TCM Differentiation and Treatment Protocol of COVID-19

NCT04306497 | Completed

• 1 other identifier: JSZYJ202001
• Study Type: observational
• Target: 340
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of the efficacy and safety of TCM differential treatment of COVID-19 in Jiangsu Province based on the historical prospective multicenter cohort study.

Conditions

COVID-19

Keywords

COVID-19; Syndrome investigation; differentiation treatment; multicenter cohort study

Outcome Measures

Primary Outcomes (2)

• The relief of main symptoms/ disappearance rate of time

  comparison of the time of relief / disappearance of three main symptoms of fever, cough and shortness of breath

  9day

• Chest CT absorption

  with reference to the "pneumonia chest X-ray absorption Evaluation scale" developed by Renyi Yin et al, the final absorption judgment will be used to evaluate the chest CT absorption of patients with pneumonia, which is divided into four levels according to the degree of absorption: complete absorption, majority absorption, partial absorption and no absorption.

  9day

Secondary Outcomes (5)

• Evaluation standard of comprehensive curative effect

  9day

• Virus antigen negative conversion rate

  9day

• The number of severe and critical conversion cases

  9day

• Incidence of complications

  9day

• Traditional Chinese Medicine Syndrome Score

  9day

Other Outcomes (4)

• CRP changes

  9day

• ESR changes

  9day

• PCTchanges

  9day

Study Arms (2)

Cohort of western medicine

1. Routine treatment： ① support treatment:maintain water and electrolyte balance . ②oxygen therapy: give nasal catheters to inhale oxygen. ③ basic treatment of traditional Chinese and western medicine: antiviral drugs and proprietary Chinese medicines with similar composition or function to the observed scheme of differentiation and treatment of traditional Chinese medicine are not included in the scope of such drugs. 2. Antiviral drugs ：Clinicians can judge according to the patient's condition according to the latest version of the diagnosis and treatment plan for COvID-19 issued by the General Office of the National Health Commission / the Office of the State Administration of traditional Chinese Medicine (currently the latest version is the sixth trial edition). Select any of the recommended antiviral drugs(for example:IFN-α、lopinavir-ritonavir、Ribavirin、Chloroquine Phosphate、Arbidol)or a combination of two antiviral drugs.

Drug: TCM prescriptions

Cohort of integrated TCM and western medicine

routine treatment + Antiviral drugs + the following TCM regimens. 1.TCM regimens:① Early stage: Dampness trapped in exterior and interior. Recommended prescription: Huoxiang 15g, Suye15g, Cangzhu15g, Houpo10g, Qianhu15g, Chaihu15g, Huangqin10g, Qinghao20g, Xingren10g, JInyinhua15g, Lianqiao15g. Take decocted or granule, one dose a day. ② Middle stage: Dampness-toxicity blocking lung Recommended prescription: Zhimahuang9g, Xingren10g, Sangbaipi30g, Tinglizi20g, Dongguazi20g, Fabanxia10g, Houpo10g, Suzi15g, Baijiezi10g, Gualoupi15g, Xuanfuhua9g, Xiangfu10g, Yujin10g, Taoren10g, Huangqi20g. Take decocted or granule, one dose a day.

Drug: TCM prescriptions

Interventions

TCM prescriptions DRUG

TCM prescriptions1:Take decocted or granule, one dose a day; TCM prescriptions2:Take decocted or granule, one dose a day.

Cohort of integrated TCM and western medicine; Cohort of western medicine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

It conforms to the diagnostic criteria of confirmed cases of COVID-19.

You may qualify if:

• It conforms to the diagnostic criteria of confirmed cases of COVID-19 that belongs to the common type;
• The age ranges from 18 to 80 years old, regardless gender；
• In the prospective study, the patient informed consent and sign the informed consent form (if the subject has no capacity, limited capacity and limited expression of personal will, he or she should obtain the consent of his guardian and sign the informed consent at the same time), the retrospective study is visa-free informed consent.

You may not qualify if:

• Women during pregnancy or lactation;
• Allergic constitution, such as those who have a history of allergy to two or more drugs or food, or who are known to be allergic to drug ingredients observed in this study.
• Severe complications such as multiple organ failure and shock occurred.
• Complicated with severe primary diseases such as heart, brain, liver, kidney and so on.
• Patients have mental illness.
• Patients who participated in or is currently participating in other clinical trials within the first month of this study.

Sponsors & Collaborators

• Jiangsu Famous Medical Technology Co., Ltd.: lead

Study Sites (1)

Huai'an fourth people's Hospital

Huaian, Jiangsu, 210029, China

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2020
• First Posted: March 13, 2020
• Study Start: January 22, 2020
• Primary Completion: April 30, 2020
• Study Completion: May 30, 2020
• Last Updated: June 4, 2020

Record last verified: 2020-06

Locations

CN (1)