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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tuberculosis-related Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: Yiqi Gubiao pill; Drug: Yiqi Gubiao Pill placebo

• Study Type: Interventional
• Enrollment (Estimated): 74
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Jin Dai, Attending Physician; Phone Number: 0316-17590826125; Email: daijintcm@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Yiqi Gubiao pill	Drug: 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.
Placebo Comparator: Yiqi Gubiao Pill placebo	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Traditional Chinese Medicine (TCM) symptom score	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.	up to 4 weeks
alanine aminotransferase	The reference range is 0-40 U/L.	up to 4 weeks
aspartate aminotransferase	The reference range is 0-40 U/L.	up to 4 weeks
urea nitrogen	Reference range value 3.2-7.1 mmol/L	up to 4 weeks
serum creatinine	Reference range value: Males 53-106 μmol/L, Females 44-97 μmol/L	up to 4 weeks
uric acid	Normal serum uric acid values: for adult males, 149-416 μmol/L; for adult females, 89-357 μmol/L.	up to 4 weeks

Collaborators and Investigators

• Sponsor: Fourth Affiliated Hospital of Xinjiang Medical University
• Collaborators: Beijing University of Chinese Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): November 30, 2024
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: November 1, 2024
• First Submitted That Met QC Criteria: November 5, 2024
• First Posted (Actual): November 6, 2024

Study Record Updates

• Last Update Posted (Actual): November 6, 2024
• Last Update Submitted That Met QC Criteria: November 5, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Chronic Obstructive Pulmonary Disease; Pulmonary tuberculosis; Yiqi Gubiao Pills; Randomized double-blind placebo-controlled trial
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Actinomycetales Infections; Mycobacterium Infections; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Tuberculosis; Tuberculosis, Pulmonary
• Other Study ID Numbers: 2021D01C215

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No