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
This trial does not accept healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
Guilu Erxian Jiao
DrugA 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.
Treatment groups
34 Participants
are divided into 2 treatment groupsGroup A: Group AExperimental treatment 1 intervention
Group B: Group BActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Frequency of Intradialytic Hypotension Episodes
Number of intradialytic hypotension (IDH) episodes, defined as a drop in systolic blood pressure \>20 mmHg or mean arterial pressure (MAP) \>10 mmHg, recorded during each dialysis session.
Time frame
From baseline through the entire 16-week crossover study, including each 4-week treatment phase and follow-up assessments conducted at 2 and 4 weeks after each treatment phaseSecondary outcomes
1
Change in Blood Pressure Before, During, and After Dialysis
Systolic and diastolic blood pressure measurements are collected before dialysis, hourly during dialysis, and after each dialysis session, then averaged for comparison between treatment phases.
Time frame
From baseline through the entire 16-week crossover study, including each 4-week treatment phase and follow-up assessments conducted at 2 and 4 weeks after each treatment phase2
Visual Analogue Scale (VAS) Scores for Dialysis-Related Clinical Symptoms
Patient-reported dialysis-related clinical symptoms, such as dizziness and fatigue, are measured using a 0-10 Visual Analogue Scale (VAS) at designated time points throughout the study.
Time frame
Assessments are conducted after each dialysis session throughout the 16-week crossover study, including each 4-week treatment phase and follow-up assessments at 2 and 4 weeks after each treatment phase, starting from baseline3
Changes in Laboratory Parameters (Na, K, Ca, P, BUN, Cr)
Serum levels of sodium, potassium, calcium, phosphate, blood urea nitrogen, and creatinine measured at specified time points to assess biochemical changes.
Time frame
At baseline and at week 4, 8, 12, and 16 of the study4
Adverse Events Related to Guilu Erxian Jiao
All adverse events reported by participants, including dry mouth, constipation, and other symptoms, recorded and monitored throughout the study.
Time frame
Throughout the entire 16-week study periodSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: