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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
324
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.
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, China
Sichuan Provincial Hospital of Traditional Chinese Medicine
Chengdu, Sichuan, China
Zhejiang Provincial Hospital of Chinese Medicine
Hangzhou, Zhejiang, China
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Monitor the sputum volume everyday and compare changes in sputum volume in the treatment.
Time frame: 0,Day 3, Day 7