The Efficacy and Safety of Guilu Erxian Jiao in the Treatment of Intradialytic Hypotension

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorChang Gung Memorial Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Age ≥ 18 years

Undergoing maintenance hemodialysis three times per week, 4 hours per session

History of intradialytic hypotension (IDH)

Willing and able to provide written informed consent

Disqualifiers

Pregnant or lactating women

Severe comorbid illness, such as cancer, stroke, or liver cirrhosis

Inability to comply with study medication regimen

Regular use of antihypertensive medication

Trial design

Treatments tested in this trial

  • Guilu Erxian Jiao

Treatment groups

34 Participants
are divided into 2 treatment groups

Sponsors and collaborators