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NCT Number: NCT07425262

A Pilot Trial of Chinese Medicine for Patients With Dialytic Hypotension

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CHM intervention group

Drug

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 treatment

Other

The waitlist control group received no JWSYSNT treatments and received no other intervention for 8 weeks after randomization.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Intradialytic blood pressure (BP) measurement

    Time frame: week 1 to 8

    Pre-, nadir-, and post-dialysis systolic and diastolic blood pressure in mmHg at each session.

  2. Pharmacotherapy

    Time frame: week 1 to 8

    Frequent and dose in mg of vasopressor agents at each session

  3. Kidney Disease and Quality of Life-36 (KDQOL-36)

    Time frame: week 1 and 8

    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.

Other outcomes

  1. Constitution in Chinese Medicine Questionnaire

    Time frame: week 0

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ming-Yen Tsai, PhD

CONTACT

[email protected]

886-975-056534

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

A Pilot Randomized Waitlist-controlled Trial of a Zheng-based Chinese Medicine Intervention for Patients With Dialytic Hypotension in Taiwan

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 20, 2026
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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