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

China Medical University

Status

Enrolling

Conditions

Respiratory Failure

Indigestion

Morality

Organ Failure, Multiple

Delayed Gastric Emptying

Treatments

Other: historical Routine ICU care

Other: Routine ICU care

Other: traditional Chinese medicine

Study type

Interventional

Funder types

Other

Identifiers

NCT06452966

CMUH113-REC3-052

Details and patient eligibility

About

Critically ill patients are at risk of or suffering from one or more key organs or organ system failure. This study will measure the effect of traditional Chinese medicine(TCM) interventions on critically ill patients admitted to the intensive care unit (ICU).

The goal of this clinical trial is to learn if traditional Chinese medicine(TCM) is effective for prevention and treatment of organ failure in ICU patients. Patients in this group will receive intervention for 2 weeks.

A multi-center non-randomized real word data study, will include 3 groups: intervention group (TCM)(n=70), control group and historical control group (admitted to the same ICU in the period of 01.2019 to 12.2023).

Main outcomes include sequential organ failure assessment (SOFA) score, ICU length of stay, hospital length of stay, number of days of respirator uses and western medicine medication used study follow up will be 2 weeks.

Full description

A multi center non-randomized real word data study, will include 3 groups: intervention group (n=70), control group (patients recruited enrolled to the ICU during the study period) and historical control group (admitted to the same ICU in the period of 01.2019 to 12.2023). The intervention group will receive traditional Chinese herbal medicine and/or acupuncture and/or low level laser applied on acupuncture points depending on TCM doctor decision and patient TCM diagnosis. Intervention period will be 2 weeks.

Enrollment

350 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 20 and above
Surgical ICU patients
The use of Chinese medicine must be approved by the attending physician in the surgical intensive care unit

Exclusion criteria

Patients' family members refuse TCM intervention

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

350 participants in 3 patient groups

intervention group

Experimental group

Description:

patients in the group will recived one of or a combination of the following intervantions: 1. Oral Chinese medicine decoction: The Chinese medicine practitioner will personally examine the patient and judge the patient's condition through the four diagnostic methods of traditional Chinese medicine(TCM): sight, smell, inquiry, and incision. Based on the syndrome differentiation and treatment of the patient's condition, he or she will prescribe an oral Chinese herbal decoction, two to three times a day, for two weeks. 2. Acupuncture or low level laser acupuncture treatment: Chinese medicine practitioners select acupuncture points for treatment based on the patient's condition and treat them twice a week for 20 minutes each time for a total of two weeks. the intervantion depents on the TCM doctor decision based on the patient's diagnosis and needs. in addition, the patients will recive ICU care and medication based on patient's needs.

Treatment:

Other: traditional Chinese medicine

control group

Active Comparator group

Description:

the patients in this group will receive routine ICU care. the patients will be recruted during the study period. the patients will not recive TCM intervantions.

Treatment:

Other: Routine ICU care

Historical control

Other group

Description:

Patients admitted to the same ICU in the period of 01.2019 to 12.2023. the patients did not recivied TCM intervantions

Treatment:

Other: historical Routine ICU care