)/mL in midstream urine
- •Presence of >20 leukocytes/µL of urine measured by dipstick test
- •No antibiotic treatment required according to the investigator
- •Women of childbearing potential were allowed to participate only if they used a highly effective method of contraception
- •Written informed consent
排除标准
- •Known hypersensitivity to any of the active substances or excipients of the study medication
- •Antibiotic treatment during the past 8 days or indication for antibiotic treatment for the current infection
- •Patients with trichomoniasis, chlamydiosis or gonorrhoea
- •Use of concomitant medication that may have an effect on the UTI, including other phytotherapeutics with similar effects, saluretics (including those in antihypertensives) or other drugs with a similar mode of action, urinary acidifying agents (e.g. Acimethin®), antibiotics, or phytotherapeutics with possible antibiotic effects
- •Patients with suspected ovarian inflammation (e.g. adnexitis)
- •Patients with suspected renal inflammation (e.g. pyelonephritis)
- •Patients with complicated UTI (e.g. obstruction, stones, reflux)
- •Patients with overactive bladder
- •Patients with vegetative urogenital syndrome
- •Patients who were currently participating or had participated in another clinical trial within 30 days before enrolment
- •Patients in poor general condition
- •Alcohol- or drug-addicted patients
- •Pregnant or nursing women or women not using highly effective methods of contraception
- •Patients with mental illness or no/limited legal capacity
- •Patients held in an institution by legal or official order
- •Patients who were not proficient in spoken or written German
- •Patients with a urine bacterial count >10*6 CFU/mL were to be excluded from further participation in the study unless they specifically wished to continue treatment with the study medication.
- •No contraindications against the study medication were known at the time of study protocol preparation
研究组 & 干预措施
Herbal medicinal product
three times daily two film coated tablets containing: extracts of restharrow root (Ononidis radix) 80mg,Java tea (Orthosiphonis folium) 90mg, goldenrod herb (Solidaginis herba) 180mg
干预措施: Herbal Medicinal Product (Combination Product)
Placebo
three times daily two film coated tablets
干预措施: Placebo (Other)
结局指标
主要结局
microbiologic response
时间窗: 7 days
Percentage of patients with a reduction in bacterial urine culture counts by at least 10\*2 CFU/ml
次要结局
- Leukocyturia(7 days)