End Stage Chronic Renal FailurePhase 1/2Fistula PainNCT07380581
The Herbal Acupoint Patch for Dialysis Patient With Fistula-related Pain
A Phase 1/2 study testing Artemisias-ginger patch (AGP) in people with End Stage Chronic Renal Failure and Myofacial Pain, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- End Stage Chronic Renal Failure, Myofacial Pain
- What is being tested?
- Artemisias-ginger patch (AGP)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Feb 2024to 31 Aug 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Chang Gung Memorial Hospital in Kaohsiung branch
Kaohsiung City, 83301
About this study
Official 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
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
- End Stage Chronic Renal Failure, Myofacial Pain
- Being tested
- Artemisias-ginger patch (AGP), Sham (No Treatment)
- Medical subject headings
- Renal Insufficiency, Chronic, Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Sham (No Treatment) | Sham comparator | Not described Receives: Other: Sham (No Treatment) |
| Artemisias-ginger patch (AGP) | Experimental | Not described Receives: Other: Artemisias-ginger patch (AGP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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").
Measured: Weeks 0 (baseline), 2, 4, and 6 (2 weeks of follow-up)
Secondary outcomes (2)
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.
Measured: Week 0 (baseline) and 4
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
Measured: Week 0(baseline) and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start15 Feb 2024
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Chronic Renal FailureStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming-Yen Tsai, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07380581
- Sponsor's protocol ID
- 202302043A3C501
- Other IDs
- CORPG8N0441
- Acronym
- Fistula Pain
- Status last verified
- Jan 2026
- First submitted
- 16 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data is being compiled and is expected to be submitted.
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07380581
- Acronym / sponsor ID
- Fistula Pain / 202302043A3C501
- Conditions
- End Stage Chronic Renal Failure, Myofacial Pain
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham (No Treatment) | Sham comparator | Other: Sham (No Treatment) |
| Artemisias-ginger patch (AGP) | Experimental | Other: Artemisias-ginger patch (AGP) |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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,
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 |
|---|---|---|
| Artemisias-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. | Other | Artemisias-ginger patch (AGP) |
| Sham (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. | Other | Sham (No Treatment) |
Primary outcome
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").
2 secondary outcomes
Health Questionnaire Depression Rating Scale (PHQ-9)
Time frame: Week 0 (baseline) and 4
EuroQol-5-dimension questionnaire (EQ-5D)
Time frame: Week 0(baseline) and 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: Undecided. Data is being compiled and is expected to be submitted.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Artemisias-ginger patch (AGP) in people with End Stage Chronic Renal Failure and Myofacial Pain, run by Chang Gung Memorial 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 5 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 2 Feb 2026. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Brief Pain Inventory (BPI) (time frame: Weeks 0 (baseline), 2, 4, and 6 (2 weeks of follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2026.