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Safety and Immunological Effects of Two Mistletoe Preparations in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01378702
Recruitment Status : Completed
First Posted : June 22, 2011
Last Update Posted : June 22, 2011
Sponsor:
Information provided by:
University Hospital Freiburg

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: mistletoe preparations Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Safety and Immunological Effects of Iscucin Populi and Viscum Mali e Planta Tota in Healthy Volunteers
Study Start Date : January 2008
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Arm Intervention/treatment
Experimental: Iscucin populi strength F, G and H
1 ampoule two times/week subcutaneously. Week 1-4: strength F. Week 5-8: strength G. Week 9-12: strength H.
Drug: mistletoe preparations
1 ampoule (1ml) twice per week subcutaneously
Other Names:
  • 1. Mistletoe from the poplar tree
  • 2. Mistletoe from the apple tree

Experimental: Viscum Mali e planta tota D3, D2, 2%
1 ampoule two times a week subcutaneously. Week 1-4: D3. Week 4-8: D2. Week 9-12: 2%.
Drug: mistletoe preparations
1 ampoule (1ml) twice per week subcutaneously
Other Names:
  • 1. Mistletoe from the poplar tree
  • 2. Mistletoe from the apple tree

Placebo Comparator: Placebo
1 ampoule two times a week subcutaneously
Drug: mistletoe preparations
1 ampoule (1ml) twice per week subcutaneously
Other Names:
  • 1. Mistletoe from the poplar tree
  • 2. Mistletoe from the apple tree




Primary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: After 4 weeks treatment with each dose ]
    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


Secondary Outcome Measures :
  1. Interleukin-6 [ Time Frame: After 4 weeks treatment with each dose ]
    see primary outcome measure

  2. Eosinophil counts [ Time Frame: After 4 weeks treatment with each dose ]
    see primary outcome measure

  3. Granulocyte counts [ Time Frame: After 4 weeks treatment with each dose ]
    see primary outcome measure

  4. Lymphocyte counts [ Time Frame: After 4 weeks treatment with each dose ]
    see primary outcome measure

  5. T-cell counts [ Time Frame: After 4 weeks treatment with each dose ]
    see primary outcome measure

  6. General tolerability of the treatment(excellent, good, moderate or bad) [ Time Frame: After 4 weeks treatment with each dose ]
    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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-45 years. Healthy volunteers

Exclusion Criteria:

  • Any disease except hay fever.
  • Smoking.
  • Drug abuse.
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01378702


Locations
Germany
Univerity Medical Center Freiburg
Freiburg, Germany, 79106
Sponsors and Collaborators
University Hospital Freiburg
Investigators
Principal Investigator: Roman Huber, Dr University Hospital Freiburg

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Roman Huber, Dr, University Hospital Freiburg
ClinicalTrials.gov Identifier: NCT01378702     History of Changes
Other Study ID Numbers: viscum-1
2007-002166-35 ( EudraCT Number )
First Posted: June 22, 2011    Key Record Dates
Last Update Posted: June 22, 2011
Last Verified: May 2007

Keywords provided by University Hospital Freiburg:
Mistletoe
Anthroposophical medicine