An interventional study of Fufang Ejiao Jiang and Matching placebo control in ICU Survivors, sponsored by Third Military Medical University. Not yet recruiting at 13 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-13.
Sponsored by Third Military Medical University · Not applicable, Interventional, and Treatment
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This study aims to evaluate the effects of Fufang E'jiao Jiang on clinical outcomes, health-related quality of life, and functional recovery in survivors of critical illness following intensive care unit (ICU) discharge.This multicenter, randomized, double-blind, placebo-controlled trial will enroll 246 participants who will be randomly assigned in a 1:1 ratio to receive either Fufang E'jiao Jiang or matching placebo. Participants will receive 20 mL orally three times daily for 90 days, alongside standard post-ICU rehabilitation and supportive care.The primary outcome is a prespecified hierarchical composite endpoint assessed within 90 days after randomization and analyzed using the win ratio method. The components are evaluated in the following order of clinical priority: (1) all-cause mortality within 90 days; (2) unplanned all-cause readmission within 90 days; and (3) change from baseline in the EQ-5D-5L utility index at day 90. Secondary outcomes include exercise tolerance, frailty, cognitive function, fatigue, anxiety and depression, sleep quality assessed by wrist actigraphy and the Pittsburgh Sleep Quality Index (PSQI), appetite, handgrip strength, body composition, and selected biochemical, hematologic, and iron metabolism-related indicators. The trial aims to provide clinical evidence regarding the potential role of Fufang E'jiao Jiang in supporting recovery and improving health-related outcomes among survivors of critical illness after ICU discharge.
Post-intensive care syndrome is common among survivors of critical illness and is associated with impaired physical function, cognitive dysfunction, psychological symptoms, reduced quality of life, and increased health care utilization after intensive care unit (ICU) discharge. Current post-ICU rehabilitation strategies remain limited, and effective pharmacologic interventions are lacking. Fufang E'jiao Jiang is a traditional Chinese medicine preparation that has been used to improve fatigue, nutritional status, and functional recovery in relevant clinical settings. Based on its traditional indications and existing pharmacologic evidence, it may have potential value in supporting recovery among survivors of critical illness after ICU discharge. This study is a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial designed to evaluate the efficacy and safety of Fufang E'jiao Jiang in adult survivors of critical illness after ICU discharge. A total of 246 participants will be enrolled and randomly assigned in a 1:1 ratio to receive either Fufang E'jiao Jiang or matching placebo. Study treatment will begin after ICU discharge once enteral nutrition has been initiated. Participants in both groups will receive standard post-ICU rehabilitation and supportive care. The investigational group will receive Fufang E'jiao Jiang, 20 mL orally three times daily for 90 consecutive days. The control group will receive a matching placebo with the same dosing schedule, appearance, packaging, color, and taste but without the active ingredients of Fufang E'jiao Jiang. The primary outcome is a prespecified hierarchical composite endpoint evaluated within 90 days after randomization and analyzed using the win ratio method. The components will be compared sequentially according to their predefined clinical priority: (1) all-cause mortality within 90 days after randomization; (2) unplanned all-cause readmission within 90 days after randomization; and (3) change from baseline in the EQ-5D-5L utility index at day 90, using a prespecified clinically meaningful threshold. The primary treatment effect will be summarized using a single win ratio. Secondary outcomes will assess multiple domains of post-ICU recovery, including physical function, frailty, cognitive function, fatigue, psychological health, sleep quality, appetite, nutritional status, body composition, and selected laboratory indicators. Physical and functional assessments will include the 6-minute walk test distance, Clinical Frailty Scale score, Montreal Cognitive Assessment score, Fatigue Severity Scale score, Hospital Anxiety and Depression Scale score, and handgrip strength. Sleep-related outcomes will be assessed using both objective and subjective measurements. Objective sleep parameters, including total sleep time, sleep efficiency, and wake after sleep onset, will be recorded using a wearable sleep wristband (actigraphy). Subjective sleep quality will be evaluated using the Pittsburgh Sleep Quality Index (PSQI). Body composition will be assessed using the Nutrilab body composition analysis system. The assessed parameters will include body fat percentage, fat mass, skeletal muscle mass, and fat-free mass. Biochemical and hematologic assessments will include hemoglobin concentration, albumin, prealbumin, C-reactive protein, creatinine, blood urea nitrogen, red blood cell count, absolute lymphocyte count, and white blood cell count. Hemoglobin concentration and blood cell counts will be assessed using whole-blood hematological analysis. The percentage of HLA-DR-positive monocytes will be assessed in peripheral blood using flow cytometry. Additional hematologic and iron metabolism-related assessments will include absolute reticulocyte count, reticulocyte hemoglobin content (RET-He or CHr), serum ferritin concentration, and transferrin saturation (TSAT). TSAT will be calculated using serum iron concentration and total iron-binding capacity, with the latter measured directly or derived from transferrin concentration using a validated laboratory method. Plasma growth differentiation factor 15 (GDF15) concentration will also be assessed. Sleep quality and body composition will be evaluated at baseline, day 30, and day 90 after randomization. The selected biochemical, hematologic, and iron metabolism-related indicators will be assessed at baseline and day 90 after randomization. The trial is intended to generate clinical evidence regarding the role of Fufang E'jiao Jiang in supporting functional recovery, health-related quality of life, and selected hematologic, nutritional, and metabolic outcomes among survivors of critical illness after ICU discharge.
106 studies on the registry are indexed under postintensive care syndrome; 49 are open to participants now.
This study's planned enrollment of 246 is above the median of 79 across 48 interventional studies indexed under postintensive care syndrome.
Browse postintensive care syndrome studies →Third Military Medical University is the lead sponsor of 84 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive Fufang Ejiao Jiang, 20 mL orally three times daily for 90 consecutive days
Drug: Fufang Ejiao Jiang
Participants will receive a matching placebo, 20 mL orally three times daily for 90 consecutive days
Drug: Matching placebo control
Oral liquid, 20 mL by mouth three times daily for 90 consecutive days.
Oral liquid placebo, 20 mL by mouth three times daily for 90 consecutive days. The placebo is matched to Fufang Ejiao Jiang in appearance, packaging, color, and taste and contains no active ingredients of Fufang Ejiao Jiang Other Name:
Win Ratio for the 90-Day Hierarchical Composite Outcome
The primary outcome is a single prespecified hierarchical composite endpoint analyzed using the win ratio method. Participants from the two randomized groups will be compared pairwise according to the following clinical priority hierarchy: (1) all-cause mortality within 90 days after randomization; (2) unplanned all-cause readmission within 90 days after randomization; and (3) change from baseline in the EQ-5D-5L utility index at day 90. Comparisons will proceed to the next component when no winner is determined at the preceding level. The primary treatment effect will be expressed as a single win ratio, calculated as the ratio of winning to losing pairs. The three components constitute one hierarchical composite endpoint rather than three separate primary outcome measures.
Time frame: From randomization through day 90
6-minute walk test distance
Exercise tolerance assessed using the 6-minute walk test
Time frame: At baseline, 30 days after randomization, and 90 days after randomization
Clinical Frailty Scale score
Frailty assessed using the Clinical Frailty Scale
Time frame: At baseline, 30 days after randomization, and 90 days after randomization
Montreal Cognitive Assessment score
Cognitive function assessed using the Montreal Cognitive Assessment
Time frame: At baseline, 30 days after randomization, and 90 days after randomization
Fatigue Severity Scale score
Fatigue assessed using the Fatigue Severity Scale
Time frame: At baseline, 30 days after randomization, and 90 days after randomization
Hospital Anxiety and Depression Scale score
Psychological symptoms assessed using the Hospital Anxiety and Depression Scale
Time frame: At baseline, 30 days after randomization, and 90 days after randomization
Total Sleep Time Measured by Wrist Actigraphy
Total sleep time will be assessed using a wearable sleep wristband (actigraphy) and reported in minutes.
Time frame: At baseline, 30 days after randomization, and 90 days after randomization.
Sleep Efficiency Measured by Wrist Actigraphy
Sleep efficiency will be assessed using a wearable sleep wristband (actigraphy) and reported as a percentage.
Time frame: At baseline, 30 days after randomization, and 90 days after randomization.
Wake After Sleep Onset Measured by Wrist Actigraphy
Wake after sleep onset (WASO) will be assessed using a wearable sleep wristband (actigraphy) and reported in minutes.
Time frame: At baseline, 30 days after randomization, and 90 days after randomization.
Global Score on the Pittsburgh Sleep Quality Index (PSQI)
Subjective sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The global score ranges from 0 to 21, with higher scores indicating poorer sleep quality.
Time frame: At baseline, 30 days after randomization, and 90 days after randomization.
Appetite
Appetite will be assessed using the Simplified Nutritional Appetite Questionnaire (SNAQ), a 4-item self-administered instrument covering appetite, feelings of fullness, taste of food, and number of meals per day. The total score ranges from 4 to 20; a score of 14 or lower indicates a significant risk of at least 5% weight loss within 6 months, with lower scores indicating poorer appetite.
Time frame: At baseline, 30 days after randomization, and 90 days after randomization
Handgrip strength
Muscle strength assessed by handgrip dynamometry
Time frame: At baseline, 30 days after randomization, and 90 days after randomization
Body Fat Percentage Measured by Nutrilab Body Composition Analysis
Body fat percentage will be measured using the Nutrilab body composition analysis system and reported as the percentage of total body weight consisting of fat mass.
Time frame: At baseline, day 30, and day 90 after randomization.
Fat Mass Measured by Nutrilab Body Composition Analysis
Total body fat mass will be measured using the Nutrilab body composition analysis system and reported in kilograms.
Time frame: At baseline, day 30, and day 90 after randomization.
Skeletal Muscle Mass Measured by Nutrilab Body Composition Analysis
Skeletal muscle mass will be measured using the Nutrilab body composition analysis system and reported in kilograms.
Time frame: At baseline, day 30, and day 90 after randomization.
Fat-Free Mass Measured by Nutrilab Body Composition Analysis
Fat-free mass will be measured using the Nutrilab body composition analysis system and reported in kilograms.
Time frame: At baseline, day 30, and day 90 after randomization.
Hemoglobin Concentration
Hemoglobin concentration will be measured in whole blood using routine complete blood count (CBC) analysis and reported in g/L.
Time frame: At baseline and day 90 after randomization.
Albumin Concentration
Albumin concentration will be measured by routine clinical laboratory analysis and reported in g/L.
Time frame: At baseline and day 90 after randomization.
Prealbumin Concentration
Prealbumin concentration will be measured by routine clinical laboratory analysis and reported in mg/L.
Time frame: At baseline and day 90 after randomization.
C-Reactive Protein Concentration
C-reactive protein (CRP) concentration will be measured by routine clinical laboratory analysis and reported in mg/L.
Time frame: At baseline and day 90 after randomization.
Creatinine Concentration
Creatinine concentration will be measured by routine clinical laboratory analysis and reported in µmol/L.
Time frame: At baseline and day 90 after randomization.
Blood Urea Nitrogen Concentration
Blood urea nitrogen (BUN) concentration will be measured by routine clinical laboratory analysis and reported in mmol/L.
Time frame: At baseline and day 90 after randomization.
Red Blood Cell Count
Red blood cell count will be measured in whole blood using routine complete blood count (CBC) analysis and reported in 10\^12 cells/L.
Time frame: At baseline and day 90 after randomization.
Absolute Lymphocyte Count
Absolute lymphocyte count will be measured in whole blood using routine hematological analysis and reported in 10\^9 cells/L.
Time frame: At baseline and day 90 after randomization.
White Blood Cell Count
White blood cell count will be measured in whole blood using routine complete blood count (CBC) analysis and reported in 10\^9 cells/L.
Time frame: At baseline and day 90 after randomization.
Percentage of HLA-DR-Positive Cells
The percentage of HLA-DR-positive monocytes will be assessed in peripheral blood using flow cytometry. HLA-DR-positive monocytes will be quantified as a percentage of the total monocyte population, with higher percentages indicating a greater proportion of monocytes expressing HLA-DR.
Time frame: At baseline and day 90 after randomization.
Absolute Reticulocyte Count
Absolute reticulocyte count will be measured in peripheral whole blood using an automated hematology analyzer and reported in 10\^9 cells/L.
Time frame: At baseline and day 90 after randomization.
Reticulocyte Hemoglobin Content (RET-He or CHr)
Reticulocyte hemoglobin content will be measured in peripheral whole blood using an automated hematology analyzer and reported in picograms (pg) per reticulocyte. The parameter will be reported as reticulocyte hemoglobin equivalent (RET-He) or reticulocyte hemoglobin content (CHr), depending on the analyzer used.
Time frame: At baseline and day 90 after randomization.
Serum Ferritin Concentration
Serum ferritin concentration will be measured using a clinical laboratory immunoassay and reported in ng/mL.
Time frame: At baseline and day 90 after randomization.
Transferrin Saturation (TSAT)
Transferrin saturation (TSAT) will be calculated from serum iron concentration and total iron-binding capacity (TIBC) using the formula: TSAT (%) = \[serum iron / TIBC\] × 100, with both measurements expressed in the same units. TIBC will be measured directly or calculated from serum transferrin concentration using the validated laboratory-specific method. TSAT will be reported as a percentage.
Time frame: At baseline and day 90 after randomization.
Plasma Growth Differentiation Factor 15 (GDF15) Concentration
Plasma growth differentiation factor 15 (GDF15) concentration will be measured using a validated immunoassay and reported in pg/mL.
Time frame: At baseline and day 90 after randomization.
Plan to share: No
Start is estimated for Nov 2026; primary completion for Jun 2029, 30 months later.
Of 39 interventional studies with no phase under postintensive care syndrome, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 38. This study's planned 30 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Third Military Medical University