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

NCT07380581 | Completed Phase 1 DMC

• 2 other identifiers: 202302043A3C501CORPG8N0441
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myofacial Pain; End Stage Chronic Renal Failure

Outcome Measures

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").

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

Secondary Outcomes (2)

• Health Questionnaire Depression Rating Scale (PHQ-9)

  Week 0 (baseline) and 4

• EuroQol-5-dimension questionnaire (EQ-5D)

  Week 0(baseline) and 4

Other Outcomes (3)

• Routine blood analysis

  Week 0(baseline) and 4

• Total number of analegics use in all HD sessions

  Week 4

• Total number of early termination of hemodialysis

  Week 4

Study Arms (2)

Sham (No Treatment)

SHAM COMPARATOR

Other: Sham (No Treatment)

Artemisias-ginger patch (AGP)

EXPERIMENTAL

Other: Artemisias-ginger patch (AGP)

Interventions

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.

Sham (No Treatment)

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.

Artemisias-ginger patch (AGP)

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital in Kaohsiung branch

Kaohsiung City, 83301, Taiwan

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Facial Pain

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Department of Chinese Medicine

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: February 2, 2026
• Study Start: February 15, 2024
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

TW (1)