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Completed

NCT Number: NCT07380581

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

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.

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Key information

Conditions

End Stage Chronic Renal Failure Chronic Disease Disease Attributes Facial Pain Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Myofacial Pain Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Signs and Symptoms Urogenital Diseases Urologic Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Chang Gung Memorial Hospital in Kaohsiung branch

Kaohsiung City, 83301, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Artemisias-ginger patch (AGP)

Other

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.

Sham (No Treatment)

Other

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.

Primary outcomes

  1. Brief Pain Inventory (BPI)

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

    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").

Secondary outcomes

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

    Time frame: Week 0 (baseline) and 4

    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.

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

    Time frame: Week 0(baseline) and 4

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

Other outcomes

  1. Routine blood analysis

    Time frame: Week 0(baseline) and 4

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

  2. Total number of analegics use in all HD sessions

    Time frame: Week 4

    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.

  3. Total number of early termination of hemodialysis

    Time frame: Week 4

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

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

The Herbal Acupoint Patch for Improving Pain, Depression, and Quality of Life in Dialysis Patient With Fistula-related Pain: Holistic Study for A Double-blind Randomized Controlled Trial

Acronym: Fistula Pain

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 2, 2026
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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