The Safety and Effectiveness of Taneasy and Actein in COPD Patients

Bun Yao Biotechnology Co., Ltd42 enrolled

Overview

To evaluate the safety and efficacy of Taneasy 600mg granules and Actein effervescent tablets 600MG administered twice daily for 14 days in treatment of COPD Disease.

The study will enroll 40\~60 patients and complete 40 patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Interventions

Taneasy 600mg granulesDRUG

Treatment of respiratory affections characterized by thick and viscous hypersecretion due to acute bronchitis,chronic bronchitis and its exacerbation, plumonary emphysema,mucoviscidosis and bronchiectasis.

Actein effervescent 600mgDRUG

Treatment of respiratory affections characterized by thick and viscous hypersecretion due to acute bronchitis,chronic bronchitis and its exacerbation, pulmonary emphysema, mucoviscidosis and bronchiectasis.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subjects aged older than 20\~75 years old. 2. Able to sign informed consent prior to the study. 3. Subjects have COPD. Exclusion Criteria: 1. Subjects with known hypersensitivity to Acetylcysteine preparations. 2. Subjects with other serious medical diseases that are judged by the attending physician to affect the evaluation results (such as: tuberculosis, pneumonia, bronchial asthma, bronchiectasis, cor pulmonale, lung cancer, acute myocardial infarction, acute hepatitis, renal failure, etc.) 3. Pregnancy or breast-feeding woman. 4. Female subjects or their sexual partners do not use contraception during the trial. 5. Joining any drug clinical trial within 3 months prior to dosing. 6. Investigator considered to be inappropriate for enrollment. 7. Phenylketonuria (PKU).

Locations (1)

Taichung Veterans General Hospital

Taichung, Taiwan

Outcomes

Primary Outcomes

To evaluate the safety and efficacy of Taneasy 600mg granules and Actein effervescent tablets 600MG administered twice daily for 14 days in treatment of COPD Disease.

Primary Evaluation Criteria: CAT score (COPD Assessment Test) The maximum score is 40. Higher scores indicate your COPD has a greater impact on your overall health and well-being.

Time frame: one month

Data from ClinicalTrials.gov

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