NCT03132610

A Study of Andrographolide Sulfonate in Patients With Acute Exacerbation of Chronic Bronchitis

Efficacy and Safety of Combined With Andrographolide Sulfonate on the Basis of Conventional Therapy in Patients With Acute Exacerbation of Chronic Bronchitis: a Randomized, Single Blind, Placebo-controlled, Multicenter Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A multicenter,randomized,single-blind, placebo-controlled,phase 4 clinical trial to evaluate the efficacy and safety of andrographolide sulfonate in patients with acute exacerbation of chronic bronchitis

Detailed description

The patient after passing the screening, with the ratio of 1:1, were randomly assigned to experimental group or control group. Experimental group: on the basis of Conventional Therapy,Xiyanping injection(andrographolide sulfonate) 10-20ml/d, With 0.9% normal saline 100ml-250ml diluted intravenous drip (not with other drugs in the same container mixed use), control drip speed per minute of 30-40 drops. control group: on the basis of Conventional Therapy,Xiyanping injection simulation(0.9% normal saline) 10-20ml/d, The treatment method is the same as the experimental group.

Conditions

• Acute Exacerbation of Chronic Bronchitis

Interventions

Type	Name	Description
DRUG	andrographolide sulfonate	Conventional Therapy+Xiyanping injection
DRUG	andrographolide sulfonate simulation	Conventional Therapy+Xiyanping injection simulation

Timeline

• Start date: 2016-12-01
• Primary completion: 2017-12-01
• Completion: 2018-06-01
• First posted: 2017-04-28
• Last updated: 2017-04-28

Locations

1 site across 1 country: China