chronic kidney disease-associated pruritus
Conditions
Interventions
Single-arm trial:The traditional Chinese medicine herbal preparation (comprising Portulaca oleracea Phellodendron amurense Sanguisorba officinalis Lithospermum erythrorhizon Salvia miltiorrhiza Sophor
Sponsors
People's Hospital of Youyang Tujia and Miao autonomous county of chongqing
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Age =18 years. 2.Non-dialysis subjects with moderate renal impairment (estimated glomerular filtration rate [eGFR] =30 and <60 mL/min/1.73 m²) or severe renal impairment (eGFR <30 mL/min/1.73 m²). 3.Hemodialysis subjects receiving hemodialysis 3 times per week for =3 months prior to screening. 4.Pruritus severity: Skin itching occurring on at least 3 days within a 2-week period with moderate-to-severe pruritus defined as a baseline Worst Itching Intensity Numeric Rating Scale (WI-NRS) score =5. 5.Exclusion of non-CKD causes: During the 7-day run-in period prior to TCM topical treatment subjects with pruritus attributable to causes other than chronic kidney disease (CKD) were excluded. 6.Signed informed consent form.
Exclusion criteria
Exclusion criteria: 1.Concurrent primary skin disorders (e.g. eczema psoriasis neurodermatitis allergic dermatitis drug-induced rash etc.). 2.Use of medications such as dextran analgesics antibiotics or lipid-lowering drugs. 3.Comorbid conditions including peripheral neuropathy thyroid disorders leukemia lymphoma cholestasis pregnancy or hearing/communication impairments that prevent completion of the study assessments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Worst Itching Intensity Numeric Rating Scale, WI-NRS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving a =3-point improvement in weekly average WI-NRS score from baseline;Change in the Skindex-10 total score from baseline to Week 12 of treatment.;Change in the 5-D Itch Scale total score from baseline to Week 12 of treatment.;Proportion of subjects with a WI-NRS score improvement of =4 points;Proportion of subjects achieving complete resolution of pruritus, defined as a WI-NRS score of 0 or 1.;Change from baseline in weekly WI-NRS score.;Change from baseline in the weekly 5-D Itch Scale total score.;Weekly change from baseline in the Skindex-10 total score.;Serum Creatinine ;Serum Calcium;Serum Phosphorus; Intact Parathyroid Hormone ;Serum Beta-2 Microglobulin;C-Reactive Protein;Ferritin;Interleukin-1;Interleukin-6; | — |
Countries
China
Contacts
Public ContactJing Guo
People's Hospital of Youyang Tujia and Miao autonomous county of chongqing
Outcome results
None listed