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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zhuli capsule | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The clinical control rate of sputum | Defined as the proportion of patients with the expectoration rate ≥90%. | Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to sputum turn white | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhong Wang, M.D. | Contact | 86-10-64093207 | zhonw@vip.sina.com | |
| Jun Liu, Ph.D. | Contact | 86-10-64093207 | franlj1104@aliyun.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Beijing | Beijing Municipality | 100029 | China |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D029481 | Bronchitis, Chronic |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| Placebo | Drug | 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 treatment | Other | Standard medical treatment will be given according to the recent guidelines with the evaluation of the clinicians, include:
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| 0,Day 3, Day 7 |
| Use of Antibiotic | 0,Day 3, Day 7 |
| Chronic obstructive pulmonary disease Assessment Test | 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. | 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. | 0,Day 3, Day 7 |
| Guangdong Provincial Hospital of Traditional Chinese Medicine | Guangzhou | Guangdong | 510120 | China |
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| Sichuan Provincial Hospital of Traditional Chinese Medicine | Chengdu | Sichuan | 610075 | China |
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| Zhejiang Provincial Hospital of Chinese Medicine | Hangzhou | Zhejiang | 310006 | China |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |