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Multicenter, Randomized and Double-blind Controlled Clinical Trial of Integrative Medicine Therapy for Treatment of multi-drug-resistant pulmonary tuberculosis

Multicenter, Randomized and Double-blind Controlled Clinical Trial of Integrative Medicine Therapy for Treatment of multi-drug-resistant pulmonary tuberculosis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12002850
Enrollment
Unknown
Registered
2012-08-09
Start date
2012-12-05
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Multi-drug resistant pulmonary tuberculosis (MDR-PTB)

Interventions

treatment group:Conventional treatment+ traditional Chinese medicine

Sponsors

Longhua Hospital Affiliated Shanghai University of TCM
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
15 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Sputum cultures positive for Mycobacterium tuberculosis that is resistant at least to isoniazid (INH) and rifampicin (RMP); 2. Syndrome differentiation belongs to syndrome of yin deficiency and lung heat, syndrome of qi and yin deficiency; 3. Aged 18 to 65 years; 4. course of tuberculosis>=2 months, <=8 years; 5. patients have fully understand the study, voluntary take the test and informed agreement signed.

Exclusion criteria

Exclusion criteria: 1. Extensively drug-resistant pulmonary tuberculosis; 2. Complicated with HIV infection; 3. Abnormal liver function(serum level of ASK and ALT was 1.2 times higher than normal level ) and/or HBsAg positive,HbeAg positive, HbcAg positive; 4. Chronic kidney disease and abnormal renal function; 5. Plasma glucose poorly controlled undertaking(FBG>7.0mmol/L or 2h PBS>11.1mmol/L); 6. Complicated with severe primary disease such as cardio-cerebrovascular disease, kidney disease, hematopoietic system disease, gastrointestinal ulcer, caners; 7. Allergic to the therapeutic medicine; 8. Pregnant, ready to be pregnant or breast-feeding women; 9. Patients with mental or legal disabilities.

Design outcomes

Secondary

MeasureTime frame
Change of the TCM syndrome scores;Treatment failure rate;Treatment completion rate;immunologic function(CD3, CD4, CD8);Change of body mass index;Quality of life score (SF36 score);Erythrocyte Sedimentation Rate (ESR);

Primary

MeasureTime frame
sputum negative conversion rate;Changes in pulmonary lesions;Time to sputum culture conversion;

Countries

China

Contacts

Public ContactHuiyong Zhang
tcmdoctorlu@163.com+86 13817729859

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 8, 2026