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The Efficacy and Safety of Guilu Erxian Jiao in the Treatment of Intradialytic Hypotension
Sponsor: Chang Gung Memorial Hospital
Summary
The goal of this clinical trial is to learn if Guilu Erxian Jiao, a traditional Chinese herbal medicine, can help manage intradialytic hypotension (IDH), a drop in blood pressure that occurs during hemodialysis in adults. The main questions it aims to answer are: 1. Does Guilu Erxian Jiao reduce the frequency and severity of low blood pressure during dialysis? 2. Is Guilu Erxian Jiao safe to use in patients receiving hemodialysis? Researchers will compare standard care plus Guilu ErXian Jiao to standard care alone to see if Guilu Erxian Jiao improves blood pressure stability during dialysis. Participants will: 1. Take Guilu Erxian Jiao once daily in addition to standard care, or receive standard care alone, for 4 weeks, then switch treatments after a 4-week washout period (crossover design). 2. Undergo follow-up assessments at weeks 2 and 4 after each treatment phase. 3. Have their blood pressure monitored before, during (hourly), and after each dialysis session. 4. Report dialysis-related symptoms such as dizziness and fatigue. 5. Receive routine laboratory tests and safety monitoring throughout the study.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
34
Start Date
2025-06-01
Completion Date
2028-05-31
Last Updated
2025-05-20
Healthy Volunteers
No
Interventions
Guilu Erxian Jiao
A traditional Chinese herbal formula composed of Testudinis Carapax, Cervi Cornu, Lycii Fructus, and Ginseng Radix, manufactured by Sun Ten Pharmaceutical Co., Ltd. (License No. 016966). Administered orally at 4 grams per day before meals for 4 weeks.
Locations (1)
Keelung Chang Gung Memorial Hospital
Keelung, Taiwan