Safety and Immunological Effects of Two Mistletoe Preparations in Healthy Volunteers

Study Overview
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Brief Summary
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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.

Official Title
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Safety and Immunological Effects of Iscucin Populi and Viscum Mali e Planta Tota in Healthy Volunteers

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: mistletoe preparations


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-45 years. Healthy volunteers Exclusion Criteria: Any disease except hay fever. Smoking. Drug abuse. Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iscucin populi strength F, G and H<br>1 ampoule two times/week subcutaneously. Week 1-4: strength F. Week 5-8: strength G. Week 9-12: strength H. | Drug: mistletoe preparations<br>* 1 ampoule (1ml) twice per week subcutaneously<br>* Other names: 2. Mistletoe from the apple tree;|
| Experimental: Viscum Mali e planta tota D3, D2, 2%<br>1 ampoule two times a week subcutaneously. Week 1-4: D3. Week 4-8: D2. Week 9-12: 2%. | Drug: mistletoe preparations<br>* 1 ampoule (1ml) twice per week subcutaneously<br>* Other names: 2. Mistletoe from the apple tree;|
| Placebo Comparator: Placebo<br>1 ampoule two times a week subcutaneously | Drug: mistletoe preparations<br>* 1 ampoule (1ml) twice per week subcutaneously<br>* Other names: 2. Mistletoe from the apple tree;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | After 4 weeks treatment with each dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interleukin-6 | see primary outcome measure | After 4 weeks treatment with each dose | 
| Eosinophil counts | see primary outcome measure | After 4 weeks treatment with each dose | 
| Granulocyte counts | see primary outcome measure | After 4 weeks treatment with each dose | 
| Lymphocyte counts | see primary outcome measure | After 4 weeks treatment with each dose | 
| T-cell counts | see primary outcome measure | 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. | After 4 weeks treatment with each dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mistletoe, Anthroposophical medicine