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Observation of the efficacy of topical application of "Hefuzhiyang lotion" in the treatment of pruritus in patients undergoing hemodialysis

Observation of the efficacy of topical application of "Hefuzhiyang lotion" in the treatment of pruritus in patients undergoing hemodialysis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000351
Enrollment
Unknown
Registered
2025-02-19
Start date
2025-03-01
Completion date
Unknown
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic kidney disease

Interventions

Intervention group:Externally applie "Hefuzhiyang lotion"
control group:Externally applie placebo

Sponsors

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria for CKD stage 5 under the American Initiative for Quality in Prognosis of Kidney Disease (K/DOQI) clinical guidelines; (2) meet the diagnostic criteria for uremic pruritus; (3) Regular hemodialysis treatment for = 3 months; (4) Age 18-70 years old; (5) The condition was stable and the adequacy of dialysis before inclusion was included KT/V=1.2; (6) Voluntarily participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Previously diagnosed primary skin diseases such as atopic dermatitis chronic eczema drug eruption psoriasis neurodermatitis etc.; (2) Those who are known to be allergic to any of the components of the test drug; (3) Those with severe skin trauma ulceration infection etc. which are not suitable for external application of traditional Chinese medicine; (4) Those who have used antibiotics anti-allergic drugs analgesics dextran and other drugs or immunosuppressants and other traditional Chinese medicine preparations for the treatment of itchy skin within 1 month; (5) Patients with severe hypertension (systolic blood pressure > 180 and/or diastolic blood pressure >110mmHg) acute cerebrovascular accident severe heart disease severe anemia (Hb<60g/L) and acute cardiac insufficiency; (6) Those who have mental disorders cognitive disorders and other reasons that cannot cooperate with the diagnosis and treatment and follow-up.

Design outcomes

Primary

MeasureTime frame
Pruritus Visual Analogue Index VAS score;Dermatology Life Quality Index(DLQI);

Secondary

MeasureTime frame
Skin barrier function test (stratum corneum water content and transdermal water loss);Serum uric acid;haemoglobin;Skin microbiota assay (16srRNA sequencing);Serum phosphorus;Serum total protein;Parathyroid hormone;Dialysis Effectiveness Index;Serum potassium;14-item uremia pruritus score in dialysis patients;Serum magnesium;Kidney Disease Quality of Life Qustionnaire(KDQOL-36TM);Serum albumin;

Countries

China

Contacts

Public ContactLu Peng

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine

yuexiangzi@163.com13751772167

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026