To evaluate the epidemiological status of traditional Chinese Medicine (TCM) constitution in patients with dialytic hypotension, and design a clinical study based on a Zheng-based herbal formulation to evaluate the clinical efficacy and safety of TCM
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
Jia Wei Sheng Yu Si Ni Tang (JWSYSNT) powder, 4.5 gm per dose, taken orally 2 times a day, for 8 weeks
The waitlist control group received no JWSYSNT treatments and received no other intervention for 8 weeks after randomization.
Chang Gung Memorial Hospital in Kaohsiung branch
Kaohsiung City, Taiwan
Total intradialytic hypotension (IDH) epidose
IDH episode was record on every dialysis session, account for 24 dialysis sessions. ( IDH was defined as a nadir SBP of \< 90 mmHg or requirement for clinical intervention).
Time frame: week 1 to 8
Intradialytic blood pressure (BP) measurement
Pre-, nadir-, and post-dialysis systolic and diastolic blood pressure in mmHg at each session.
Time frame: week 1 to 8
Pharmacotherapy
Frequent and dose in mg of vasopressor agents at each session
Time frame: week 1 to 8
Kidney Disease and Quality of Life-36 (KDQOL-36)
The Taiwanese version of the. KDQOL-36 questionnaire is reliable and valid for evaluating the quality of life in dialysis patients. It includes 12 items that provide a generic chronic disease core (i.e., the SF-12, a shorter version of the SF-36), as well as 24 additional items (i.e., kidney-disease-targeted items). The 24 additional items focus on particular health-related concerns of individuals with kidney disease (i.e., symptom/problem list, 12 items; effects of kidney disease, 8 items; and burden of disease, 4 items).KDQOL-36 subscale scores ranged from 0 to 100, and lower scores indicated worse self-reported quality of life.
Time frame: week 1 and 8
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