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CompletedNCT07380581Fistula PainUpdated Feb 2, 2026

The Herbal Acupoint Patch for Dialysis Patient With Fistula-related Pain

A Phase 1/2 interventional study of Artemisias-ginger patch (AGP) and Sham (No Treatment) in End Stage Chronic Renal Failure and Myofacial Pain, sponsored by Chang Gung Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-02-02.

Sponsored by Chang Gung Memorial Hospital · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled Feb 2024, registered Jan 2026).
Phase
Phase 1/2
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Study summary

To evaluate the effect of a traditional Chinese medicine (TCM) intervention on pain relief, mood and quality of life (QOL) in hemodialytic patients at a dialysis center in Southern Taiwan.

02

Conditions studied

  • End Stage Chronic Renal Failure
  • Myofacial Pain
03

In context

Renal Insufficiency, Chronic

3,144 studies on the registry are indexed under Renal Insufficiency, Chronic; 704 are open to participants now.

This study's enrollment of 21 is below the median of 74 across 2,176 interventional studies indexed under Renal Insufficiency, Chronic.

Browse Renal Insufficiency, Chronic studies →

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.

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

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • maintenance HD > 6 months ,
  • reporting fistula pain during HD sessions that was associated with a hypersensitive palpable nodule in a taut band, at least 6 times in the past month,
  • a NRS pain score >4,
  • no changes in pain relievers such as NSAIDs, opioids, topical ointments, or muscle relaxants over the past week,
  • voluntarily agreed to participate in the trial and presented written informed consent.

Exclusion criteria

Exclusion Criteria:

  • severe comorbid organ dysfunction,
  • existence of cervical radiculopathy or thoracic outlet syndrome
  • inflammation of the skin or soft tissue at the fistula site,
  • dementia,
  • psychiatric diseases,
  • allergy to herbal patch
  • currently participating in other clinical studies
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
21 participants (actual)

Study arms

  • Sham comparator
    Sham (No Treatment)

    Other: Sham (No Treatment)

  • Experimental
    Artemisias-ginger patch (AGP)

    Other: Artemisias-ginger patch (AGP)

Interventions

  • OtherArtemisias-ginger patch (AGP)

    The TCM powder using extract powder that consists of Draconis Sanguis, Rz. Zingiberis Recens, and Artemisia princeps had been formulated into uniform 3X3 cm patch under the supervision of senior pharmacists. The 3 acupoints applied by study drug were LI 10, LU 5 and TE 5 with HD three times a week for 4 weeks.

  • OtherSham (No Treatment)

    The sham HAT was applied on 3 acupoints including LI 10, LU 5 and TE 5 with HD three times a week for 4 weeks.

06

What researchers measure

Primary outcomes

  1. Brief Pain Inventory (BPI)

    Pain severity and interference are rated on a numerical rating scale (NRS) from 0 ("no pain"/"does not interfere") to 10 ("worst imaginable pain"/"completely interferes").

    Time frame: Weeks 0 (baseline), 2, 4, and 6 (2 weeks of follow-up)

Secondary outcomes

  1. Health Questionnaire Depression Rating Scale (PHQ-9)

    PHQ-9 is a 9-item, self-administered diagnostic tool used to screen for, diagnose, monitor, and measure the severity of depression in primary care and mental health settings. It scores symptoms based on the DSM-5 criteria over the past two weeks, with a total score ranging from 0 to 27.

    Time frame: Week 0 (baseline) and 4

  2. EuroQol-5-dimension questionnaire (EQ-5D)

    The EQ-5D consists of five dimensions that are rated on a 3-point scale, where lower scores indicate better health status

    Time frame: Week 0(baseline) and 4

Other outcomes

  1. Routine blood analysis

    The outine blood analysis includes CBC, Kt/V, K, Ca, P, K, albumin, hsCRP, AST, and ALT.

    Time frame: Week 0(baseline) and 4

  2. Total number of analegics use in all HD sessions

    Frequency of pain management including local analgesics, cryotherapy and oral painkillers during each dialysis was assessed within 12 sessions of study and was calculated by the number of participants in total.

    Time frame: Week 4

  3. Total number of early termination of hemodialysis

    Total number of stopping the dialysis machine before the scheduled time (e.g., less than 4 hours) during 4-week treatment

    Time frame: Week 4

07

Study locations

1 site
  • Chang Gung Memorial Hospital in Kaohsiung branch
    Kaohsiung City, 83301, Taiwan
08

References and documents

Individual participant data

Plan to share: Undecided — Data is being compiled and is expected to be submitted.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07380581
Lead sponsor
Chang Gung Memorial Hospital
Responsible party
Ming-Yen Tsai (Chief of Department of Chinese Medicine, Chang Gung Memorial Hospital) — Principal investigator
First posted
Feb 2, 2026
Start date
Feb 15, 2024
Primary completion
Aug 31, 2025
Completion
Aug 31, 2025
Last update
Feb 2, 2026

Oversight

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

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This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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