Healthy VolunteersPhase 1NCT01378702
Safety and Immunological Effects of Two Mistletoe Preparations in Healthy Volunteers
A Phase 1 study testing mistletoe preparations in people with Healthy Volunteers, run by University Hospital Freiburg at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- mistletoe preparations
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2008to Jun 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-45 years. Healthy volunteers
Who cannot join
- Any disease except hay fever.
- Smoking.
- Drug abuse.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Univerity Medical Center Freiburg
Freiburg im Breisgau, Germany, 79106
About this study
Official title: 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.
- Conditions
- Healthy Volunteers
- Being tested
- mistletoe preparations
- Keywords
- Mistletoe, Anthroposophical medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mistletoe preparationsDrug
Also called 1. Mistletoe from the poplar tree, 2. Mistletoe from the apple tree
1 ampoule (1ml) twice per week subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Iscucin populi strength F, G and H | Experimental | 1 ampoule two times/week subcutaneously. Week 1-4: strength F. Week 5-8: strength G. Week 9-12: strength H. Receives: Drug: mistletoe preparations |
| Viscum Mali e planta tota D3, D2, 2% | Experimental | 1 ampoule two times a week subcutaneously. Week 1-4: D3. Week 4-8: D2. Week 9-12: 2%. Receives: Drug: mistletoe preparations |
| Placebo | Placebo comparator | 1 ampoule two times a week subcutaneously Receives: Drug: mistletoe preparations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: After 4 weeks treatment with each dose
Secondary outcomes (6)
Interleukin-6
see primary outcome measure
Measured: After 4 weeks treatment with each dose
Eosinophil counts
see primary outcome measure
Measured: After 4 weeks treatment with each dose
Granulocyte counts
see primary outcome measure
Measured: After 4 weeks treatment with each dose
Lymphocyte counts
see primary outcome measure
Measured: After 4 weeks treatment with each dose
T-cell counts
see primary outcome measure
Measured: 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.
Measured: After 4 weeks treatment with each dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2011 (estimated)
- Study startJan 2008
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Freiburg
- Sponsor type
- University, hospital or other
- Investigators
- Roman Huber, Dr, Principal investigator, University Hospital Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01378702
- Sponsor's protocol ID
- viscum-1
- Other IDs
- 2007-002166-35
- Status last verified
- May 2007
- First submitted
- 15 Jun 2011
- Last updated
- 22 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 22114899
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunological Effects of Iscucin Populi and Viscum Mali e Planta Tota in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01378702
- Acronym / sponsor ID
- viscum-1
- Conditions
- Healthy Volunteers
- Keywords
- Mistletoe, Anthroposophical medicine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University Hospital FreiburgUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 22 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Iscucin populi strength F, G and H | Experimental | Drug: mistletoe preparations1 ampoule two times/week subcutaneously. Week 1-4: strength F. Week 5-8: strength G. Week 9-12: strength H. |
| Viscum Mali e planta tota D3, D2, 2% | Experimental | Drug: mistletoe preparations1 ampoule two times a week subcutaneously. Week 1-4: D3. Week 4-8: D2. Week 9-12: 2%. |
| Placebo | Placebo comparator | Drug: mistletoe preparations1 ampoule two times a week subcutaneously |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 18-45 years. Healthy volunteers
Key exclusion criteria (4 listed)
- Any disease except hay fever.
- Smoking.
- Drug abuse.
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mistletoe preparationsAlso: 1. Mistletoe from the poplar tree, 2. Mistletoe from the apple tree1 ampoule (1ml) twice per week subcutaneously | Drug | Iscucin populi strength F, G and H, Placebo, Viscum Mali e planta tota D3, D2, 2% |
Primary outcome
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
6 secondary outcomes
Interleukin-6
Time frame: After 4 weeks treatment with each dose
Eosinophil counts
Time frame: After 4 weeks treatment with each dose
Granulocyte counts
Time frame: After 4 weeks treatment with each dose
Lymphocyte counts
Time frame: After 4 weeks treatment with each dose
T-cell counts
Time frame: After 4 weeks treatment with each dose
General tolerability of the treatment(excellent, good, moderate or bad)
Time frame: After 4 weeks treatment with each dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2011.
- Derived from this study: PubMed 22114899Huber 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.
- Center for Complementary Medicine, University Hospital FreiburgLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roman Huber, Dr principal investigator
University Hospital Freiburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing mistletoe preparations in people with Healthy Volunteers, run by University Hospital Freiburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (time frame: After 4 weeks treatment with each dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01378702, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2011.