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Syndrome differentiation treatment of Traditional Chinese Medicine reduces the re-hospitalization rate of discharged elderly patients with COVID-19 infection: a prospective, multicenter, double-blind, randomized controlled study

Syndrome differentiation treatment of Traditional Chinese Medicine reduces the re-hospitalization rate of discharged elderly patients with COVID-19 infection: a prospective, multicenter, double-blind, randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067897
Enrollment
Unknown
Registered
2023-01-31
Start date
2023-01-31
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

COVID-19 infection

Interventions

treatment group:Shenqi Baofei prescription or Shenmai Baofei prescription
control group:Shenqi Baofei prescription placebo or Shenmai Baofei prescription placebo

Sponsors

The First Affiliated Hospital of Henan University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Elderly patients with COVID-19 infection (medium/severe/critical type) who meet the diagnostic criteria and classification within 1 week after discharge; 2. It is consistent with the syndrome differentiation of Qi deficiency and phlegm-dampness (lung qi deficiency, phlegm-dampness not exhausted), Qi Yin deficiency and phlegm-heat syndrome (Qi Yin deficiency, phlegm-heat not clear); 3. Aged >= 65 years; 4. At least one or more symptoms (cough, phlegm, fever, conscious fever, shortness of breath/dyspnea, chest pain, headache, palpitation, fatigue/fatigue, sleep disorders, cognitive dysfunction, activity restriction, reduced taste/loss, decreased smell/loss, poor appetite, diarrhea, etc.) were reported within 12 hours before screening. 5. Pulmonary CT imaging is not completely absorbed; 6. Voluntary treatment and oral medication; 7. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Delirious, consciousness disorder, dementia, various mental patients; 2. Patients with infectious diseases such as bronchiectasis, active pulmonary tuberculosis or lung abscess; 3. Patients with neuromuscular diseases associated with aspiration risk and long-term bed rest; 4. Tumor patients who have received radiotherapy and chemotherapy, targeted, immune, antivascular therapy in the past 6 months; 5. Patients with severe cardiovascular disease (acute myocardial infarction, grade 3 or above cardiac function) and severe liver and kidney disease (severe liver disease refers to bleeding from cirrhosis, portal hypertension and varicose veins, severe kidney disease including dialysis and kidney transplantation); 6. People who are participating in clinical trials of other drugs, who are known to be allergic to the treatment, and who are not considered suitable for inclusion by the researchers.

Design outcomes

Primary

MeasureTime frame
Readmission rate;

Secondary

MeasureTime frame
mortality;Clinical symptom score;dyspnea scores;6 minutes' walk distance;Pulmonary Function Testing;Chest CT imaging;SF-36, Medical Outcomes Study 36-item Short Form Health Survey;Patient Health Questionnaire-9 (PHQ-9);7 items of General Anxiety Disorder (GAD-7); Pittsburghsleepqualityindex;The post-traumatic stress disorder cheeklist (PCL-C);Safety observation index;

Countries

China

Contacts

Public ContactLi Jiansheng

The First Affiliated Hospital of He'nan University of Chinese Medicine

li_js8@163.com+86 13703717893

Outcome results

None listed

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