Clinical study on the treatment of asymptomatic and mild patients with COVID-19 by Tibetan Medicine

Not Applicable

Recruiting

• Conditions: Mild and asymptomatic COVID-19

• Registration Number: ITMCTR2200006549
• Lead Sponsor: Tibetan Hospital Mentsee Khang of Tibet Autonomous Region

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Meet the novel coronavirus diagnostic criteria for asymptomatic infection

Tibetan Medicine Diagnosis and Treatment Plan for COVID-19 in Tibet Autonomous Region (trial version 3).

The COVID-19 nucleic acid test was positive. No clinical manifestations or imaging manifestations of pneumonia.

2. Meet the novel coronavirus diagnostic criteria for mild coronavirus;

Mild cases may present with fever, dry cough, headache, sore throat, etc. The clinical symptoms were mild, and imaging showed no signs of pneumonia.

2.1 General Inspection

In the early stage of the disease, the total number of peripheral blood white blood cells is normal or decreased, and the lymphocyte count is decreased. Some patients may have increased liver enzymes, lactate dehydrogenase, muscle enzymes, myoglobin, troponin and ferritin. C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) were elevated in most patients, while procalcitonin (PCT) was normal. In severe and critical patients, D-dimer increased, peripheral blood lymphocytes decreased progressively, and inflammatory factors increased.

2.2 Etiological and serological examination

2.2.1 Pathogenic examination: Test novel coronavirus nucleic acid on nose and oropharyngeal swabs, sputum and other lower respiratory tract secretions, and feces by nucleic acid amplification test. Nucleic acid detection will be affected by the course of disease, specimen collection, detection process, detection reagents and other factors. In order to improve the accuracy of detection, the collection of specimens should be standardized, and specimens should be submitted to test as soon as possible after collection.

2.2.2 Serological examination: novel coronavirus specific IgM and IgG antibodies are positive, and the positive rate within 1 week after onset is low.

2.3 Chest Imaging

In the early stage, multiple small patches and interstitial changes were observed, especially in the outer lung zone. Further, it develops into multiple ground-glass shadows and infiltrating shadows in both lungs. In severe cases, lung consolidation may occur, and pleural effusion is rare. At MIS-C, cardiac shadow enlargement and pulmonary edema can be seen in patients with cardiac dysfunction.

3. It meets the development stage standards of immature fever and mature fever of Tibetan medical diseases;

Tibetan Medicine Diagnosis and Treatment Plan for COVID-19 in Tibet Autonomous Region (trial version 4).

3.1 Symptoms of disease

Immature heat stage: manifested as headache, fatigue, limb pain, frequent yawn, body shivering, dream, chills, fever, deafness of both ears, like sun exposure, bitter mouth, do not think about food, malaise, especially the first night pain. The pulse is fine and sometimes shaken, and the urine is cloudy.

Ripe heat stage: fever, fatigue, sweating, red eyes, yellow and greasy tongue coating, headache, polydipsia, wandering consciousness, etc. Pulse fine tight and number, red and yellow urine color, strong taste gas.

Cold and hot junction period: lumbar acid bone pain, sweating less sleep, dizziness, tinnitus, red and dry tongue rough, frequent empty vomiting, delirium, occasional body trembling, body surface fever. Pulse virtual and number, urine red clear, foam.

3.2 Specific symptoms

When the disease invaded the lungs, it was manifested as chest, ribs and back pain, shortness of breath, cough, red and yellow phlegm, smell and other symptoms. The main manifestations were

Exclusion Criteria

1. Patients with serious diseases of heart, brain, liver, kidney and hematopoietic system;

2. Allergic constitution or allergic to a variety of drugs.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Asymptomatic nucleic acid turn negative time: observe the time period of nucleic acid positive indicators to turn negative, nucleic acid positive to negative within 7 days.;Nucleic acid turn negative time: observe the time period when nucleic acid positive indicators turn negative.;Changes in CT value of nucleic acid: Changes in CT value of N gene and ORF gene detected by nucleic acid.;Changes of CT value of nucleic acid in mild cases: the changes of CT value of nucleic acid in asymptomatic infected patients were observed, and the CT value results were evaluated, and the CT value was =35.;Mild nucleic acid negative time: observe the nucleic acid positive indicators to negative time period.;

Secondary Outcome Measures

Name	Time	Method
Symptom indicators of Tibetan medicine: Observe the relief of symptom indicators of Tibetan medicine.;Asymptomatic conversion rate: the conversion of asymptomatic infected persons to mild or common patients.;Changes in CT values of asymptomatic nucleic acids: observed changes in CT values of nucleic acids in asymptomatic infected persons, and evaluated the results of CT values. CT values were all =35.;Rate of progression from mild disease to mild or severe disease, reducing the rate of progression.;Mild symptom indicators: fever, headache, sore throat and other symptom indicators have been relieved or disappeared.;