A Pilot Trial of Chinese Medicine for Patients With Dialytic Hypotension
A Pilot Randomized Waitlist-controlled Trial of a Zheng-based Chinese Medicine Intervention for Patients With Dialytic Hypotension in Taiwan
1 other identifier
interventional
100
1 country
1
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 2, 2026
CompletedFirst Submitted
Initial submission to the registry
February 15, 2026
CompletedFirst Posted
Study publicly available on registry
February 20, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2028
February 25, 2026
February 1, 2026
2 years
February 15, 2026
February 23, 2026
Conditions
Outcome Measures
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).
week 1 to 8
Secondary Outcomes (3)
Intradialytic blood pressure (BP) measurement
week 1 to 8
Pharmacotherapy
week 1 to 8
Kidney Disease and Quality of Life-36 (KDQOL-36)
week 1 and 8
Other Outcomes (1)
Constitution in Chinese Medicine Questionnaire
week 0
Study Arms (2)
CHM intervention group
EXPERIMENTALControl group
OTHERParticipants who do not receive the active CHM treatment during the study's initial phase (8 weeks) but are offered it after the trial ends.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- Participate in other clinical trials.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chang Gung Memorial Hospital in Kaohsiung branch
Kaohsiung City, 83301, Taiwan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Chinese medicine
Study Record Dates
First Submitted
February 15, 2026
First Posted
February 20, 2026
Study Start
February 2, 2026
Primary Completion (Estimated)
February 1, 2028
Study Completion (Estimated)
February 1, 2028
Last Updated
February 25, 2026
Record last verified: 2026-02