Safety and Immunological Effects of Two Mistletoe Preparations in Healthy Volunteers

University Hospital Freiburg

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: mistletoe preparations

Study type: Interventional

Funder types: Other

Identifiers

NCT01378702

2007-002166-35 (EudraCT Number)

viscum-1

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18-45 years. Healthy volunteers

Exclusion criteria

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

Trial design

71 participants in 3 patient groups, including a placebo group

Iscucin populi strength F, G and H

Experimental group

Description:

1 ampoule two times/week subcutaneously. Week 1-4: strength F. Week 5-8: strength G. Week 9-12: strength H.

Treatment:

Drug: mistletoe preparations

Viscum Mali e planta tota D3, D2, 2%

Experimental group

Description:

1 ampoule two times a week subcutaneously. Week 1-4: D3. Week 4-8: D2. Week 9-12: 2%.

Treatment:

Drug: mistletoe preparations

Placebo

Placebo Comparator group

Description:

1 ampoule two times a week subcutaneously

Treatment:

Drug: mistletoe preparations