Lianhua Qingwen for the Rehabilitation of Patient With Coronavirus Infection
Phase 4
Recruiting
- Conditions
- Traditional Chinese MedicineCoronavirus
- Interventions
- Drug: Lianhua Qingwen capsules
- Registration Number
- NCT05625035
- Lead Sponsor
- Qilu Hospital of Shandong University
- Brief Summary
The patients with coronavirus infection usually have fever, respiratory symptoms, headache, toothache, muscle soreness, physical decline, and so on, while others are asymptomatic patients. It is urgent to find drugs to improve the long-term rehabilitation of symptomatic patients with coronavirus infection and decrease the duration of viral shedding in both symptomatic and asymptomatic patients. This study aims to investigate the efficacy and safety of Lianhua Qingwen capsules in patients with coronavirus infection. The duration of viral shedding and symptoms before discharge, as well as the negative conversion ratio and disappearance ratio of main symptoms after 7-day treatment, will be evaluated. 6-month follow-up will be performed to evaluate the effect of Lianhua Qingwen on all infection events and the long-term rehabilitation of the symptoms induced by coronavirus infection.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 4000
Inclusion Criteria
- confirmed SARS-CoV-2 Infection by virus testing;
- ≥18 years of age;
- informed consent provided.
Exclusion Criteria
- overt bacterial infection in the respiratory tract resulting from common pathologies, including primary immunodeficiency disease, acquired immunodeficiency syndrome, congenital respiratory malformation, congenital heart disease, gastroesophageal reflux disease, and abnormal lung development;
- asthma treated daily, chronic airway disease, respiratory bacterial infections (e.g., purulent tonsillitis), acute tracheobronchitis, sinusitis, otitis media, and further respiratory tract pathologies potentially affecting the trial's data analysis;
- common pulmonary diseases (e.g., severe pulmonary interstitial lesions and bronchiectasis) confirmed by chest CT;
- severe pneumonia requiring ventilator use;
- previous or present diseases potentially affecting trial participation or influencing study outcome, based on the investigator's judgment;
- pregnancy or lactation in women;
- participation in a clinical study in the past 3 months;
- history of allergy to ≥2 drugs or foods or known allergy to the drug's constituents.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lianhua Qingwen plus conventional therapy Lianhua Qingwen capsules -
- Primary Outcome Measures
Name Time Method Incidence of all Infection events From discharge to 6 months Recurrence coronavirus infection or any new infection events
- Secondary Outcome Measures
Name Time Method Disappearance ratio of nasal congestion or runny nose 7 days Frequency of chest distress From discharge to 6 months Mean duration of chest distress From discharge to 6 months Duration of chest distress before discharge 6 months Disappearance ratio of chest distress 7 days Frequency of palpitations From discharge to 6 months Mean duration of palpitations From discharge to 6 months Duration of palpitations before discharge 6 months Disappearance ratio of palpitations 7 days Frequency of pharyngeal discomfort From discharge to 6 months Mean duration of pharyngeal discomfort From discharge to 6 months Duration of pharyngeal discomfort before discharge 6 months Disappearance ratio of pharyngeal discomfort 7 days Frequency of headache From discharge to 6 months Mean duration of headache From discharge to 6 months Duration of headache before discharge 6 months Disappearance ratio of headache 7 days Frequency of dizziness From discharge to 6 months Mean duration of dizziness From discharge to 6 months Duration of dizziness before discharge 6 months Disappearance ratio of dizziness 7 days Frequency of gastrointestinal symptoms From discharge to 6 months Duration of viral shedding 6 months Negative conversion ratio 7 days Positive conversion ratio From discharge to 6 months Duration of main symptoms before discharge 6 months Disappearance ratio of main symptoms 7 days Recurrence frequency of main clinical symptoms From discharge to 6 months Mean duration of main clinical symptoms From discharge to 6 months Heart rate Baseline Blood pressure Baseline both systolic and diastolic blood pressure
Infection events except SARS-CoV-2 From discharge to 6 months Frequency of fever From discharge to 6 months Mean duration of fever From discharge to 6 months Duration of toothache before discharge 6 months Disappearance ratio of toothache 7 days Frequency of toothache From discharge to 6 months Mean duration of toothache From discharge to 6 months Frequency of muscle soreness From discharge to 6 months Mean duration of muscle soreness From discharge to 6 months Duration of muscle soreness before discharge 6 months Disappearance ratio of muscle soreness 7 days Frequency of physical decline From discharge to 6 months Mean duration of physical decline From discharge to 6 months Duration of fever before discharge 6 months Disappearance ratio of fever 7 days Frequency of respiratory symptoms From discharge to 6 months Mean duration of respiratory symptoms From discharge to 6 months Duration of respiratory symptoms before discharge 6 months Disappearance ratio of respiratory symptoms 7 days Frequency of nasal congestion or runny nose From discharge to 6 months Mean duration of nasal congestion or runny nose From discharge to 6 months Duration of physical decline before discharge 6 months Disappearance ratio of physical decline 7 days Duration of nasal congestion or runny nose before discharge 6 months Drug-related adverse events 7 days Mean duration of gastrointestinal symptoms From discharge to 6 months Duration of gastrointestinal symptoms before discharge 6 months Disappearance ratio of gastrointestinal symptoms 7 days Frequency of urinary symptoms From discharge to 6 months Mean duration of urinary symptoms From discharge to 6 months Duration of urinary symptoms before discharge 6 months Disappearance ratio of urinary symptoms 7 days
Trial Locations
- Locations (1)
International Convention and Exhibition Center Shelter Hospital
🇨🇳Urumqi, Xinjiang, China