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A multi-center, randomized, double-blind, parallel placebo trial to evaluate the clinical efficacy of glucocorticosteroid for tuberculous pleurisy

A multi-center, randomized, double-blind, parallel placebo trial to evaluate the clinical efficacy of glucocorticosteroid for tuberculous pleurisy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-09000747
Enrollment
Unknown
Registered
2009-12-17
Start date
2010-01-01
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

Group A:prednisone:orally taken 30 mg once daily for two weeks, then reduce to 20 mg once daily for 3th week
finally reduce to 10 mg for 4th week
Group B:Placebo:orally taken 30 mg once daily for two weeks, then reduce to 20 mg once daily for 3th week

Sponsors

Wuhan Union Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. To be aged 18 to 65 years; Male or female; 2. Presented with typical clinical features and signs suggesting pleurisy; 3. Willing to join this study and sign informed consent form; 4. Consisten;t with the diagnosis criteria in patients with tuberculous pleurisy.

Exclusion criteria

Exclusion criteria: 1. Severe cardiac diseases,lung diseases, hematological diseases, malignant tumor, hypoimmunity diseases, mental diseases, diabetes; 2. digestive system diseases,such as peptic ulcer or alimentary tract hemorrhage; 3. Abnormal of blood-fasting sugar or postprandial blood sugar(2 hours); 4. Chronic liver diseases,such as viral hepatitis type B or C; 5. Chronic hepatic or renal inadequacy (ALT>1.5 upper limits of normal;Cr>upper limits of normal); 6. Alcohol or drug abuse; 7. Package chest or pachynsis pleurae; 8. The course of disease >14 days; 9. Anti-tuberculosis therapy >30 days; 10. Woman with pregnant or lactation; 11. Have accepted glucocorticosteroid; 12. Participate in other clinical trials within three weeks; 13. Contraindication to glucocorticosteroid.

Design outcomes

Secondary

MeasureTime frame
time of pleural thickening;time of pleural effussion absorptionsorption;

Primary

MeasureTime frame
time of pleural thickening;

Countries

China

Contacts

Public ContactHuangzhong Shi
xinjbwh@163.com+86 027 85726010

Outcome results

None listed

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