Effect of Gui-Lu-Er-Xian-Jiao-Wan on Intradialytic Hypotension
Phase 2
Not yet recruiting
- Conditions
- Intradialytic Hypotension
- Interventions
- Registration Number
- NCT05517993
- Lead Sponsor
- Chang Gung Memorial Hospital
- Brief Summary
Intradialytic hypotension (IDH), a common complication during hemodialysis (HD) could increase patients' morbidity and mortality. Previous studies considered that some Chinese herbal medicine (CHM) plays a complementary role in reducing the frequency of IDH. This trial is aimed to investigate the effect of Gui-Lu-Er-Xian-Jiao-Wan (GLEXJW) in patients with intradialytic hypotension.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- End stage renal disease treated with hemodialysis for ≥3 months
- Receive a standard thrice-weekly hemodialysis schedule
- More than 25% of hemodialysis sessions complicated by intradialytic hypotension
Exclusion Criteria
- Active malignancy
- Life-threatening conditions
- Pregnancy
- Recent participation in another clinical trial for intradialytic hypotension
- History of hypersensitivity or contraindication to herbal medicine
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Group A Gui-Lu-Er-Xian-Jiao-Wan Gui-Lu-Er-Xian-Jiao-Wan (GLEXJW) 3g orally twice daily for 12 weeks.
- Primary Outcome Measures
Name Time Method Intradialytic hypotension episode Each time of dialysis during 12-weeks study period. Hypotension episode during hemodialysis
- Secondary Outcome Measures
Name Time Method Early termination of hemodialysis Each time of dialysis during 12-weeks study period. The episode of early termination in hemodialysis due to hypotension
SF-36 Baseline, 12 weeks, 28 weeks Short Form (36) Health Survey (SF-36)
Trial Locations
- Locations (1)
Kaohsiung Chang Gung Memorial Hospital
🇨🇳Kaohsiung, Taiwan