Critically Ill PatientsNCT07157748

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

A study testing Fufang E'jiao Jiang in people with Critically Ill Patients, run by Third Military Medical University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Critically Ill Patients
What is being tested?: Fufang E'jiao Jiang
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 178 participants
Where: 1 siteChina
Study dates: Dec 2025to Sep 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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 Patients expected to die or for whom life-sustaining treatment will be withdrawn within 48 hours after ICU discharge; 2.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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Changlin Yin, Ph,D contact

86-139-8315-5227

ycl0315@tmmu.edu.cn

China1 site

the Southwest hospital
Chongqing, Chongqing Municipality
Changlin Yin, MD, +86-139-8315-5227, ycl0315@tmmu.edu.cn
Liang Tan, MD

Other trials in China

About this study

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

Read the detailed 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:

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

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).
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.

Outcome Indicator System (Comprehensively Evaluate the Rehabilitation Effect)
Primary Endpoint (Core Efficacy Indicator) 6 - Minute Walk Distance (6MWT): Measured on the 90th day after randomization to evaluate the patients' exercise tolerance.
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.

Conditions: Critically Ill Patients
Being tested: Fufang E'jiao Jiang, Matching Placebo
Keywords: critically ill patients, exercise tolerance, exercise quality, Compound Ejiao Oral Liquid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fufang E'jiao JiangDrug
Oral solution; 20 mL TID for 90 days;
Matching PlaceboDrug
Oral solution; 20 mL TID for 90 days;

Study groups in NCT07157748
Study group	Role	What they receive
Experimental: Fufang E'jiao Jiang	Experimental	Participants receive Fufang E'jiao Jiang, 20 mL orally three times daily for 90 days. Receives: 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). Receives: Drug: Matching Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2025Sep 2027

First posted5 Sep 2025
Study startDec 2025 (estimated)
Primary completionJun 2027 (estimated)
Study completionSep 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Critically Ill PatientsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Model Description
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 178 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07157748
Sponsor's protocol ID: ThirdMMU-YCL
Status last verified: Aug 2025
First submitted: 28 Aug 2025
Last updated: 5 Sep 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Zhang Y, Ye T, Hong Z, Gong S, Zhou X, Liu H, Qian J, Qu H. Pharmacological and transcriptome profiling analyses of Fufang E'jiao Jiang during chemotherapy-induced myelosuppression in mice. J Ethnopharmacol. 2019 Jun 28;238:111869. doi: 10.1016/j.jep.2019.111869. Epub 2019 Apr 9.
PubMed 30978457
Li Y, Zhang Z, Yang L, Li X, Zhou J, Li D, Luo S. Colla corii asini might upregulate ZNF471 and THOC5 by KRAB domain-containing zinc-finger protein pathway and THO complex subunit 5 pathway to improve anemia of pregnant women with beta-thalassemia. Ann Hematol. 2019 Aug;98(8):1813-1826. doi: 10.1007/s00277-019-03710-1. Epub 2019 May 16.
PubMed 31098739
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.
PubMed 27456464
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.
PubMed 36563889
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.
PubMed 25014703
Iwashyna TJ, Ely EW, Smith DM, Langa KM. Long-term cognitive impairment and functional disability among survivors of severe sepsis. JAMA. 2010 Oct 27;304(16):1787-94. doi: 10.1001/jama.2010.1553.
PubMed 20978258
Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62. doi: 10.1001/jama.291.14.1753.
PubMed 15082703
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.
PubMed 24638143
Pandharipande PP, Girard TD, Ely EW. Long-term cognitive impairment after critical illness. N Engl J Med. 2014 Jan 9;370(2):185-6. doi: 10.1056/NEJMc1313886. No abstract available.
PubMed 24401069
Herridge MS, Tansey CM, Matte A, Tomlinson G, Diaz-Granados N, Cooper A, Guest CB, Mazer CD, Mehta S, Stewart TE, Kudlow P, Cook D, Slutsky AS, Cheung AM; Canadian Critical Care Trials Group. Functional disability 5 years after acute respiratory distress syndrome. N Engl J Med. 2011 Apr 7;364(14):1293-304. doi: 10.1056/NEJMoa1011802.
PubMed 21470008
Puthucheary ZA, Rawal J, McPhail M, Connolly B, Ratnayake G, Chan P, Hopkinson NS, Phadke R, Dew T, Sidhu PS, Velloso C, Seymour J, Agley CC, Selby A, Limb M, Edwards LM, Smith K, Rowlerson A, Rennie MJ, Moxham J, Harridge SD, Hart N, Montgomery HE. Acute skeletal muscle wasting in critical illness. JAMA. 2013 Oct 16;310(15):1591-600. doi: 10.1001/jama.2013.278481.
PubMed 24108501
Needham DM, Davidson J, Cohen H, Hopkins RO, Weinert C, Wunsch H, Zawistowski C, Bemis-Dougherty A, Berney SC, Bienvenu OJ, Brady SL, Brodsky MB, Denehy L, Elliott D, Flatley C, Harabin AL, Jones C, Louis D, Meltzer W, Muldoon SR, Palmer JB, Perme C, Robinson M, Schmidt DM, Scruth E, Spill GR, Storey CP, Render M, Votto J, Harvey MA. Improving long-term outcomes after discharge from intensive care unit: report from a stakeholders' conference. Crit Care Med. 2012 Feb;40(2):502-9. doi: 10.1097/CCM.0b013e318232da75.
PubMed 21946660

Interested in taking part?

Changlin Yin, Ph,D

86-139-8315-5227

ycl0315@tmmu.edu.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Not yet recruitingObservational study
Ultrasound-Calibrated Pulse Contour Cardiac Output Monitoring: Value and Accuracy in Hemodynamic Care
Sepsis, Circulatory Instability
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Soap-and-Water Bed Bath Versus Disposable Wipe Bath in the Same ICU Patients
Critical Illness, Pain
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
Not yet recruitingObservational study
Pharmacokinetics and Optimal Dosing of Levetiracetam in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy
Continuous Renal Replacement Therapy (CRRT), Pharmacokinetics

All Critically Ill Patients trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT07157748
Acronym / sponsor ID: ThirdMMU-YCL
Conditions: Critically Ill Patients
Keywords: critically ill patients, exercise tolerance, exercise quality, Compound Ejiao Oral Liquid
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 178 participants (estimated)
Lead sponsor: Third Military Medical UniversityUniversity, hospital or other
Study start: Dec 2025 (estimated)
Primary completion: Jun 2027 (estimated)
Study completion: Sep 2027 (estimated)
First posted: 5 Sep 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

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:

III. Screening of Study Subjects

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).
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).

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

Outcome Indicator System (Comprehensively Evaluate the Rehabilitation Effect)
Primary Endpoint (Core Efficacy Indicator) 6 - Minute Walk Distance (6MWT): Measured on the 90th day after randomization to evaluate the patients' exercise tolerance.
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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Model Description

Arm	Type	Receives
Experimental: Fufang E'jiao Jiang	Experimental	Drug: Fufang E'jiao JiangParticipants receive Fufang E'jiao Jiang, 20 mL orally three times daily for 90 days.
Placebo Comparator: Matching Placebo	Placebo comparator	Drug: Matching PlaceboPatients 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).

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (1 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fufang E'jiao JiangOral solution; 20 mL TID for 90 days;	Drug	Experimental: Fufang E'jiao Jiang
Matching PlaceboOral solution; 20 mL TID for 90 days;	Drug	Placebo Comparator: Matching Placebo

Primary outcome

6-minute walk test (6MWT)
Time frame: 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
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.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
Background: PubMed 30978457Zhang Y, Ye T, Hong Z, Gong S, Zhou X, Liu H, Qian J, Qu H. Pharmacological and transcriptome profiling analyses of Fufang E'jiao Jiang during chemotherapy-induced myelosuppression in mice. J Ethnopharmacol. 2019 Jun 28;238:111869. doi: 10.1016/j.jep.2019.111869. Epub 2019 Apr 9.
Background: PubMed 31098739Li Y, Zhang Z, Yang L, Li X, Zhou J, Li D, Luo S. Colla corii asini might upregulate ZNF471 and THOC5 by KRAB domain-containing zinc-finger protein pathway and THO complex subunit 5 pathway to improve anemia of pregnant women with beta-thalassemia. Ann Hematol. 2019 Aug;98(8):1813-1826. doi: 10.1007/s00277-019-03710-1. Epub 2019 May 16.
Background: PubMed 27456464Li 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.
Background: PubMed 36563889Shi 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.
Background: PubMed 25014703Kress 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.
Background: PubMed 20978258Iwashyna TJ, Ely EW, Smith DM, Langa KM. Long-term cognitive impairment and functional disability among survivors of severe sepsis. JAMA. 2010 Oct 27;304(16):1787-94. doi: 10.1001/jama.2010.1553.
Background: PubMed 15082703Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62. doi: 10.1001/jama.291.14.1753.
Background: PubMed 24638143Kaukonen 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.
Background: PubMed 24401069Pandharipande PP, Girard TD, Ely EW. Long-term cognitive impairment after critical illness. N Engl J Med. 2014 Jan 9;370(2):185-6. doi: 10.1056/NEJMc1313886. No abstract available.
Background: PubMed 21470008Herridge MS, Tansey CM, Matte A, Tomlinson G, Diaz-Granados N, Cooper A, Guest CB, Mazer CD, Mehta S, Stewart TE, Kudlow P, Cook D, Slutsky AS, Cheung AM; Canadian Critical Care Trials Group. Functional disability 5 years after acute respiratory distress syndrome. N Engl J Med. 2011 Apr 7;364(14):1293-304. doi: 10.1056/NEJMoa1011802.
Background: PubMed 24108501Puthucheary ZA, Rawal J, McPhail M, Connolly B, Ratnayake G, Chan P, Hopkinson NS, Phadke R, Dew T, Sidhu PS, Velloso C, Seymour J, Agley CC, Selby A, Limb M, Edwards LM, Smith K, Rowlerson A, Rennie MJ, Moxham J, Harridge SD, Hart N, Montgomery HE. Acute skeletal muscle wasting in critical illness. JAMA. 2013 Oct 16;310(15):1591-600. doi: 10.1001/jama.2013.278481.
Background: PubMed 21946660Needham DM, Davidson J, Cohen H, Hopkins RO, Weinert C, Wunsch H, Zawistowski C, Bemis-Dougherty A, Berney SC, Bienvenu OJ, Brady SL, Brodsky MB, Denehy L, Elliott D, Flatley C, Harabin AL, Jones C, Louis D, Meltzer W, Muldoon SR, Palmer JB, Perme C, Robinson M, Schmidt DM, Scruth E, Spill GR, Storey CP, Render M, Votto J, Harvey MA. Improving long-term outcomes after discharge from intensive care unit: report from a stakeholders' conference. Crit Care Med. 2012 Feb;40(2):502-9. doi: 10.1097/CCM.0b013e318232da75.
Individual participant dataSharing planned: No

Related trials for Critically Ill Patients

Not yet recruitingObservational study
Ultrasound-Calibrated Pulse Contour Cardiac Output Monitoring: Value and Accuracy in Hemodynamic Care
Sepsis, Circulatory Instability
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Soap-and-Water Bed Bath Versus Disposable Wipe Bath in the Same ICU Patients
Critical Illness, Pain
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
Not yet recruitingObservational study
Pharmacokinetics and Optimal Dosing of Levetiracetam in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy
Continuous Renal Replacement Therapy (CRRT), Pharmacokinetics

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Changlin Yin, Ph,D contact

86-139-8315-5227

ycl0315@tmmu.edu.cn

Changlin Yin, Ph,D principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Fufang E'jiao Jiang in people with Critically Ill Patients, run by Third Military Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Changlin Yin, Ph,D (86-139-8315-5227, ycl0315@tmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6-minute walk test (6MWT) (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07157748, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.