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Study for Screening of Chinese Patent Drugs in the Rehabilitation Treatment of novel coronavirus pneumonia (COVID-19)

A randomized, double-blind, placebo, parallel controlled trial for Pien-Tze-Huang Capsules in treating convalescent novel coronavirus pneumonia (COVID-19) patient with SARS-CoV-2 positive.

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032635
Enrollment
Unknown
Registered
2020-05-04
Start date
2020-05-06
Completion date
Unknown
Last updated
2020-05-11

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

Conditions

Novel coronavirus pneumonia (COVID-19)

Interventions

Sponsors

Hubei Provincial Hospital of TCM
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Patients who meet the COVID-19 diagnostic criteria and discharge standards, but the later SARS-CoV-2 virus nucleic acid test is positive; (2) Aged 18 to 70 years old; (3) Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Accompanied by severe basic diseases affecting survival, including uncontrolled clinically significant heart, kidney, digestive, blood diseases, neuropsychiatric diseases, immune diseases, metabolic diseases, malignant tumors, severe malnutrition, etc.; 2. Unstable angina pectoris or myocardial infarction in the last 1 month; 3. Allergic constitution, allergic to the drug ingredients involved in the treatment program; 4. Pregnant or nursing women; 5. Mental state cannot cooperate, suffer from mental illness, have no self-control, cannot express clearly; 6. Participating in other clinical trials; 7. According to the judgment of the researchers, patients who will be included in the group will have complications or poor compliance, which will affect the efficacy and safety evaluation.

Design outcomes

Primary

MeasureTime frame
Qualitative RT-PCR results of SARS-CoV-2 nucleic acid of oral / nasopharyngeal swabs, anal swabs, sputum and blood ;

Secondary

MeasureTime frame
2019-nCoV Antibody Test;Sars-cov-2 viral load levels in Oral / nasopharyngeal swab, anal swab, sputum, blood;Leukocyte, neutrophil, lymphocyte counts;lung CT;PBMC lymphocyte flow cytometry;Plasma cytokine assay;Detection and analysis of molecular immunogram;Detection of SARS-CoV-2 N and S proteins in pharyngeal swabs and saliva;Isolation and cultivation of SARS-CoV-2 virus;SARS-CoV-2 virus content in blood cell;Clinical symptoms by Visual analogue scale (VAS);

Countries

China

Contacts

Public ContactHe Shaobin

Hubei Provincial Hospital of TCM

heshaobin@hbhtcm.com+86 18986261166

Outcome results

None listed

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