An open label, Balanced, Randomized, Active control clinical trial to compare Safety and Efficacy of Risorine Capsule in adult patients with RNTCP Category I Pulmonary Tuberculosis

Dr Randeep Guleria0 个研究点目标入组 144 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1. 18 to 65 years of age
•2. Either sex
•3. Weight below 60 kg
•4. Patients with first time diagnosed of pulmonary tuberculosis that are sputum positive and have radiological and clinical features
•5. Patients who are willing to sign informed consent

•1. Hypersensitive to any of the study drugs
•2. Pregnant and lactating females
•3. Seriously ill and moribund patients
•4. Presence of systemic diseases such as HIV, seizure disorder, diabetes mellitus, congestive heart failure or malignancy
•5. Hepatitis B and hepatitis C positive patients
•6. Currently receiving cytotoxic therapy, or have received it within the last 3 months
•7. Patients of organ transplantation receiving immunosuppressive drugs.
•8. Patients on systemic corticosteroids for more than 7 days
•9. Patients with abnormal renal function
•10. Patients with abnormal hepatic function
•11. Patients with abnormal hematologic function 12. Patient unable, in the judgement of investigator, to comply with the treatment regimen
•13. Patients unwilling or unable to comply with study procedures
•14. Patients with history of alcohol or drug abuse.

发起方

Dr Randeep Guleria