Effectiveness of nutritional supplementation in improving tuberculosis treatment outcomes

Phase 4

Completed

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

• Registration Number: CTRI/2019/12/022574
• Lead Sponsor: Indian Council of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-02-01
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 335

Inclusion Criteria

1.Sputum positive for M. tuberculosis either by sputum smear microscopy or by (CBNAAT)

2.Aged 18 years or more

3.Has BMI between 14 -18.5 Kg/m2

4.No prior history of ATT (i.e. < 7 daily or 3 intermittent doses of ATT)

5.At least 1 sputum should be RMP sensitive by CBNAAT

6.Is willing to have an HIV test.

7.Female of child bearing age with no intention to become pregnant during the study period

8.Residing in Ballabgarh Block.

Exclusion Criteria

5.Sero-positive for HIV virus antibodies either by ELISA or by rapid test

6.Is pregnant or lactating

7.Known case of diabetes mellitus/RBS > 200mg /FBS >126 mg/dl

8.Poor general condition or has any condition (social or medical) which in the opinion of the investigator would make trial participation unreliable or unsafe.

9.Is allergic to the constituents of EDNS such as peanut etc.

Study & Design

• Study Type: Interventional
• Study Design: Not specified