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TCM Differentiation and Treatment Protocol of COVID-19 (TDATPOC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04306497
Recruitment Status : Completed
First Posted : March 13, 2020
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Jiangsu Famous Medical Technology Co., Ltd.

Tracking Information
First Submitted Date March 1, 2020
First Posted Date March 13, 2020
Last Update Posted Date June 4, 2020
Actual Study Start Date January 22, 2020
Actual Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 2, 2020)
  • The relief of main symptoms/ disappearance rate of time [ Time Frame: 9day ]
    comparison of the time of relief / disappearance of three main symptoms of fever, cough and shortness of breath
  • Chest CT absorption [ Time Frame: 9day ]
    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.
Original Primary Outcome Measures
 (submitted: March 10, 2020)
  • The relief / disappearance rate of main symptoms [ Time Frame: 9day ]
    disappearance of fever, cough and shortness of breath/ the rate of complete relief /.
  • Chest CT absorption [ Time Frame: 9day ]
    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.
Change History
Current Secondary Outcome Measures
 (submitted: June 2, 2020)
  • Evaluation standard of comprehensive curative effect [ Time Frame: 9day ]
    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.
  • Virus antigen negative conversion rate [ Time Frame: 9day ]
    the detection negative rate of nasopharyngeal swab, conjunctival sac secretion virus nucleic acid.
  • The number of severe and critical conversion cases [ Time Frame: 9day ]
    the number of severe and critical cases occurred after the start of intervention.
  • Incidence of complications [ Time Frame: 9day ]
    defined as complications during isolation and hospitalization due to pneumonia infected by novel coronavirus, including bacterial infection, aggravation of underlying diseases, etc
  • Traditional Chinese Medicine Syndrome Score [ Time Frame: 9day ]
    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.
Original Secondary Outcome Measures
 (submitted: March 10, 2020)
  • Virus antigen negative conversion rate [ Time Frame: 9day ]
    detection negative rat of nasopharyngeal swab, conjunctival sac secretion virus nucleic acid e
  • Clinical effective time: the average effective time [ Time Frame: 9day ]
    the average time it takes for the clinical curative effect to reach the effective standard. Median response time: the average time it takes for 50% of patients to reach the effective standard.
  • The number of severe and critical conversion cases [ Time Frame: 9day ]
    the number of severe and critical cases occurred after the start of intervention.
  • Incidence of complications [ Time Frame: 9day ]
    defined as complications during isolation and hospitalization due to pneumonia infected by novel coronavirus, including bacterial infection, aggravation of underlying diseases, etc
  • Traditional Chinese Medicine Syndrome Score [ Time Frame: 9day ]
    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.
Current Other Pre-specified Outcome Measures
 (submitted: March 10, 2020)
  • CRP changes [ Time Frame: 9day ]
    Changes in c-reactive protein.
  • ESR changes [ Time Frame: 9day ]
    Changes in erythrocyte sedimentation rate.
  • PCTchanges [ Time Frame: 9day ]
    Changes in procalcitonin.
  • The index of T cell subsets changed [ Time Frame: 9day ]
    Changes of CD4+ and CD8+
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title TCM Differentiation and Treatment Protocol of COVID-19
Official Title Clinical Trial of TCM Differentiation and Treatment Protocol of COVID-19 in Jiangsu Province
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.
Detailed 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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population It conforms to the diagnostic criteria of confirmed cases of COVID-19.
Condition 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.
Study Groups/Cohorts
  • 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.
    Intervention: 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.

    Intervention: Drug: TCM prescriptions
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 10, 2020)
340
Original Estimated Enrollment Same as current
Actual Study Completion Date May 30, 2020
Actual Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04306497
Other Study ID Numbers JSZYJ202001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: All researchers in this study
Responsible Party Jiangsu Famous Medical Technology Co., Ltd.
Study Sponsor Jiangsu Famous Medical Technology Co., Ltd.
Collaborators Not Provided
Investigators Not Provided
PRS Account Jiangsu Famous Medical Technology Co., Ltd.
Verification Date June 2020