The Safety and Effectiveness of Taneasy and Actein in COPD Patients

NCT ID: NCT06688292

Last Updated: 2025-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-20

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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

Conditions

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COPD (Chronic Obstructive Pulmonary Disease)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Taneasy 600mg granules

Dose: 600 mg/time. Use :two times per day.

Group Type EXPERIMENTAL

Taneasy 600mg granules

Intervention Type DRUG

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 tablets 600MG

Dose: 600 mg/time. Use :two times per day

Group Type ACTIVE_COMPARATOR

Actein effervescent 600mg

Intervention Type DRUG

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

Interventions

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Taneasy 600mg granules

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

Intervention Type DRUG

Actein effervescent 600mg

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

Intervention Type DRUG

Other Intervention Names

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acetylcysteine effervesecent 600mg

Eligibility Criteria

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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).
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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KGS Pharmamate Co., Ltd

UNKNOWN

Sponsor Role collaborator

Taichung Veterans General Hospital, Taichung

UNKNOWN

Sponsor Role collaborator

Bun Yao Biotechnology Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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BCQ230209TC

Identifier Type: -

Identifier Source: org_study_id

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