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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900027432
Enrollment
Unknown
Registered
2019-11-13
Start date
2019-12-01
Completion date
Unknown
Last updated
2019-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pulmonary tuberculosis

Interventions

Sponsors

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

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

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.

Design outcomes

Primary

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

Countries

China

Contacts

Public ContactLU Zhenhui

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

tcmdoctorlu@163.com+86 13817729859

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026