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NCT07157748

Effects of Compound Ejiao Syrup on Exercise Tolerance and Quality of Life in Critically Ill Patients After ICU Discharge: A Double-Blind, Multicenter,Randomized Controlled Clinical Study

Sponsor: Third Military Medical University

View on ClinicalTrials.gov

Summary

This study, titled "Effect of Compound Ejiao Jiang on Exercise Tolerance and Quality of Life of Critically Ill Patients after Discharge from ICU: A Double-Blind, Multicenter, Randomized Controlled Clinical Study (LIFT Study)," intends to enroll 156 patients (78 in the experimental group and 78 in the control group). A double-blind design will be adopted, with patients receiving Compound Ejiao Jiang (20 ml each time, three times a day for 90 consecutive days) or a placebo for intervention. The primary outcome measure is the 6-minute walking distance on the 90th day after randomization. Meanwhile, secondary endpoints such as physical function, quality of life, and nutritional and inflammatory indicators will also be monitored. The aim of this study is to explore the rehabilitation value of Compound Ejiao Jiang for patients with post-intensive care syndrome (PICS) through high-level evidence-based medicine methods and to provide scientific evidence for the integrated traditional Chinese and Western medicine approach to improving the long-term prognosis of critically ill patients

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

178

Start Date

2025-12

Completion Date

2027-09

Last Updated

2025-09-05

Healthy Volunteers

Conditions

Critically Ill Patients

Interventions

DRUG

Fufang E'jiao Jiang

Oral solution; 20 mL TID for 90 days;

DRUG

Matching Placebo

Oral solution; 20 mL TID for 90 days;

Inclusion Criteria: * 1\. Obtain informed consent; 2. Age between 18 and 75 years (inclusive); 3. Discharged from the ICU within 24 hours; 4. Received mechanical ventilation for at least 48 hours during this ICU stay; 5. Has been in the ICU for at least 8 days but no more than 28 days; 6. Enteral nutrition has been initiated. 7. Able to breathe spontaneously, with an oxygenation index (PaO2/FiO2) ≥ 200, and not requiring continuous high-flow oxygen therapy (e.g., nasal cannula flow ≤ 5 L/min); 8. Glasgow Coma Scale (GCS) score ≥ 13 at ICU discharge, and able to cooperate with study-related tests and follow-up; 9. Able to perform simple bedside activities with assistance (e.g., sitting up, standing, or short-distance walking); 10. No severe heart failure, no end-stage chronic respiratory failure, no lower-limb conditions that impair mobility, and no severe central nervous system disease; Able to stand independently and expected to complete the 6MWT at follow-up. Exclusion Criteria: * 1\. Patients expected to die or for whom life-sustaining treatment will be withdrawn within 48 hours after ICU discharge; 2. Patients who need to be readmitted to the ICU within 1 week after ICU discharge; 3. Patients with persistent severe hepatic failure at ICU discharge (Child-Pugh class C); 4. Patients with persistent chronic kidney disease at ICU discharge (creatinine clearance \< 40 mL/min); 5. Pregnant or breastfeeding patients; 6. Patients unable to walk independently before ICU admission (those who can walk independently with assistive devices may be included); 7. Traumatic brain injury, primary cerebrovascular diseases, brain tumors, or intracranial infections; 8. Primary cognitive impairment: Alzheimer's disease, vascular dementia, hydrocephalus, etc., and other serious central nervous system diseases; 9. History of psychiatric disorders such as depression, anxiety, or schizophrenia; 10. Occurrence of respiratory or cardiac arrest; 11. Patients with known cognitive impairment, lower-limb injury, systemic neuromuscular disease, or cranial/spinal conditions that could affect outcome assessment; 12. Patients currently taking other Qi- and blood-tonifying traditional Chinese medicines or patent Chinese medicines.

Locations (1)

the Southwest hospital

Chongqing, Chongqing Municipality, China