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Tuberculosis-related Obstructive Pulmonary DiseaseEarly Phase 1NCT06676800

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

A Early Phase 1 study testing Yiqi Gubiao pill in people with Tuberculosis-related Obstructive Pulmonary Disease, run by Fourth Affiliated Hospital of Xinjiang Medical University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 to 75 years
What is being tested?
Yiqi Gubiao pill
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
74 participants
Where
No sites listed yet
Study dates
30 Nov 2024to 31 Mar 2025
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • -
  • 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.

Who cannot join

  • -
  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Jin Dai, Attending Physician contact

0316-17590826125

daijintcm@163.com

About this study

Official 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

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.

Being tested
Yiqi Gubiao pill, Yiqi Gubiao Pill placebo
Keywords
Pulmonary tuberculosis, Yiqi Gubiao Pills, Chronic Obstructive Pulmonary Disease, Randomized double-blind placebo-controlled trial
Medical subject headings
Tuberculosis, Pulmonary, Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Yiqi Gubiao pillDrug

    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 placeboDrug

    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.

Study groups in NCT06676800
Study groupRoleWhat they receive
Yiqi Gubiao pillExperimentalNot described
Receives: Drug: Yiqi Gubiao pill
Yiqi Gubiao Pill placeboPlacebo comparatorNot described
Receives: Drug: Yiqi Gubiao Pill placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: up to 4 weeks

  2. 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.

    Measured: up to 4 weeks

  3. 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).

    Measured: up to 4 weeks

  4. 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.

    Measured: up to 4 weeks

  5. 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."

    Measured: up to 4 weeks

  6. 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.

    Measured: up to 4 weeks

  7. 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.

    Measured: up to 4 weeks

Secondary outcomes (6)

  1. 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.

    Measured: up to 4 weeks

  2. alanine aminotransferase

    The reference range is 0-40 U/L.

    Measured: up to 4 weeks

  3. aspartate aminotransferase

    The reference range is 0-40 U/L.

    Measured: up to 4 weeks

  4. urea nitrogen

    Reference range value 3.2-7.1 mmol/L

    Measured: up to 4 weeks

  5. serum creatinine

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

    Measured: up to 4 weeks

  6. uric acid

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

    Measured: up to 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2024
  2. Study start30 Nov 2024 (estimated)
  3. Primary completion28 Feb 2025 (estimated)
  4. Study completion31 Mar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
74 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06676800
Sponsor's protocol ID
2021D01C215
Status last verified
Nov 2024
First submitted
1 Nov 2024
Last updated
6 Nov 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 36521512

  • 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.

    PubMed 41132532

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Yiqi Gubiao pill in people with Tuberculosis-related Obstructive Pulmonary Disease, run by Fourth Affiliated Hospital of Xinjiang Medical University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jin Dai, Attending Physician (0316-17590826125, daijintcm@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Forced Vital Capacity (time frame: up to 4 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06676800, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2024.

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