CTRI/2008/091/000089招募中2 期
A proof of concept prospective, randomized parallel open clinical study to evaluate the effect of PHP-TB in patients of Pulmonary Tuberculosis.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Patients between 25-50 yrs. of age of either sex,
- •2.Newly diagnosed untreated patients of pulmonary tuberculosis.
排除标准
- •1.Extra pulmonary cases of tuberculosis.
- •2. History of chronic alcohol intake or smoking.
- •3. HIV Positivity, diabetes mellitus, autoimmune disease, Hepatitis B.
- •4. Pregnancy and lactation.
- •5. Has participated in any investigational study 4 weeks prior to the enrollment in this study.
- •6. Known history of hypersensitivity reactions.
- •7. Confirmed or suspected immunosuppressive or immune deficient condition.
- •8. Family h/o congenital or hereditary immunodeficiency
- •9. Chronic administration of immunosuppressants or other immune modifying agents 6 months prior to the study.
- •10. Administration of immunoglobulins 3 months preceding the enrollment in the study.
- •11. Patients with impaired hepatic functions.
- •12. Patients with impaired renal functions.
- •13. Seizure disorder
- •14. Patients with known symptoms of cardiac disease like Coronary artery disease, arrhythmias.
研究者
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