Using BaidiZiyin and ShenqiYifei Pills to treat pulmonary tuberculosis

A Randomized, Controlled, Multicenter Clinical Study on the Efficacy and Safety of BaiDiZiYin Pill and ShenQiYiFei Pill as Adjunctive Treatments for Newly Diagnosed Pulmonary Tuberculosis Patients

This study is testing if adding BaidiZiyin and ShenqiYifei pills to standard treatment can help people newly diagnosed with pulmonary tuberculosis feel better and reduce side effects from their medication.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 292 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Beijing Chest Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06403943 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of BaidiZiyin Pill and ShenqiYifei Pill as adjunctive treatments for patients newly diagnosed with pulmonary tuberculosis. Participants will receive these traditional Chinese medicine pills alongside standard Western anti-tuberculosis chemotherapy. The study aims to assess symptom improvement, sputum negative conversion rates, and the protective effects of these pills against chemotherapy-related adverse reactions. It is designed as a randomized, controlled, multicenter clinical trial.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 who have been newly diagnosed with pulmonary tuberculosis and have not previously received anti-tuberculosis treatment.

Not a fit: Patients who have received anti-tuberculosis treatment for more than one week or do not meet the diagnostic criteria for pulmonary tuberculosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance treatment outcomes for patients with pulmonary tuberculosis by improving symptom management and reducing side effects from chemotherapy.

How similar studies have performed: While the use of traditional Chinese medicine in conjunction with Western treatments is common, the specific combination of BaidiZiyin and ShenqiYifei Pills for tuberculosis treatment is relatively novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Beijing, Beijing Municipality

• Beijing Chest Hospital affiliated to Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Wenjuan Nie, Dr

Conditions Adjuvant; Treatment; Tuberculosis