Chronic Respiratory FailureEarly Phase 1NCT04694755
Treatment of CRF With Syndrome Differentiation of TCM
A Early Phase 1 study testing Traditional Chinese medicine prescription in people with Chronic Respiratory Failure, run by Henan University of Traditional Chinese Medicine.
Trial summary
Taking the patients with chronic respiratory failure caused by COPD as the research object and the acute exacerbation of COPD as the main outcome index, the investigators hope to establish the syndrome differentiation and treatment scheme of COPD treated by traditional Chinese medicine, reduce the acute exacerbation… Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Respiratory Failure
- What is being tested?
- Traditional Chinese medicine prescription
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jan 2021to Oct 2022
- Phase
- Early Phase 1
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients who meet the diagnostic criteria of COPD in stable stage;
- patients whose blood gas analysis meets PaO2 < 60mmhg and / or PaCO2 > 50mmhg in calm breathing at sea level;
- patients whose syndrome differentiation meets the syndrome of heart lung qi deficiency and lung kidney qi deficiency;
- patients whose age is ≥ 40 years and ≤ 80 years;
- patients who are willing to receive treatment and sign the informed consent.
Who cannot join
- chronic respiratory failure caused by bronchial asthma, bronchiectasis, cystic pulmonary fibrosis, lung cancer and other respiratory diseases;
- acute aggravation of the original chronic respiratory failure;
- patients with tumor, serious cardiovascular and cerebrovascular diseases (acute myocardial infarction, cardiac function level 3 and above, stroke, cerebral hemorrhage, etc.) and serious liver and kidney diseases (serious liver disease refers to liver cirrhosis, portal hypertension and varicose bleeding, and serious kidney disease includes dialysis and kidney transplantation) and other people who cannot participate in clinical research;
- pregnant and lactating women;
- patients with mental diseases and mental disorders;
- those who are participating in clinical trials of other drugs, known to be allergic to treatment drugs.
Trial locations and contacts
No sites are listed yet.
Suyun Li, doctor contact
About this study
Official title: An Exploratory Clinical Study on Reducing AECOPD of Chronic Respiratory Failure With COPD by Syndrome Differentiation
Taking the patients with chronic respiratory failure caused by COPD as the research object and the acute exacerbation of COPD as the main outcome index, the investigators hope to establish the syndrome differentiation and treatment scheme of COPD treated by traditional Chinese medicine, reduce the acute exacerbation of AECOPD, improve the clinical symptoms, improve the quality of life, reduce the mortality, preliminarily explore the mechanism of action, and lay the foundation for further research.
Read the detailed description
Chronic respiratory failure of chronic obstructive pulmonary disease belongs to the category of "lung distention", "asthma syndrome", "dyspnea" and "phlegm drink" in traditional Chinese medicine. According to traditional Chinese medicine, the pathology of this disease is mainly the dysfunction of lung ventilation. The basic pathogenesis is that the viscera are repeatedly affected by evil, the lung qi is damaged due to long-term disease, the lung function is damaged, the air mechanism is blocked, the application is publicized, the phlegm is turbid, the blood stasis is inevitable for a long time, and the lung qi is further damaged. The main clinical manifestations are shortness of breath, wheezing, shortness of breath, superficial shortness of breath and "drama of wheezing when moving", which may be accompanied by cough, expectoration, chest tightness, palpitation, lips, purple darkness, swelling of floating limbs, etc. The treatment of chronic respiratory failure patients with COPD can be significantly improved clinical symptoms such as shortness of breath and wheezing, reduce the number of acute exacerbations of patients, but there is still a lack of high-level evidence-based medicine research. Therefore, this project puts forward the hypothesis that "syndrome differentiation therapy can reduce AECOPD of COPD".It is proposed to adopt a multicenter, randomized, double-blind, placebo-controlled trial design, taking the patients with chronic respiratory failure caused by chronic obstructive pulmonary disease as the research object. The patients who meet the inclusion criteria, are divided into heart lung qi deficiency and lung kidney qi deficiency according to syndrome differentiation. The participants are randomly divided into the experimental group of 60 cases and the control group of 60 cases. The control group is given placebo treatment, and the experimental group is given Chinese medicine granules. The patients were followed up for 26 weeks. The main outcome indicators include the number of times of acute exacerbation of COPD, and the secondary outcome indicators include all-cause mortality, severity of acute exacerbation of COPD, clinical symptoms, CCQ score of COPD clinical questionnaire, quality of life score, dyspnea score, 6MWD, arterial blood gas analysis index, incidence and use time of mechanical ventilation, use time of oxygen therapy, serology index, health and economy Learning indicators, safety indicators, etc. To establish the TCM treatment scheme of chronic respiratory failure of COPD, reduce the acute aggravation of AECOPD, improve the clinical symptoms, improve the quality of life, reduce the mortality rate, preliminarily explore the mechanism of action, and lay the foundation for further research.
- Conditions
- Chronic Respiratory Failure
- Being tested
- Placebo, Traditional Chinese medicine prescription
- Keywords
- COPD, Chronic respiratory failure
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Placebo for invigorating heart and lung, Tonifying kidney and protecting lung prescription placebo
On the basis of dextrin and bitter agent, 5% of the drug was used to prepare.Its appearance, weight, color and smell are basically the same as traditional Chinese medicine granule.Tianjiang brand formula granules, in line with GMP standards
Traditional Chinese medicine prescriptionDrug
Also called Tonic heart and lung prescription, Prescription for tonifying kidney and protecting lung
Tianjiang brand formula granules, in line with GMP standards
| Study group | Role | What they receive |
|---|---|---|
| Heart lung qi deficiency syndrome placebo group | Placebo comparator | Buyixinfei placebo was given.Tianjiang brand formula granules were used. One dose a day, two times orally, five days a week. Receives: Drug: Placebo |
| Deficiency of lung and Kidney Qi placebo group | Placebo comparator | Tonifying kidney and protecting lung prescription placebo was given. Tianjiang brand granule was used as the drug, one dose a day, twice orally, five days a week. Receives: Drug: Placebo |
| Heart lung qi deficiency syndrome drugs group | Experimental | Buyixinfei formula was given. Tianjiang brand granule was used as the drug, one dose a day, twice orally, five days a week. Receives: Drug: Traditional Chinese medicine prescription |
| Deficiency of lung and Kidney Qi drugs group | Experimental | The prescription of invigorating the kidney and protecting the lung was given. The drug was Tianjiang brand granule, one dose a day, two times orally, five days a week Receives: Drug: Traditional Chinese medicine prescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of acute exacerbation
It will be assessed by frequencies of AECOPD-related hospitalizations.
Measured: Up to week 52.
Duration of acute exacerbation
Duration of acute exacerbation will be recorded.
Measured: Up to week 52.
Secondary outcomes (11)
All-cause mortality
The all-cause mortality will be calculated in each group at the end of the trial.
Measured: up to 52 weeks.
Dyspnea
Dyspnea will be assessed by modified Medical Research Council (mMRC) scores set up by American Thoracic Society. A score of 0-4 will be given according to the degree of immediate dyspnea. A higher score indicates a worse dyspnea.
Measured: Change from baseline mMRC scores at week 4, 13, 26, 39 and 52.
COPD assessment test (CAT)
CAT will be used to evaluate quality of life. A total score of 0-40 will be given with a higher score indicating a worse condition.
Measured: Change from baseline CAT scores at week 4, 13, 26, 39 and 52.
Clinical symptoms and Signs
Assessment will be performed by clinical symptom assessment questionnaire. The clinical symptoms to be evaluated in this study include cough, expectoration, chest tightness, shortness of breath, wheezing and cyanosis. A score of 0-3 will be given to every symptom or sign with a higher score indicating a worse conditoin.
Measured: Change from baseline clinical symptoms assessment questionnaire scores at week 4, 13, 26, 39 and 52.
Six-minute walking distance(6MWD)
6MWD will be applied to evaluate the exercise capacity. The higher values indicate the better exercise capacity.
Measured: Change from baseline 6MWD at week 4, 13, 26, 39 and 52
CCQ
Clinical symptom assessment questionnaire of COPD (CCQ) will be used to assess symptom. There are 10 items with a score of 0-6 for each item. A higher value will indicate a worse symptom.
Measured: Change from baseline clinical symptom assessment questionnaire scores at week 4, 13, 26, 39 and 52.
FEV1
Forced expiratory volume in one second ( FEV1) will be applied to assess pulmonary function.
Measured: Change from baseline FEV1 at week 26 and 52.
FVC
Forced vital capacity (FVC) will be applied to assess pulmonary function.
Measured: Change from baseline FVC at week 26 and 52.
PaO2
Partial pressure of oxygen (PaO2) will be applied to assess artery blood gas. PaO2≤60mmHg will indicatea the body is in a state of hypoxi.
Measured: Change from baseline ABG at week 13, 26, 39 and 52.
PaCO2
Partial pressure of carbon dioxide (PaCO2) will be applied to assess artery blood gas. PaCO2≥50mmHg will indicatea the body is in a state of carbon dioxide retention.
Measured: Change from baseline ABG at week 13, 26, 39 and 52.
Duration of oxygen inhalation
Duration of oxygen inhalation will be used to evaluate quality of life. The longer the use, the worse the condition.
Measured: Change from baseline Duration of oxygen inhalation at week 4, 13, 26, 39 and 52.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study startJan 2021 (estimated)
- Primary completionMay 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Respiratory FailureStudies 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The experimental group was given TCM syndrome differentiation treatment granules, heart and lung qi deficiency was given invigorating heart and lung formula, lung and kidney qi deficiency was given invigorating kidney and protecting lung formula; the control group was given TCM syndrome differentiation treatment placebo.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Minghang Wang, doctor, Study director, The First Affiliated Hospital of Henan University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04694755
- Sponsor's protocol ID
- Treatment of CRF with TCM
- Status last verified
- Aug 2020
- First submitted
- 22 Jan 2020
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study on Reducing AECOPD of Chronic Respiratory Failure With COPD by Syndrome Differentiation
- ClinicalTrials.gov ID
- NCT04694755
- Acronym / sponsor ID
- Treatment of CRF with TCM
- Conditions
- Chronic Respiratory Failure
- Keywords
- COPD, Chronic respiratory failure
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Henan University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Jan 2021 (estimated)
- Primary completion
- May 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 5 Jan 2021 (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.
Taking the patients with chronic respiratory failure caused by COPD as the research object and the acute exacerbation of COPD as the main outcome index, the investigators hope to establish the syndrome differentiation and treatment scheme of COPD treated by traditional Chinese medicine, reduce the acute exacerbation of AECOPD, improve the clinical symptoms, improve the quality of life, reduce the mortality, preliminarily explore the mechanism of action, and lay the foundation for further research.
Detailed description
Chronic respiratory failure of chronic obstructive pulmonary disease belongs to the category of "lung distention", "asthma syndrome", "dyspnea" and "phlegm drink" in traditional Chinese medicine. According to traditional Chinese medicine, the pathology of this disease is mainly the dysfunction of lung ventilation. The basic pathogenesis is that the viscera are repeatedly affected by evil, the lung qi is damaged due to long-term disease, the lung function is damaged, the air mechanism is blocked, the application is publicized, the phlegm is turbid, the blood stasis is inevitable for a long time, and the lung qi is further damaged. The main clinical manifestations are shortness of breath, wheezing, shortness of breath, superficial shortness of breath and "drama of wheezing when moving", which may be accompanied by cough, expectoration, chest tightness, palpitation, lips, purple darkness, swelling of floating limbs, etc. The treatment of chronic respiratory failure patients with COPD can be significantly improved clinical symptoms such as shortness of breath and wheezing, reduce the number of acute exacerbations of patients, but there is still a lack of high-level evidence-based medicine research. Therefore, this project puts forward the hypothesis that "syndrome differentiation therapy can reduce AECOPD of COPD".It is proposed to adopt a multicenter, randomized, double-blind, placebo-controlled trial design, taking the patients with chronic respiratory failure caused by chronic obstructive pulmonary disease as the research object. The patients who meet the inclusion criteria, are divided into heart lung qi deficiency and lung kidney qi deficiency according to syndrome differentiation. The participants are randomly divided into the experimental group of 60 cases and the control group of 60 cases. The control group is given placebo treatment, and the experimental group is given Chinese medicine granules. The patients were followed up for 26 weeks. The main outcome indicators include the number of times of acute exacerbation of COPD, and the secondary outcome indicators include all-cause mortality, severity of acute exacerbation of COPD, clinical symptoms, CCQ score of COPD clinical questionnaire, quality of life score, dyspnea score, 6MWD, arterial blood gas analysis index, incidence and use time of mechanical ventilation, use time of oxygen therapy, serology index, health and economy Learning indicators, safety indicators, etc. To establish the TCM treatment scheme of chronic respiratory failure of COPD, reduce the acute aggravation of AECOPD, improve the clinical symptoms, improve the quality of life, reduce the mortality rate, preliminarily explore the mechanism of action, and lay the foundation for further research.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- The experimental group was given TCM syndrome differentiation treatment granules, heart and lung qi deficiency was given invigorating heart and lung formula, lung and kidney qi deficiency was given invigorating kidney and protecting lung formula; the control group was given TCM syndrome differentiation treatment placebo.
| Arm | Type | Receives |
|---|---|---|
| Heart lung qi deficiency syndrome placebo group | Placebo comparator | Drug: PlaceboBuyixinfei placebo was given.Tianjiang brand formula granules were used. One dose a day, two times orally, five days a week. |
| Deficiency of lung and Kidney Qi placebo group | Placebo comparator | Drug: PlaceboTonifying kidney and protecting lung prescription placebo was given. Tianjiang brand granule was used as the drug, one dose a day, twice orally, five days a week. |
| Heart lung qi deficiency syndrome drugs group | Experimental | Drug: Traditional Chinese medicine prescriptionBuyixinfei formula was given. Tianjiang brand granule was used as the drug, one dose a day, twice orally, five days a week. |
| Deficiency of lung and Kidney Qi drugs group | Experimental | Drug: Traditional Chinese medicine prescriptionThe prescription of invigorating the kidney and protecting the lung was given. The drug was Tianjiang brand granule, one dose a day, two times orally, five days a week |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients who meet the diagnostic criteria of COPD in stable stage;
- patients whose blood gas analysis meets PaO2 < 60mmhg and / or PaCO2 > 50mmhg in calm breathing at sea level;
- patients whose syndrome differentiation meets the syndrome of heart lung qi deficiency and lung kidney qi deficiency;
- patients whose age is ≥ 40 years and ≤ 80 years;
- patients who are willing to receive treatment and sign the informed consent.
Key exclusion criteria (6 listed)
- chronic respiratory failure caused by bronchial asthma, bronchiectasis, cystic pulmonary fibrosis, lung cancer and other respiratory diseases;
- acute aggravation of the original chronic respiratory failure;
- patients with tumor, serious cardiovascular and cerebrovascular diseases (acute myocardial infarction, cardiac function level 3 and above, stroke, cerebral hemorrhage, etc.) and serious liver and kidney diseases (serious liver disease refers to liver cirrhosis, portal hypertension and varicose bleeding, and serious kidney disease includes dialysis and kidney transplantation) and other people who cannot participate in clinical research;
- pregnant and lactating women;
- patients with mental diseases and mental disorders;
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 |
|---|---|---|
| PlaceboAlso: Placebo for invigorating heart and lung, Tonifying kidney and protecting lung prescription placeboOn the basis of dextrin and bitter agent, 5% of the drug was used to prepare.Its appearance, weight, color and smell are basically the same as traditional Chinese medicine granule.Tianjiang brand formula granules, in line with GMP standards | Drug | Deficiency of lung and Kidney Qi placebo group, Heart lung qi deficiency syndrome placebo group |
| Traditional Chinese medicine prescriptionAlso: Tonic heart and lung prescription, Prescription for tonifying kidney and protecting lungTianjiang brand formula granules, in line with GMP standards | Drug | Deficiency of lung and Kidney Qi drugs group, Heart lung qi deficiency syndrome drugs group |
Primary outcome
Frequency of acute exacerbation
Time frame: Up to week 52.
It will be assessed by frequencies of AECOPD-related hospitalizations.
Duration of acute exacerbation
Time frame: Up to week 52.
Duration of acute exacerbation will be recorded.
11 secondary outcomes
All-cause mortality
Time frame: up to 52 weeks.
Dyspnea
Time frame: Change from baseline mMRC scores at week 4, 13, 26, 39 and 52.
COPD assessment test (CAT)
Time frame: Change from baseline CAT scores at week 4, 13, 26, 39 and 52.
Clinical symptoms and Signs
Time frame: Change from baseline clinical symptoms assessment questionnaire scores at week 4, 13, 26, 39 and 52.
Six-minute walking distance(6MWD)
Time frame: Change from baseline 6MWD at week 4, 13, 26, 39 and 52
CCQ
Time frame: Change from baseline clinical symptom assessment questionnaire scores at week 4, 13, 26, 39 and 52.
FEV1
Time frame: Change from baseline FEV1 at week 26 and 52.
FVC
Time frame: Change from baseline FVC at week 26 and 52.
PaO2
Time frame: Change from baseline ABG at week 13, 26, 39 and 52.
PaCO2
Time frame: Change from baseline ABG at week 13, 26, 39 and 52.
Duration of oxygen inhalation
Time frame: Change from baseline Duration of oxygen inhalation at week 4, 13, 26, 39 and 52.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
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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.
Suyun Li, doctor contact
Minghang Wang, doctor study director
The First Affiliated Hospital of Henan University of Chinese Medicine
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Traditional Chinese medicine prescription in people with Chronic Respiratory Failure, run by Henan University of Traditional Chinese Medicine.
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 5 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: status not confirmed, as of the sponsor's last update on 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Minghang Wang, doctor (18638392188 ext. 86-371-6624862, wmh107hn@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of acute exacerbation (time frame: Up to week 52.). 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 6 Jan 2021.