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CompletedNCT00338793Updated Aug 26, 2008

Corticosteroids in the Treatment of Tuberculous Pleurisy

An interventional study of prednisolone in Tuberculous Pleurisy, sponsored by Guangxi Medical University. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-08-26.

Sponsored by Guangxi Medical University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
1,500
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Tuberculous pleurisy is associated with inflammation and fibrosis. Adjunctive corticosteroids are used for tuberculous pleurisy because their anti-inflammatory effect is thought to minimise pleural reactivity and thereby reduce residual pleural thickening. The purpose is to evaluate the efficacy and safety of oral prednisolone for treatment of adult patients with tuberculous pleurisy.

02

Conditions studied

  • Tuberculous Pleurisy

Keywords

  • Tuberculosis;
  • Pleural effusion;
  • Corticosteroids.
03

In context

Tuberculosis

1,435 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.

This study's planned enrollment of 1,500 is above the median of 150 across 963 interventional studies indexed under Tuberculosis.

Browse Tuberculosis studies →

Lead sponsor

Guangxi Medical University is the lead sponsor of 69 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Signed written informed consent;
  • Presented with clinical features suggesting pleural tuberculosis;
  • Had not previously received treatment or prophylaxis for tuberculosis;
  • Had not recently received treatment with glucocorticoids;
  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
1,500 participants (estimated)

Interventions

06

What researchers measure

Primary outcomes

  1. Death

  2. Presence of pleural thickening

  3. Pulmonary function at completion of treatment

  4. Adverse drug effects

Secondary outcomes

  1. Improvement in clinical symptoms and signs (such as pleuritic chest pain, temperature)

  2. Reabsorption of pleural effusion

  3. Failure rate at the end of treatment

07

Study locations

1 site
  • Huan-Zhong Shi
    Nanning, Guangxi 530021, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00338793
Lead sponsor
Guangxi Medical University
Collaborators
National Natural Science Foundation of China, Ministry of Education, China, Bureau of Science and Technology of Guangxi Province, China
First posted
Jun 20, 2006
Start date
Jul 2006
Completion
Aug 2008
Last update
Aug 26, 2008

Study contacts

Huan-Zhong Shi, MD, PhD
study chair · Institute of Respiratory Diseases, First Affiliated Hospital, Guangxi Medical University, Nanning 530021, Guangxi, China
Zhan-Cheng Gao, MD, PhD
principal investigator · Department of Respiratory Diseases, People's Hospital, Peking University, Beijing, China
Xin Zhou, MD
principal investigator · Department of Respiratory Diseases, First Affiliated Hospital, Shanghai Jiaotong University, Shanghai, China

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2008. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Prednisolone

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