CTRI/2021/12/038621尚未招募不适用
A double blind, placebo controlled, parallel group, prospective clinical study to evaluate the urodynamic parameters and tolerability of a standardized saw palmetto oil, VISPO in healthy 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
- Changes in Uroflowmetry parameters and laboratory parameters
研究概览
简要总结
This is a double blind, placebo controlled, parallel group,two-arm, prospective clinical study. Healthy subjects meeting all inclusion andno exclusion criteria, after signing a written informed consent will beenrolled in the study.After passing the eligibility criteria, subjects will berandomized into 2 treatment arms to receive VISPO or placebo in1:1 ratio.The subject will arrive at the study site in a fasting stateand blood samples will be collected for laboratory assessment . Post blood sample collection, subjects will undergo uroflowmetry assessments. The study will be conducted in 3 visits over a period of 84 days
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
- 40.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Subjects with normal BMI of 18.5-24.9 kg/m2 2.Subjects who have no evidence of any underlying disease 3.Women of child bearing potential practicing an acceptable method of birth control as judged by the investigator(s) [such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), oral or long acting injected contraceptives] from at least 2 months prior to study entry and through the duration of the study; or postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject); with a negative urine pregnancy test.
- •4.Must be willing and able to give informed consent and comply with the study procedures.
排除标准
- •1.Subjects suffering from any chronic health conditions (e.g. diabetes, hypertension, chronic renal failure, heart, thyroid and liver disease) requiring medical treatment 2.History of Chronic metabolic disease.Psychiatric illness,Drug abuse, smoking, abuse/addiction to alcohol,Eating disorder such as bulimia or binge eating,Endocrine abnormalities including stable thyroid disease,Cardiovascular surgery / History of any major surgery 3.Subjects allergic to herbal products 4.Known HIV or Hepatitis B positive or any other immuno-compromised state 5.Diagnosis of any other clinically significant medical condition which in opinion of investigator may jeopardize subject’s safety and preclude trial participation.
- •6.Currently participating or having participated in another clinical trial during the last 1 month prior to the beginning of this study 7.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
Changes in Uroflowmetry parameters and laboratory parameters
时间窗: Day 0, Day 42, Day 84
次要结局
- overall safety assessment(Day 0, Day 42, Day 84)
研究者
研究点 (1)
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