Chang Gung Memorial Hospital in Kaohsiung branch
Kaohsiung City, 83301, Taiwan
NCT Number: NCT07425262
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
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 2 / Phase 3
Kaohsiung City, 83301, Taiwan
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: week 1 to 8
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
Pre-, nadir-, and post-dialysis systolic and diastolic blood pressure in mmHg at each session.
Time frame: week 1 to 8
Frequent and dose in mg of vasopressor agents at each session
Time frame: week 1 and 8
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 0
All participants were asked to complete a basic information questionnaire before CHM treatment and an assessment of their TCM constitution. The CCMQ consisted of 60 items (clinical observations, indicators of constitutions, Table 2) categorized into 9 subscales, each measuring one of the 9 different body constitutions, namely, Yang-deficient (7 items), Yin-deficient (8 items), Qi-deficient (8 items), Phlegm-dampness (8 items), Damp-heat (6 items), Stagnant Blood (7 items), Inherited Special (7 items), Stagnant Qi (7 items), and Balanced (8 items). The items were on a 5-point Likert scale, with high scores indicating a higher likelihood of having the given constitution. Usually, a threshold of 30 or higher points on a subscale was used to classify a person as having that body constitution.
Contact information is provided by the study sponsor or research team.
Chang Gung Memorial Hospital
Other
A Pilot Randomized Waitlist-controlled Trial of a Zheng-based Chinese Medicine Intervention for Patients With Dialytic Hypotension in Taiwan
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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