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
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The patients will be evaluated for various parameters like weight gain, improved QOL , sputum for AFB , X-ray chest ,Elisa for TNF - α and IL-1β and flow cytometry for various immune parameters like IFN-Ύ, IL-2, CD3+, CD4+, CD8+.
研究概览
简要总结
The present prospective open randomized parallel study will be conducted in the post graduate department of pharmacology and therapeutics in collaboration with the department of chest diseases, Govt. Medical College Jammu and Indian Institute of Integrative Medicine (CSIR), JammuThe study will be done to evaluate the effect of PHP-TB i.e. formulation containing hydro-alcoholic extracts of the roots of Withania somnifera (300mg) in comparison with Placebo (300mg) in patients of Pulmonary Tuberculosis. Newly diagnosed 60 patients of pulmonary tuberculosis will be given anti-tubercular treatment for 6 months – Group I. Likewise, newly diagnosed 60 patients of pulmonary tuberculosis will be given anti-tubercular treatment along with Withania somnifera (PHP-TB) cap.for 6 months –Group II. 60 normal healthy individuals from similar population will be taken as a control group – Group III. The primary outcome measures will be 10% improvement in biochemical and immunological parameters over and above that obtained in the group receiving placebo and less than 10% difference in adverse events between placebo and active treatment groups.Both the groups will be evaluated for parameters like weight, LFT, sputum, X-ray chest and Elisa and flow cytometry for immune parameters.
研究设计
- 分配方式
- Random Number Table
- 盲法
- Open Label
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.
- •History of chronic alcohol intake or smoking.
- •HIV Positivity, diabetes mellitus, autoimmune disease, Hepatitis B.
- •Pregnancy and lactation.
- •Has participated in any investigational study 4 weeks prior to the enrollment in this study.
- •Known history of hypersensitivity reactions.
- •Confirmed or suspected immunosuppressive or immune deficient condition.
- •Family h/o congenital or hereditary immunodeficiency
- •Chronic administration of immunosuppressants or other immune modifying agents 6 months prior to the study.
- •Administration of immunoglobulins 3 months preceding the enrollment in the study.
- •Patients with impaired hepatic functions.
- •Seizure disorder
- •Patients with known symptoms of cardiac disease like Coronary artery disease, arrhythmias.
结局指标
主要结局
The patients will be evaluated for various parameters like weight gain, improved QOL , sputum for AFB , X-ray chest ,Elisa for TNF - α and IL-1β and flow cytometry for various immune parameters like IFN-Ύ, IL-2, CD3+, CD4+, CD8+.
时间窗: 8 weeks onwards
次要结局
- Not Applicable(Not Applicable)