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Completed

NCT Number: NCT01378702

Safety and Immunological Effects of Two Mistletoe Preparations in Healthy Volunteers

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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Key information

Conditions

Healthy Volunteers

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Univerity Medical Center Freiburg

Freiburg im Breisgau, Germany, 79106

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-45 years. Healthy volunteers

Exclusion criteria

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

Treatment and study plan

mistletoe preparations

Drug

1 ampoule (1ml) twice per week subcutaneously

Other names: 1. Mistletoe from the poplar tree, 2. Mistletoe from the apple tree

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Hospital Freiburg

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jun 22, 2011
Registry last updated
Jun 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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