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Effect of Yong Chong Cao Capsule on Outcomes in Patients With Mild to Severe COPD

NCT03745261 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2018-11-19

No results posted yet for this study

Summary

The aim of this study is to evaluate the effectiveness of Yong Chong Cao capsule on outcomes in patients with mild to severe Chronic Obstructive Pulmonary Disease (COPD).

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

Salbutamol (Ventolin®)

According to the revised 2017 GOLD, patients will be divided into Group A, B, C, and D based on individualized assessment. Salbutamol will be used to Group A patients: Salbutamol (Ventolin®, GlaxoSmithKline) 100μg/dose. 100 μg each time (when needed), and the maximum dose is 8-12 inhalations a day.

DRUG

Tiotropium Bromide (Spiriva®)

Tiotropium Bromide Powder for Inhalation will be used to Group B and Group C patients: Tiotropium Bromide Powder for Inhalation(Spiriva®, Boehringer Ingelheim), 18μg/ capsule, 10 capsules. 18μg each time, once daily.

DRUG

Salmeterol / fluticasone (Seretide®)

Salmeterol / fluticasone will be used to Group D patients: Salmeterol / fluticasone (Seretide®, GlaxoSmithKline), 50/250 μg / dose, 60 inhalations. 50/250 μg each time, twice daily.

DRUG

YCC capsule

According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of insufficiency of qi of the lung and kidney will be given Yong Chong Cao (YCC)capsule (Kecai®, Guangdong daguang pharmaceutical group Co., Ltd), 1 g each time, three times a day.

DRUG

BL capsule

According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of insufficiency of qi of the lung and kidney will be given Bailing(BL) capsule (Bailing®, Huadong Medicine Co.,Ltd), 1 g each time, three times a day

Sponsors & Collaborators

  • Jiangsu Famous Medical Technology Co., Ltd.

    collaborator INDUSTRY

  • Henan University of Traditional Chinese Medicine

    lead OTHER

Principal Investigators

  • Suyun Li, Doctor · The First Affiliated Hospital of HUCM

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-20
Primary Completion
2019-12-31
Completion
2020-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03745261 on ClinicalTrials.gov