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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01378702

Enrollment

Registered

2011-06-22

Start date

2008-01-31

Completion date

2008-06-30

Last updated

2011-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Mistletoe, Anthroposophical medicine

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.

Interventions

DRUGmistletoe preparations

1 ampoule (1ml) twice per week subcutaneously

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* 18-45 years. Healthy volunteers

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Number of participants with adverse events	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

Measure	Time frame	Description
Eosinophil counts	After 4 weeks treatment with each dose	see primary outcome measure
Granulocyte counts	After 4 weeks treatment with each dose	see primary outcome measure
Interleukin-6	After 4 weeks treatment with each dose	see primary outcome measure
T-cell counts	After 4 weeks treatment with each dose	see primary outcome measure
General tolerability of the treatment(excellent, good, moderate or bad)	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.
Lymphocyte counts	After 4 weeks treatment with each dose	see primary outcome measure

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026