NCT01355341Unknown2 期
A Phase II, 28 Week, Randomized, Double- Blind, Placebo- Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of 'Herbmed Plus' an Ayurvedic Formulation in Patients With Renal Calculi
Amai Charitable Trust1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2010年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of "Herbmed plus"in patients with urinary calculi by assessing the reduction in the stone size & surface area/ or the expulsion of stone
研究概览
简要总结
More specifically, the present invention relates to a 'Herbal Preparation' that is useful for
- Treatment of Renal calculi
- Reduction in the stone size & surface area
- The expulsion of stone
- Decreased need of Analgesic(Antiinflammatory Effect)
- Stops the recurrence and reformation of renal
详细描述
- Study duration 28 weeks
- No. of Scheduled visits 8 visits
- Study product Dose, Group one-:1capsule (of 500 mg) orally twice a day with meals for 24 weeks. Group two-:placebo1capsule (of 500 mg) orally twice a day with meals for 24 weeks.
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
- 10 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 10-75 years (Both inclusive)
- •Patients with Renal calculi, diagnosis confirmed by plain X-ray KUB &/or ultrasound KUB/CT scan Abdomen
- •Size of the calculi ranging from 04 mm -09 mm
- •Able and willing to give written informed consent and comply with the requirements of the study protocol
- •Patients of reproductive potential (males and females) and willing to use a reliable means of contraception (e.g hormonal contraceptive patch, intrauterine device and physical barrier) throughout study participation
- •Patients will to cooperate & give consent for the trial& comes for regular follow up.
排除标准
- •Patients having acute condition of renal calculi.
- •Any systemic disease requiring other medications of surgery for calculus condition.
- •Complicated cases of Renal Calculi requiring surgical condition.
- •Chronic or current infectious disease such as but not limited to chronic renal infection including active urinary tract infection.Uncontrolled diabetes, hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction
- •Any other urogenital disorders.
- •Liver dysfunction, defined as total bilirubin more then 1.5 the upper limit of Normal, aspartate aminotransferase more then 2.5 upper limit of Normal, or alanine aminotransferase more then 2.5 upper limit of Normal,
- •Kidney disease, including serum creatinine level more then 1.5 upper limit of Normal,
- •Subjects on herbal supplements for stone disease (plant extracts preparations or herbal medicines etc.) within previous 3 months.
- •Participated in another clinical drug trial within 3 months before recruitment.
- •Pregnancy or breast feeding
- •Evidence of significant uncontrolled concomitant disease which in the Investigator's opinion would preclude patient participation
- •Currently active alcohol or drug abuse or history of alcohol or drug abuse within 24 weeks prior to baseline
- •Patients with psychiatric illness or other condition that would limit compliance with study requirements
- •Patients receiving or has received any investigational drug within 30 days before receiving the first dose of study medication
- •Subjects who refuse to sign the informed consent document .
研究组 & 干预措施
HERBMED PLUS
Experimental
Herbal formulation of four constituents i.e.Varuna,Yav,Aghada,Kadali as per ayurvedic literature.
干预措施: HERBMED PLUS (Drug)
结局指标
主要结局
To evaluate the efficacy of "Herbmed plus"in patients with urinary calculi by assessing the reduction in the stone size & surface area/ or the expulsion of stone
时间窗: In 210 days
次要结局
- Reduction in the size of stone Reduction in the density of the stone Painless expulsion of the stone/fragments Reduction in pain Consumption of Analgesics(In 210 days)
研究者
研究点 (1)
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