Safety and Immunological Effects of Two Mistletoe Preparations in Healthy Volunteers
2 other identifiers
interventional
71
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy-volunteers
Started Jan 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 15, 2011
CompletedFirst Posted
Study publicly available on registry
June 22, 2011
CompletedJune 22, 2011
May 1, 2007
5 months
June 15, 2011
June 20, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Interleukin-6
After 4 weeks treatment with each dose
Eosinophil counts
After 4 weeks treatment with each dose
Granulocyte counts
After 4 weeks treatment with each dose
Lymphocyte counts
After 4 weeks treatment with each dose
T-cell counts
After 4 weeks treatment with each dose
- +1 more secondary outcomes
Study Arms (3)
Iscucin populi strength F, G and H
EXPERIMENTAL1 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%
EXPERIMENTAL1 ampoule two times a week subcutaneously. Week 1-4: D3. Week 4-8: D2. Week 9-12: 2%.
Placebo
PLACEBO COMPARATOR1 ampoule two times a week subcutaneously
Interventions
1 ampoule (1ml) twice per week subcutaneously
Eligibility Criteria
You may qualify if:
- years. Healthy volunteers
You may not qualify if:
- Any disease except hay fever.
- Smoking.
- Drug abuse.
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Univerity Medical Center Freiburg
Freiburg im Breisgau, Germany, 79106, Germany
Related Publications (1)
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.
PMID: 22114899DERIVED
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Roman Huber, Dr
University Hospital Freiburg
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 15, 2011
First Posted
June 22, 2011
Study Start
January 1, 2008
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
June 22, 2011
Record last verified: 2007-05