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

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 Overview

• Status: Not yet recruiting
• Conditions: End Stage Renal Disease on Dialysis; Intradialytic Hypotension
• Intervention / Treatment: Drug: CHM intervention group; Other: No CHM treatment

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Ming-Yen Tsai, PhD; Phone Number: 886-975-056534; Email: missuriae@yahoo.com.tw

Study Locations

• Taiwan
  • Kaohsiung City, Taiwan, 83301
    • Chang Gung Memorial Hospital in Kaohsiung branch
    • Contact: Ming-Yen Tsai, PhD; Phone Number: +886-975-056534; Email: missuriae@yahoo.com.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CHM intervention group	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: Control group; 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.	Other: No CHM treatment; The waitlist control group received no JWSYSNT treatments and received no other intervention for 8 weeks after randomization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	week 1 and 8
Intradialytic blood pressure (BP) measurement	Pre-, nadir-, and post-dialysis systolic and diastolic blood pressure in mmHg at each session.	week 1 to 8
Pharmacotherapy	Frequent and dose in mg of vasopressor agents at each session	week 1 to 8

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	week 0

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): February 2, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: February 15, 2026
• First Submitted That Met QC Criteria: February 15, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 202501538A3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No