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Study for the Effectiveness and Safety of Yi-Qi Hua-shi Jie-Du-Fang in the Treatment of the Novel Coronavirus Pneumonia (COVID-19)

Study for the Effectiveness and Safety of Yi-Qi Hua-shi Jie-Du-Fang in the Treatment of the Novel Coronavirus Pneumonia (COVID-19)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003080
Enrollment
Unknown
Registered
2020-03-03
Start date
2020-02-26
Completion date
Unknown
Last updated
2023-02-20

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

Affiliated Hospital of traditional Chinese and Western Medicine Nanjing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Confirmed or clinically diagnosed patients with the novel coronavirus disease; 2) Those who have been identified by Chinese medicine as pestilence stagnant in Lung; 3) Inpatients aged 18 to 75 years male or female; 4) Volunteer to receive treatment under their own scheme and sign informed consent.

Exclusion criteria

Exclusion criteria: 1) Patients with mild, severe or critical novel coronavirus disease; 2) According to the researcher's judgment, previous or current diseases may affect patients' participation in the trial or influence the outcome of the study, including: malignant disease, autoimmune disease, severe malnutrition, liver and kidney disease, blood disease, nervous system Diseases and endocrine diseases; currently suffering from diseases that seriously affect the immune system, such as: human immunodeficiency virus (HIV) infection, or the blood system, or splenectomy, organ transplantation, etc .; 3) Those who are allergic to the research drug and its main ingredients; 4) pregnant or lactating women; 5) Those who have difficulty taking medicine orally.

Design outcomes

Primary

MeasureTime frame
lasting time of fever;lasting time of novel coronavirus pneumonia virus nucleic acid detected by RT-PCR and negative result rate of the novel coronavirus disease nucleic acid;

Secondary

MeasureTime frame
Comparison of changes in SpO2, oxygen saturation, lymphocyte count comparison;Comparison of conversion rates of severe (severe or critical) subjects in each group;Clinical recovery time: the body temperature returned to normal and lasting for more than 3 days, the respiratory symptoms improved significantly, and the test result was negative for two consecutive times(ended at the time of the first negative result);Comparison of TCM symptom score (degree of fever, cough, sputum, chest tightness, shortness of breath, anorexia, abdominal distension, the tongue proper and the tongue coating, pulse condition);Comparison of changes in inflammation indicators (white blood cell count, C-reactive protein, ESR, procalcitonin) before and after treatment;

Countries

China

Contacts

Public ContactZhijun Fang

Affiliated Hospital of traditional Chinese and Western Medicine Nanjing University of Chinese Medicine

fangzjnj@hotmail.com+86 13372018676

Outcome results

None listed

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