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

Early Phase 1
Completed
Conditions
Sepsis
Registration Number
ITMCTR2024000097
Lead Sponsor
Capital Medical University Affiliated Beijing Traditional Chinese Medicine Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
Not specified
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

(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.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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