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Effect of Gui-Lu-Er-Xian-Jiao-Wan on Intradialytic Hypotension

Primary Purpose

Intradialytic Hypotension

Status
Not yet recruiting
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Gui-Lu-Er-Xian-Jiao-Wan
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intradialytic Hypotension focused on measuring Intradialytic Hypotension, Chinese herbal medicine, Gui-Lu-Er-Xian-Jiao

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • Kaohsiung Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group A

Group B

Arm Description

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

No intervention.

Outcomes

Primary Outcome Measures

Intradialytic hypotension episode
Hypotension episode during hemodialysis

Secondary Outcome Measures

Early termination of hemodialysis
The episode of early termination in hemodialysis due to hypotension
SF-36
Short Form (36) Health Survey (SF-36)

Full Information

First Posted
August 24, 2022
Last Updated
August 24, 2022
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05517993
Brief Title
Effect of Gui-Lu-Er-Xian-Jiao-Wan on Intradialytic Hypotension
Official Title
Effect of Gui-Lu-Er-Xian-Jiao-Wan on Intradialytic Hypotension: a Randomized Crossover Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intradialytic Hypotension
Keywords
Intradialytic Hypotension, Chinese herbal medicine, Gui-Lu-Er-Xian-Jiao

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Gui-Lu-Er-Xian-Jiao-Wan (GLEXJW) 3g orally twice daily for 12 weeks.
Arm Title
Group B
Arm Type
No Intervention
Arm Description
No intervention.
Intervention Type
Drug
Intervention Name(s)
Gui-Lu-Er-Xian-Jiao-Wan
Other Intervention Name(s)
GLEXJW
Intervention Description
Gui-Lu-Er-Xian-Jiao-Wan (GLEXJW) is an ancient CHM formula, mainly originating from processed tortoise shells, antlers, Ginseng, and wolfberry.
Primary Outcome Measure Information:
Title
Intradialytic hypotension episode
Description
Hypotension episode during hemodialysis
Time Frame
Each time of dialysis during 12-weeks study period.
Secondary Outcome Measure Information:
Title
Early termination of hemodialysis
Description
The episode of early termination in hemodialysis due to hypotension
Time Frame
Each time of dialysis during 12-weeks study period.
Title
SF-36
Description
Short Form (36) Health Survey (SF-36)
Time Frame
Baseline, 12 weeks, 28 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Active malignancy Life-threatening conditions Pregnancy Recent participation in another clinical trial for intradialytic hypotension History of hypersensitivity or contraindication to herbal medicine
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chun-Ting Liu
Phone
+88677317123
Email
juntin0214@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chun-Ting Liu
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Gui-Lu-Er-Xian-Jiao-Wan on Intradialytic Hypotension

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