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

NCT06676800 | Not Yet Recruiting Early Phase 1

• 1 other identifier: 2021D01C215
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

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

Keywords

Pulmonary tuberculosis; Yiqi Gubiao Pills; Chronic Obstructive Pulmonary Disease; Randomized double-blind placebo-controlled trial

Outcome Measures

Primary Outcomes (7)

• Forced Vital Capacity

  Forced Vital Capacity (FVC) refers to the volume of air exhaled as quickly and forcefully as possible after taking the maximum inhalation.

  up to 4 weeks

• the percentage of FVC predicted

  The volume of air exhaled rapidly within one second after inhaling to the total lung capacity. Normal values are 70-85%, mild is less than 80% of the predicted value; moderate is less than 70% of the predicted value; moderately severe is less than 60% of the predicted value; severe is less than 50% of the predicted value.

  up to 4 weeks

• the ratio of FEV1 to FVC

  The ratio of FEV1 to FVC should be above 70%. If the ratio is below 70%, it may indicate the presence of chronic obstructive pulmonary disease (COPD).

  up to 4 weeks

• COPD Assessment Test (CAT) score

  The CAT score questionnaire is primarily used to assess the health status and impact on daily life of patients with chronic obstructive pulmonary disease (COPD). It quantifies the degree of health impairment in COPD patients by asking questions related to symptoms, activity ability, mental state, and social impact based on the patients' self-reports. The total score of the CAT questionnaire ranges from 0 to 40, with higher scores indicating poorer health status and lower quality of life for the patients.

  up to 4 weeks

• modified Medical Research Council (mMRC) score

  The mMRC is only used for the assessment of dyspnea and is often applied in conjunction with the CAT score. An mMRC score of 2 or above is the threshold for distinguishing "mild dyspnea" from "severe dyspnea."

  up to 4 weeks

• Baseline Dyspnea Index (BDI) score

  It measures activity-related dyspnea from three dimensions: degree of functional impairment, amount of activity, and effort required to complete activities. Each dimension is graded on a 5-level scale, with scores ranging from 0 to 4, indicating increasing severity. The total score ranges from 0 to 12.

  up to 4 weeks

• Transition Dyspnea Index (TDI) score

  The TDI should be used in conjunction with the BDI to measure the extent of change in prognostic functional impairment, activity level, and effort required to complete activities. The TDI scores each dimension on a scale from significantly worse (-3) to significantly better (+3), with a total score ranging from -9 to +9.

  up to 4 weeks

Secondary Outcomes (6)

• Traditional Chinese Medicine (TCM) symptom score

  up to 4 weeks

• alanine aminotransferase

  up to 4 weeks

• aspartate aminotransferase

  up to 4 weeks

• urea nitrogen

  up to 4 weeks

• serum creatinine

  up to 4 weeks

Study Arms (2)

Yiqi Gubiao pill

EXPERIMENTAL

Drug: Yiqi Gubiao pill

Yiqi Gubiao Pill placebo

PLACEBO COMPARATOR

Drug: Yiqi Gubiao Pill placebo

Interventions

Yiqi Gubiao pill 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

Yiqi Gubiao Pill placebo 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.

Yiqi Gubiao Pill placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients who meet any of the following criteria will be excluded:
• Patients with pneumothorax, pleural effusion, lung cancer and other serious lung diseases;
• Patients with severe cardiovascular and cerebrovascular, hepatorenal and hematopoietic diseases;
• mentally ill;
• Patients with tumors;
• Congenital or acquired immunodeficiency.

Sponsors & Collaborators

• Fourth Affiliated Hospital of Xinjiang Medical University: lead
• Beijing University of Chinese Medicine: collaborator

Related Publications (2)

• 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.

  PMID: 36521512 BACKGROUND

• 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.

  PMID: 41132532 DERIVED

MeSH Terms

Conditions

Tuberculosis, Pulmonary; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jin Dai, Attending Physician

CONTACT

0316-17590826125; daijintcm@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 6, 2024
• Study Start: November 30, 2024
• Primary Completion: February 28, 2025
• Study Completion: March 31, 2025
• Last Updated: November 6, 2024

Record last verified: 2024-11