Evaluation the Effect of Fumaria Parviflora L. on Uremic Pruritus of End-stage Renal Disease Patients: A Randomized Double- Blind Placebo-controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 63
- 主要终点
- Severity of Pruritis as measured by a visual analogue scale (VAS)
研究概览
简要总结
The purpose of this study is to determine whether Fumaria Parviflora L. can minimize severity of pruritus in patients with end-stage renal disease.
详细描述
Uremic Pruritus is still a common complication in end-stage renal disease patients. The pathogenesis of Uremic Pruritus is unknown, therefore treatments are ineffective. According to several studies Uremic Pruritus is not an isolated skin disease. It seems to be a systemic inflammatory disease with a deranged balance of T helper cell differentiation. In this study investigators considered to evaluate effect of Fumaria Parviflora L. in uremic pruritus by a double blind placebo control clinical trial. It is hypothesized that oral Fumaria Parviflora L. may minimize uremic pruritus by decreasing serum Interferon gamma (IFN-γ) and high-sensitive C reactive protein (hs-CRP).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hemodialysis patients
- •Suffering from pruritus for at least 6 weeks
- •Have not responded to other drugs
- •visual analogue scale (VAS) equal or more than 4
排除标准
- •Liver disease
- •Respiratory disease
- •Dermatological disease
- •Hemoglobin less than 10
- •Cholestasis
- •Malignancies
研究组 & 干预措施
Wheat
Placebo capsule/ 2 capsule 3 times per day
干预措施: Wheat (Drug)
Fumaria
Fumaria capsule (0.5 mg Fumaria parviflora L.) / 2 capsule 3 times per day.
干预措施: Fumaria (Drug)
结局指标
主要结局
Severity of Pruritis as measured by a visual analogue scale (VAS)
时间窗: 3 months
A '0' score represented absence of pruritus and a '10' represented the greatest severity of symptoms.
次要结局
- Serum Interferon-gamma level(4 months)
- Serum IL-4 level(4 months)
- Serum high-sensitive C reactive protein (hs-CRP)(4 months)
研究者
Rahimeh Akrami
Dr.
Shiraz University of Medical Sciences