Observation Study on the Efficacy of Yiqi Gubiao Pill in the Treatment of Chronic Obstructive Pulmonary Disease Secondary to Active Pulmonary Tuberculosis

Fourth Affiliated Hospital of Xinjiang Medical University

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Tuberculosis-related Obstructive Pulmonary Disease

Treatments: Drug: Yiqi Gubiao pill; Drug: Yiqi Gubiao Pill placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06676800

2021D01C215

Details and patient eligibility

About

Tuberculosis-related obstructive pulmonary disease (TOPD), as a high-burden disease in most countries, poses difficulties in the diagnosis and treatment of the disease when coexisting, and increases the risk of death for patients. Preliminary studies have shown that Yiqi Gubiao Wan has significant effects in relieving cough, alleviating asthma, expectorating phlegm, and delaying airway obstruction. The purpose of this study is to verify the therapeutic effect of Yiqi Gubiao pill on patients with TOPD through rigorous methodological design and to evaluate its safety. We will conduct a prospective, double-blind, randomized controlled trial. First, participants will be randomly assigned 1:1 to the Yiqi Gubiao pill treatment group and the Yiqi Gubiao pill placebo control group. This will be followed by a 12-week treatment. During the treatment period, we will measure and record the patients' lung function and quality of life. We will also score the patients' TCM symptoms. Finally, the safety of the medication will be assessed.

Enrollment: 74 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients who meet the following criteria will be included:

1. Age 40-75 years old;
2. Meet the Western medical diagnostic criteria and typing standards for active PTB;
3. Patients who have not taken steroids, anti-tuberculosis drugs, or other immunosuppressants and have not undergone desensitization treatment within one month.
4. Have understood the treatment methods and voluntarily signed the informed consent form.

Exclusion criteria

Patients who meet any of the following criteria will be excluded:

1. Patients with pneumothorax, pleural effusion, lung cancer and other serious lung diseases;
2. Patients with severe cardiovascular and cerebrovascular, hepatorenal and hematopoietic diseases;
3. mentally ill;
4. Patients with tumors;
5. Congenital or acquired immunodeficiency.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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74 participants in 2 patient groups, including a placebo group

Yiqi Gubiao pill

Experimental group

Treatment:

Drug: Yiqi Gubiao pill

Yiqi Gubiao Pill placebo

Placebo Comparator group

Treatment:

Drug: Yiqi Gubiao Pill placebo