Actively Recruiting

Phase Not Applicable
Age: 20Years +
All Genders
ID06452966

The Impact and Effect of Traditional Chinese Medicine Treatment on Organ Failure in Critically Ill Patients

Led by China Medical University Hospital · Updated on 2024-06-11

350

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Critically ill patients in intensive care units (ICUs) are at risk of or suffering from failure of one or more vital organs or organ systems. Researchers are evaluating the impact and effect of traditional Chinese medicine (TCM) treatments on these patients to see if TCM can help prevent or treat organ failure. This is a multi-center, non-randomized real-world data study that includes three groups: an intervention group receiving TCM, a control group receiving routine ICU care, and a historical control group that received routine ICU care between 2019 and 2023. Patients in the intervention group receive one or a combination of TCM treatments including oral Chinese herbal decoctions prescribed after a TCM diagnosis, acupuncture, or low-level laser acupuncture applied to acupuncture points. The oral decoctions are taken two to three times daily for two weeks, while acupuncture or laser treatments are given twice a week for 20 minutes each session during the same two-week period. All patients continue to receive ICU care and medication based on their needs. The control groups receive routine ICU care without TCM interventions. Participants will be monitored over a follow-up period of two weeks, during which researchers will assess outcomes such as Sequential Organ Failure Assessment (SOFA) scores, length of stay in the ICU and hospital, days using mechanical ventilation, and usage of Western medicine medications. Additional measurements include kidney and liver function, respiratory parameters, cardiovascular function, and neurological status assessed by Glasgow Coma Scale. Data collection occurs daily during the two-week intervention period to evaluate the effect of TCM alongside standard ICU care.

CONDITIONS

Brief Title

The Impact and Effect of Traditional Chinese Medicine Treatment on Organ Failure in Critically Ill Patients

Who Can Participate

Age: 20Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 20 years or older
  • Patients admitted to a surgical intensive care unit (ICU)
  • Use of traditional Chinese medicine must be approved by the attending physician in the surgical ICU
Not Eligible

You will not qualify if you...

  • Patients whose family members refuse traditional Chinese medicine intervention

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 2 weeks

Participants receive traditional Chinese medicine interventions, which may include oral Chinese herbal decoction two to three times a day, acupuncture or low level laser acupuncture twice a week, along with routine ICU care and medication based on their needs.

Twice-weekly visits for acupuncture or low level laser acupuncture; oral medication taken daily

Follow-up

Duration - Up to 3 months

Participants are monitored for outcomes such as organ function, ICU and hospital length of stay, mechanical ventilation time, and survival for up to 3 months following treatment.

Regular assessments during ICU and hospital stay as part of routine care

Trial Site Locations

Total: 1 location

1

China Medical University Hospital

Taichung, Taiwan, 403

Actively Recruiting

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Research Team

Y

Yu-Chen Lee, M.D.,PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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