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

NCT06980922 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-05-20

No results posted yet for this study

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.

Conditions

  • Intradialytic Hypotension
  • End-Stage Renal Disease
  • Hemodialysis

Interventions

DRUG

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.

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • Huan-Hsuan Hsu, M.D. · Department of Chinese Medicine, Keelung Chang Gung Memorial Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2027-05-31
Completion
2028-05-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06980922 on ClinicalTrials.gov