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
Qualifiers
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
Treatments tested in this trial
- CHM intervention group
- No CHM treatment
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov