An observational study in COVID-19, sponsored by Jiangsu Famous Medical Technology Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-06-04.
Sponsored by Jiangsu Famous Medical Technology Co., Ltd. · Observational
Evaluation of the efficacy and safety of TCM differential treatment of COVID-19 in Jiangsu Province based on the historical prospective multicenter cohort study.
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 340 is above the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →Jiangsu Famous Medical Technology Co., Ltd. is the lead sponsor of 20 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
It conforms to the diagnostic criteria of confirmed cases of COVID-19.
Exclusion Criteria:
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
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
TCM prescriptions1:Take decocted or granule, one dose a day; TCM prescriptions2:Take decocted or granule, one dose a day.
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
Time frame: 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.
Time frame: 9day
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.
Time frame: 9day
Virus antigen negative conversion rate
the detection negative rate of nasopharyngeal swab, conjunctival sac secretion virus nucleic acid.
Time frame: 9day
The number of severe and critical conversion cases
the number of severe and critical cases occurred after the start of intervention.
Time frame: 9day
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
Time frame: 9day
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.
Time frame: 9day
CRP changes
Changes in c-reactive protein.
Time frame: 9day
ESR changes
Changes in erythrocyte sedimentation rate.
Time frame: 9day
PCTchanges
Changes in procalcitonin.
Time frame: 9day
The index of T cell subsets changed
Changes of CD4+ and CD8+
Time frame: 9day
Plan to share: Undecided — All researchers in this study
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Jiangsu Famous Medical Technology Co., Ltd.