Uremic Pruritus
Conditions
Keywords
Uremic pruritus; Hemodialysis; Chinese medicine; Xiao-Feng-San; Shian Fang Hwa Ming Yiin
Brief summary
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
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.
Interventions
DRUGXiao-Feng-San+Shian-Fang-Hwa-Ming-Yiin
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.
DRUGPlacebo
Similar placebo 4g twice a day for two months
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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 2. An intermittent itch over a period of 6 months or more, with a clinical appearance, but with a lower frequency than in (1) 3. People with clear consciousness, without cognitive impairment 4. Those who can cooperate to fill in relevant questionnaires 5. Willing to sign consent forms 6. Blood test indicators: (1) Intact parathyroid hormone (iPTH) \<600 pg/ml (2) Kt/V \>1.2 (3) Serum phosphate \<6 mg/dl 7. 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
1. Be younger than 20 years old. 2. People suffering from diagnosed skin diseases (scabies, drug allergy, atopic dermatitis), severe infections, liver failure, blood diseases or biliary diseases. 3. Patients with abnormal liver and kidney function. 4. People suffering from cognitive dysfunction caused by neurological diseases or mental diseases. 5. People with severe visual impairment, hearing impairment, and physical impairment that affect the scale test. 6. Those who are undergoing other trials. 7. Those who are pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale(VAS) | on starting day (day 0) | Measuring itch intensity |
| 5-D itch scale | on starting day (day 0) | (1) duration of itchiness, (2) degree of itchiness, (3) direction of itchiness, (4) disability caused by itchiness, and (5) distribution of itchiness |
Contacts
Primary ContactJiun-Liang Chen, Ph.D
Outcome results
None listed