UremiaNCT06875115

Evaluation of the Efficacy of Laser Acupuncture on Uremic Pruritus

A study testing laser acupuncture in people with Uremia, run by Dalin Tzu Chi General Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 to 90 years
Conditions the study is for: Uremia
What is being tested?: laser acupuncture
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteTaiwan
Study dates: 9 Apr 2024to 11 Apr 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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Avoiding a high-phosphorus diet.
Adjusting dialysate calcium concentration to 8.6-10 mg/dL.
Replacing the artificial kidney or increasing dialysis blood flow

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Dalin Tzu Chi Hospital
Dalin, Chiayi, 622

Other trials in Taiwan

About this study

Official title: Evaluation of the Efficacy of Laser Acupuncture on Uremic Pruritus-Randomized Controlled Trial Double Blind

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.

Conditions: Uremia
Being tested: laser acupuncture
Keywords: uremia
Medical subject headings: Uremia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

laser acupunctureDevice
laser acupuncture on acupoints

Study groups in NCT06875115
Study group	Role	What they receive
laser acupuncture on acupoint	Active comparator	The experimental group is a powered, functional laser device, Receives: Device: laser acupuncture
shame laser on acupoints	Placebo comparator	the control group is a non-functional laser device that does not emit light and has no therapeutic effect. Receives: Device: laser acupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Apr 202411 Apr 2025

First posted13 Mar 2025
Study start9 Apr 2024
Primary completion11 May 2024
Study completion11 Apr 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for UremiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06875115
Sponsor's protocol ID: B11301036
Status last verified: Nov 2025
First submitted: 23 Aug 2024
Last updated: 24 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Uremia trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Efficacy of Laser Acupuncture on Uremic Pruritus-Randomized Controlled Trial Double Blind
ClinicalTrials.gov ID: NCT06875115
Acronym / sponsor ID: B11301036
Conditions: Uremia
Keywords: uremia
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Dalin Tzu Chi General HospitalUniversity, hospital or other
Study start: 9 Apr 2024 (actual)
Primary completion: 11 May 2024 (actual)
Study completion: 11 Apr 2025 (actual)
First posted: 13 Mar 2025 (actual)
Results: Posted 24 Dec 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
laser acupuncture on acupoint	Active comparator	Device: laser acupunctureThe experimental group is a powered, functional laser device,
shame laser on acupoints	Placebo comparator	Device: laser acupuncturethe control group is a non-functional laser device that does not emit light and has no therapeutic effect.

Who may qualify

Ages: 20 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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.

Key exclusion criteria (7 listed)

Pregnant or nursing.
History of photosensitivity.
Recent use of systemic or local medications for pruritus (e.g., immunosuppressants, opioid agonists/antagonists, glucocorticoids, antihistamines, ultraviolet B therapy).
Hepatobiliary dysfunction based on medical history and liver function tests.
Malignancies.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
laser acupuncturelaser acupuncture on acupoints	Device	laser acupuncture on acupoint, shame laser on acupoints

Primary outcome

Title: Evaluation of the Efficacy of Laser Acupuncture on Ureimc Pruritus
Time frame: A 4-week timeframe from enrollment to treatment completion.
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.

Results and safety

Results posted to the registry on 24 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sham Laser	30	30
Laser Acupuncture	30	30

Primary outcome: Title: Evaluation of the Efficacy of Laser Acupuncture on Ureimc Pruritus

Time frame: A 4-week timeframe from enrollment to treatment completion.. Mean (Standard Deviation). Unit: points

Measure	Laser Acupuncture n = 30	Sham Laser n = 30
baesline	18.13 (3.71)	17.47 (3.58)
Week 4	10.20 (4.96)	17.10 (3.72)

Laser Acupuncture vs Sham Laser: p <0.05, t-test, 1 sided

Adverse events

Time frame: From baseline to week 4 during the intervention period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sham Laser	0 of 30 (0%)	0 of 30 (0%)	0 of 30
Laser Acupuncture	0 of 30 (0%)	0 of 30 (0%)	0 of 30

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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RecruitingObservational study
Collection of Human Samples to Study Hairy Cell and Other Leukemias, and to Develop Recombinant Immunotoxins for Cancer Treatment
Hairy Cell Leukemia (HCL), Chronic Lymphocytic Leukemia (CLL)
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
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Active, not recruitingObservational study
A Prospective, Non-interventional, Observational Study of Presentation, Treatment Patterns and Outcomes in Atypical Hemolytic Uremic Syndrome Patients
Atypical Hemolytic Uremic Syndrome(aHUS)
Active, not recruitingPhase 3
A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Pediatric Participants With Atypical Hemolytic Uremic Syndrome (aHUS)
Atypical Hemolytic Uremic Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ying-HSU Juan, doctor study chair

doctor

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing laser acupuncture in people with Uremia, run by Dalin Tzu Chi General Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Title: Evaluation of the Efficacy of Laser Acupuncture on Ureimc Pruritus (time frame: A 4-week timeframe from enrollment to treatment completion.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06875115.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.