The Treatment Effect of Chinese Medicine Formula on Uremic Pruritus
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 60
- 主要终点
- Visual Analogue Scale(VAS)
研究概览
简要总结
The prevalence of hemodialysis patients is increasing in recent years. And the uremic pruritus is a common and bothersome symptom among the patients. Current therapies for uremic pruritus, including dialysis modification, topical treatment such as emollients and topical analgesic agent, phototherapy, acupuncture, and gabapentin. However, the efficacy of these treatments remains poorly defined.
In our experiment, the investigators tried to find an effective way to control uremic pruritus through Chinese traditional medicine.
详细描述
The prevalence of hemodialysis patients is increasing in recent years. And the uremic pruritus is a common and bothersome symptom among the patients. Current therapies for uremic pruritus, including dialysis modification, topical treatment such as emollients and topical analgesic agent, phototherapy, acupuncture, and gabapentin. However, the efficacy of these treatments remains poorly defined.
In our experiment, the investigators tried to find an effective way to control uremic pruritus through Chinese traditional medicine. "Xiao-Feng-San" is a common Chinese herbal preparation, composed of 13 herbs, which is used to treat patients with dermatitis. The component of "Xiao-Feng-San" has immunomodulatory activity. "Shian Fang Hwa Ming Yiin" is another common Chinese herbal preparation, composed of 12 herbs, which is used to treat patients with carbuncles and acne. The component of "Shian Fang Hwa Ming Yiin" has anti-inflammation and anti-microbial effect.
The purpose of this study is to evaluate the treatment effect of Xiao-Feng-San and Shian Fang Hwa Ming Yiin on uremic pruritus among hemodialysis patients in this randomized, double-blind, placebo-controlled study design.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 3 episodes of itch during 2 weeks or less, the itch occurring several times a day, lasting for more than 5 min and being bothersome
- •An intermittent itch over a period of 6 months or more, with a clinical appearance, but with a lower frequency than in (1)
- •People with clear consciousness, without cognitive impairment
- •Those who can cooperate to fill in relevant questionnaires
- •Willing to sign consent forms
- •Blood test indicators: (1) Intact parathyroid hormone (iPTH) <600 pg/ml (2) Kt/V >1.2 (3) Serum phosphate <6 mg/dl
- •Refractory uremic pruritus; The patient failed to respond to following treatments (1) avoiding food containing high amounts of phosphate (2) haemodialysis with a dialysate containing 3.0 or 2.5 mEq/l of calcium (3) changing the dialyser or increasing blood flow
排除标准
- •Be younger than 20 years old.
- •People suffering from diagnosed skin diseases (scabies, drug allergy, atopic dermatitis), severe infections, liver failure, blood diseases or biliary diseases.
- •Patients with abnormal liver and kidney function.
- •People suffering from cognitive dysfunction caused by neurological diseases or mental diseases.
- •People with severe visual impairment, hearing impairment, and physical impairment that affect the scale test.
- •Those who are undergoing other trials.
- •Those who are pregnant or breastfeeding.
研究组 & 干预措施
Xiao-Feng-San; Shian-Fang-Hwa-Ming-Yiin
Xiao-Feng-San 2g+ Shian Fang Hwa Ming Yiin 2g; twice a day for two months
干预措施: Xiao-Feng-San+Shian-Fang-Hwa-Ming-Yiin (Drug)
Placebo
Similar placebo 4g twice a day for two months
干预措施: Placebo (Drug)
结局指标
主要结局
Visual Analogue Scale(VAS)
时间窗: on day 84
Measuring itch intensity
5-D itch scale
时间窗: on day 84
(1) duration of itchiness, (2) degree of itchiness, (3) direction of itchiness, (4) disability caused by itchiness, and (5) distribution of itchiness
次要结局
未报告次要终点