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

Third Military Medical University

Status: Not yet enrolling

Conditions: Critically Ill Patients

Treatments: Drug: Matching Placebo; Drug: Fufang E'jiao Jiang

Study type: Interventional

Funder types: Other

Identifiers

NCT07157748

ThirdMMU-YCL

Details and patient eligibility

About

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

Full description

This study aims to systematically evaluate the impact of the traditional Chinese medicine compound Ejiao Jiang on the long - term rehabilitation outcomes of critically ill patients after leaving the ICU through a rigorous double - blind, multi - center randomized controlled design, and provide scientific evidence for the improvement of the prognosis of critically ill patients through the combination of traditional Chinese and Western medicine. The following is a detailed breakdown of the protocol:

I. Basic Information of the Study Study Type: Multi - center, double - blind, randomized controlled trial. Study Period: From September 2025 to September 2027, covering the entire process of patient enrollment, follow - up, and data collation.

Sample Size: It is planned to include 156 eligible patients, who will be randomly assigned to the experimental group (78 cases) and the control group (78 cases) at a 1:1 ratio. The sample size calculation is based on the pre - experimental results of the primary endpoint (6 - minute walk distance).

II. Study Objectives

To evaluate the improvement effect of Ejiao Jiang on the exercise tolerance and quality of life of critically ill patients after leaving the ICU, specifically including:

Verify whether Ejiao Jiang can improve the patients' exercise tolerance (with the 6 - minute walk distance as the core indicator); Explore its impact on the patients' physical function, quality of life, nutritional status, and inflammatory response; Evaluate the safety of Ejiao Jiang during the critical illness rehabilitation period (such as the incidence of adverse reactions).

III. Screening of Study Subjects

1. Inclusion Criteria (Strictly Define the Target Population) Age: 18 - 75 years old (covering adult to elderly critically ill patients, excluding age - related extreme cases); Time Window: Within 24 hours after leaving the ICU (ensuring that the intervention starts in the early stage of rehabilitation, in line with the intervention timing of PICS); History of Critical Illness: Having received mechanical ventilation for ≥48 hours (indicating severe respiratory failure), and an ICU stay of 8 - 28 days (excluding patients with short - term mild illness or long - term dependence on the ICU); General Condition: Having started enteral nutrition (able to tolerate oral/tube feeding), spontaneous breathing (off mechanical ventilation), and clear consciousness (Glasgow Coma Scale, GCS ≥13 points); Exercise Ability: Being able to stand independently and complete the 6 - minute walk test (6MWT) (ensuring that the primary endpoint indicator can be measured).
2. Exclusion Criteria (Avoid Interfering Factors) Extremely Poor Prognosis: Expected to die within 48 hours or need to be readmitted to the ICU (unable to complete the follow - up); Severe Organ Dysfunction: Child - Pugh Class C (severe liver failure), creatinine clearance rate <40 mL/min (severe renal failure); Special Populations: Pregnant women and lactating women (to avoid the impact of the drug on the fetus/infant); Neurological/Psychiatric Diseases: Having a history of severe stroke, Parkinson's disease, schizophrenia, etc. (affecting the assessment of movement or cognition); Drug Conflict: Currently taking other traditional Chinese medicines for tonifying qi and nourishing blood (such as ginseng and astragalus preparations) (to avoid the superposition of traditional Chinese medicine components affecting the results).

IV. Design of Intervention Measures Experimental Group: Given Ejiao Jiang (specification: 20 ml/bottle), orally, 20 ml each time, 3 times a day, for 90 consecutive days (covering the critical period of critical illness rehabilitation, i.e., 3 months after leaving the ICU); Control Group: Given a placebo (with the same appearance and taste as Ejiao Jiang, prepared by a third - party institution), with the same usage and dosage as the experimental group;

Basic Treatment: Both groups of patients will receive a unified critical illness rehabilitation program, including:

Rehabilitation Guidance: 30 - minute bedside exercise, gait training, etc. every day; Nutritional Support: A personalized enteral nutrition plan will be developed according to the NRS - 2002 score; Regular Follow - up: A telephone follow - up once a week and an outpatient review once a month.

V. Outcome Indicator System (Comprehensively Evaluate the Rehabilitation Effect)

1. Primary Endpoint (Core Efficacy Indicator) 6 - Minute Walk Distance (6MWT): Measured on the 90th day after randomization to evaluate the patients' exercise tolerance.
2. Secondary Endpoints (Multi - dimensional Evaluation of Rehabilitation Outcomes) Physical Function: Including handgrip strength (muscle strength), gait speed (balance and coordination ability), Barthel Index (activities of daily living ability), and Fried Frailty Scale (frailty assessment); Quality of Life: The EQ - 5D - 5L questionnaire (European Quality of Life - 5 Dimensions - 5 Levels) will be used to evaluate the patients' self - perceived health (including 5 dimensions: mobility, self - care, usual activities, pain/discomfort, and anxiety/depression); Nutritional and Inflammatory Indicators: Laboratory tests of albumin (nutritional status), pre - albumin (short - term nutritional indicator), C - reactive protein (CRP, inflammatory response), procalcitonin (PCT, bacterial infection indicator), etc.; Clinical Outcomes: Mortality, readmission rate (to the ICU or general ward), non - hospitalized survival days (i.e., the number of days after discharge without readmission), etc.

Enrollment: 178 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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178 participants in 2 patient groups, including a placebo group

Experimental: Fufang E'jiao Jiang

Experimental group

Description:

Participants receive Fufang E'jiao Jiang, 20 mL orally three times daily for 90 days.

Treatment:

Drug: Fufang E'jiao Jiang

Placebo Comparator: Matching Placebo

Placebo Comparator group

Description:

Patients were given an equal-volume placebo (each vial containing compound Ejiao oral liquid \[1 mL, 5%\], caramel color \[800 mg\], and steviol glycosides \[25 mg\]) 20 mL orally, three times daily, for 90 consecutive days (identical to the compound Ejiao oral liquid in appearance, packaging, and taste).

Treatment:

Drug: Matching Placebo