ITMCTR1900002746RecruitingPhase 4
A multicenter, double-blind, randomized, placebo-controlled clinical trial to evaluate efficacy and safety of Liu Shen capsule in the treatment of seasonal influenza
The First Affiliated Hospital of Guangzhou Medical University0 sitesStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional study
Eligibility Criteria
- Ages
- 18 to 65 (—)
- Sex
- All
Inclusion Criteria
- •(1) Aged 18 to 65 years;
- •(2) Patients whose rapid influenza diagnostic tests (RIDTs) result is positive, and consistent with the clinical diagnosis of influenza;
- •(3) Patients whose onset of symptoms occurred <= 48h (with fever >=38.0 degree C and any influenza symptom);
- •(4) Patients whose temperature (armpit) >= 38.0 degree C in the past 24 hours;
- •(5) At least one of the following systemic symptoms: headache, muscle aches, chills, sweating, fatigue;
- •(6) At least one of the folloeing respiratory symptoms: cough, sore throat, stuffy nose;
- •(7) Patients who sign the informed consent form freely and voluntarily.
Exclusion Criteria
- •(1) Lateral and anteroposterior chest radiography or chest CT scan results showed bronchitis, pneumonia, pleural effusion, interstitial lesions, etc.;
- •(2) White blood cell count (WBC) > 10.0 x 10^9/L, or < 4.0x10^9/L;
- •(3) Patients with purulent sputum, bloody sputum or purulent tonsillitis;
- •(4) Patients with severe vomiting, diarrhea or dehydration;
- •(5) Patients with rapid breathing, dyspnea, or blue lips;
- •(6) Patients with altered mental state, such as sluggish, lethargy, dysphoria, convulsions, etc.;
- •(7) BMI > 30kg/m^2;
- •(8) Diabetic; Patients with severe underlying illness, such as hematopathy, severe COPD (FEV1/EVC < 70%, FEV1/pred < 50%), bronchial asthma, bronchiectasis, respiratory failure, right heart failure, severe liver insufficiency (ALT or AST >= 3ULN, TBIL >= 1.5ULN); Severe renal insufficiency (SCr >177µmol/L or 2mg/dL); Congestive heart failure(NYHA III-IV); Psychopath;
- •(9) Patients used anti-influenza drugs within 7 days prior screening (such as oseltamivir, zanamivir, peramivir, favipiravir, arbidol, amantadine, rimantadine etc.); Or Chinese medicine with antiviral effect was used within 7 days prior screening(such as Jin Hua Qing Gan, Lian Hua Qing Wen, Qing Kai Ling, Shu Feng Jie Du, Yin Qiao Jie Du, Sang Ju Gan Mao, Yin Huang, Kang Bing Du Kou Fu Ye etc);Or Liu Shen Capsule was used within 7 days prior screening;
- •(10) Allergic constitution patients,who are allergic to the drugs which used in this research;
- •(11) Lactating or pregnant female, or planning for pregnancy within 6 months after screening, or urine pregnancy test was positive; Family planning male, or planning for sperm donation;
- •(12) Immunodeficiency (such as malignant tumor, solid organ or bone marrow transplant, aids, using immunosuppressive drugs within 3 months prior screening);
- •(13) Suspected or existing history of alcohol and drug abuse;
- •(14) Participated in any other clinical treatment within 3 months prior to screening;
- •(15) Patients who have had acute respiratory infection, otitis media, or sinusitis within 2 weeks prior to screening;
- •(16) Patients who have been vaccinated against seasonal flu or the H1N1 flu;
- •(17) The researchers consider the patients are not suitable.
Investigators
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