Not Yet RecruitingEarly Phase 1

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

74 participantsStarted 2024-11-30

Plain-language 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.

Who can participate

Age range

40 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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 with pneumothorax, pleural effusion, lung cancer and other serious lung diseases;
. Patients with severe cardiovascular and cerebrovascular, hepatorenal and hematopoietic diseases;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Forced Vital Capacity

Timeframe: up to 4 weeks

the percentage of FVC predicted

Timeframe: up to 4 weeks

the ratio of FEV1 to FVC

Timeframe: up to 4 weeks

COPD Assessment Test (CAT) score

Timeframe: up to 4 weeks

modified Medical Research Council (mMRC) score

Timeframe: up to 4 weeks

Baseline Dyspnea Index (BDI) score

Timeframe: up to 4 weeks

Transition Dyspnea Index (TDI) score

Timeframe: up to 4 weeks

Trial details

NCT IDNCT06676800

SponsorFourth Affiliated Hospital of Xinjiang Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02-28

Contact for this trial

Jin Dai, Attending Physician

0316-17590826125 daijintcm@163.com

View on ClinicalTrials.gov More Tuberculosis-related Obstructive Pulmonary Disease trials

Plain-language summary

Who can participate

Age range

40 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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 with pneumothorax, pleural effusion, lung cancer and other serious lung diseases;
. Patients with severe cardiovascular and cerebrovascular, hepatorenal and hematopoietic diseases;

What they're measuring

Forced Vital Capacity

Timeframe: up to 4 weeks

the percentage of FVC predicted

Timeframe: up to 4 weeks

the ratio of FEV1 to FVC

Timeframe: up to 4 weeks

COPD Assessment Test (CAT) score

Timeframe: up to 4 weeks

modified Medical Research Council (mMRC) score

Timeframe: up to 4 weeks

Baseline Dyspnea Index (BDI) score

Timeframe: up to 4 weeks

Transition Dyspnea Index (TDI) score

Timeframe: up to 4 weeks