Enhancing patients defense against TB for early recovery.

Not Applicable

• Conditions: Health Condition 1: A150- Tuberculosis of lung

• Registration Number: CTRI/2020/03/023815
• Lead Sponsor: Department of Biotechnology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Patients of 18 to 60 yrs of age; either sex.

2. DR-TB patients.

3. DS-TB patients.

Exclusion Criteria

1.Hypersensitivity anti-TB drugs.

2.Presence of secondary immunodeficiency states : Organ transplantation, diabetes mellitus, malignancy, treatment with cytotoxic drugs and corticosteroids

4. Currently receiving cytotoxic therapy, or have received it within the last 3 months

5. Pregnancy and lactation.

6. Patients with known symptomatic cardiac disease, such as arrhythmias or coronary artery disease, marked tachypnoea, chronic cor pulmonale, congestive cardiac failure.

7. Patients with hematological abnormalities (WBC less than or equal to 3000/mm3; platelets less than or equal to 100,000/mm3).

8. Seriously ill and moribund patients with complications.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients with Sputum Culture Negative Time to Sputum culture conversion, Number of patients with reduction of bacillary load, Number of patients with improvement or resolution of clinical signs and symptoms, Number of patients with improvement or resolution of chest RX image associated with active TB, Immunogenic properties compared to placebo assessed by cellular populations in ex vivo stimulated peripheral blood mononuclear cellsTimepoint: Month 1, 2 and 6 for DS patients <br/ ><br>Month 1,2, 6, 12, and 24 for DR patients

Secondary Outcome Measures

Name	Time	Method
Time to Sputum culture conversion, Number of patients with reduction of bacillary load, Number of patients with improvement or resolution of clinical signs and symptoms, Number of patients with improvement or resolution of chest RX image associated with active TB, Immunogenic properties compared to placebo assessed by cellular populations in ex vivo stimulated peripheral blood mononuclear cellsTimepoint: month 1, 2 and 6 for DS patients <br/ ><br>Month 1,2, 6, 12, and 24 for DR patients