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

Chang Gung Medical Foundation

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Intradialytic Hypotension

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05517993

CMRPG8M0841

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Group A

Experimental group

Description:

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

Treatment:

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

Group B

No Intervention group

Description:

No intervention.