Clinical Trial: Adjunct Immunotherapy With Immunoxel in Patients With TB and TB/HIV

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase III, Double-blind, Placebo-controlled, Randomized, 1-month Clinical Trial of Immunoxel Combined With Anti-TB Therapy Versus Anti-TB Therapy With Placebo

Brief Summary: Dzherelo (Immunoxel) is an oral immunomodulating botanical agent available over-the-counter in Ukraine. After many years of laboratory and clinical testing the formulation was approved in 1997 by the Ministry of Health of Ukraine as a dietary herbal supplement, which enhances immunity against viral and infectious diseases. The goal of this study is to conduct confirmatory clinical trial in Ukraine and Mongolia for TB indications.

Detailed Summary: Phase III, placebo-controlled trial, aimed to seek the therapeutic benefit of Immunoxel in combination with standard of care anti-TB therapy (ATT) at the end of the 1-month period (p<0.05) among subjects with sputum-positive pulmonary TB. The results will be compared to standard ATT therapy + placebo. The trial will consist of one stage with laboratory evaluation after one month. Two cohorts or arms of at least 150 subjects each (total 300) with pulmonary TB positive for sputum AFB smear will be randomized in a 1:1 ratio to receive once-daily, honey lozenge of Immunoxel in combination with standard ATT for 1 month. Patients who receive standard ATT + placebo preparation will be used as a group of comparison.
Sponsor: Lisichansk Regional Tuberculosis Dispensary

Current Primary Outcome: To compare the efficacy of combination of Immunoxel with anti-TB treatment versus anti-TB treatment with placebo in adults with sputum smear positive pulmonary tuberculosis [ Time Frame: 1 month ]

Original Primary Outcome: To compare the efficacy of combination of Immunoxel with first-line anti-TB treatment versus first-line anti-TB treatment with placebo in adults with sputum smear positive pulmonary tuberculosis [ Time Frame: 6 months ]

Current Secondary Outcome: To confirm the safety of Immunoxel as demonstrated by Liver functions tests (ALT and bilirubin) and hemoglobin; effect on TB-associated wasting by measuring body weight. Effect on lymphocytes and CD4+ cells, CD4/CD8 ratio among those who have HIV. [ Time Frame: 1 month ]

Original Secondary Outcome: To confirm the safety of Immunoxel as demonstrated by Liver functions tests (AST and ALT, and bilirubin) and hemoglobin ; quality of life improvement by Karnofsky Score; effect on TB-associated wasting by measuring body weight. [ Time Frame: 6 months ]

Information By: Lisichansk Regional Tuberculosis Dispensary

Dates:
Date Received: February 2, 2010
Date Started: January 2010
Date Completion:
Last Updated: May 18, 2015
Last Verified: May 2015