At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 269 enrolled
Drug / intervention
Immunoxel +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase III, Double-blind, Placebo-controlled, Randomized, 1-month Clinical Trial of Immunoxel Combined With Anti-TB Therapy Versus Anti-TB Therapy With Placebo
In Brief
A Phase 3 clinical trial evaluating Immunoxel and Placebo for Tuberculosis and HIV. Completed, enrolled 269 participants across 2 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberculosis, HIV
CountriesMongolia, Ukraine
CollaboratorsEkomed LLC
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2010
First PostedFeb 2010
Primary CompletionMar 2015
Study CompletionApr 2015
TodayJul 2026
First PostedFeb 3, 2010
Enrollment StartJan 1, 2010
Primary CompletionMar 1, 2015
Study CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 16.4 years ago
Interventions
Immunoxeldietary
1 lozenge once per day
Placeboother
1 lozenge once per day