Pulmonary Disease, Chronic ObstructivePhase 3NCT03428412
Effects of Traditional Chinese Medicine on AECOPD Patients
A Phase 3 study testing TCM and conventional drug in people with Pulmonary Disease, Chronic Obstructive and Acute Exacerbation, run by Henan University of Traditional Chinese Medicine.
Trial summary
This is a multi-center, randomized, double-blind, controlled trial to compare the efficacy of two therapies for patients with AECOPD. 378 subjects will be randomly assigned to one therapies (conventional drug, and the combination of conventional drug and TCM) for 14 days treatment. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Acute Exacerbation, Medicine, Chinese Traditional
- What is being tested?
- TCM and conventional drug
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 378 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2018to 31 Dec 2019
- Phase
- Phase 3
- 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 moderate to very severe AECOPD
- Age between 40 and 80 years
- Syndrome differentiation meets criteria of syndrome of external cold and internal fluid,syndrome of phlegm-heat congesting lung,or syndrome of phlegm-damp amassing in lung
- 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)
- Combined tumor
- Treated outside the hospital for more than 7 days
Show all 10Show fewer
- Need to carry out invasive mechanical ventilation respiratory failure
- 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
No sites are listed yet.
About this study
Official title: Effects of Traditional Chinese Medicine on AECOPD Patients: A Multi-center, Randomized, Double-blind, Controlled Trial
This is a multi-center, randomized, double-blind, controlled trial to compare the efficacy of two therapies for patients with AECOPD. 378 subjects will be randomly assigned to one therapies (conventional drug, and the combination of conventional drug and TCM) for 14 days treatment. After the treatment period, subjects in two arms will be followed up for 4 weeks. The primary outcomes will include COPD Assessment Test (CAT), and secondary outcomes include treatment failure rate, treatment success rate, hospitalization time, hospital admission rate, endotracheal intubation rate, mortality and quality of life (COPD-PRO, SF-36).
- Being tested
- TCM and conventional drug, TCM placebo and conventional drug
- Keywords
- Chronic Obstructive Pulmonary Disease, Acute exacerbation, Traditional Chinese medicine
- 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 and conventional drugDrug
All patients were treated with medicine based on 2017 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Treatment Guidelines for AECOPD.
The Experimental group will receive TCM according to the TCM syndrome. Sanhanhuayin granule (Jiangyin Tian Jiang Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for syndrome of external cold and internal fluid in 14 treatment days.
Qingrehuatan granule (Jiangyin Tian Jiang Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for syndrome of phlegm-heat congesting lung in 14 treatment days.
Zaoshihuatan granule (Jiangyin Tian Jiang Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for syndrome of phlegm-damp amassing in lung in 14 treatment days.
TCM placebo and conventional drugDrug
All patients were treated with medicine based on 2017 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Treatment Guidelines for AECOPD.
The control group will receive TCM placebo according to the TCM syndrome. Placebo Sanhanhuayin granule (Jiangyin Tian Jiang Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for syndrome of external cold and internal fluid in 14 treatment days.
Placebo Qingrehuatan granule (Jiangyin Tian Jiang Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for syndrome of phlegm-heat congesting lung in 14 treatment days.
Placebo Zaoshihuatan granule (Jiangyin Tian Jiang Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for syndrome of phlegm-damp amassing in lung in 14 treatment days.
| Study group | Role | What they receive |
|---|---|---|
| TCM plus conventional drug | Experimental | The experimental group will receive three type of TCM in addition conventional drug according to 2017 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Treatment Guidelines for AECOPD. Receives: Drug: TCM and conventional drug |
| TCM placebo plus conventional drug | Placebo comparator | The control group will receive three type of placebo TCM in addition conventional drug according to 2017 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Treatment Guidelines for AECOPD. Receives: Drug: TCM placebo and conventional drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
COPD Assessment Test(CAT)
Using COPD Assessment Test ( CAT) to asses the impact of AECOPD on a person's life, and how this changes over time.
Measured: Change from baseline CAT score at day 0, 14 of the treatment phase, at day 14, 28 of the follow-up phase.
Secondary outcomes (9)
Treatment failure rate
Measured: The numbers of treatment failure at day 14 of the treatment phase.
Treatment success rate
Measured: The numbers of treatment success at day 14 of the treatment phase.
Length of hospital stays
length hospital stays will be recorded.
Measured: The length hospital stays in 14 Days of the treatment phase
Readmission due to AECOPD
Readmission due to AECOPD will be recorded.
Measured: The numbers of readmission due to AECOPD in 28 Days of the followup phase.
Intubation rate
Intubation will be recorded.
Measured: The numbers of intubation at day 4,7,10，14 of the treatment phase, at day 14, 28 of the follow-up phase.
Mortality
Measured: The numbers of mortality at day 14 of the treatment phase and day 28 of the follow-up phase.
Dyspnea
Using modified Medical Research Council (mMRC) to asses the dyspnea of COPD, and how this changes over time.
Measured: Change from Baseline in the mMRC at day 0, 4, 7, 10,14 of the treatment phase, at day 14, 28 of the follow-up phase.
SF-36
Using the MOS item short from health survey (SF-36) to asses the impact of COPD on a person's life, and how this changes over time.
Measured: Change from Baseline in the SF-36 at day 0,14 of the treatment phase, at day 14, 28 of the follow-up phase.
COPD-PRO
Using the COPD patient reported outcome scale (COPD-PRO) to asses the impact of COPD on a person's life, and how this changes over time.
Measured: Change from Baseline in the COPD-PRO at day 0,14 of the treatment phase, at day 14, 28 of the follow-up phase.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start1 Mar 2018 (estimated)
- Primary completion30 Sep 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 378 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03428412
- Sponsor's protocol ID
- TCM for AECOPD
- Status last verified
- Jan 2018
- First submitted
- 19 Jan 2018
- Last updated
- 9 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang H, Li J, Yu X, Li S, Wang H, Ruan H, Si Y, Xie Y, Wang M. Effects of Chinese medicine on patients with acute exacerbations of COPD: study protocol for a randomized controlled trial. Trials. 2019 Dec 16;20(1):735. doi: 10.1186/s13063-019-3772-y.
PubMed 31842969
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Traditional Chinese Medicine on AECOPD Patients: A Multi-center, Randomized, Double-blind, Controlled Trial
- ClinicalTrials.gov ID
- NCT03428412
- Acronym / sponsor ID
- TCM for AECOPD
- Keywords
- Chronic Obstructive Pulmonary Disease, Acute exacerbation, Traditional Chinese medicine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 378 participants (estimated)
- Lead sponsor
- Henan University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Mar 2018 (estimated)
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 9 Feb 2018 (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 is a multi-center, randomized, double-blind, controlled trial to compare the efficacy of two therapies for patients with AECOPD. 378 subjects will be randomly assigned to one therapies (conventional drug, and the combination of conventional drug and TCM) for 14 days treatment. After the treatment period, subjects in two arms will be followed up for 4 weeks. The primary outcomes will include COPD Assessment Test (CAT), and secondary outcomes include treatment failure rate, treatment success rate, hospitalization time, hospital admission rate, endotracheal intubation rate, mortality and quality of life (COPD-PRO, SF-36).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCM plus conventional drug | Experimental | Drug: TCM and conventional drugThe experimental group will receive three type of TCM in addition conventional drug according to 2017 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Treatment Guidelines for AECOPD. |
| TCM placebo plus conventional drug | Placebo comparator | Drug: TCM placebo and conventional drugThe control group will receive three type of placebo TCM in addition conventional drug according to 2017 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Treatment Guidelines for AECOPD. |
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 moderate to very severe AECOPD
- Age between 40 and 80 years
- Syndrome differentiation meets criteria of syndrome of external cold and internal fluid,syndrome of phlegm-heat congesting lung,or syndrome of phlegm-damp amassing in lung
- Without participations in other interventional trials in the previous one month
- With the informed consent signed
Key exclusion criteria (10 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)
- Combined tumor
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 and conventional drugAll patients were treated with medicine based on 2017 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Treatment Guidelines for AECOPD. The Experimental group will receive TCM according to the TCM syndrome. Sanhanhuayin granule (Jiangyin Tian Jiang Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for syndrome of external cold and internal fluid in 14 treatment days. Qingrehuatan granule (Jiangyin Tian Jiang Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for syndrome of phlegm-heat congesting lung in 14 treatment days. Zaoshihuatan granule (Jiangyin Tian Jiang Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for syndrome of phlegm-damp amassing in lung in 14 treatment days. | Drug | TCM plus conventional drug |
| TCM placebo and conventional drugAll patients were treated with medicine based on 2017 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Treatment Guidelines for AECOPD. The control group will receive TCM placebo according to the TCM syndrome. Placebo Sanhanhuayin granule (Jiangyin Tian Jiang Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for syndrome of external cold and internal fluid in 14 treatment days. Placebo Qingrehuatan granule (Jiangyin Tian Jiang Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for syndrome of phlegm-heat congesting lung in 14 treatment days. Placebo Zaoshihuatan granule (Jiangyin Tian Jiang Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for syndrome of phlegm-damp amassing in lung in 14 treatment days. | Drug | TCM placebo plus conventional drug |
Primary outcome
COPD Assessment Test(CAT)
Time frame: Change from baseline CAT score at day 0, 14 of the treatment phase, at day 14, 28 of the follow-up phase.
Using COPD Assessment Test ( CAT) to asses the impact of AECOPD on a person's life, and how this changes over time.
9 secondary outcomes
Treatment failure rate
Time frame: The numbers of treatment failure at day 14 of the treatment phase.
Treatment success rate
Time frame: The numbers of treatment success at day 14 of the treatment phase.
Length of hospital stays
Time frame: The length hospital stays in 14 Days of the treatment phase
Readmission due to AECOPD
Time frame: The numbers of readmission due to AECOPD in 28 Days of the followup phase.
Intubation rate
Time frame: The numbers of intubation at day 4,7,10，14 of the treatment phase, at day 14, 28 of the follow-up phase.
Mortality
Time frame: The numbers of mortality at day 14 of the treatment phase and day 28 of the follow-up phase.
Dyspnea
Time frame: Change from Baseline in the mMRC at day 0, 4, 7, 10,14 of the treatment phase, at day 14, 28 of the follow-up phase.
SF-36
Time frame: Change from Baseline in the SF-36 at day 0,14 of the treatment phase, at day 14, 28 of the follow-up phase.
COPD-PRO
Time frame: Change from Baseline in the COPD-PRO at day 0,14 of the treatment phase, at day 14, 28 of the follow-up phase.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2018.
- Derived from this study: PubMed 31842969Zhang H, Li J, Yu X, Li S, Wang H, Ruan H, Si Y, Xie Y, Wang M. Effects of Chinese medicine on patients with acute exacerbations of COPD: study protocol for a randomized controlled trial. Trials. 2019 Dec 16;20(1):735. doi: 10.1186/s13063-019-3772-y.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TCM and conventional drug in people with Pulmonary Disease, Chronic Obstructive and Acute Exacerbation, 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 10 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 9 Feb 2018. 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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Hailong Zhang, doctor (86-371-66248624, zhanghailong6@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COPD Assessment Test(CAT) (time frame: Change from baseline CAT score at day 0, 14 of the treatment phase, at day 14, 28 of the follow-up phase.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03428412, which also lists 1 linked publication.
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 9 Feb 2018.