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| ID | Type | Description | Link |
|---|---|---|---|
| CORPG8N0441 | Other Grant/Funding Number | Chang Gung Memorial Hospital in Kaohsiung branch |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham (No Treatment) | Sham Comparator |
| |
| Artemisias-ginger patch (AGP) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 0 (baseline) and 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Routine blood analysis | The outine blood analysis includes CBC, Kt/V, K, Ca, P, K, albumin, hsCRP, AST, and ALT. | Week 0(baseline) and 4 |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital in Kaohsiung branch | Kaohsiung City | 83301 | Taiwan |
Data is being compiled and is expected to be submitted.
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D005157 | Facial Pain |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
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| 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. |
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| 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 | Week 0(baseline) and 4 |
| Week 4 |
| 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 | Week 4 |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |