NCT06403943 Efficacy Safety BaiDiZiYin ShenQiYiFei Adjunctive Treatments Pulmonary Tuberculosis
| NCT ID | NCT06403943 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Beijing Chest Hospital |
| Condition | Adjuvant |
| Study Type | INTERVENTIONAL |
| Enrollment | 292 participants |
| Start Date | 2023-05-29 |
| Primary Completion | 2026-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 292 participants in total. It began in 2023-05-29 with a primary completion date of 2026-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is designed to further strengthen the clinical application evidence of BaidiZiyin Pill and ShenqiYifei Pill in the treatment of tuberculosis. To be included in the initial treatment of pulmonary tuberculosis patients, on the basis of standardized Western medicine treatment, BaidiZiyin Pills and ShenqiYifei Pills will be used to evaluate the clinical efficacy and safety of their products. 1. Evaluate the improvement of symptoms in the adjuvant treatment of newly treated pulmonary tuberculosis with BaidiZiyin Pill and ShenqiYifei Pill. 2. Explore the sputum negative conversion time and sputum negative conversion rate of BaidiZiyin Pill and ShenqiYifei Pill as adjunctive treatments for newly treated pulmonary tuberculosis. 3. Explore the protective effects of BaidiZiyin Pill and ShenqiYifei Pill on adverse reactions caused by chemotherapy.
Eligibility Criteria
Inclusion Criteria: * 1\. Age: 18 to 65 years old, regardless of gender; * 2\. Meets the diagnostic criteria for Western medicine pulmonary tuberculosis (formulated in accordance with the health industry standard WS 288-2017 "Diagnosis of Pulmonary Tuberculosis" of the People's Republic of China \[9\]) * 3\. Have not received anti tuberculosis treatment in the past, or have received HRZE anti tuberculosis treatment for less than 1 week as a first-line option * 4\. The subjects themselves have informed consent, voluntarily participate in this study, have good medication compliance, and have signed the subject's informed consent form. Conforming to the diagnostic criteria for Qi and Yin deficiency syndrome in traditional Chinese medicine (in accordance with the industry standards of traditional Chinese medicine in the People's Republic of China - Traditional Chinese Medicine Internal Medicine - Diagnosis and Efficacy Criteria for Disease Symptoms ZY/T0011.1-94) Main symptoms: shortness of breath, fatigue, mental fatigue, weak pulse Secondary symptoms: hemoptysis, spontaneous sweating, night sweating, insufficient appetite, bloating, red and tender tongue, thin coating Diagnosis can be made by having two main symptoms and one secondary symptom. Exclusion Criteria: * 1\. Patients who received similar traditional Chinese medicine treatment 4 weeks prior to enrollment; * 2\. Patients with drug-resistant and extensively drug-resistant pulmonary tuberculosis; * 3\. Known or suspected to have a history of allergies or serious adverse reactions to the investigational drug and its excipients, or allergic constitution. * 4\. Patients with drug sensitivity indicating the growth of non tuberculosis mycobacteria (more than twice) or clinically diagnosed with non tuberculosis mycobacterial disease or concomitant non tuberculosis mycobacterial disease; * 5\. For patients with recurrent pulmonary tuberculosis, those with bacterial negative pulmonary tuberculosis or those with initial bacterial positive pulmonary tuberculosis who have received anti tuberculosis treatment for more than one week; * 6\. Patients with combined autoimmune diseases, malignant tumors, severe hematological and hematopoietic system diseases, epilepsy, and psychiatric disorders; * 7\. Concomitant severe organic cardiovascular and cerebrovascular diseases (such as congestive heart failure, myocardial infarction, and acute stroke with NYHA heart function grading of III-IV); * 8\. Merge uncontrolled hypertension (blood pressure ≥ 160/100mmHg at enrollment); * 9\. diabetes with poor glycemic control; * 10\. Concomitant severe liver and kidney diseases, or abnormal liver and kidney function tests (ALT, AST ≥ 2.5 times the upper limit of normal, Scr\>the upper limit of normal); * 11\. Patients with extrapulmonary tuberculosis such as lymph node tuberculosis, intestinal tuberculosis, bone tuberculosis, renal tuberculosis, epididymal tuberculosis, urogenital tuberculosis, nervous system tuberculosis, and tuberculous meningitis; * 12\. Concomitant with other lung diseases, such as lung tumors, cysts, abscesses, interstitial lung disease, silicosis, pneumoconiosis, etc * 13\. Pregnant and lactating women; * 14\. HIV patients; Syphilis antibody positive patients; * 15\. Individuals who have participated in other clinical trials within 15.1 months; * 16\. Those who suspect or have a history of alcohol or drug abuse or a tendency towards drug dependence; * 17\. The researchers believe that patients are not suitable for inclusion in this trial.
Contact & Investigator
WENJUAN NIE, DR
STUDY DIRECTOR
Beijing Chest Hospital
Frequently Asked Questions
Who can join the NCT06403943 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Adjuvant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06403943 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06403943 currently recruiting?
Yes, NCT06403943 is actively recruiting participants. Contact the research team at 94642975@qq.com for enrollment information.
Where is the NCT06403943 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06403943 clinical trial?
NCT06403943 is sponsored by Beijing Chest Hospital. The principal investigator is WENJUAN NIE, DR at Beijing Chest Hospital. The trial plans to enroll 292 participants.