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Sponsors and Collaborators: |
Guangxi Medical University National Natural Science Foundation of China Ministry of Education, China Bureau of Science and Technology of Guangxi Province, China |
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Information provided by: | Guangxi Medical University |
ClinicalTrials.gov Identifier: | NCT00338793 |
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.
Condition | Intervention |
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Tuberculous Pleurisy |
Drug: prednisolone |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Placebo-Controlled, Double-Blind, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Corticosteroids for Treatment of Patients With Tuberculous Pleurisy |
Estimated Enrollment: | 1500 |
Study Start Date: | July 2006 |
Study Completion Date: | August 2008 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
China, Guangxi | |
Huan-Zhong Shi | |
Nanning, Guangxi, China, 530021 |
Study Chair: | Huan-Zhong Shi, MD, PhD | Institute of Respiratory Diseases, First Affiliated Hospital, Guangxi Medical University, Nanning 530021, Guangxi, China |
Principal Investigator: | Zhan-Cheng Gao, MD, PhD | Department of Respiratory Diseases, People's Hospital, Peking University, Beijing, China |
Principal Investigator: | Xin Zhou, MD | Department of Respiratory Diseases, First Affiliated Hospital, Shanghai Jiaotong University, Shanghai, China |
Study ID Numbers: | Shi-TB-01 |
Study First Received: | June 19, 2006 |
Last Updated: | August 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00338793 |
Health Authority: | China: Ministry of Health |
Tuberculosis; Pleural effusion; Corticosteroids. |
Bacterial Infections Pleurisy Methylprednisolone Pleural Diseases Methylprednisolone acetate Prednisolone acetate Pleural Effusion Gram-Positive Bacterial Infections |
Respiratory Tract Diseases Respiratory Tract Infections Prednisolone Mycobacterium Infections Tuberculosis Tuberculosis, Pleural Methylprednisolone Hemisuccinate |
Anti-Inflammatory Agents Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs |
Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Glucocorticoids Pharmacologic Actions Actinomycetales Infections |