Safety and Immunological Effects of Two Mistletoe Preparations in Healthy Volunteers

Safety and Immunological Effects of Iscucin Populi and Viscum Mali e Planta Tota 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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: mistletoe preparations

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Freiburg, Germany, 79106
    • Univerity Medical Center Freiburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18-45 years. Healthy volunteers

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital Freiburg
• Investigators: Principal Investigator: Roman Huber, Dr, University Hospital Freiburg

Publications and helpful links

General Publications

• 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.

Helpful Links

• Center for Complementary Medicine, University Hospital Freiburg

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: June 15, 2011
• First Submitted That Met QC Criteria: June 20, 2011
• First Posted (Estimate): June 22, 2011

Study Record Updates

• Last Update Posted (Estimate): June 22, 2011
• Last Update Submitted That Met QC Criteria: June 20, 2011
• Last Verified: May 1, 2007

More Information

Terms related to this study

• Keywords: Mistletoe; Anthroposophical medicine
• Other Study ID Numbers: viscum-1; 2007-002166-35 (EudraCT Number)