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Randomized, double - blind, placebo - controlled, multi - center clinical study of Lianhuaqinwen Grain for the treatment of viral pneumonia without influenza

Randomized, double - blind, placebo - controlled, multi - center clinical study of Lianhuaqingwen Grain for the treatment of viral pneumonia without influenza

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-16007773
Enrollment
Unknown
Registered
2016-01-15
Start date
2016-01-31
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

viral pneumonia without influenza

Interventions

treatment group:Conventional treatment +lianhuaqingwen
placebo group:Conventional therapy + placebo

Sponsors

Beijing Ditan Hospital Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients of community-acquaired pneumonia; 2. Meet the clinical-defined virus pneumonia criteria: (1) fever; (2) respiratory symptom; with or without dyspenia; (3) normal or low leukocyte count; with or without low blood platelet count; (4) Chest radiogram manifestation: unilateral or bilateral chest radiogram test showed multiple (at least two lesions) or diffuse distribution of patchy or glass attenuation infiltrates (with or without consolidation) 3. Etiological examination confirm virus infection besides influza virus.All cases are further do digital PCR quantitative detection of the virus; 4. Onset time<=5d; 5. Ages Eligible for Study: 14-75 Years Genders Eligible for Study: Both 6. Accepts Healthy Volunteers: No 7. Willing and able to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Clear laboratory and clinical evidence of bacterial infection; PCT>1ug/L; 2. Use antiviral drugs within 1 week, include anti-virus herbs; 3. Patients of sever pneumonia; 4. Critical lung basic diseases, such as bronchiectasis, and interstitial lung disease confirmed by chest CT; 5. Clear laboratory evidence of Streptococcus ,Legionella pneumophila, Mycoplasma and Chlamydia infection, influza virus; 6. Severe hepatic and renal function with significant abnormalities:1)AST, ALT is over 3 times more than the upper limits of normal 2)serum creatinine is over 1.5 times more than the upper limits of normal; 7. Those diseases affect virus pneumonia progress: tumor, autoimmune diseases, hematologic disease, endocrine disease, centeral nervous system disease, hepatic disease, renal disease, as determined by the investigator; 8. Exiting affecting immune system disease, for example: HIV infection, those subjects who accept stem transplantation, splenectomy and organ transplantation; 9. History of epilepsy or other central nervous system diseases,History of alcohol abuse,History of substance abuse; 10. Pregnant or nursing; 11. Those subjects are not suitable for this study, as investigator suggests.

Design outcomes

Primary

MeasureTime frame
Clinical symptom;

Countries

China

Contacts

Public ContactLixingwang
mcj1126@163.com+86 010 84322057

Outcome results

None listed

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