Clinical trial for comparing Safety and Efficacy of Bio-enhanced Rifampicin (Risorine) Capsule in Newly Diagnosed Pulmonary Tuberculosis in Adult Patients
- Conditions
- Health Condition 1: null- Newly Diagnosed Pulmonary Tuberculosis in Adult Patients
- Registration Number
- CTRI/2017/04/008329
- Lead Sponsor
- Dr Randeep Guleria
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 144
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method