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Clinical study of sodium p-aminosalicylate enteric coated tablets in the treatment of retreated pulmonary tuberculosis

The safety and early efficacy of sodium aminosalicylate enteric coated tablets in the treatment of first retreated sputum biologically positive pulmonary tuberculosis patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036179
Enrollment
Unknown
Registered
2020-08-21
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-08-31

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

Conditions

Tuberculosis

Interventions

experimental group:Use The amino acid sodium
control group:streptomycin

Sponsors

Shanghai pulmonary hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. For the first time the retreatment tuberculosis patients comply with any of the following conditions: (1) The AFB sputum smear positive and/or sputum culture positive TB and non rifampicin resistance; (2) Device MTB/RIF sputum positive; 2. Without recurrent scheme anti-tuberculosis treatment, ages 18 to 65 years old; 3. Normal kidney function; 4. Good blood sugar control in diabetic patients, the group is less than 7 tendency/L and fasting glucose Hb1AC < 7.0%.

Exclusion criteria

Exclusion criteria: 1) With pulmonary tuberculosis (TB), including but not limited to, tuberculous pleurisy and intrathoracic lymph node tuberculosis, tracheal bronchial tuberculosis (see national tuberculosis classification standard WS196-2017); 2) The scheme of any drug allergies; 3) Pregnancy or combined liver and kidney, metabolism, autoimmune disease, nerve, spirit or endocrine disease, blood system diseases, malignant tumor, long-term use of immunosuppressive or HIV/AIDS patients, etc.

Design outcomes

Primary

MeasureTime frame
liver function test;sputum culture;

Countries

China

Contacts

Public ContactHaiyan Cui

Shanghai Pulmonary Hospital

cuihaiyan23@163.com+86 18616807019

Outcome results

None listed

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