A new scheme of traditional Chinese medicine treatment for drug-resistant tuberculosis

Not Applicable

• Conditions: pulmonary tuberculosis

• Registration Number: ITMCTR1900002749
• Lead Sponsor: onghua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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.

Exclusion Criteria

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
Height;Local absorptivity;age;Adverse reaction rate;Weight;Improvement rate;survival time;Negative conversion rate of Mycobacterium tuberculosis in sputum culture;cure rate;cavities closen rate;