End Stage Renal Disease on DialysisPhase 2/3NCT07425262
A Pilot Trial of Chinese Medicine for Patients With Dialytic Hypotension
A Phase 2/3 study testing CHM intervention group and No CHM treatment in people with End Stage Renal Disease on Dialysis and Intradialytic Hypotension, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease on Dialysis, Intradialytic Hypotension
- What is being tested?
- CHM intervention group and No CHM treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Feb 2026to 1 Feb 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Chang Gung Memorial Hospital in Kaohsiung branch
Kaohsiung City, 83301
Ming-Yen Tsai, PhD, +886-975-056534, missuriae@yahoo.com.tw
About this study
Official title: A Pilot Randomized Waitlist-controlled Trial of a Zheng-based Chinese Medicine Intervention for Patients With Dialytic Hypotension in Taiwan
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
- Being tested
- CHM intervention group, No CHM treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHM intervention groupDrug
Jia Wei Sheng Yu Si Ni Tang (JWSYSNT) powder, 4.5 gm per dose, taken orally 2 times a day, for 8 weeks
No CHM treatmentOther
The waitlist control group received no JWSYSNT treatments and received no other intervention for 8 weeks after randomization.
| Study group | Role | What they receive |
|---|---|---|
| CHM intervention group | Experimental | Not described Receives: Drug: CHM intervention group |
| Control group | Other | Participants who do not receive the active CHM treatment during the study's initial phase (8 weeks) but are offered it after the trial ends. Receives: Other: No CHM treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: week 1 to 8
Secondary outcomes (3)
Intradialytic blood pressure (BP) measurement
Pre-, nadir-, and post-dialysis systolic and diastolic blood pressure in mmHg at each session.
Measured: week 1 to 8
Pharmacotherapy
Frequent and dose in mg of vasopressor agents at each session
Measured: week 1 to 8
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.
Measured: week 1 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start2 Feb 2026 (estimated)
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal Disease on DialysisStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming-Yen Tsai, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07425262
- Sponsor's protocol ID
- 202501538A3
- Status last verified
- Feb 2026
- First submitted
- 15 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Waitlist-controlled Trial of a Zheng-based Chinese Medicine Intervention for Patients With Dialytic Hypotension in Taiwan
- ClinicalTrials.gov ID
- NCT07425262
- Acronym / sponsor ID
- 202501538A3
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 2 Feb 2026 (estimated)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHM intervention group | Experimental | Drug: CHM intervention group |
| Control group | Other | Other: No CHM treatmentParticipants who do not receive the active CHM treatment during the study's initial phase (8 weeks) but are offered it after the trial ends. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHM intervention groupJia Wei Sheng Yu Si Ni Tang (JWSYSNT) powder, 4.5 gm per dose, taken orally 2 times a day, for 8 weeks | Drug | CHM intervention group |
| No CHM treatmentThe waitlist control group received no JWSYSNT treatments and received no other intervention for 8 weeks after randomization. | Other | Control group |
Primary outcome
Total intradialytic hypotension (IDH) epidose
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).
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing CHM intervention group and No CHM treatment in people with End Stage Renal Disease on Dialysis and Intradialytic Hypotension, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ming-Yen Tsai, PhD (886-975-056534, missuriae@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total intradialytic hypotension (IDH) epidose (time frame: week 1 to 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.