Efficacy Safety BaiDiZiYin ShenQiYiFei Adjunctive Treatments Pulmonary Tuberculosis

Launched by BEIJING CHEST HOSPITAL · May 3, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at the effectiveness and safety of two herbal treatments, BaidiZiyin Pill and ShenqiYifei Pill, when added to standard Western medicine for patients with newly diagnosed pulmonary tuberculosis (TB). The goal is to see if these herbal treatments can help improve symptoms, speed up the time it takes for patients to stop producing TB bacteria in their sputum (the mucus from the lungs), and reduce any side effects from the main TB medications.

To participate in this trial, you need to be between 18 and 65 years old and have a confirmed diagnosis of pulmonary tuberculosis. You should not have started TB treatment before or have only been on it for less than a week. Participants will be closely monitored throughout the study for any changes in their symptoms and overall health. This trial is currently recruiting and aims to provide valuable information on how these herbal pills might support traditional TB treatments.

Gender

ALL

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.