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To evaluate the efficacy and safety of diammonium glycyrrhizinate enteric-coated capsules combined with hydrogen-rich water in the treatment of novel coronavirus pneumonia (COVID-19)

To evaluate the efficacy and safety of diammonium glycyrrhizinate enteric-coated capsules combined with hydrogen-rich water in the treatment of novel coronavirus pneumonia (COVID-19)

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000030490
Enrollment
Unknown
Registered
2020-03-04
Start date
2020-02-01
Completion date
Unknown
Last updated
2020-03-09

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

Case series:diammonium glycyrrhizinate enteric-coated capsule combined with hydrogen-rich water

Sponsors

Huo-Shen-Shan Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Must meet all of the following criteria 1. aged 18 to 75 years male or female; 2. Body Weight 40-100kg, and BMI >=18kg/M2; 3. to meet the diagnostic criteria in the fourth edition of the diagnostic protocol for pneumonia caused by 2019-ncov infection issued by the National Health Commission, and to identify patients with pneumonia caused by common type of 2019-ncov infection. Note: suspected patient with one of the following etiological evidence: (1) Respiratory Specimens or blood samples were positive for 2019-ncov acid by real-time fluorescent RT-PCR; (2) Respiratory Specimens or blood samples were genetically sequenced and highly homologous to known 2019-ncov. 4. has fever, respiratory symptoms, imaging can see the performance of pneumonia. 5. the positive test result of etiological evidence within 72 hours; 6. A woman must: (1) Surgical sterilization has been performed. (2) Menopause, menopause at least 1 year; (3) The following conditions must be met for the child to be fertile; The pre-trial Serum / urine pregnancy test was negative in the study group, and during the study period (interview 1-5), consenting to an approved method of contraception (E. G. Oral, injectable or implantable, barrier-forming, spermicide and condom, or intrauterine device) , contraceptive methods remained the same throughout the study period. Men must meet one of the following requirements: (1) Surgical sterilization has been performed; (2) An approved method of contraception must be used throughout the study period and the method remains the same throughout the study period; 7. those who agree to take part in the test and sign the informed consent form voluntarily.

Exclusion criteria

Exclusion criteria: 1. according to the clinical classification of severe and critical cases in the sixth edition of Diagnosis and treatment of pneumonia with 2019-ncov infection issued by the National Health Commission. Note: those who comply with any of the following provisions shall not be included: Heavy duty: (1) Respiratory Distress, Rr >=3/Min; (2) At rest, oxygen saturation <=93% ; (3) Arterial Partial Oxygen Pressure (PAO2) / oxygen uptake concentration (FIO2)<=300 MMHG 10.133 KPA Critical type: (1) Respiratory Failure with Mechanical Ventilation; (2) Go into shock;. (3) Patients with other organ failure need intensive care in ICU. 2. merger other virus like HCV, HIV, syphilis and so on infection person; 3. Chest radiography or CT confirmed interstitial lesions and other diseases; 4. combined with severe liver and kidney damage, ALT, AST, Tbil or any of the above items; 1.5 times the upper limit of normal value, or CR & GT; 5. those diagnosed as immunodeficient or who have taken immunosuppressive drugs or glucocorticoid within 3 months; 6. Known history of allergy to experimental drugs or their excipients 7. The risk factors are as follows: (1) chronic obstructive pulmonary disease, chronic respiratory disease such as asthma; (2) serious cardiovascular diseases such as congenital heart defect, heart failure and coronary artery disease, except hypertension; (3) neurological and neuromuscular diseases such as cerebral palsy, epilepsy, stroke, mental retardation, muscular dystrophy or spinal cord injury; (4) serious hematological diseases such as sickle cell disease; (5) malignant tumors; 8. Female subjects who were pregnant, lactating or positive in pregnancy during the screening period or during the trial; male and female patients with reproductive potential who were unwilling to use an effective, protocol-prescribed method of contraception during the study period; 9. persons with Infectious Disease and mental illness; 10. Who have been in clinical trials for other drugs in the last 3 months; 11. The researchers did not consider it appropriate to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Cure rate;

Contacts

Public ContactWang Hao

Huo-Shen-Shan Hospital

wanghaohh@vip.126.com+86 13901883868

Outcome results

None listed

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