NCT04834531

Effect of Zhuli Capsule on Phlegm-heat Syndrome (Tan-re Zheng)

Effect of Zhuli Capsule on Phlegm-heat Syndrome (Tan-re Zheng) in the Acute Exacerbations of Chronic Obstructive Pulmonary Disease or Chronic Bronchitis

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 324 (estimated)
• Sponsor: Zhong Wang · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Obstructive Pulmonary Disease
• Chronic Bronchitis

Interventions

Type	Name	Description
DRUG	Zhuli capsule	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.
DRUG	Placebo	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.
OTHER	Standard medical treatment	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.

Timeline

• Start date: 2021-07-01
• Primary completion: 2023-10-01
• Completion: 2023-10-01
• First posted: 2021-04-08
• Last updated: 2021-06-15

Locations

4 sites across 1 country: China