Clinical trial NCT06676800: Observation Study on the Efficacy of Yiqi Gubiao Pill in the Treatment of Chronic Obstructive Pulmonary Disease Secondary to Active Pulmonary Tuberculosis
Official title: Observation Study on the Efficacy of Yiqi Gubiao Pill in the Treatment of Chronic Obstructive Pulmonary Disease Secondary to Active Pulmonary Tuberculosis: A Double-Blind Randomized Controlled Trial Protocol
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Tuberculosis-related Obstructive Pulmonary Disease
Keywords: Pulmonary tuberculosis
Yiqi Gubiao Pills
Chronic Obstructive Pulmonary Disease
Randomized double-blind placebo-controlled trial
Lead sponsor: Fourth Affiliated Hospital of Xinjiang Medical University
Sponsor class: OTHER
Collaborators: name: Beijing University of Chinese Medicine
First posted: 2024-11-06
Enrollment: 74
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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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:

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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.

Primary outcomes:
measure: Forced Vital Capacity
timeFrame: up to 4 weeks
measure: the percentage of FVC predicted
timeFrame: up to 4 weeks
measure: the ratio of FEV1 to FVC
timeFrame: up to 4 weeks
measure: COPD Assessment Test (CAT) score
timeFrame: up to 4 weeks
measure: modified Medical Research Council (mMRC) score
timeFrame: up to 4 weeks
measure: Baseline Dyspnea Index (BDI) score
timeFrame: up to 4 weeks
measure: Transition Dyspnea Index (TDI) score
timeFrame: up to 4 weeks
Secondary outcomes:
measure: Traditional Chinese Medicine (TCM) symptom score
timeFrame: up to 4 weeks
measure: alanine aminotransferase
timeFrame: up to 4 weeks
measure: aspartate aminotransferase
timeFrame: up to 4 weeks
measure: urea nitrogen
timeFrame: up to 4 weeks
measure: serum creatinine
timeFrame: up to 4 weeks
measure: uric acid
timeFrame: up to 4 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Bagcchi S. WHO's Global Tuberculosis Report 2022. Lancet Microbe. 2023 Jan;4(1):e20. doi: 10.1016/S2666-5247(22)00359-7. Epub 2022 Dec 12. No abstract available.