COVID-19TDATPOCNCT04306497
TCM Differentiation and Treatment Protocol of COVID-19
An observational study of COVID-19, run by Jiangsu Famous Medical Technology Co., Ltd. at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID-19
- What is being tested?
- TCM prescriptions
- How many people
- 340 participants
- Where
- 1 siteChina
- Study dates
- 22 Jan 2020to 30 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: It conforms to the diagnostic criteria of confirmed cases of COVID-19.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial of TCM Differentiation and Treatment Protocol of COVID-19 in Jiangsu Province
Evaluation of the efficacy and safety of TCM differential treatment of COVID-19 in Jiangsu Province based on the historical prospective multicenter cohort study.
Read the 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.
- Conditions
- COVID-19
- Being tested
- TCM prescriptions
- Keywords
- COVID-19, Syndrome investigation, differentiation treatment, multicenter cohort study
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCM prescriptionsDrug
TCM prescriptions1:Take decocted or granule, one dose a day; TCM prescriptions2:Take decocted or granule, one dose a day.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: TCM prescriptions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 9day
Secondary outcomes (5)
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.
Measured: 9day
Virus antigen negative conversion rate
the detection negative rate of nasopharyngeal swab, conjunctival sac secretion virus nucleic acid.
Measured: 9day
The number of severe and critical conversion cases
the number of severe and critical cases occurred after the start of intervention.
Measured: 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
Measured: 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.
Measured: 9day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start22 Jan 2020
- Primary completion30 Apr 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Famous Medical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04306497
- Sponsor's protocol ID
- JSZYJ202001
- Acronym
- TDATPOC
- Status last verified
- Jun 2020
- First submitted
- 1 Mar 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All researchers in this study
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of TCM Differentiation and Treatment Protocol of COVID-19 in Jiangsu Province
- ClinicalTrials.gov ID
- NCT04306497
- Acronym / sponsor ID
- TDATPOC / JSZYJ202001
- Conditions
- COVID-19
- Keywords
- COVID-19, Syndrome investigation, differentiation treatment, multicenter cohort study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Jiangsu Famous Medical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Jan 2020 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 13 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort of western medicine | – | Drug: TCM prescriptions1. 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. |
| Cohort of integrated TCM and western medicine | – | Drug: TCM prescriptionsroutine 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- It conforms to the diagnostic criteria of confirmed cases of COVID-19.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TCM prescriptionsTCM prescriptions1:Take decocted or granule, one dose a day; TCM prescriptions2:Take decocted or granule, one dose a day. | Drug | Cohort of integrated TCM and western medicine, Cohort of western medicine |
Primary outcome
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.
5 secondary outcomes
Evaluation standard of comprehensive curative effect
Time frame: 9day
Virus antigen negative conversion rate
Time frame: 9day
The number of severe and critical conversion cases
Time frame: 9day
Incidence of complications
Time frame: 9day
Traditional Chinese Medicine Syndrome Score
Time frame: 9day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Individual participant dataSharing planned: Undecided. All researchers in this study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Jiangsu Famous Medical Technology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The relief of main symptoms/ disappearance rate of time (time frame: 9day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.