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NCT Number: NCT06676800

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

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.

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Key information

Conditions

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

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-

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.

Exclusion criteria

-

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.

Treatment and study plan

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 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.

Primary outcomes

  1. Forced Vital Capacity

    Time frame: up to 4 weeks

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

  2. the percentage of FVC predicted

    Time frame: up to 4 weeks

    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.

  3. the ratio of FEV1 to FVC

    Time frame: up to 4 weeks

    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).

  4. COPD Assessment Test (CAT) score

    Time frame: up to 4 weeks

    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.

  5. modified Medical Research Council (mMRC) score

    Time frame: up to 4 weeks

    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."

  6. Baseline Dyspnea Index (BDI) score

    Time frame: up to 4 weeks

    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.

  7. Transition Dyspnea Index (TDI) score

    Time frame: up to 4 weeks

    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.

Secondary outcomes

  1. Traditional Chinese Medicine (TCM) symptom score

    Time frame: up to 4 weeks

    The main symptoms and secondary symptoms are graded from mild to severe into 4 levels. The main symptoms are scored 0, 2, 4, 6 points respectively, and the secondary symptoms are scored 0, 1, 2, 3 points respectively. The tongue and pulse are not scored. The sum of the scores for all symptoms is the total TCM symptom score.

  2. alanine aminotransferase

    Time frame: up to 4 weeks

    The reference range is 0-40 U/L.

  3. aspartate aminotransferase

    Time frame: up to 4 weeks

    The reference range is 0-40 U/L.

  4. urea nitrogen

    Time frame: up to 4 weeks

    Reference range value 3.2-7.1 mmol/L

  5. serum creatinine

    Time frame: up to 4 weeks

    Reference range value: Males 53-106 μmol/L, Females 44-97 μmol/L

  6. uric acid

    Time frame: up to 4 weeks

    Normal serum uric acid values: for adult males, 149-416 μmol/L; for adult females, 89-357 μmol/L.

Study contacts

Contact information is provided by the study sponsor or research team.

Jin Dai, Attending Physician

CONTACT

[email protected]

0316-17590826125

Sponsors and collaborators

Lead sponsor

Fourth Affiliated Hospital of Xinjiang Medical University

Other

Collaborators

  • Beijing University of Chinese Medicine

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 6, 2024
Registry last updated
Nov 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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