Efficacy Safety BaiDiZiYin ShenQiYiFei Adjunctive Treatme... | NCT06403943

NCT06403943

Protocol Section

Identification Module

Results Section

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Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

Status Module

Name	Class
The First Affiliated Hospital with Nanjing Medical University	OTHER
Shenyang Tenth People's Hospital	OTHER
Lanzhou Pulmonary Hospital	UNKNOWN

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental group	Experimental	BaidiZiyin Wan and ShenqiYifei Wan are traditional Chinese medicines. Used as an adjuvant therapy for pulmonary tuberculosis. It is mainly used to improve the symptoms of tuberculosis (including fever, cough, expectoration, blood sputum or hemoptysis, anorexia, chest pain, emaciation, night sweats).	Drug: BaiDiZiYin Pill, ShenQiYiFei Pill Drug: Anti tuberculosis chemotherapy
Control group	Active Comparator	2 months' intensive regimen of anti tuberculosis chemotherapy Recommended first-line anti tuberculosis regimen: 2HRZE	Drug: Anti tuberculosis chemotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BaiDiZiYin Pill, ShenQiYiFei Pill	Drug	Indications of BaidiZiyin Pill: Nourishing the lungs and kidneys, cooling blood and removing steam. Used as an adjunctive treatment for tuberculosis caused by lung and kidney deficiency and qi yin injury, including coughing, shortness of breath, dry cough with less phlegm, hot flashes and night sweats, cold and spontaneous sweating, hoarseness, palpitations, cold limbs, and emaciation. Indications of ShenqiYifei Pill: expectorant and cough relieving. It is suitable for patients with pulmonary tuberculosis and spleen diseases, as well as phlegm dampness retention. Symptoms include short breath, low sound, clear and thin phlegm, limited appetite, bloating and loose stools, pale complexion, fatigue and chest tightness, emaciation, and fear of cold and spontaneous sweating.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary Outcome: Improvement of symptoms	The change rate of symptoms and the overall clinical symptom score of pulmonary tuberculosis. The following indicators are divided into: none (0 points); Light (1 point); Medium (2 points); Heavy (3 points). Fatigue: None; Labor leads to fatigue; If you move, you will feel tired; Not moving is also lacking. Hemoptysis: None; Occasional hemoptysis or sputum with blood streaks; Occasional or minor hemoptysis; Frequent or moderate to massive hemoptysis. Cough: None; Intermittent coughing during the day does not affect work and life; Can persist in working despite coughing during the day or occasional coughing at night; Frequent coughing or working during the day and night can affect work and life. Phlegm: None; Cough 10-15ml of phlegm day and night; Cough 50-100ml of phlegm day and night; Coughing more than 100ml day and night. Chest pain: None; Mild chest pain; Chest pain is obvious but tolerable; Chest pain significantly affects respiratory cough.	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).

Eligibility Module

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.

ID	Term
D009164	Mycobacterium Infections
D000193	Actinomycetales Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections

ID	Term
D007538	Isoniazid
D012293	Rifampin
D004977	Ethambutol

ID	Term
D006834	Hydrazines
D009930	Organic Chemicals
D007539	Isonicotinic Acids
D000147	Acids, Heterocyclic