The objective of this clinical trial is to describe safety, tolerability and the course of parameters of the immune system during administration of different doses of two subcutaneously administered mistletoe preparations (Iscucin populi and Viscum Mali e planta tota) in healthy volunteers, compared to placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
QUADRUPLE
Enrollment
71
1 ampoule (1ml) twice per week subcutaneously
Univerity Medical Center Freiburg
Freiburg im Breisgau, Germany, Germany
Number of participants with adverse events
Week 4 after baseline: evaluation of Iscucin populi strength F and Viscum Mali D3, respectively, compared to placebo. Week 8 after baseline: evaluation of Iscucin populi strength G and Viscum Mali D2, respectively, compared to placebo. Week 12 after baseline: evaluation of Iscucin populi strength H and Viscum mali 2%, respectively, compared to placebo. Week 16 after baseline: final follow up
Time frame: After 4 weeks treatment with each dose
Interleukin-6
see primary outcome measure
Time frame: After 4 weeks treatment with each dose
Eosinophil counts
see primary outcome measure
Time frame: After 4 weeks treatment with each dose
Granulocyte counts
see primary outcome measure
Time frame: After 4 weeks treatment with each dose
Lymphocyte counts
see primary outcome measure
Time frame: After 4 weeks treatment with each dose
T-cell counts
see primary outcome measure
Time frame: After 4 weeks treatment with each dose
General tolerability of the treatment(excellent, good, moderate or bad)
see primary outcome measure. Toleability will be indicated by the participants on a 4-point rating scale with the items "excellent", "good", "moderate" or "bad", which will be coded by 1, 2, 3 or 4.
Time frame: After 4 weeks treatment with each dose
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