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Study on the optimal dosage of Liugan Shuangjie Granules in the treatment of viral pneumonia and the mechanism of regulating macrophage polarization based on energy metabolism

Study on the optimal dosage of Liugan Shuangjie Granules in the treatment of viral pneumonia and the mechanism of regulating macrophage polarization based on energy metabolism

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070723
Enrollment
Unknown
Registered
2023-04-21
Start date
2023-04-21
Completion date
Unknown
Last updated
2023-06-04

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

Conditions

Viral pneumonia

Interventions

Liugan Shuangjie Formula Group:Liugan Shuangjie Formulas
Liugan Shuangjie Granules Standard Dose Group:Liugan Shuangjie Granules Standard Dose
Liugan Shuangjie Granules High-Dose Group:Liugan Shuangjie Granules High-Dose
Liugan Shuangjie Granules Low-Dose Group:Liugan Shuangjie Granules Low-Dose
Antiviral Drug Group:Oseltamivir Capsules/ Paxlovid

Sponsors

Guangdong Provincial Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: (1)Age = 18 years old (2)Diagnostic criteria meet the viral pneumonia (3)Traditional Chinese medicine differentiation as Phlegm Heat Staying in the Lung Syndrome (4)Patient's clinical symptoms present with at least 2 of the following 5 main symptoms:fever, cough, sputum, dyspnea (shortness of breath), pleuritic chest pain (5)CURB-65 score of 0-3 (6)Patient informed and signed informed consent form

Exclusion criteria

Exclusion criteria: (1)Patients with severe pneumonia, multi-organ failure, acute respiratory distress syndrome, etc (2)Patients with hospital acquired pneumonia or ventilator associated pneumonia (3)Patients with other serious respiratory diseases, such as chronic obstructive pulmonary disease, bronchiectasis, active pulmonary tuberculosis, etc (4)Patients with severe basic diseases such as heart, brain, lung, liver, kidney, blood system diseases, and mental illness (5)Abnormal liver function[ALT or AST=2.0 ULN(upper limits of normal)] or renal dysfunction(serum creatinine =1.5 ULN) (6)Patients with immunodeficiency such as malignancy, organ or bone marrow transplantation, HIV infection or taking immunosuppressive drugs or glucocorticoids within the last 3 months (7)Patients with swallowing difficulties, patients who have undergone gastrectomy or combined with Crohn's disease and other diseases that severely affect gastrointestinal absorption (8)Patients who are pregnant, planning pregnancy and breastfeeding (9)Allergic, or known to be allergic to the ingredients of Liugan Shuangjie Granules and to the underlying therapeutic class of drugs (10)Patients who are participating in clinical trials of other drugs (11)Patients deemed unsuitable for clinical trials by researchers

Design outcomes

Primary

MeasureTime frame
Early clinical symptom improvement rate;

Secondary

MeasureTime frame
Clinical symptom cure rate;Modified Pneumonia Imaging Absorption Evaluation Scale;Cough and Sputum Assessment Questionnaire;CURB-65 rating;Scoring of Traditional Chinese Medicine Syndrome Efficacy;Viral antigen conversion rate;

Countries

China

Contacts

Public ContactLin Lin

Guangdong Provincial Hospital of Traditional Chinese Medicine

drlinlin620@163.com+86 15812487498

Outcome results

None listed

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