NCT05517993
Not yet recruiting
Phase 2
Effect of Gui-Lu-Er-Xian-Jiao-Wan on Intradialytic Hypotension: a Randomized Crossover Pilot Trial
Chang Gung Memorial Hospital1 site in 1 country50 target enrollmentSeptember 1, 2022
Overview
- Phase
- Phase 2
- Intervention
- Gui-Lu-Er-Xian-Jiao-Wan
- Conditions
- Intradialytic Hypotension
- Sponsor
- Chang Gung Memorial Hospital
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Intradialytic hypotension episode
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Group A
Gui-Lu-Er-Xian-Jiao-Wan (GLEXJW) 3g orally twice daily for 12 weeks.
Intervention: Gui-Lu-Er-Xian-Jiao-Wan
Outcomes
Primary Outcomes
Intradialytic hypotension episode
Time Frame: Each time of dialysis during 12-weeks study period.
Hypotension episode during hemodialysis
Secondary Outcomes
- Early termination of hemodialysis(Each time of dialysis during 12-weeks study period.)
- SF-36(Baseline, 12 weeks, 28 weeks)
Study Sites (1)
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