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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-002166-35 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iscucin populi strength F, G and H | Experimental | 1 ampoule two times/week subcutaneously. Week 1-4: strength F. Week 5-8: strength G. Week 9-12: strength H. |
|
| Viscum Mali e planta tota D3, D2, 2% | Experimental | 1 ampoule two times a week subcutaneously. Week 1-4: D3. Week 4-8: D2. Week 9-12: 2%. |
|
| Placebo | Placebo Comparator | 1 ampoule two times a week subcutaneously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mistletoe preparations | Drug | 1 ampoule (1ml) twice per week subcutaneously |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roman Huber, Dr | University Hospital Freiburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univerity Medical Center Freiburg | Freiburg im Breisgau | Germany | 79106 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22114899 | Derived | Huber R, Ludtke H, Wieber J, Beckmann C. Safety and effects of two mistletoe preparations on production of Interleukin-6 and other immune parameters - a placebo controlled clinical trial in healthy subjects. BMC Complement Altern Med. 2011 Nov 24;11:116. doi: 10.1186/1472-6882-11-116. |
| Label | URL |
|---|---|
| Center for Complementary Medicine, University Hospital Freiburg | View source |
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| 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 |