Clinical trial NCT04650750: The Treatment Effect of Chinese Medicine Formula on Uremic Pruritus
Official title: The Treatment Effect of Chinese Medicine Formula on Uremic Pruritus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Uremic Pruritus
Keywords: Uremic pruritus; Hemodialysis; Chinese medicine; Xiao-Feng-San; Shian Fang Hwa Ming Yiin
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2020-12-03
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Visual Analogue Scale(VAS)
timeFrame: on starting day (day 0)
measure: Visual Analogue Scale(VAS)
timeFrame: on day 28
measure: Visual Analogue Scale(VAS)
timeFrame: on day 56
measure: Visual Analogue Scale(VAS)
timeFrame: on day 84
measure: 5-D itch scale
timeFrame: on starting day (day 0)
measure: 5-D itch scale
timeFrame: on day 28
measure: 5-D itch scale
timeFrame: on day 56
measure: 5-D itch scale
timeFrame: on day 84
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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