TCM Differentiation and Treatment Protocol of COVID-19 (TDATPOC)
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| ClinicalTrials.gov Identifier: NCT04306497 |
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Recruitment Status :
Completed
First Posted : March 13, 2020
Last Update Posted : June 4, 2020
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| Condition or disease | Intervention/treatment |
|---|---|
| COVID-19 | Drug: TCM prescriptions |
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 |
| Actual Enrollment : | 340 participants |
| Observational Model: | Cohort |
| Time Perspective: | Other |
| Official Title: | Clinical Trial of TCM Differentiation and Treatment Protocol of COVID-19 in Jiangsu Province |
| Actual Study Start Date : | January 22, 2020 |
| Actual Primary Completion Date : | April 30, 2020 |
| Actual Study Completion Date : | May 30, 2020 |
| Group/Cohort | Intervention/treatment |
|---|---|
Cohort of western medicine
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Drug: TCM prescriptions
TCM prescriptions1:Take decocted or granule, one dose a day; TCM prescriptions2:Take decocted or granule, one dose a day. |
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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. |
- 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.
- 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.
- 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+
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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.
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
| China, Jiangsu | |
| Huai'an fourth people's Hospital | |
| Huaian, Jiangsu, China, 210029 | |
| 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: | June 4, 2020 |
| Last Verified: | June 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Plan Description: | All researchers in this study |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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COVID-19 Syndrome investigation differentiation treatment multicenter cohort study |