NCT06452966

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: China Medical University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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

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

• Organ Failure, Multiple
• Indigestion
• Delayed Gastric Emptying
• Respiratory Failure
• Morality

Interventions

Type	Name	Description
OTHER	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.
OTHER	Routine ICU care	Patients will receive ICU care
OTHER	historical Routine ICU care	Patients had received ICU care

Timeline

• Start date: 2024-05-07
• Primary completion: 2026-12-30
• Completion: 2027-05-30
• First posted: 2024-06-11
• Last updated: 2024-06-11

Locations

1 site across 1 country: Taiwan