Chronic Obstructive Pulmonary DiseasePhase 4NCT04834531
Effect of Zhuli Capsule on Phlegm-heat Syndrome (Tan-re Zheng)
A Phase 4 study testing Zhuli capsule and Standard medical treatment in people with Chronic Obstructive Pulmonary Disease and Chronic Bronchitis, run by Zhong Wang at 4 sites in China.
Trial summary
This trial aims to evaluate the clinical control rate of sputum by Zhuli Capsule in the treatment of the Phlegm-heat Syndrome （Tan-re Zheng）in the patients with acute exacerbation of chronic obstructive pulmonary disease or chronic bronchitis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Chronic Bronchitis
- What is being tested?
- Zhuli capsule and Standard medical treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 324 participants
- Where
- 4 sitesChina
- Study dates
- Jul 2021to Oct 2023
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the diagnostic criteria of acute exacerbation in chronic obstructive pulmonary disease or chronic bronchitis;
- Meet the diagnostic criteria of Phlegm-heat Syndrome (Tan-re Zheng) in TCM
- Age from 18 to 75 years old, regardless of gender;
- The score of each dimension of the sputum assement scale is ≥1;
- Those who have not participated in other drug clinical research in the past one month;
- Sign the informed consent letter.
Who cannot join
- Patients with pulmonary tuberculosis, bronchial cancer or other lung diseases.
- Loose stools due to Spleen deficiency and stomachache caused by cold.
- Diabetes or severe cardiovascular, liver (ALT>1.5×ULN), kidney (Cr>1.5×ULN) and other primary diseases.
- Pregnant and lactating women.
- Patients with acute and chronic respiratory failure.
- Those who cannot give full informed consent due to mental disorders.
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- People with disabilities recognized by law.
- People with allergies, or allergic to the ingredients of the drug used in this test.
- Those who have used drugs with expectorant effects within the day.
- Patients who are participating in clinical trials of other drugs. -
Trial locations and contacts
4 sites in 1 country.
China4 sites
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Hongchun Zhang, Prof., 86-10-84205298, 13701226664@139.com
Sichuan Provincial Hospital of Traditional Chinese Medicine
Chengdu, Sichuan, 610075
Qing-Song Huang, Prof, 86-28-87783481, 252465965@qq.com
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, 510120
Lin Lin, Prof, 86-20-81887233-34430, drlinlin620@163.com
Zhejiang Provincial Hospital of Chinese Medicine
Hangzhou, Zhejiang, 310006
Zhen Wang, Prof., 86-571-86620303, wangzhen610@sina.cn
About this study
Official title: Effect of Zhuli Capsule on Phlegm-heat Syndrome (Tan-re Zheng) in the Acute Exacerbations of Chronic Obstructive Pulmonary Disease or Chronic Bronchitis
This trial aims to evaluate the clinical control rate of sputum by Zhuli Capsule in the treatment of the Phlegm-heat Syndrome （Tan-re Zheng）in the patients with acute exacerbation of chronic obstructive pulmonary disease or chronic bronchitis.
- Being tested
- Zhuli capsule, Placebo, Standard medical treatment
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zhuli capsuleDrug
This capsule is made from the exact of Phyllostachys glauca McClure or Phyllostachysnuda McClure, which has the expectorant effects. It is oral used,2 capsules for once, three times a day, for 7 days.
PlaceboDrug
The placebo capsule is filled with amylodextrin made with food colour and flavor，with the similar appearance, smell and flavor with Zhuli Capsule. It is oral used, 2 capsules for once, three times a day, for 7 days.
Standard medical treatmentOther
Standard medical treatment will be given according to the recent guidelines with the evaluation of the clinicians, include:
- if the patient with AECOPD, he or she will be given with oxygen therapy, bronchodilators, glucocorticoid or antibacterial drugs;
- if the patient with AECB, he or she will be given with antibacterial drugs or anti-asthmatic drugs for asthma attacks.
| Study group | Role | What they receive |
|---|---|---|
| Zhuli capsule | Experimental | Base on the standard medical treatment, the patients in this group will be used Zhuli capsule, 2 capsules (1.2 g) once, three time a day for 7 days. Receives: Drug: Zhuli capsule; Other: Standard medical treatment |
| Placebo | Placebo comparator | Base on the standard medical treatment, the patients in this group will be used placebo capsule, 2 capsules (1.2 g) once, three time a day for 7 days. Receives: Drug: Placebo; Other: Standard medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The clinical control rate of sputum
Defined as the proportion of patients with the expectoration rate ≥90%.
Measured: Day 7
Secondary outcomes (6)
Time to sputum turn white
Measured: up to Day 7
Cough Symptom Score Scale
Cough Symptom Score Scale include Day Cough Symptom Score and Night cough symptom score. In Day Cough Symptom Score, zero means no cough,one means occasionally short cough,two means frequent cough, slightly affecting daily activities,three means frequent coughing seriously affects daily activities;In Night cough symptom score,zero means no cough,one means short-term cough when falling asleep or occasional night cough,two means cough slightly affects night sleep,three means cough seriously affects night sleep.
Measured: 0,Day 3, Day 7
Use of Antibiotic
Measured: 0,Day 3, Day 7
Chronic obstructive pulmonary disease Assessment Test
Measured: 0,Day 3, Day 7
The Phlegm-heat Syndrome (Tan-re Zheng) scale
The Phlegm-heat Syndrome (Tan-re Zheng) scale include measures of the main symptoms and the secondary symptoms. The main symptom is about the color ，the characteristics and the amount of sputum.Each one includes four levels,0 represents normal，3 represents mild symptom,6 represents moderate symptom,9 represents Severe symptom.The secondary symptoms include Day cough，Night cough，Dry throat thirst，fever，blush，Dry stool，Yellow urine ，Red tongue and pulse.Each one includes different levels.The higher score represents the more meeting The Phlegm-heat Syndrome (Tan-re Zheng) ，the lower score means the opposite.
Measured: 0,Day 3, Day 7
The change value about the volume of sputum after treatment
Monitor the sputum volume everyday and compare changes in sputum volume in the treatment.
Measured: 0,Day 3, Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study startJul 2021 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhong Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhong Wang, China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04834531
- Sponsor's protocol ID
- ZLJN-V2.0
- Status last verified
- Jun 2021
- First submitted
- 21 Sep 2020
- Last updated
- 15 Jun 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 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Zhuli Capsule on Phlegm-heat Syndrome (Tan-re Zheng) in the Acute Exacerbations of Chronic Obstructive Pulmonary Disease or Chronic Bronchitis
- ClinicalTrials.gov ID
- NCT04834531
- Acronym / sponsor ID
- ZLJN-V2.0
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 324 participants (estimated)
- Lead sponsor
- Zhong WangUniversity, hospital or other
- Study start
- Jul 2021 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 8 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 trial aims to evaluate the clinical control rate of sputum by Zhuli Capsule in the treatment of the Phlegm-heat Syndrome （Tan-re Zheng）in the patients with acute exacerbation of chronic obstructive pulmonary disease or chronic bronchitis.
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 |
|---|---|---|
| Zhuli capsule | Experimental | Drug: Zhuli capsule, Other: Standard medical treatmentBase on the standard medical treatment, the patients in this group will be used Zhuli capsule, 2 capsules (1.2 g) once, three time a day for 7 days. |
| Placebo | Placebo comparator | Drug: Placebo, Other: Standard medical treatmentBase on the standard medical treatment, the patients in this group will be used placebo capsule, 2 capsules (1.2 g) once, three time a day for 7 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Meet the diagnostic criteria of acute exacerbation in chronic obstructive pulmonary disease or chronic bronchitis;
- Meet the diagnostic criteria of Phlegm-heat Syndrome (Tan-re Zheng) in TCM
- Age from 18 to 75 years old, regardless of gender;
- The score of each dimension of the sputum assement scale is ≥1;
- Those who have not participated in other drug clinical research in the past one month;
Key exclusion criteria (10 listed)
- Patients with pulmonary tuberculosis, bronchial cancer or other lung diseases.
- Loose stools due to Spleen deficiency and stomachache caused by cold.
- Diabetes or severe cardiovascular, liver (ALT>1.5×ULN), kidney (Cr>1.5×ULN) and other primary diseases.
- Pregnant and lactating women.
- Patients with acute and chronic respiratory failure.
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 |
|---|---|---|
| Zhuli capsuleThis capsule is made from the exact of Phyllostachys glauca McClure or Phyllostachysnuda McClure, which has the expectorant effects. It is oral used,2 capsules for once, three times a day, for 7 days. | Drug | Zhuli capsule |
| PlaceboThe placebo capsule is filled with amylodextrin made with food colour and flavor，with the similar appearance, smell and flavor with Zhuli Capsule. It is oral used, 2 capsules for once, three times a day, for 7 days. | Drug | Placebo |
| Standard medical treatmentStandard medical treatment will be given according to the recent guidelines with the evaluation of the clinicians, include: 1. if the patient with AECOPD, he or she will be given with oxygen therapy, bronchodilators, glucocorticoid or antibacterial drugs; 2. if the patient with AECB, he or she will be given with antibacterial drugs or anti-asthmatic drugs for asthma attacks. | Other | Placebo, Zhuli capsule |
Primary outcome
The clinical control rate of sputum
Time frame: Day 7
Defined as the proportion of patients with the expectoration rate ≥90%.
6 secondary outcomes
Time to sputum turn white
Time frame: up to Day 7
Cough Symptom Score Scale
Time frame: 0,Day 3, Day 7
Use of Antibiotic
Time frame: 0,Day 3, Day 7
Chronic obstructive pulmonary disease Assessment Test
Time frame: 0,Day 3, Day 7
The Phlegm-heat Syndrome (Tan-re Zheng) scale
Time frame: 0,Day 3, Day 7
The change value about the volume of sputum after treatment
Time frame: 0,Day 3, Day 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zhuli capsule and Standard medical treatment in people with Chronic Obstructive Pulmonary Disease and Chronic Bronchitis, run by Zhong Wang at 4 sites 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 6 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 15 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Zhong Wang, M.D. (86-10-64093207, zhonw@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The clinical control rate of sputum (time frame: Day 7). 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 15 Jun 2021.