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Clinical Observation and Research on the Treatment of Consciousness Disorder in Sepsis-Associated Encephalopathy of Phlegm and Fire Disturbing the Upper Jiao with Modified Shengtie Luo Decoction

Clinical Observation and Research on the Treatment of Consciousness Disorder in Sepsis-Associated Encephalopathy of Phlegm and Fire Disturbing the Upper Jiao with Modified Shengtie Luo Decoction

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001786
Enrollment
Unknown
Registered
2025-09-21
Start date
2025-05-29
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis-associated encephalopathy

Interventions

control group :Standard Western medical treatment + drinking water
treatment group :Standard Western medical treatment + Modified Shengtie Luo Decoction

Sponsors

Shanghai Yueyang Integrated Traditional Chinese Medicine and Western Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1: Age = 18 years and = 80 years gender unrestricted; 2: Conforming to the diagnostic criteria of phlegm-fire disturbing the upper body in traditional Chinese medicine; 3: Meet the Western medical diagnostic criteria for sepsis-associated encephalopathy; 4: Met the criteria for consciousness disorder (CAM-ICU positive); 5: The patient or the legal representative understands agrees to participate in this study and signs the informed consent form.

Exclusion criteria

Exclusion criteria: 1: Patients with severe underlying diseases such as malignant tumors (non-stable stage) liver cirrhosis chronic renal failure (uremic stage) hematological diseases and HIV; 2: Patients with a SOFA score of =15 or organ dysfunction with a single SOFA score of =4 or an Acute Physiology and Chronic Health Evaluation II (APACHE II) score of =30 or those who refuse active treatment; 3: Patients with endotracheal intubation; 4: Patients with drug allergies in this study; 5: Patients who are pregnant or lactating; 6: Those who have participated in other drug clinical trials within 3 months prior to the trial.

Design outcomes

Primary

MeasureTime frame
Delirium Rating Scale - Revised 98 (DRS-R98) score ;

Secondary

MeasureTime frame
Biomarkers of nerve injury ;SOFA score ;RASS score ;Systemic inflammatory markers ;Glasgow Coma Scale score ;TCM syndrome score ;APACHE II score ;inflammatory factor ;Duration of use of restraint belts;

Countries

China

Contacts

Public ContactQianYiMing

Shanghai Yueyang Integrated Traditional Chinese Medicine and Western Medicine Hospital

qianym2004@163.com18930568223

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026