NCT05517993

Brief Summary

Intradialytic hypotension (IDH), a common complication during hemodialysis (HD) could increase patients' morbidity and mortality. Previous studies considered that some Chinese herbal medicine (CHM) plays a complementary role in reducing the frequency of IDH. This trial is aimed to investigate the effect of Gui-Lu-Er-Xian-Jiao-Wan (GLEXJW) in patients with intradialytic hypotension.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 26, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

August 26, 2022

Status Verified

August 1, 2022

Enrollment Period

1.9 years

First QC Date

August 24, 2022

Last Update Submit

August 24, 2022

Conditions

Intradialytic Hypotension

Keywords

Intradialytic HypotensionChinese herbal medicineGui-Lu-Er-Xian-Jiao

Outcome Measures

Primary Outcomes (1)

  • Intradialytic hypotension episode

    Hypotension episode during hemodialysis

    Each time of dialysis during 12-weeks study period.

Secondary Outcomes (2)

  • Early termination of hemodialysis

    Each time of dialysis during 12-weeks study period.

  • SF-36

    Baseline, 12 weeks, 28 weeks

Study Arms (2)

Group A

EXPERIMENTAL

Gui-Lu-Er-Xian-Jiao-Wan (GLEXJW) 3g orally twice daily for 12 weeks.

Drug: Gui-Lu-Er-Xian-Jiao-Wan

Group B

NO INTERVENTION

No intervention.

Interventions

Gui-Lu-Er-Xian-Jiao-WanDRUG

Gui-Lu-Er-Xian-Jiao-Wan (GLEXJW) is an ancient CHM formula, mainly originating from processed tortoise shells, antlers, Ginseng, and wolfberry.

Also known as: GLEXJW
Group A

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • End stage renal disease treated with hemodialysis for ≥3 months
  • Receive a standard thrice-weekly hemodialysis schedule
  • More than 25% of hemodialysis sessions complicated by intradialytic hypotension

You may not qualify if:

  • Active malignancy
  • Life-threatening conditions
  • Pregnancy
  • Recent participation in another clinical trial for intradialytic hypotension
  • History of hypersensitivity or contraindication to herbal medicine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

Location

Study Officials

  • Chun-Ting Liu

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chun-Ting Liu

CONTACT

+88677317123juntin0214@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2022

First Posted

August 26, 2022

Study Start

September 1, 2022

Primary Completion

July 31, 2024

Study Completion

December 31, 2024

Last Updated

August 26, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)