A Pilot Trial of Chinese Medicine for Patients With Dialytic Hypotension
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CHM intervention group, No CHM treatment.
- Who it may be relevant to
- Registry conditions: End Stage Renal Disease on Dialysis, Intradialytic Hypotension. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Pilot Randomized Waitlist-controlled Trial of a Zheng-based Chinese Medicine Intervention for Patients With Dialytic Hypotension in Taiwan
Overview
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
Interventions
- Drug CHM intervention group
Jia Wei Sheng Yu Si Ni Tang (JWSYSNT) powder, 4.5 gm per dose, taken orally 2 times a day, for 8 weeks - Other No CHM treatment
The waitlist control group received no JWSYSNT treatments and received no other intervention for 8 weeks after randomization.
Primary outcome measures
- Total intradialytic hypotension (IDH) epidose [Time frame: week 1 to 8]
Secondary outcome measures (3)
- Intradialytic blood pressure (BP) measurement [Time frame: week 1 to 8]
- Pharmacotherapy [Time frame: week 1 to 8]
- Kidney Disease and Quality of Life-36 (KDQOL-36) [Time frame: week 1 and 8]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- Chang Gung Memorial Hospital in Kaohsiung branch — Kaohsiung City
Identifiers
NCT: NCT07425262 · 202501538A3