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Randomized controlled trial of Shuanghuang formula in the treatment of patients with Persistent inflammatory immunosuppressed catabolic syndrome (PICS)

Randomized controlled trial of Shuanghuang formula in the treatment of patients with Persistent inflammatory immunosuppressed catabolic syndrome (PICS)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000097
Enrollment
Unknown
Registered
2024-06-09
Start date
2022-08-01
Completion date
Unknown
Last updated
2024-06-24

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

Conditions

Sepsis

Interventions

Control group:Conventional therapy for sepsis.
Treatment group:Based on the conventional therapy for sepsis, the Shenhuang Formula granules are added, to be taken once a day (one bag, containing 15g of ginseng and 7.5g of rhubarb), dissolved in 20

Sponsors

Capital Medical University Affiliated Beijing Traditional Chinese Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 96 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria for sepsis PICS: presence of infection, SOFA score = 2, and hospitalization for more than 14 days, and fulfillment of at least two of the following three indicators: C-reactive protein (CRP) > 2.0 mg/dL, albumin (Albumin, Alb) < 3.0 g/dL, lymphocytes < 800/µL. (2) Age = 18 years; (3) Voluntarily participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Pregnant or planning to become pregnant; (2) Severe mental illness; (3) Expected survival time of less than 28 days due to underlying diseases, such as uncontrolled malignant tumors or a heart attack within the past 30 days; (4) Vegetative state; (5) Diagnosed or highly suspected of having an acute infectious disease, such as active viral hepatitis or active tuberculosis; (6) Allergy to the active ingredient or excipients of the trial drug; (7) Participated in a clinical intervention trial within the past 3 months.

Design outcomes

Primary

MeasureTime frame
90-Day Mortality Rate;28-Day Mortality Rate;

Secondary

MeasureTime frame
TNF-a;BMI;Neutrophil Absolute Count;CD3+CD4;D-dimer;ß2-microglobulin;Immunoglobulin;C-Reactive Protein;Fibrin degradation products;IFN-?;ß-N-acetylglucosaminidase;Acute Gastrointestinal Injury Ranks;Mean arterial pressure;PBMC transcriptome sequencing;Direct bilirubin;Activated partial thromboplastin time;transferrin;Serum total bile acids;IL-1;1,3-ß-D-glucan;Lymphocyte Absolute Count;CD3+CD4+CD25;Serum Albumin;Blood urea nitrogen;triglyceride;Twelve-lead electrocardiogram;Glomerular filtration rate;SOFA score;Clinical Pulmonary Infection Score;Respiratory rate;IL-6;pH;Aspartate Aminotransferase;Creatine Kinase-Myocardial Band;Hemoglobin;Total bilirubin;TGF-ß;Treg;Arterial carbon dioxide partial pressure;Procalcitonin;Cardiac troponin I;Arterial oxygen partial pressure;Platelet count;APACHE ? score;Lactic acid;IL-4;Alanine Aminotransferase;N-terminal pro-brain natriuretic peptide;Serum pre-albumin;Blood pressure;IL-10;Prothrombin time;Galactomannan;Blood Creatinine;International normalized ratio;

Countries

China

Contacts

Public ContactLiu Qingquan, Xu Xiaolong

Capital Medical University Affiliated Beijing Traditional Chinese Medicine Hospital

xiaolong_xu3013@126.com18811554937

Outcome results

None listed

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