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A placebo-controlled, double-blind, randomized clinical trial to evaluate the efficacy and safety of corticosteroids for treatment of patients with tuberculous pleurisy

A placebo-controlled, double-blind, randomized clinical trial to evaluate the efficacy and safety of corticosteroids for treatment of patients with tuberculous pleurisy

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13003163
Enrollment
Unknown
Registered
2013-02-28
Start date
2013-04-01
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

Tuberculous Pleurisy

Interventions

Intervention Group:prednisolone
Control:Placebo

Sponsors

Beijing Chao-Yang Hospital, Capital Medical University,Beijing Institute of Respiratory Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 65 years; 2. Genders Eligible for Study: Both; 3. Signed written informed consent; 4. Presented with clinical features suggesting pleural tuberculosis; 5. Had not previously received treatment or prophylaxis for tuberculosis; 6. Had not recently received treatment with glucocorticoids; 7. Were not pregnant or breast-feeding.

Exclusion criteria

Exclusion criteria: Failed to complete the screening procedures; Were seropositive for HIV; Tuberculous meningitis; Had risk factors for serious steroid-related adverse events (a history of diabetes or positive urine glucose, a history or clinical finding of hypertension, or a history of peptic ulcer disease or mental illness); Standard doses of antituberculosis drugs could not be used (as in participants with concurrent liver disease); Psychiatric illness; Alcoholism.

Design outcomes

Primary

MeasureTime frame
Presence of pleural thickening;Death rate;Pulmonary function at completion of treatment;Adverse drug effect;

Countries

China

Contacts

Public ContactShi huanzhong
shihuanzhong@sina.com+86 13911791398

Outcome results

None listed

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