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Search / Trial NCT07030465

Therapeutic Effects of Press Needle on 5-D Pruritus Scale in Hemodialysis Patients With Chronic Kidney Disease-Associated Pruritus

Launched by INDONESIA UNIVERSITY · Jun 12, 2025

Trial Information

Current as of June 27, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is studying whether a special type of acupuncture called press needle (PN) can help reduce itching in people with chronic kidney disease who are on regular dialysis. Itching, or pruritus, is a common and uncomfortable problem for these patients. The study will compare real press needle treatment, where tiny needles are gently placed on specific points on the body, to a fake treatment that uses just tape without needles, to see which works better in easing the itching. Researchers will check how the itching changes after several treatment sessions and also four weeks after the final session, while keeping an eye on any possible side effects.

People who might join this study are adults aged 18 to 65 who have been on hemodialysis at least twice a week for six months or more and who have moderate to severe itching related to their kidney condition. Before starting, participants will have a simple memory and thinking test to make sure they can accurately report their symptoms. During the study, they will receive either the real or fake press needle treatment applied to certain spots on one side of their body, with the needles or tape replaced every few days over four weeks. They will be asked to fill out an itching questionnaire several times during and after the treatment to track any changes. This study aims to find a safe and effective way to help relieve itching for patients undergoing dialysis.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients with CKD-associated pruritus (CKDaP) undergoing regular hemodialysis twice a week for at least 6 months and in a hemodynamically stable condition, who meet the criteria for moderate to severe pruritus based on the 5-D itch scale.
  • Subjects aged between 18 and 65 years.
  • Subjects have not received acupuncture therapy for at least one month prior to the study.
  • Subjects have good cognitive function as assessed by the MMSE.
  • Subjects are willing to participate in the study according to the scheduled timeline and have signed the informed consent form.
  • Exclusion Criteria:
  • Subjects have malignancies or infectious lesions at the acupuncture points to be treated.
  • Subjects have primary skin diseases such as allergic dermatitis, irritant contact dermatitis, neurodermatitis, or psoriasis.
  • Subjects have a history of hypersensitivity reactions to previous acupuncture therapy (such as metal allergy, atopy, keloids, or other hypersensitivities).

About Indonesia University

Indonesia University is a leading academic institution dedicated to advancing healthcare through rigorous clinical research. As a trial sponsor, the university leverages its extensive expertise in medical science and collaboration with top-tier researchers to design and implement innovative clinical trials. Committed to ethical standards and patient safety, Indonesia University aims to contribute to the global body of knowledge in medicine, enhance therapeutic options, and improve health outcomes for diverse populations. Through its comprehensive approach, the university fosters an environment of scientific inquiry and collaboration, driving progress in clinical research and education.

Locations

Jakarta Pusat, Dki Jakarta, Indonesia

Patients applied

0 patients applied

Trial Officials

KPEK FKUI-RSCM

Principal Investigator

The Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia and Dr. Cipto Mangunkusumo National Hospita

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported