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Double-blind, Randomized, Masked, Placebo-controlled, Clinical Trial to Investigate the Efficacy of the Nutraceutical Nyaditum Resae(R) Administered to Contacts of Active Tuberculosis in Georgia. (NCT02897180)

National Center for Tuberculosis and Lung Diseases (NCTLD)
The use of a supplement food like "Nyaditum resae" is a reliable opportunity to stop the progression towards active TB through the most updated knowledge of this disease:the induction of tolerance. In order to demonstrate the percentage of efficacy of this approach, different studies must be run to elucidate the percentage of protection in different setting all over the world. The strategy is to establish its efficacy through a simple clinical trial, aimed just to know the incidence of TB in Placebo and NR treated contacts of active TB cases.
  • Biological: Nyaditum resae(R)
    Capsules containing Nyaditum resae(R)
    • Biological: Placebo
      Capsules containin Placebo
      Ages eligible for Study
      5 Years and older
      Genders eligible for Study
      All
      Accepts Healthy Volunteers
      Accepts Healthy Volunteers
      Inclusion Criteria:
      • Have completed the written informed consent process prior to undergoing any screening evaluations.
      • Have ability to complete follow-up period as required by the protocol.
      • Willing to allow the investigators to discuss the subject's medical history with the subject's health care provider.
      • Close contact of an active TB case not eligible for chemoprophylaxis.
      Exclusion Criteria:
      • Investigator assessment of lack of understanding or willingness to participate and comply with all requirements of the trial protocol.
      • Any other finding which in the opinion of the investigator would compromise the protocol compliance or significantly influence the interpretation of results on the effects of the vaccine.
      • Being eligible for chemoprophylaxis (children of <5 years old and HIV-positive adults)
      • Pregnancy or lactation
      • Hypersensitivity to mannitol
      • Suffering active TB
      Evaluation of a supplement food "Nyaditum resae" in the uincidence of TB. This is a ranzomized doube-blind controlled clinical trial to evaluate the efficacy and safety of a supplememt food in comparison to placebo in TB.

      1 locations

      Georgia (1)
      • National Center for Tuberculosis and Lung Diseases
        recruiting
        Tbilisi, Georgia
      Status:
      recruiting
      Type:
      Interventional
      Phase:
      Ⅱ, Ⅲ
      Start:
      09 March, 2017
      Updated:
      02 September, 2017
      Participants:
      3300
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