Efficacy of Calmmax Cream in the Management of Chronic Uremic Pruritus
试验速览
- 阶段
- 不适用
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Improvement of UP measured by reduction of VAS by more than 50 percent from baseline score
研究概览
简要总结
Uraemic pruritus (UP) remains a frequent and distressing problem in patients with advanced chronic kidney disease (CKD) and end-stage renal disease (ESRD).
Calmmax is a new topical cream that was introduced recently by Calmmax Pharma, an Israeli pharmaceutical company developed a topical cream based on active plant extracts for treatment of skin inflammation. We intend to conduct a prospective, double blind, placebo controlled, randomized trial that will assess the therapeutic effect of Calmmax cream on UP in a cohort of CKD and ESRD patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of pruritus of >8 weeks duration.
- •Severity score of pruritus ≥5 as defined by VAS
- •Discontinuation of any medication with presumed antipruritic effects at least 1 week before the study (including Calmmax cream)
- •Negative pregnancy test result for all participating women of childbearing age;
排除标准
- •Known allergy to Calmmax cream
- •Any acute illness
- •Liver cirrhosis
- •Active dermatological disorder other than UP
- •Decompensated heart failure
- •Inability to give informed consent
- •Known poor adherence to medical recommendations
研究组 & 干预措施
Callmax cream
干预措施: Callmax cream application over affected skin (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Improvement of UP measured by reduction of VAS by more than 50 percent from baseline score
时间窗: 1 year
次要结局
- quality of life assessed by questionnaire(1 year)
研究者
Linda Shavit
Dr
Shaare Zedek Medical Center