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Intradialytic HypotensionPhase 2NCT06980922

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

A Phase 2 study testing Guilu Erxian Jiao in people with Intradialytic Hypotension and End-Stage Renal Disease, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Guilu Erxian Jiao
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteTaiwan
Study dates
1 Jun 2025to 31 May 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Huan-Hsuan Hsu, M.D. contact

+886-2-24313131 ext. 2677

10356017a@cgmh.org.tw

Chun-Jung Lin, M.D. contact

+886-2-24313131 ext. 2677

s81101911@cgmh.org.tw

Taiwan1 site

  • Keelung Chang Gung Memorial Hospital

    Keelung

    Huan-Hsuan Hsu, M.D., +886-2-24313131 ext. 2677, 10356017a@cgmh.org.tw

    Chun-Jung Lin, M.D., +886-2-24313131 ext. 2677, s81101911@cgmh.org.tw

Other trials in Taiwan

About this study

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?
Read more

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.
Read the detailed description
  1. Clinical Background and Study Rationale Intradialytic hypotension (IDH) is defined as a decrease in systolic blood pressure of more than 20 mmHg or a drop of more than 10 mmHg in mean arterial pressure during hemodialysis, often accompanied by symptoms such as dizziness, nausea, or cramps. The incidence of IDH among dialysis patients is approximately 5% to 30%. Risk factors include advanced age, diabetes, female sex, and high body mass index. IDH can cause premature termination of dialysis sessions, resulting in decreased uremic toxin clearance and increased long-term mortality and complications. Severe IDH may lead to bowel ischemia, stroke, or myocardial infarction. Common management strategies for IDH include adjusting the dialysis rate, lowering dialysate temperature, avoiding eating during dialysis, and strict sodium intake control. In cases of frequent IDH episodes, drugs such as Midodrine or Vasopressin may be used. However, oral Midodrine can cause side effects such as urinary retention, paresthesia, and pruritus. Its long-term safety in dialysis patients is yet to be confirmed. According to Traditional Chinese Medicine (TCM), IDH results from spleen and kidney Qi deficiency, requiring tonification of these organs. Guilu Erxian Jiao (GLJ) is a classical formula composed of Testudinis Carapax, Cervi Cornu, Lycii Fructus, and Ginseng Radix, commonly used to treat Qi deficiency and hypotension. Clinical experience suggests potential efficacy in reducing IDH frequency, but large-scale trials are lacking. This trial aims to evaluate the efficacy and safety of GLJ in treating IDH in patients undergoing hemodialysis.
  2. Study Design and Methods This is a randomized, open-label, crossover clinical trial enrolling 34 patients aged over 18 years who receive thrice-weekly hemodialysis for four hours per session and have a history of IDH. Patients are recruited from nephrology and TCM outpatient clinics and the dialysis unit of Keelung Chang Gung Memorial Hospital. Participants will be randomized 1:1 into two groups. Randomization will be performed using a computer-generated random sequence. Participants will be assigned to groups according to sealed envelopes that indicate their allocation. Group A receives GLJ plus conventional treatment for four weeks, followed by a four-week washout period, then four weeks of conventional treatment alone. Group B follows the reverse sequence. GLJ (Guilu Erxian Jiao) is administered once daily before meals at a dose of 4 grams for four weeks. The preparation used is Jipin Guilu Baishen San produced by Sun Ten Pharmaceutical Co., Ltd. (License number: 016966). Data collected include demographic information, medical history, allergy history, family history, medication history, and socioeconomic status. Evaluations include blood pressure measurements before, during, and after dialysis; frequency of IDH episodes; symptoms such as dizziness and fatigue (via VAS score); laboratory parameters (Na, K, Ca, P, BUN, Cr); and adverse events. Follow-up evaluations occur at weeks 2 and 4 after each treatment phase. Each assessment takes approximately 30 minutes.
  3. Participant Safety, Compensation, and Withdrawal Rights Guilu Erxian Jiao is generally well tolerated. Reported side effects in prior studies include mild dry mouth and constipation. During the study, blood and biochemical parameters will be regularly monitored to detect any possible adverse effects. If allergic reactions or serious adverse events occur during the trial, the participant will be withdrawn from the study and provided with appropriate medical evaluation and care. Participants may voluntarily withdraw from the study at any time without providing a reason and without any impact on their standard medical care. Likewise, the principal investigator reserves the right to terminate a participant's involvement or discontinue the trial at any time for safety or administrative reasons. In case of adverse events or injuries resulting from participation in this study, and if they occur in accordance with the approved protocol, the institution and the principal investigator will be legally responsible for providing necessary compensation. However, no compensation will be provided for anticipated side effects explicitly stated in the study protocol. In addition to compensation, the hospital will also provide professional medical care and consultation at no cost for treating the injury.
  4. Data Privacy and Confidentiality Participant identities will be anonymized using unique study codes, and no personally identifiable information (e.g., name, medical record number) will appear in the case reports or publications. Study data will be securely stored in locked cabinets and password-protected, encrypted folders for at least two years after the end of the study. Only the principal investigator, authorized research team members, auditors, the ethics committee, and regulatory authorities will have access to the original data for monitoring and auditing purposes. The research team is committed to maintaining confidentiality and protecting participants' privacy throughout the study.
  5. Statistical Analysis Sample size calculation was based on previous studies with a significance level of 0.05 and power of 0.99, resulting in a required 28 participants; with an estimated 20% dropout rate, 34 participants will be enrolled. Statistical analyses include Student's t-test, Chi-square test, ANOVA, and paired t-tests as appropriate. Non-parametric tests will be used if data are not normally distributed. All efficacy analyses will be performed using the intention-to-treat (ITT) principle, including all randomized participants who received at least one dose of study intervention. A one-sided alpha of 0.05 defines statistical significance.
  6. IRB Review and Approval This study has been reviewed and approved by the Institutional Review Board of Chang Gung Memorial Hospital, Keelung Branch (IRB No. 2402010026, Protocol Version 5, approved on 2025/03/12).
Being tested
Guilu Erxian Jiao
Keywords
Intradialytic Hypotension, Hemodialysis, Traditional Chinese Medicine, Herbal Medicine, Guilu Erxian Jiao, End-Stage Renal Disease, Randomized Controlled Trial, Kidney Disease, Dialysis Complications, Blood Pressure
Medical subject headings
Kidney Failure, Chronic, Kidney Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Guilu Erxian JiaoDrug

    Also called Jipin Guilu Baishen San

    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.

Study groups in NCT06980922
Study groupRoleWhat they receive
Group AExperimentalParticipants in Group A will receive Guilu Erxian Jiao (GLJ) plus usual care for 4 weeks, followed by a 4-week washout period, then 4 weeks of usual care alone.
Receives: Drug: Guilu Erxian Jiao
Group BActive comparatorParticipants in Group B will receive usual care alone for 4 weeks, followed by a 4-week washout period, then 4 weeks of Guilu Erxian Jiao (GLJ) plus usual care.
Receives: Drug: Guilu Erxian Jiao

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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 phase

Secondary outcomes (5)

  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.

    Measured: 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 phase

  2. 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.

    Measured: 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 baseline

  3. 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.

    Measured: At baseline and at week 4, 8, 12, and 16 of the study

  4. 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.

    Measured: Throughout the entire 16-week study period

  5. Dialysis Nurse Interventions for IDH

    Clinical interventions performed by dialysis nurses in response to intradialytic hypotension, including ultrafiltration adjustment, lowering dialysate temperature, and physician-directed interventions such as fluid administration or early termination of dialysis, as well as other standard nursing responses to IDH, will be recorded at each dialysis session during all study phases.

    Measured: During each dialysis session throughout the 16-week crossover study, including each 4-week treatment phase, and follow-up assessments conducted at 2 and 4 weeks after each treatment phase

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2025
  2. Study start1 Jun 2025 (estimated)
  3. Primary completion31 May 2027 (estimated)
  4. Study completion31 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
This is a two-period, two-sequence crossover trial with a 4-week treatment phase and a 4-week washout period. Participants are randomized in a 1:1 ratio to receive either Guilu Erxian Jiao plus usual care followed by usual care alone, or the reverse sequence.
Masking
None (open label)
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06980922
Sponsor's protocol ID
202400179A3C601
Status last verified
Apr 2025
First submitted
19 May 2025
Last updated
20 May 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared due to privacy protection concerns and no current plan for secondary data use.

Publications

  • Brunelli SM, Cohen DE, Marlowe G, Van Wyck D. The Impact of Midodrine on Outcomes in Patients with Intradialytic Hypotension. Am J Nephrol. 2018;48(5):381-388. doi: 10.1159/000494806. Epub 2018 Nov 13.

    PubMed 30423552

  • Jindal K, Chan CT, Deziel C, Hirsch D, Soroka SD, Tonelli M, Culleton BF; Canadian Society of Nephrology Committee for Clinical Practice Guidelines. Hemodialysis clinical practice guidelines for the Canadian Society of Nephrology. J Am Soc Nephrol. 2006 Mar;17(3 Suppl 1):S1-27. doi: 10.1681/ASN.2005121372. No abstract available.

    PubMed 16497879

  • Flythe JE, Xue H, Lynch KE, Curhan GC, Brunelli SM. Association of mortality risk with various definitions of intradialytic hypotension. J Am Soc Nephrol. 2015 Mar;26(3):724-34. doi: 10.1681/ASN.2014020222. Epub 2014 Sep 30.

    PubMed 25270068

  • Morfin JA, Fluck RJ, Weinhandl ED, Kansal S, McCullough PA, Komenda P. Intensive Hemodialysis and Treatment Complications and Tolerability. Am J Kidney Dis. 2016 Nov;68(5S1):S43-S50. doi: 10.1053/j.ajkd.2016.05.021.

    PubMed 27772642

  • Flythe JE, Inrig JK, Shafi T, Chang TI, Cape K, Dinesh K, Kunaparaju S, Brunelli SM. Association of intradialytic blood pressure variability with increased all-cause and cardiovascular mortality in patients treated with long-term hemodialysis. Am J Kidney Dis. 2013 Jun;61(6):966-74. doi: 10.1053/j.ajkd.2012.12.023. Epub 2013 Mar 6.

    PubMed 23474007

  • Tattersall J, Martin-Malo A, Pedrini L, Basci A, Canaud B, Fouque D, Haage P, Konner K, Kooman J, Pizzarelli F, Tordoir J, Vennegoor M, Wanner C, ter Wee P, Vanholder R. EBPG guideline on dialysis strategies. Nephrol Dial Transplant. 2007 May;22 Suppl 2:ii5-21. doi: 10.1093/ndt/gfm022. No abstract available.

    PubMed 17507427

  • Mo Y, Liu X, Qin X, Huang J, He Z, Lin J, Hu Q, Cai Y, Liu Z, Wang L. Shenfu injection for intradialytic hypotension: a systematic review and meta-analysis. Evid Based Complement Alternat Med. 2014;2014:279853. doi: 10.1155/2014/279853. Epub 2014 Dec 22.

    PubMed 25587340

  • Sands JJ, Usvyat LA, Sullivan T, Segal JH, Zabetakis P, Kotanko P, Maddux FW, Diaz-Buxo JA. Intradialytic hypotension: frequency, sources of variation and correlation with clinical outcome. Hemodial Int. 2014 Apr;18(2):415-22. doi: 10.1111/hdi.12138. Epub 2014 Jan 27.

    PubMed 24467830

  • Kooman J, Basci A, Pizzarelli F, Canaud B, Haage P, Fouque D, Konner K, Martin-Malo A, Pedrini L, Tattersall J, Tordoir J, Vennegoor M, Wanner C, ter Wee P, Vanholder R. EBPG guideline on haemodynamic instability. Nephrol Dial Transplant. 2007 May;22 Suppl 2:ii22-44. doi: 10.1093/ndt/gfm019. No abstract available.

    PubMed 17507425

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Guilu Erxian Jiao in people with Intradialytic Hypotension and End-Stage Renal Disease, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Huan-Hsuan Hsu, M.D. (+886-2-24313131 ext. 2677, 10356017a@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of Intradialytic Hypotension Episodes (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 phase). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06980922, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.

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