NCT06980922Not yet recruitingPhase 2
The Efficacy and Safety of Guilu Erxian Jiao in the Treatment of Intradialytic Hypotension
Source: ClinicalTrials.gov · Last updated 20 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 34 (estimated)
- First submitted
- 19 May 2025
- Start date
- 1 Jun 2025
- Primary completion date
- 31 May 2027
- Lead sponsor
- Chang Gung Memorial Hospital
- Diseases
- Chronic kidney disease
- NCT number
- NCT06980922
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 34
- From 1 Jun 2025 to the primary completion date, 31 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Inability to comply with study medication regimen
- Regular use of antihypertensive medication
Other illness
- Severe comorbid illness, such as cancer, stroke, or liver cirrhosis
Other
- Pregnant or lactating women
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Keelung Chang Gung Memorial Hospital Coordinator of this site? Confirm its status | Keelung | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.