TCM Differentiation and Treatment Protocol of COVID-19

COVID-19 Clinical Trial

— TDATPOC  

Official title:

Clinical Trial of TCM Differentiation and Treatment Protocol of COVID-19 in Jiangsu Province

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04306497
• Other study ID #: JSZYJ202001
• Status: Completed
• Start date: January 22, 2020
• Est. completion date: May 30, 2020

Study information

• Verified date: June 2020
• Source: Jiangsu Famous Medical Technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This is a multi-center cross-sectional syndrome investigation study, taking confirmed cases as the main observation object, A prospective multicenter cohort study was designed, focusing on the common type with the largest number of confirmed cases, to evaluate the intervention effect of this project in relieving the disEvaluation of the efficacy and safety of TCM differential treatment of COVID-19 inease and preventing disease progressio.

According to the actual situation of receiving treatment, if the subjects received the combination of western medicine and traditional Chinese medicine, it was the exposure group (integrated traditional Chinese and western medicine cohort), and if the subjects only received western medicine treatment, it was the control group (western medicine cohort). The choice of treatment for patients is entirely determined by clinicians according to the patient's condition, and patients are free to choose after fully understanding different schemes).The choice of control group: COVID-19 (common type) who received routine treatment + antiviral therapy；The choice of exposure group: COVID-19 (common type) who received routine treatment + TCM.The sample size is tentatively set at 340.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 340
• Est. completion date: May 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• COVID-19

Intervention

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

Locations

Country	Name	City	State
China	Huai'an fourth people's Hospital	Huaian	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Famous Medical Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	CRP changes	Changes in c-reactive protein.	9day
Other	ESR changes	Changes in erythrocyte sedimentation rate.	9day
Other	PCTchanges	Changes in procalcitonin.	9day
Other	The index of T cell subsets changed	Changes of CD4+ and CD8+	9day
Primary	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
Primary	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	Evaluation standard of comprehensive curative effect	With reference to the "Therapeutic effect Standard for diagnosis and Syndrome of Traditional Chinese Medicine" and "guiding principles for Clinical Research of New drugs of traditional Chinese Medicine", the final evaluation was based on clinical remission.	9day
Secondary	Virus antigen negative conversion rate	the detection negative rate of nasopharyngeal swab, conjunctival sac secretion virus nucleic acid.	9day
Secondary	The number of severe and critical conversion cases	the number of severe and critical cases occurred after the start of intervention.	9day
Secondary	Incidence of complications	defined as complications during isolation and hospitalization due to pneumonia infected by novel coronavirus, including bacterial infection, aggravation of underlying diseases, etc	9day
Secondary	Traditional Chinese Medicine Syndrome Score	According to the Traditional Chinese Medicine symptom score scale, the change of symptom score before and after treatment was observed.The highest score was 92 points, and the lowest was 23 points. The higher the score, the more severe the symptoms.	9day