Chronic Obstructive Pulmonary DiseaseNCT04851093
Effects of Traditional Chinese Medicine on Outcomes in Patients With AECOPD Risk Window
A study testing TCM granule plus conventional drug in people with Chronic Obstructive Pulmonary Disease, run by Henan University of Traditional Chinese Medicine at 1 site in China.
Trial summary
This study aims to objectively evaluate the clinical efficacy and safety of Traditional Chinese Medicine in the treatment of AECOPD Risk Window, providing a basis for the formulation of TCM treatment plan with AECOPD. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- TCM granule plus conventional drug
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 336 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2021to 31 Dec 2022
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A confirmed diagnosis of AECOPD Risk Window;
- Age ranges from 40 years to 80 years;
- Syndrome differentiation meets criteria of qi deficiency and internal cold fluid syndrome, qi and yin deficiency and unclean phlegm heat syndrome, or lung and spleen qi deficiency and phlegm-damp amassing in lung syndrome;
- Without participations in other interventional trials in the previous one month;
- With the informed consent signed.
Who cannot join
- Pregnant and lactating women;
- Dementia, mental disorders and reluctant partners;
- Complicated with heart failure (NYHA Class IV), or Serious cardiac arrhythmias, or unstable hemodynamics;
- Current respiratory disorders other than COPD (e.g., bronchiectasis, active tuberculosis, pneumothorax, Pleural effusion, pulmonary thromboembolic, or Neuromuscular diseases affect respiratory movement function);
- Complicated with serious hepatic and renal diseases (liver cirrhosis, portal hypertension, bleeding of varicose veins, dialysis, or renal transplantation);
- Bedridden for various reasons;
- Allergic to the used medicine.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Zhengzhou, Henan, 450000
Hailong Zhang, doctor, +86-0371-66248624, zhanghailong6@126.com
About this study
Official title: Effects of Traditional Chinese Medicine on AECOPD Risk Window Patients: A Multi-center, Randomized, Double-blind, Controlled Trial
This study aims to objectively evaluate the clinical efficacy and safety of Traditional Chinese Medicine in the treatment of AECOPD Risk Window, providing a basis for the formulation of TCM treatment plan with AECOPD.
Read the detailed description
The incidence, mortality, and prevalence of chronic obstructive pulmonary disease (COPD) are high, with a prevalence among people 40 years of age or older of 10.1% worldwide and 13.7% in China. COPD has become the third leading cause of death worldwide. Acute exacerbations of COPD (AECOPD) are important events in the management of COPD because they negatively impact health status, readmission, and disease progression.
Due to the non-random and non-accidental occurrence of AECOPD，with acute exacerbations occurring mainly in a centralized period after an acute exacerbation, and wide open to attack easily in this period, we call this "highly dangerous period" as "AECOPD Risk Window". The AECOPD Risk Window has persistent systemic inflammation and unstable lung function, which increases the risk of AECOPD recurrence and readmission.
At present, western medicine has relatively mature treatment measures for COPD at the acute exacerbation stage and stable stage, however, there is no specific guidance on the medication of AECOPD Risk Window. COPD have been effectively treated with Chinese medicine for a long time. The study of syndrome regularity of "AECOPD Risk Window" provides a basis for the formulation of syndrome differentiation plan.
This is a multi-center, randomized, double-blind, controlled trial to compare the efficacy of two therapies for patients with AECOPD Risk Window. 336 subjects will be randomly assigned in a 1:1 ratio to experimental group or control group for 8 weeks treatment and 18 weeks follow-up. On the basis of health education and conventional treatment, the experimental group will receive TCM granule according to the TCM syndrome, while the control group will receive TCM placebo granule according to the TCM syndrom. The primary outcomes are acute exacerbation rate in the AECOPD Risk Window, COPD Assessment Test (CAT) in the AECOPD Risk Window; and secondary outcomes are time to the first acute exacerbation, degree of acute exacerbation in the AECOPD Risk Window, acute exacerbation rate in the follow-up period, degree of acute exacerbation in the follow-up period, COPD Assessment Test (CAT) in the follow-up period, lung function, clinical symptom scores, mMRC, quality of life and index of security.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- TCM granule plus conventional drug, TCM placebo granule plus conventional drug
- Keywords
- Chronic Obstructive Pulmonary Disease, Acute Exacerbation Risk Window, Traditional Chinese Medicine, Randomized Controlled Trial
- 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.
TCM granule plus conventional drugDrug
All patients will receive conventional drug according to 2020 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Medicine Diagnosis Treatment Guidelines.
Yiqiwenfei granule for qi deficiency and internal cold fluid syndrome.
Fuzhengqinghua granule for qi and yin deficiency and unclean phlegm heat syndrome.
Fuzhengzaohua granule for lung and spleen qi deficiency and phlegm-damp amassing in lung syndrome.
TCM granule (Jiangyin Tian Jiang Pharmaceutical Co.,Ltd, 10g/packet) will be administered twice daily for 8 weeks.
TCM placebo granule plus conventional drugDrug
All patients will receive conventional drug according to 2020 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Medicine Diagnosis Treatment Guidelines.
Placebo Yiqiwenfei granule for qi deficiency and internal cold fluid syndrome.
Placebo Fuzhengqinghua granule for qi and yin deficiency and unclean phlegm heat syndrome.
Placebo Fuzhengzaohua granule for lung and spleen qi deficiency and phlegm-damp amassing in lung syndrome.
TCM placebo granule (Jiangyin Tian Jiang Pharmaceutical Co.,Ltd, 10g/packet) will be administered twice daily for 8 weeks.
The appearance, weight, color and odor of the preparation are the same as those of experimental group.
The placebo granule consists of dextrin, bitter and 5% of the TCM granule.
| Study group | Role | What they receive |
|---|---|---|
| TCM granule plus conventional drug | Experimental | The experimental group will receive three types of TCM granule and conventional drug according to 2020 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Medicine Diagnosis Treatment Guidelines. Receives: Drug: TCM granule plus conventional drug |
| TCM placebo granule plus conventional drug | Placebo comparator | The control group will receive three types of TCM placebo granule and conventional drug according to 2020 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Medicine Diagnosis Treatment Guidelines. Receives: Drug: TCM placebo granule plus conventional drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute exacerbation rate in the AECOPD Risk Window
The numbers of acute exacerbation in the AECOPD Risk Window will be recorded.
Measured: in 8 weeks of the treatment period.
COPD Assessment Test (CAT) in the AECOPD Risk Window
The COPD assessment test (CAT) is a self-administered questionnaire that measures health-related quality of life. It is an 8-item questionnaire on a 0-5 point scale with higher values indicating greater impact of COPD. The item response values of CAT are summed to produce a single score that ranges from 0-9 (low impact), 10-20 (medium impact), 21-30 (high impact) and 31-40 (very high impact).
Measured: Change from baseline CAT scores at week 0, 8 of the treatment period.
Secondary outcomes (11)
Time to the first acute exacerbation
Time from the first exacerbation to the last exacerbation will be recorded.
Measured: up to week 26 during the study period.
Degree of acute exacerbation in the AECOPD Risk Window
The numbers of acute exacerbation of different severity in the AECOPD Risk Window will be recorded..
Measured: in 8 weeks of the treatment period.
Acute exacerbation rate in the follow-up period
The numbers of acute exacerbation in the follow-up period will be recorded.
Measured: in 18 weeks of the follow-up period.
Degree of acute exacerbation in the follow-up period
The numbers of acute exacerbation of different severity in the follow-up period will be recorded.
Measured: in 18 weeks of the follow-up period.
COPD Assessment Test (CAT) in the follow-up period
The COPD assessment test (CAT) is a self-administered questionnaire that measures health-related quality of life. It is an 8-item questionnaire on a 0-5 point scale with higher values indicating greater impact of COPD. The item response values of CAT are summed to produce a single score that ranges from 0-9 (low impact), 10-20 (medium impact), 21-30 (high impact) and 31-40 (very high impact).
Measured: Change from baseline CAT scores at week 16, 26 of the follow-up period.
Pulmonary function
The Forced expiratory volume in one second ( FEV1), Forced Vital Capacity (FVC), FEV1% (FEV1/FVC) will be used to assess pulmonary function.
Measured: at week 0, 8 of the treatment period and at week 26 of the follow-up period.
Clinical symptom scores
Clinical symptom scores of COPD will be used to assess symptoms. The clinical symptoms to be evaluated in this study include cough, expectoration, wheezing, chest tightness, shortness of breath, and fatigue. 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 symptom scores at week 0, 8 of the treatment period and at week 16, 26 of the follow-up period.
mMRC
The modified Medical Research Council (mMRC) scale is a 5-point (0-4) scale based on the severity of dyspnoea. "0" means no dyspnea perception, "4" means severe dyspnea perception.
Measured: Change from baseline mMRC scores at week 0, 8 of the treatment period and at week 16, 26 of the follow-up period.
SGRQ
The St. George's Respiratory Questionnaire (SGRQ) scores will be used to evaluate quality of life with a total score of 0-100. The higher scores will indicate the worse outcomes.
Measured: Change from baseline SGRQ scores at week 0, 8 of the treatment period and at week 16, 26 of the follow-up period.
mCOPD-PRO
The modified COPD Patient-Reported Outcome scale (mCOPD-PRO) will be used to assess quality of life. The mCOPD-PRO contains 27 items in three domains. mCOPD-PRO scores range from 0 to 4 with a decrease in score showing higher health status.
Measured: Change from baseline mPRO-COPD scores at week 0, 8 of the treatment period and at week 16, 26 of the follow-up period
mESQ-COPD
The modified Effectiveness Satisfaction Questionnaire for COPD (mESQ-COPD) will be used to assess treatment satisfaction. The mESQ-COPD contains 19 items in four domains. mESQ-COPD scores range from 0 to 4 with a decrease in score showing higher treatment satisfaction.
Measured: Change from baseline mESQ-COPD scores at week 0, 8 of the treatment period and at week 16, 26 of the follow-up period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start15 Mar 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 336 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiansheng Li, doctor, Study chair, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04851093
- Sponsor's protocol ID
- TCM for AECOPD Risk Window
- Status last verified
- Apr 2021
- First submitted
- 1 Apr 2021
- Last updated
- 20 Apr 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 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Traditional Chinese Medicine on AECOPD Risk Window Patients: A Multi-center, Randomized, Double-blind, Controlled Trial
- ClinicalTrials.gov ID
- NCT04851093
- Acronym / sponsor ID
- TCM for AECOPD Risk Window
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease, Acute Exacerbation Risk Window, Traditional Chinese Medicine, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 336 participants (estimated)
- Lead sponsor
- Henan University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 20 Apr 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.
This study aims to objectively evaluate the clinical efficacy and safety of Traditional Chinese Medicine in the treatment of AECOPD Risk Window, providing a basis for the formulation of TCM treatment plan with AECOPD.
Detailed description
The incidence, mortality, and prevalence of chronic obstructive pulmonary disease (COPD) are high, with a prevalence among people 40 years of age or older of 10.1% worldwide and 13.7% in China. COPD has become the third leading cause of death worldwide. Acute exacerbations of COPD (AECOPD) are important events in the management of COPD because they negatively impact health status, readmission, and disease progression.
Due to the non-random and non-accidental occurrence of AECOPD，with acute exacerbations occurring mainly in a centralized period after an acute exacerbation, and wide open to attack easily in this period, we call this "highly dangerous period" as "AECOPD Risk Window". The AECOPD Risk Window has persistent systemic inflammation and unstable lung function, which increases the risk of AECOPD recurrence and readmission.
At present, western medicine has relatively mature treatment measures for COPD at the acute exacerbation stage and stable stage, however, there is no specific guidance on the medication of AECOPD Risk Window. COPD have been effectively treated with Chinese medicine for a long time. The study of syndrome regularity of "AECOPD Risk Window" provides a basis for the formulation of syndrome differentiation plan.
This is a multi-center, randomized, double-blind, controlled trial to compare the efficacy of two therapies for patients with AECOPD Risk Window. 336 subjects will be randomly assigned in a 1:1 ratio to experimental group or control group for 8 weeks treatment and 18 weeks follow-up. On the basis of health education and conventional treatment, the experimental group will receive TCM granule according to the TCM syndrome, while the control group will receive TCM placebo granule according to the TCM syndrom. The primary outcomes are acute exacerbation rate in the AECOPD Risk Window, COPD Assessment Test (CAT) in the AECOPD Risk Window; and secondary outcomes are time to the first acute exacerbation, degree of acute exacerbation in the AECOPD Risk Window, acute exacerbation rate in the follow-up period, degree of acute exacerbation in the follow-up period, COPD Assessment Test (CAT) in the follow-up period, lung function, clinical symptom scores, mMRC, quality of life and index of security.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCM granule plus conventional drug | Experimental | Drug: TCM granule plus conventional drugThe experimental group will receive three types of TCM granule and conventional drug according to 2020 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Medicine Diagnosis Treatment Guidelines. |
| TCM placebo granule plus conventional drug | Placebo comparator | Drug: TCM placebo granule plus conventional drugThe control group will receive three types of TCM placebo granule and conventional drug according to 2020 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Medicine Diagnosis Treatment Guidelines. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A confirmed diagnosis of AECOPD Risk Window;
- Age ranges from 40 years to 80 years;
- Syndrome differentiation meets criteria of qi deficiency and internal cold fluid syndrome, qi and yin deficiency and unclean phlegm heat syndrome, or lung and spleen qi deficiency and phlegm-damp amassing in lung syndrome;
- Without participations in other interventional trials in the previous one month;
- With the informed consent signed.
Key exclusion criteria (7 listed)
- Pregnant and lactating women;
- Dementia, mental disorders and reluctant partners;
- Complicated with heart failure (NYHA Class IV), or Serious cardiac arrhythmias, or unstable hemodynamics;
- Current respiratory disorders other than COPD (e.g., bronchiectasis, active tuberculosis, pneumothorax, Pleural effusion, pulmonary thromboembolic, or Neuromuscular diseases affect respiratory movement function);
- Complicated with serious hepatic and renal diseases (liver cirrhosis, portal hypertension, bleeding of varicose veins, dialysis, or renal transplantation);
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 granule plus conventional drugAll patients will receive conventional drug according to 2020 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Medicine Diagnosis Treatment Guidelines. Yiqiwenfei granule for qi deficiency and internal cold fluid syndrome. Fuzhengqinghua granule for qi and yin deficiency and unclean phlegm heat syndrome. Fuzhengzaohua granule for lung and spleen qi deficiency and phlegm-damp amassing in lung syndrome. TCM granule (Jiangyin Tian Jiang Pharmaceutical Co.,Ltd, 10g/packet) will be administered twice daily for 8 weeks. | Drug | TCM granule plus conventional drug |
| TCM placebo granule plus conventional drugAll patients will receive conventional drug according to 2020 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Medicine Diagnosis Treatment Guidelines. Placebo Yiqiwenfei granule for qi deficiency and internal cold fluid syndrome. Placebo Fuzhengqinghua granule for qi and yin deficiency and unclean phlegm heat syndrome. Placebo Fuzhengzaohua granule for lung and spleen qi deficiency and phlegm-damp amassing in lung syndrome. TCM placebo granule (Jiangyin Tian Jiang Pharmaceutical Co.,Ltd, 10g/packet) will be administered twice daily for 8 weeks. The appearance, weight, color and odor of the preparation are the same as those of experimental group. The placebo granule consists of dextrin, bitter and 5% of the TCM granule. | Drug | TCM placebo granule plus conventional drug |
Primary outcome
Acute exacerbation rate in the AECOPD Risk Window
Time frame: in 8 weeks of the treatment period.
The numbers of acute exacerbation in the AECOPD Risk Window will be recorded.
COPD Assessment Test (CAT) in the AECOPD Risk Window
Time frame: Change from baseline CAT scores at week 0, 8 of the treatment period.
The COPD assessment test (CAT) is a self-administered questionnaire that measures health-related quality of life. It is an 8-item questionnaire on a 0-5 point scale with higher values indicating greater impact of COPD. The item response values of CAT are summed to produce a single score that ranges from 0-9 (low impact), 10-20 (medium impact), 21-30 (high impact) and 31-40 (very high impact).
11 secondary outcomes
Time to the first acute exacerbation
Time frame: up to week 26 during the study period.
Degree of acute exacerbation in the AECOPD Risk Window
Time frame: in 8 weeks of the treatment period.
Acute exacerbation rate in the follow-up period
Time frame: in 18 weeks of the follow-up period.
Degree of acute exacerbation in the follow-up period
Time frame: in 18 weeks of the follow-up period.
COPD Assessment Test (CAT) in the follow-up period
Time frame: Change from baseline CAT scores at week 16, 26 of the follow-up period.
Pulmonary function
Time frame: at week 0, 8 of the treatment period and at week 26 of the follow-up period.
Clinical symptom scores
Time frame: Change from baseline clinical symptom scores at week 0, 8 of the treatment period and at week 16, 26 of the follow-up period.
mMRC
Time frame: Change from baseline mMRC scores at week 0, 8 of the treatment period and at week 16, 26 of the follow-up period.
SGRQ
Time frame: Change from baseline SGRQ scores at week 0, 8 of the treatment period and at week 16, 26 of the follow-up period.
mCOPD-PRO
Time frame: Change from baseline mPRO-COPD scores at week 0, 8 of the treatment period and at week 16, 26 of the follow-up period
mESQ-COPD
Time frame: Change from baseline mESQ-COPD scores at week 0, 8 of the treatment period and at week 16, 26 of the follow-up period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 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.
Jiansheng Li, doctor study chair
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TCM granule plus conventional drug in people with Chronic Obstructive Pulmonary Disease, run by Henan University of Traditional Chinese Medicine 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 5 inclusion and 7 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 20 Apr 2021. 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. 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.
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 Hailong Zhang, doctor (+86-0371-66248624, zhanghailong6@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute exacerbation rate in the AECOPD Risk Window (time frame: in 8 weeks of the treatment period.). 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 20 Apr 2021.