A Pilot Trial of Chinese Medicine for Patients With Dialytic Hypotension
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorChang Gung Memorial Hospital
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Maintenance bicarbonate hemodialysis (HD) for more than 1 year, three times a week 3.5 to 4.5 h HD schedule.
Have experienced more than 30% episodes of IDH (defined as a systolic BP<90 mmHg on dialysis or requirement for clinical intervention) during the exposure assessment period (months 1-3) of this study
Cognitive ability to give written informed consent.
Disqualifiers
Allergic history to Chinese herbal medicine
Systemic diseases such as coagulation disorders, malignancy, liver diseases and cardiovascular diseases.
Estimated survival time < 1 year.
Mental illness.
Trial design
Design model
Parallel
Treatments tested in this trial
CHM intervention group
DrugJia Wei Sheng Yu Si Ni Tang (JWSYSNT) powder, 4.5 gm per dose, taken orally 2 times a day, for 8 weeks
No CHM treatment
Other interventionThe waitlist control group received no JWSYSNT treatments and received no other intervention for 8 weeks after randomization.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: CHM intervention groupExperimental treatment 1 intervention
Group B: Control groupOther 1 intervention
Trial outcomes
Primary outcomes
1
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 8Secondary outcomes
1
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 82
Pharmacotherapy
Frequent and dose in mg of vasopressor agents at each session
Time frame
week 1 to 83
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 8Other outcomes
1
Constitution in Chinese Medicine Questionnaire
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.
Time frame
week 0Sponsors and contacts
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Source ClinicalTrials.gov
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