Pulmonary Tuberculosis
Conditions
Interventions
Treatment Group:Western Medicine Chemotherapy Protocol + NiuBeiXiaoHe Decoction
Control Group:Western Medicine Chemotherapy Protocol
Sponsors
The Eighth Medical Center of the PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Western Medicine Inclusion Criteria (according to the health industry standard of the People's Republic of China "WS 288-2017 Diagnosis for Pulmonary Tuberculosis"): (1) Age:18 to 65 years old, gender (unspecified); (2) Suspicious symptoms of pulmonary tuberculosis, such as cough, expectoration, or hemoptysis, with or without night sweats, fatigue, intermittent or persistent low fever in the afternoon, loss of appetite, weight loss, etc.; (3) Pulmonary X-ray examination shows lesions; (4) Sputum or bronchoalveolar lavage fluid examination: positive acid-fast staining test on smear; or positive mycobacterial culture with Mycobacterium tuberculosis complex identified; or positive nucleic acid test for Mycobacterium tuberculosis. 2.Traditional Chinese Medicine Diagnostic Criteria: Yin deficiency with hyperactivity of fire, phlegm-heat obstructing the lungs (Yin deficiency with phlegm heat). Elements of pulse and tongue diagnosis: fine or rapid or fine and slippery pulse, red tongue. Main symptoms: cough, expectoration, tidal fever, hemoptysis. Yin deficiency syndrome elements: emaciation, redness of cheekbones, night sweats, dry mouth, difficulty in bowel movements. Possible accompanying symptoms: Spontaneous sweating, fatigue, shortness of breath.
Exclusion criteria
Exclusion criteria: 1. Patients with multidrug-resistant or extensively drug-resistant pulmonary tuberculosis; 2. Those with HIV co-infection; 3. Individuals with abnormal liver function (AST and ALT levels exceeding the normal upper limit by three times) and/or positive for both HBeAg and HbcAg; 4. Patients with serious primary diseases such as cardiovascular and cerebrovascular, kidney, or hematopoietic system diseases, gastrointestinal ulcer diseases, or severe diseases affecting their survival (such as cancers); 5. Exclusion criteria for Traditional Chinese Medicine (TCM): Yang deficiency syndrome elements, such as a pale tongue, loose stools, cold intolerance, and delayed pulse. The patient with anyone mentioned above can be ruled out; 6. Patients who are allergic to any of the Western medicine or Traditional Chinese Medicine in the trial protocol; 7. Pregnant, planning to become pregnant, or breastfeeding women, or those with plans for pregnancy within the past 12 months; 8. Patients with mental or legal disabilities. 9. Those who have participated in other clinical trials within the past 3 months, or other situations deemed unsuitable for participation in this trial by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sputum smear;Rapid Mycobacterial Culture (for sputum or other clinical samples);Chest Computed Tomography (CT);Nucleic Acid Detection of Mycobacterium Tuberculosis; | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptom Score;Lymphocyte Subset Analysis;? Interferon Release Assay (IGRA); Quality of Life Assessment; | — |
Countries
China
Contacts
Public ContactXueqiong Wu
The Eighth Medical Center of PLA General Hospital
Outcome results
None listed