Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy of Laser Acupuncture on Pruritus in Patients With Chronic Kidney Disease Undergoing Hemodialysis: A Multiple Centers, Randomized, Assessor- and Participant-blind, Controlled, Cross-over Clinical Trial
Brief Summary: Uremic pruritus is a clinically significant symptom which imposes heavy impact on the quality of life of patients with chronic kidney disease undergoing hemodialysis. In order to investigate the clinical efficacy and mechanism, the investigators designed a multiple centers, randomized, assessor- and participant-blind, controlled, cross-over clinical trial. This trial will be conducted at Taichung branch, Feng-yuan branch and the Eastern branch of CMUH.


Options:
A: Inclusion Criteria:

* Diagnosis of end-stage renal disease (ESRD) requiring hemodialysis for at least 3 months prior to the Screening Period
* Receiving conventional hemodialysis (i.e., not hemofiltration or hemodiafiltration)
* Pruritus present for at least 6 weeks of Screening
* Mean pruritus severity score on a numerical rating scale (NRS) \> 4
* Patient-Assessed Disease Severity Scale Type B or C at Screening
* Documentation of a urea reduction ratio (URR) \>65% or single-pooled Kt/V\> 1.4 during Screening
* Willing and able to provide written informed consent

Exclusion Criteria:

* Current or recent history of clinically significant medical condition, laboratory abnormality, or illness that could put the patient at risk or compromise the quality of the study data as determined by the investigator
* Myocardial infarction within 6 months or unstable angina, acute coronary syndrome, or interventional coronary procedure within 2 months of Screening
* Upper or lower respiratory tract infection (including sinus infection) within 4 weeks of Screening
* Severely symptomatic cardiopulmonary disease defined by the use of home oxygen treatment, dyspnea at rest or with minimal exertion, uncontrolled arrhythmias (e.g. atrial fibrillation with inadequate rate control), or history of life-threatening arrhythmias (e.g. cardiac arrest or syncope related to arrhythmia)
* Acute exacerbation of asthma or chronic obstructive pulmonary disease resulting in hospitalization or visit to an emergency department or urgent care clinic within 6 months of Screening
* Hospitalization for any medical reason other than for a pre-planned procedure or dialysis access related procedure within the 2 weeks of Screening
* Malignancy requiring active treatment with a systemic drug
* Participation in any other investigation drug study within 4 weeks of Screening
* Current or anticipated use of baclofen, gabapentin, pregabalin and nalbuphine for the treatment of pruritus
* Current or anticipated use of glucocorticoids administered intravenously, orally, or transdermally
* Pregnant or breastfeeding females, or if of child-bearing potential unwilling to practice acceptable means of birth control or abstinence during the study
B: Inclusion Criteria:

* Hemodialysis patients
* Suffering from pruritus for at least 6 weeks
* Have not responded to other drugs
* visual analogue scale (VAS) equal or more than 4

Exclusion Criteria:

* Liver disease
* Respiratory disease
* Dermatological disease
* Hemoglobin less than 10
* Cholestasis
* Malignancies
C: Inclusion Criteria:

* Age\>20y/o, ESRD patient, pruritus symptoms persist longer than 4 weeks

Exclusion Criteria:

* immunosupression agents use, undergo chemotherapy
* drug abuser
* pregnancy women
* patient with psychiological disorder
* arrhythemia, pacemaker device use
* local skin infection over laser acupuncture site
* patient allergy to laser acupuncture treament
D: Inclusion Criteria:

\[At the time of obtaining the consent form\]

* Chronic renal failure patients who regularly receive hemodialysis three times a week and are not likely to have a serious treatment change or acute symptoms during the study period
* Patients who received both of the drug pruritus treatments in section 1 and 2 below within one year before the day of singing consent form

  1. Systemic therapy of more than two consecutive weeks depending on antihistamine or antiallergic drugs falling under "prescription drugs with indication of pruritus" (oral drugs, injections, etc.)
  2. Local therapy depending on "prescription drugs with indication of pruritus" (ointment, etc.) or a moisturizer prescribed by a doctor (topical preparation, etc.)
* Patients for whom all the conventional pruritus treatments in section (2) are not enough
* Patients aged 20 years or older at time of signing the consent form

\[At the time of enrollment\]

* Patients whose VAS scores are measured both after breakfast and dinner for five days or more of the last 7 days of the predose observation period and whose mean of whichever the higher VAS scores after breakfast or dinner is ≥50 mm
* Patients whose whichever the higher VAS score after breakfast or dinner for the last 7 days during the preliminary observation day (measured VAS score if one is missing) is more than ≥20 mm for five days or more
* Patients who are judged to have pruritus both during the day and at night for more than two days based on the Shiratori's severity criteria assessed by the subject at days of fifth and sixth hemodialysis and the day of hemodialysis after the completion of the predose observation period, and whose whichever the higher pruritis score measured during the day or at night is 3 (moderate) for two days or more

Exclusion Criteria:

* Patients with malignant tumor
* Patients with depression, schizophrenia or dementia as complications
* Patients who currently have Child-pugh class B or C hepatic cirrhosis as complications
* Patients with clinically significant hepatic or cardiovascular diseases which cannot be controlled by diet or drug therapy
* Patients who currently have the following heart diseases: life-threatening arrhythmia; unstable angina or myocardiac infarction within 6 months; PCI or CABG within 6 months; NYHA class III or IV congestive heart failure
* Patients with atopic dermatitis or chronic urticaria as complications
* Patients who are allergic to opioid drugs
* Patients with dependence on drug or alcohol
* Patients who received phototherapy for pruritus within one month before signing the consent form
* Patients who participated in the study of TRK-820 and received the study drug or who were already enrolled in this study
* Patients who participated in other clinical studies (including the ones using artificial kidney and medical equipment), and received the study drug or treatment with clinical equipment within one month before signing the consent form
* Pregnant women, lactating women and patients of childbearing potential who do not use contraceptive methods
* Patients who cannot report VAS scores by their own for any reason at the principal investigator or study personnel's discretion
* Patients whose complications or history can impact the results of this study at the principal investigator or subinvestisator's discretion
* Other patients who are not proper to participate in this study at the principal investigator or study personnel's discretion

Answer: C