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Clinical Trial on Regularity of TCM Syndrome and Differentiation Treatment of COVID-19. (CTOROTSADTOC)

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ClinicalTrials.gov Identifier: NCT04306497
Recruitment Status : Recruiting
First Posted : March 13, 2020
Last Update Posted : March 17, 2020
Sponsor:
Information provided by (Responsible Party):
Jiangsu Famous Medical Technology Co., Ltd.

Study Description
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Brief Summary:
Evaluation of the efficacy and safety of TCM differential treatment of COVID-19 in Jiangsu Province based on a prospective multicenter cohort study.

Condition or disease Intervention/treatment
COVID-19 Drug: TCM prescriptions

Detailed Description:

In order to further observe the efficacy and safety of this project under natural intervention. 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 disease and preventing disease progression, in order to provide more sufficient clinical evidence for the further improvement and application of this project.

According to the actual situation of receiving treatment, according to whether or not exposed to this study to observe the treatment of TCM, COVID-19 (common type) will be divided into two cohorts: control group (western medicine cohort) and exposure group (integrated traditional Chinese and 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). western medicine cohort:Routine treatment + one or both of the following antiviral drugs.Cohort of integrated TCM and western medicine: routine treatment + one or two of the following antiviral drugs + the following TCM regimens.The sample size is tentatively set at 340.

Study Design
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Study Type : Observational
Estimated Enrollment : 340 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Trial on Regularity of TCM Syndrome and Differentiation Treatment of COVID-19 in Jiangsu Province
Actual Study Start Date : March 2, 2020
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020
Groups and Cohorts
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Group/Cohort Intervention/treatment
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
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

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.


Outcome Measures
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Primary Outcome Measures :
  1. The relief / disappearance rate of main symptoms [ Time Frame: 9day ]
    disappearance of fever, cough and shortness of breath/ the rate of complete relief /.

  2. 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.


Secondary Outcome Measures :
  1. Virus antigen negative conversion rate [ Time Frame: 9day ]
    detection negative rat of nasopharyngeal swab, conjunctival sac secretion virus nucleic acid e

  2. 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.

  3. The number of severe and critical conversion cases [ Time Frame: 9day ]
    the number of severe and critical cases occurred after the start of intervention.

  4. 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

  5. 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.


Other Outcome Measures:
  1. CRP changes [ Time Frame: 9day ]
    Changes in c-reactive protein.

  2. ESR changes [ Time Frame: 9day ]
    Changes in erythrocyte sedimentation rate.

  3. PCTchanges [ Time Frame: 9day ]
    Changes in procalcitonin.

  4. The index of T cell subsets changed [ Time Frame: 9day ]
    Changes of CD4+ and CD8+


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
It conforms to the diagnostic criteria of confirmed cases of COVID-19.
Criteria

Inclusion Criteria:

  • It conforms to the diagnostic criteria of confirmed cases of COVID-19;
  • Age from 18-75, regardless gender.
  • 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).

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04306497


Contacts
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Contact: Haibo Cheng, phD 13815857118 363994906@qq.com
Contact: Zhe Feng, phD 13584046875 794200027@qq.com

Locations
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China, Jiangsu
Huai'an fourth people's Hospital Recruiting
Huaian, Jiangsu, China, 210029
Contact: Lei Cui, phD    13951266803    houy@famousmed.net   
Sponsors and Collaborators
Jiangsu Famous Medical Technology Co., Ltd.
More Information
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Responsible Party: Jiangsu Famous Medical Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT04306497    
Other Study ID Numbers: JSZYJ202001
First Posted: March 13, 2020    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: All researchers in this study

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jiangsu Famous Medical Technology Co., Ltd.:
COVID-19
Syndrome investigation
differentiation treatment
multicenter cohort study
Additional relevant MeSH terms:
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Syndrome
Disease
Pathologic Processes