A multicenter randomized, double-blind, parallel controlled, trial for integrated traditional Chinese medicine and western short-course chemotherapy in the treatment of multidrug resistance pulmonary tub
- Conditions
- Pulmonary tuberculosis
- Registration Number
- ITMCTR1900002779
- Lead Sponsor
- onghua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1. Mycobacterium tuberculosis in sputum (rifampicin resistant) was diagnosd positive by Xpert PCR;
2. BD960 Mycobacterium tuberculosis in sputum was positive for Mycobacterium tuberculosis;
3. The drug sensitivity test of BD960 showed that isoniazid and rifampicin were resistant simultaneously;
4. Conform to the established TCM syndrome standard;
5. Aged 18 to 65 years;
6. Accept the drug treatment voluntarily and sign the informed consent.
1. ten items of BD drug sensitivity exclude XDR-TB;
2. the continuous course of disease was more than 5 years and the number of retreatment times was more than 2 times in the past;
3. chest CT showed that the diameter of pulmonary cavity was more than 5cm or the number of cavities was more than 5;
4. with the history of massive hemoptysis;
5. body mass index (BMI) was less than 19;
6. tuberculosis but not Pulmonary tuberculosis, such as lymphoid tuberculosis, bone tuberculosis and brain tuberculosis;
7. family history of mental disease; respiratory failure; severe peptic ulcer; malignant tumor; AIDS; autoimmune disease;
8. legally disabled patients;
9. do not take oral medication;
10. pregnant, preparing pregnant or lactating women;
11. those who are allergic to the test drug and its components;
12. QT interval in ECG is greater than 500 ms after correction;
13. patients with abnormal liver function (ALT more than 1.2 times of the upper limit of normal), or positive for HBsAg, HBeAg and HBcAg at the same time;
14. poor control of blood glucose in diabetic patients (fasting blood glucose > 7mmol/L, postprandial blood glucose > 11mmol/L);
15. the researchers determined that the patients could not complete the treatment in the trial period because of the existence risk of other diseases;
16. those who cannot judge the efficacy or incomplete data, which affect the efficacy or safety judgment.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse reaction rate;Cure rate;improvement ratio;Adverse reaction rate;Sputum smear positive rate;the detection rate of Mycobacterium tuberculosis culture in sputum;
- Secondary Outcome Measures
Name Time Method the rate cavity closing up;rates of focus absorption;