NCT06676800Not 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
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
Source: ClinicalTrials.gov · Last updated 6 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 74 (estimated)
- First submitted
- 1 Nov 2024
- Start date
- 30 Nov 2024
- Primary completion date
- 28 Feb 2025
- Lead sponsor
- Fourth Affiliated Hospital of Xinjiang Medical University
- Diseases
- Tuberculosis, COPD
- NCT number
- NCT06676800
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 74
- From 30 Nov 2024 to the primary completion date, 28 Feb 2025
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with pneumothorax, pleural effusion, lung cancer and other serious lung diseases;
- Patients with severe cardiovascular and cerebrovascular, hepatorenal and hematopoietic diseases;
Other
- \-
- Patients who meet any of the following criteria will be excluded:
- mentally ill;
- Patients with tumors;
- Congenital or acquired immunodeficiency.
Who the study is looking for
- \-
- 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.
Age in the registry: 40 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.