ClinicalTrials.gg
CompletedNCT06875115Updated Dec 24, 2025Results posted

Evaluation of the Efficacy of Laser Acupuncture on Uremic Pruritus

An interventional study of laser acupuncture in Uremia, sponsored by Dalin Tzu Chi General Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-12-24.

Sponsored by Dalin Tzu Chi General Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Apr 2024, registered Aug 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years to 90 Years
Sex
All
01

Study summary

Sixty patients were randomly assigned to either the experimental group (n=30) receiving laser acupuncture or the control group (n=30) receiving sham laser acupuncture. Treatment sessions were conducted during dialysis sessions. The experimental group received laser acupuncture at Xuehai, Quchi, and Bai Chongwo acupoints three times per week for four weeks. The control group received sham laser acupuncture at the same acupoints. The 5-D Pruritus Scale and DLQI were used to assess pruritus severity before and after the intervention.

Read the detailed description

The subjects were divided into two groups to investigate whether laser acupuncture can improve uremic pruritus.

02

Conditions studied

  • Uremia

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Keywords

  • uremia
03

In context

Uremia

53 studies on the registry are indexed under Uremia; 10 are open to participants now.

This study's enrollment of 60 is close to the median of 60 across 38 interventional studies indexed under Uremia.

Browse Uremia studies →

Lead sponsor

Dalin Tzu Chi General Hospital is the lead sponsor of 37 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥ 20 years.
  • Intact parathyroid hormone (iPTH) levels \< 68 pg/mL (patients with -thyroidectomy excluded).
  • Urea nitrogen (BUN) clearance rate (Kt/V) ≥ 1.2 at each dialysis session.
  • Serum phosphate levels \< 5.5 mg/dL.
  • Receiving hemodialysis three times weekly for at least three consecutive months.
  • No history of acute illnesses like infections or cardiovascular disease.
  • Avoiding a high-phosphorus diet.
  • Adjusting dialysate calcium concentration to 8.6-10 mg/dL.
  • Replacing the artificial kidney or increasing dialysis blood flow

Exclusion criteria

Exclusion Criteria:

  • Pregnant or nursing.
  • History of photosensitivity.
  • Recent use of systemic or local medications for pruritus (e.g., , opioid agonists/antagonists, , antihistamines, ultraviolet B therapy).
  • Hepatobiliary dysfunction based on medical history and liver function tests.
  • .
  • Other itchy skin conditions diagnosed by a dermatologist.
  • Wounds near acupuncture points, contraindicating laser acupuncture
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    laser acupuncture on acupoint

    The experimental group is a powered, functional laser device,

    Device: laser acupuncture

  • Placebo comparator
    shame laser on acupoints

    the control group is a non-functional laser device that does not emit light and has no therapeutic effect.

    Device: laser acupuncture

Interventions

  • Devicelaser acupuncture

    laser acupuncture on acupoints

06

What researchers measure

Primary outcomes

  1. Title: Evaluation of the Efficacy of Laser Acupuncture on Ureimc Pruritus

    The severity of uremic pruritus was assessed using the 5-D Itch Scale, a validated instrument that measures itch duration, degree, direction, disability, and distribution. The total score ranges from 5 to 25, with higher scores indicating worse pruritus. Measurements were taken at baseline and at week 4 after completion of the laser acupuncture or sham intervention.

    Time frame: A 4-week timeframe from enrollment to treatment completion.

07

Results

Posted Dec 24, 2025
Limitations and caveats
This study was conducted in a single center with a relatively small sample size, which may limit the generalizability of the findings. The follow-up period was short (4 weeks), and longer-term effects of laser acupuncture on uremic pruritus could not be evaluated. The study population consisted of stable hemodialysis patients, and results may not apply to other patient groups.

Participant flow

Participants were recruited from the hemodialysis center of Dalin Tzu Chi Hospital between January 2024 and December 2024. Eligible patients were screened based on inclusion/exclusion criteria during routine dialysis visits. Written informed consent was obtained prior to enrollment. A total of 60 participants met eligibility criteria and agreed to join the study.

Participant flow — Overall Study
MilestoneSham LaserLaser Acupuncture
Started3030
Completed3030
Not completed00

Outcome measures

PrimaryTitle: Evaluation of the Efficacy of Laser Acupuncture on Ureimc Pruritus

The severity of uremic pruritus was assessed using the 5-D Itch Scale, a validated instrument that measures itch duration, degree, direction, disability, and distribution. The total score ranges from 5 to 25, with higher scores indicating worse pruritus. Measurements were taken at baseline and at week 4 after completion of the laser acupuncture or sham intervention.

Time frame:
A 4-week timeframe from enrollment to treatment completion.
Reported as:
Mean · points
Title: Evaluation of the Efficacy of Laser Acupuncture on Ureimc Pruritus
pointsLaser AcupunctureSham Laser
baesline18.13 ± 3.7117.47 ± 3.58
Week 410.20 ± 4.9617.10 ± 3.72
Statistical analysis
  • Laser Acupuncture vs Sham Laser · t-test, 1 sided · p = <0.05

Adverse events

Collected over From baseline to week 4 during the intervention period.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Sham Laser0/30 (0%)0/30 (0%)0/30 (0%)
Laser Acupuncture0/30 (0%)0/30 (0%)0/30 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Sham LaserLaser AcupunctureTotal
Mean57.27 ± 12.3959.20 ± 11.5258.24 ± 12.02
Sex: Female, Male
Sex: Female, Male(Participants)Sham LaserLaser AcupunctureTotal
Female151631
Male151429
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Sham LaserLaser AcupunctureTotal
American Indian or Alaska Native000
Asian303060
Native Hawaiian or Other Pacific Islander000
Black or African American000
White000
More than one race000
Unknown or Not Reported000
08

Study locations

1 site
  • Dalin Tzu Chi Hospital
    Dalin, Chiayi 622, Taiwan
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT06875115
Lead sponsor
Dalin Tzu Chi General Hospital
Responsible party
Sponsor
First posted
Mar 13, 2025
Start date
Apr 9, 2024
Primary completion
May 11, 2024
Completion
Apr 11, 2025
Results posted
Dec 24, 2025
Last update
Dec 24, 2025

Study contacts

Ying-HSU Juan, doctor
study chair · doctor

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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