Clinical trial NCT06403943: Efficacy Safety BaiDiZiYin ShenQiYiFei Adjunctive Treatments Pulmonary Tuberculosis
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Adjuvant
Treatment
Tuberculosis
Lead sponsor: Beijing Chest Hospital
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital with Nanjing Medical University
name: Shenyang Tenth People's Hospital
name: Lanzhou Pulmonary Hospital
name: Hebei Chest Hospital
name: Anhui Chest Hospital
name: Chongqing Public Health
name: Chengdu Public Health Clinical Medical Center
name: Guangzhou Chest Hospital.
name: Third People's Court of Shenzhen
name: Heilongjiang Provincial Institute of Infectious Disease Prevention and Control
name: Wuhan tuberculosis Hospital
name: Suzhou Fifth Hospital
First posted: 2024-05-08
Enrollment: 292
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 1. Research drugs: Bai Di Zi Yin Wan and Shen Qi Yi Fei Wan.
2. Research objective: To evaluate the symptom improvement of Baidi Ziyin Pill and Shenqi Yifei Pill in the adjuvant treatment of newly treated pulmonary tuberculosis; Explore the sputum negative conversion time and sputum negative conversion rate of Baidi Ziyin Pill and Shenqi Yifei Pill as adjunctive treatments for newly treated pulmonary tuberculosis; Explore the protective effects of Baidi Ziyin Pill and Shenqi Yifei Pill on adverse reactions caused by chemotherapy.
3. Study design: A randomized, controlled, multicenter clinical study.
4. Clinical staging: re evaluation after listing.
5. Treatment plan:

Experimental group: Take Bai Di Zi Yin Wan in the morning, 45 pills per time; Take 45 pills of Shenqi Yifei Pill per time at night, combined with a first-line anti tuberculosis regimen of 2HRZE Control group: Antituberculosis chemotherapy Recommended frontline anti tuberculosis regimen: 2HRZE Isoniazid (0.3g), rifampicin (0.45g for weight 50kg and below, 0.6g for weight 50kg and above), pyrazinamide (1.5g), ethambutol (0.75g for weight 50kg and below, 1.0g for weight 50kg and above), once a day, for a course of 8 weeks.

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.

Primary outcomes:
measure: Primary Outcome: Improvement of symptoms
timeFrame: The Time Frame is 2 months. After 2 months, the following indicators are divided into: none (0 points); Light (1 point); Medium (2 points); Heavy (3 points).
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chest Hospital affiliated to Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Chest Hospital
name: WENJUAN NIE, DR
role: STUDY_DIRECTOR
References: