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

NCT07157748 | Not Yet Recruiting DMC

• 1 other identifier: ThirdMMU-YCL
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Critically Ill Patients

Keywords

critically ill patients; exercise tolerance; exercise quality; Compound Ejiao Oral Liquid

Outcome Measures

Primary Outcomes (1)

• 6-minute walk test (6MWT)

  This evaluation is based on the walking distance that patients cover in six minutes when walking as fast as possible along a straight corridor, which is a indicator for assessing the lower limb motor function.

  Preoperative stage; One week after surgery; One week after device activation; Four weeks after device activation; Four weeks after discharge from hospital; Six months after discharge from hospital

Study Arms (2)

Experimental: Fufang E'jiao Jiang

EXPERIMENTAL

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

Drug: Fufang E'jiao Jiang

Placebo Comparator: Matching Placebo

PLACEBO COMPARATOR

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).

Drug: Matching Placebo

Interventions

Fufang E'jiao Jiang DRUG

Oral solution; 20 mL TID for 90 days;

Experimental: Fufang E'jiao Jiang

Matching Placebo DRUG

Oral solution; 20 mL TID for 90 days;

Placebo Comparator: Matching Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Third Military Medical University: lead

Study Sites (1)

the Southwest hospital

Chongqing, Chongqing Municipality, China

Location

Related Publications (12)

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  PMID: 31098739 BACKGROUND

• Li Y, He H, Yang L, Li X, Li D, Luo S. Therapeutic effect of Colla corii asini on improving anemia and hemoglobin compositions in pregnant women with thalassemia. Int J Hematol. 2016 Nov;104(5):559-565. doi: 10.1007/s12185-016-2069-0. Epub 2016 Jul 25.

  PMID: 27456464 BACKGROUND

• Shi WB, Wang ZX, Liu HB, Jia YJ, Wang YP, Xu X, Zhang Y, Qi XD, Hu FD. Study on the mechanism of Fufang E'jiao Jiang on precancerous lesions of gastric cancer based on network pharmacology and metabolomics. J Ethnopharmacol. 2023 Mar 25;304:116030. doi: 10.1016/j.jep.2022.116030. Epub 2022 Dec 20.

  PMID: 36563889 BACKGROUND

• Kress JP, Hall JB. ICU-acquired weakness and recovery from critical illness. N Engl J Med. 2014 Jul 17;371(3):287-8. doi: 10.1056/NEJMc1406274. No abstract available.

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• Kaukonen KM, Bailey M, Suzuki S, Pilcher D, Bellomo R. Mortality related to severe sepsis and septic shock among critically ill patients in Australia and New Zealand, 2000-2012. JAMA. 2014 Apr 2;311(13):1308-16. doi: 10.1001/jama.2014.2637.

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  PMID: 21946660 BACKGROUND

Study Officials

• Changlin Yin, Ph,D

  The First Affiliated Hospital of Army Medical University, Chongqing, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Changlin Yin, Ph,D

CONTACT

86-139-8315-5227; ycl0315@tmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Masking Description
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Southwest hospital

Model Details: Model Description

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 5, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)