A Phase 4 interventional study of Zhuli capsule and Placebo in Chronic Obstructive Pulmonary Disease and Chronic Bronchitis, sponsored by Zhong Wang. Status unknown at 4 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-06-15.
Sponsored by Zhong Wang · Phase 4, Interventional, and Treatment
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.
268 studies on the registry are indexed under Bronchitis; 26 are open to participants now.
This study's planned enrollment of 324 is above the median of 120 across 184 interventional studies indexed under Bronchitis.
Browse Bronchitis studies →Zhong Wang is the lead sponsor of 12 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Zhuli capsule · Other: Standard medical treatment
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.
Drug: Placebo · Other: Standard medical treatment
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.
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 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.
The clinical control rate of sputum
Defined as the proportion of patients with the expectoration rate ≥90%.
Time frame: Day 7
Time to sputum turn white
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 0,Day 3, Day 7
This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Zhong Wang