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

NCT06980922 | Not Yet Recruiting Phase 2

• 1 other identifier: 202400179A3C601
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does Guilu Erxian Jiao reduce the frequency and severity of low blood pressure during dialysis?
2. 2.Is Guilu Erxian Jiao safe to use in patients receiving hemodialysis?
3. 3.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).
4. 4.Undergo follow-up assessments at weeks 2 and 4 after each treatment phase.
5. 5.Have their blood pressure monitored before, during (hourly), and after each dialysis session.
6. 6.Report dialysis-related symptoms such as dizziness and fatigue.
7. 7.Receive routine laboratory tests and safety monitoring throughout the study.

Conditions

Intradialytic Hypotension; End-Stage Renal Disease; Hemodialysis

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

Outcome Measures

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.

  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)

• Change in Blood Pressure Before, During, and After Dialysis

  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

• Visual Analogue Scale (VAS) Scores for Dialysis-Related Clinical Symptoms

  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

• Changes in Laboratory Parameters (Na, K, Ca, P, BUN, Cr)

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

• Adverse Events Related to Guilu Erxian Jiao

  Throughout the entire 16-week study period

• Dialysis Nurse Interventions for IDH

  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

Study Arms (2)

Group A

EXPERIMENTAL

Participants 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.

Drug: Guilu Erxian Jiao

Group B

ACTIVE COMPARATOR

Participants 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.

Drug: Guilu Erxian Jiao

Interventions

Guilu Erxian Jiao DRUG

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.

Also known as: Jipin Guilu Baishen San

Group A; Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Keelung Chang Gung Memorial Hospital

Keelung, Taiwan

Location

Related Publications (9)

• 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.

  PMID: 30423552 BACKGROUND

• 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.

  PMID: 16497879 BACKGROUND

• 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.

  PMID: 25270068 BACKGROUND

• 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.

  PMID: 27772642 BACKGROUND

• 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.

  PMID: 23474007 BACKGROUND

• 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.

  PMID: 17507427 BACKGROUND

• 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.

  PMID: 25587340 BACKGROUND

• 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.

  PMID: 24467830 BACKGROUND

• 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.

  PMID: 17507425 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic; Kidney Diseases

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Huan-Hsuan Hsu, M.D.

  Department of Chinese Medicine, Keelung Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huan-Hsuan Hsu, M.D.

CONTACT

+886-2-24313131; 10356017a@cgmh.org.tw

Chun-Jung Lin, M.D.

CONTACT

+886-2-24313131; s81101911@cgmh.org.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: May 20, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2028
• Last Updated: May 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)