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Adjunct Immunotherapy With Immunoxel in Patients With TB and TB/HIV

NCT01061593 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 269

Last updated 2015-05-20

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Immunoxel

1 lozenge once per day

OTHER

Placebo

1 lozenge once per day

Sponsors & Collaborators

  • Ekomed LLC

    collaborator INDUSTRY

  • Lisichansk Regional Tuberculosis Dispensary

    lead OTHER

Principal Investigators

  • Galyna kutsyna, MD, PhD · Ekomed LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2015-03-31
Completion
2015-04-30

Countries

  • Mongolia
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01061593 on ClinicalTrials.gov