Uremic Pruritus
Conditions
Sponsors
Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) age from 18 to 80 years; (2) match the diagnostic criteria of UP and have had at least 6 weeks pruritus duration; (3) have been undergoing hemodialysis 2-3 times per week for at least 3 months; (4) have moderate-to-severe pruritus (which was defined as a weekly mean score of more than 4 points on the 24-hour Worst Itching Intensity Numerical Rating Scale (WI-NRS) ranging from 0 to 10); Or have a weekly mean score of 24-hour Worst Itching Intensity Numerical Rating Scale (WI-NRS)=4(range from 0 to 10); (5) have at least 1 single-pool Kt/V measurement =1.2 and 1 urea reduction ratio measurement (URR) =65% on different dialysis days during the 3 months period prior to screening; (6) have signed the informed-consent form voluntarily.
Exclusion criteria
Exclusion criteria: (1) suffering from pruritus contributed to a cause other than ESRD (eg dermatological disease such as psoriasis atopic dermatitis urticaria contact dermatitis etc); (2) with severe chronic liver disease or alanine aminotransferase (ALT) aspartate aminotransferase (AST) glutamyl transferase (GGT) total bilirubin (TBIL) any of which is twice higher than the upper limit of normal value; (3) with malignant tumors or other serious diseases requiring hospitalization; (4) with severe mental illness or cognitive impairment (such as dementia); (5) scheduling to receive a kidney transplant or change dialysis regimen to peritoneal dialysis during the study period; (6) suffering from pruritus only during the dialysis session; (7) receiving acupressure acupuncture moxibustion phototherapy or other relative physical therapy to pruritus within 1 month prior to screening; (8) with coagulation dysfunction or fester on the acupuncture points; (9) participating in other clinical trials within 6 months as assessed by the investigator that the result may interfere with this study or planning to participate in other clinical trial while enrolled in this study. (10) women being pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in weekly mean 24-hour Worst Itch Numeric Rating Scale (24h-WI-NRS) scores at week 4 versus baseline. ; | — |
Secondary
| Measure | Time frame |
|---|---|
| response rate;The weekly mean 24h-WI-NRS score at each assessing time point except week 4.;recurrence rate;Changes in blood indicators (calcium phosphorus parathyroid hormone C-reactive protein interleukin-6 interleukin-13 interleukin-31);The proportion of participants demonstrating improvement in DLQI categories;The proportion of participants demonstrating improvement in14-Item UP-Dial Scale score categories;The proportion of participants demonstrating improvement in GAD-7 categories;The proportion of participants demonstrating improvement in PHQ-9 categories;The change in the weekly average number of medication days compared to baseline; | — |
Countries
China
Contacts
Public ContactZeng Fang
Chengdu University of Traditional Chinese Medicine
Outcome results
None listed