A Double-Blind, Randomized, Placebo Controlled, Parallel Group,Clinical Trial Assessing the Effectiveness and Safety of VISPO on Urinary Symptoms in Female Subjects.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- improvement in the Lower urinary tract symptoms
研究概览
简要总结
This is a double-blind, randomized, placebo controlled, parallel group, two arm investigator-initiated study. Female subjects older than 50 years suffering with urinary symptoms and meeting all inclusion and no exclusion criteria after signing a written informed consent will be enrolled in the study. After passing the eligibility criteria, subjects were randomized into 2 treatment arms to receive 500 mg capsule of VISPO or placebo in 1:1 ratio. The subject will arrive at the study site in a fasted state and blood samples will be collected for laboratory assessments. The study will be conducted in 3 visits over a period of 12-weeksand telephonic follow-up at week 4th week and 8th week.
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
- 50.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Women with frequent urination, nocturia, and/or urgency for at least 2 months 2.Urinary symptoms that do not require medical treatment based on definitions by physicians 3.Must be able to read and understand in English or local language and maintain a subject diary 4.Must be willing and able to give informed consent and comply with the study procedures.
排除标准
- •1.Suspected to have overactive bladder (OAB) according to the core lower urinary tract symptom score (CLSS) and the OAB symptom score (OABSS).
- •2.Currently receiving or have received treatments for urinary disorders within the past 2 months 3.Subjects who are unable to have the desire to urinate.
- •4.Subjects who have dysuria as the main symptom 5.Subjects allergic to herbal products or any component of the study product 6.History of uncontrolled chronic or lifestyle related disease
- •Known HIV or Hepatitis B positive or any other immuno-compromised state
- •Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study
- •Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.
结局指标
主要结局
improvement in the Lower urinary tract symptoms
时间窗: Day 1, Day 28, Day 42, Day 56, Day 84
次要结局
- Safety(Day 1, Day 28, Day 42, Day 56, Day 84)