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

NCT ID: NCT06676800

Last Updated: 2024-11-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-30
• Study Completion Date: 2025-03-31

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.

Conditions

Tuberculosis-related Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Yiqi Gubiao pill

Group Type: EXPERIMENTAL

Yiqi Gubiao pill

Intervention Type: DRUG

Take 10 pills orally each time, three times a day, after meals, for a continuous period of 12 weeks. Receiving basic treatment: standardized quadruple anti-tuberculosis therapy is administered, with Rifampicin, Isoniazid, Ethambutol, and Pyrazinamide used for the first 2 months, followed by Rifampicin and Isoniazid for the next 4 months.

Yiqi Gubiao Pill placebo

Group Type: PLACEBO_COMPARATOR

Yiqi Gubiao Pill placebo

Intervention Type: DRUG

The placebo's appearance and content color are similar to that of Yiqi Gubiao Pill, with the main ingredients being starch and caramel. Take 10 pills orally each time, three times a day, after meals, for a continuous period of 12 weeks. Receiving basic treatment: standardized quadruple anti-tuberculosis therapy is administered, with Rifampicin, Isoniazid, Ethambutol, and Pyrazinamide used for the first 2 months, followed by Rifampicin and Isoniazid for the next 4 months.

Interventions

Yiqi Gubiao pill

Take 10 pills orally each time, three times a day, after meals, for a continuous period of 12 weeks. Receiving basic treatment: standardized quadruple anti-tuberculosis therapy is administered, with Rifampicin, Isoniazid, Ethambutol, and Pyrazinamide used for the first 2 months, followed by Rifampicin and Isoniazid for the next 4 months.

Intervention Type: DRUG

Yiqi Gubiao Pill placebo

The placebo's appearance and content color are similar to that of Yiqi Gubiao Pill, with the main ingredients being starch and caramel. Take 10 pills orally each time, three times a day, after meals, for a continuous period of 12 weeks. Receiving basic treatment: standardized quadruple anti-tuberculosis therapy is administered, with Rifampicin, Isoniazid, Ethambutol, and Pyrazinamide used for the first 2 months, followed by Rifampicin and Isoniazid for the next 4 months.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing University of Chinese Medicine

OTHER

Sponsor Role: collaborator

Fourth Affiliated Hospital of Xinjiang Medical University

OTHER

Sponsor Role: lead

Responsible Party

Jin Dai

Attending Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Jin Dai, Attending Physician

Role: CONTACT

daijintcm@163.com

0316-17590826125

References

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.

Reference Type: BACKGROUND

PMID: 36521512 (View on PubMed)

Dai J, Zhang Y, Su J, Yuan G, Li F, Zhou Z, Aziza, Ye C, Seyiti A, Pida M, Zhang J. Yiqi Gubiao Pill for tuberculosis-associated obstructive pulmonary disease: protocol for a double-blind randomized controlled trial. Front Pharmacol. 2025 Oct 8;16:1610889. doi: 10.3389/fphar.2025.1610889. eCollection 2025.

Reference Type: DERIVED

PMID: 41132532 (View on PubMed)

Other Identifiers

2021D01C215

Identifier Type: -

Identifier Source: org_study_id