The Treatment Effect of Chinese Medicine Formula on Uremic Pruritus

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Treatment Effect of Chinese Medicine Formula on Uremic Pruritus

Conditions
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Uremic Pruritus

Intervention / Treatment
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* Drug: Xiao-Feng-San+Shian-Fang-Hwa-Ming-Yiin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Xiao-Feng-San; Shian-Fang-Hwa-Ming-Yiin<br>Xiao-Feng-San 2g+ Shian Fang Hwa Ming Yiin 2g; twice a day for two months | Drug: Xiao-Feng-San+Shian-Fang-Hwa-Ming-Yiin<br>* 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.<br>|
| Placebo Comparator: Placebo<br>Similar placebo 4g twice a day for two months | Drug: Placebo<br>* Similar placebo 4g twice a day for two months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale(VAS) | Measuring itch intensity | on starting day (day 0) | 
| Visual Analogue Scale(VAS) | Measuring itch intensity | on day 28 | 
| Visual Analogue Scale(VAS) | Measuring itch intensity | on day 56 | 
| Visual Analogue Scale(VAS) | Measuring itch intensity | on day 84 | 
| 5-D itch scale | (1) duration of itchiness, (2) degree of itchiness, (3) direction of itchiness, (4) disability caused by itchiness, and (5) distribution of itchiness | on starting day (day 0) | 
| 5-D itch scale | (1) duration of itchiness, (2) degree of itchiness, (3) direction of itchiness, (4) disability caused by itchiness, and (5) distribution of itchiness | on day 28 | 
| 5-D itch scale | (1) duration of itchiness, (2) degree of itchiness, (3) direction of itchiness, (4) disability caused by itchiness, and (5) distribution of itchiness | on day 56 | 
| 5-D itch scale | (1) duration of itchiness, (2) degree of itchiness, (3) direction of itchiness, (4) disability caused by itchiness, and (5) distribution of itchiness | on day 84 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uremic pruritus; Hemodialysis; Chinese medicine; Xiao-Feng-San; Shian Fang Hwa Ming Yiin