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NCT05517993 Clinical Trial

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

Intradialytic Hypotension Clinical Trial

Official title:
Effect of Gui-Lu-Er-Xian-Jiao-Wan on Intradialytic Hypotension: a Randomized Crossover Pilot Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05517993
Other study ID # CMRPG8M0841
Secondary ID
Status Not yet recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date September 1, 2022
Est. completion date December 31, 2024

Study information
Verified date August 2022
Source Chang Gung Memorial Hospital
Contact Chun-Ting Liu
Phone +88677317123
Email juntin0214@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date December 31, 2024
Est. primary completion date July 31, 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Taiwan Kaohsiung Chang Gung Memorial Hospital Kaohsiung

Sponsors (1)
Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Intradialytic hypotension episode Hypotension episode during hemodialysis Each time of dialysis during 12-weeks study period.
Secondary Early termination of hemodialysis The episode of early termination in hemodialysis due to hypotension Each time of dialysis during 12-weeks study period.
Secondary SF-36 Short Form (36) Health Survey (SF-36) Baseline, 12 weeks, 28 weeks
See also
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Recruiting NCT04163614 - Blood Pressure Slopes and Ultrafiltration in Hemodialysis Patients N/A
Recruiting NCT05936710 - Improved Hemodynamic Tolerance of Intermittent Hemodialysis Sessions in Intensive Care Unite Using Citrate- vs Acetate-based Dialysate N/A
Completed NCT00657046 - Safety and Benefit Study of Droxidopa to Treat Patients With Intradialytic Hypotension Phase 2