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

NCT ID: NCT06452966

Last Updated: 2024-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-07

Study Completion Date

2027-05-30

Brief Summary

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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.

Detailed Description

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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).

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.

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.

Conditions

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Organ Failure, Multiple Indigestion Delayed Gastric Emptying Respiratory Failure Morality

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

a non-randomized real world data
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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intervention group

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.

Group Type EXPERIMENTAL

traditional Chinese medicine

Intervention Type OTHER

patients in the group will receive one of or a combination of the following interventions:

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.

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.

control group

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.

Group Type ACTIVE_COMPARATOR

Routine ICU care

Intervention Type OTHER

Patients will receive ICU care

Historical control

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

Group Type OTHER

historical Routine ICU care

Intervention Type OTHER

Patients had received ICU care

Interventions

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traditional Chinese medicine

patients in the group will receive one of or a combination of the following interventions:

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.

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.

Intervention Type OTHER

Routine ICU care

Patients will receive ICU care

Intervention Type OTHER

historical Routine ICU care

Patients had received ICU care

Intervention Type OTHER

Other Intervention Names

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Oral Chinese medicine decoction and/or Acupuncture or low level laser acupuncture ICU care Routine ICU care

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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China Medical University Hospital

Taichung, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yu-Chen Lee, M.D.,PhD

Role: CONTACT

886-975-682023

Facility Contacts

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Yu-Chen Lee, PHD

Role: primary

Other Identifiers

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CMUH113-REC3-052

Identifier Type: -

Identifier Source: org_study_id

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