CancerNCT01126931
Wormwood in Chronic Progressive Disorders With Reduced Appetite
An observational study of Cancer, run by University Hospital Freiburg at 1 site in Germany.
Trial summary
Wormwood is approved herbal medicine for the treatment of reduced appetite in Germany (Registration No.: 1339.99.99). Reduced appetite is observed in many chronic health disorders such as old age, immune disorders and cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2006to Dec 2012
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with reduced appetite and reduced quality of life as a result of chronic progressive disorders such as cancer, autoimmune diseases (Crohn, IgA-Nephropathy), old age and depression
Who may be able to join
- Appetite and weight loss
- Chronic progressive disease
Who cannot join
- Life expectancy less than 3 months
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Freiburg, Medical Faculty
Freiburg im Breisgau, Baden, 79110
Simone S Krebs, MD, PhD, (+49) -761-27-3913, simone.krebs@uniklinik-freiburg.de
Simone S Krebs, MD, PhD
About this study
Official title: Pilot Trial With Wormwood to Improve Appetite in Cancer, Autoimmune Diseases, Depression and Old Age
Wormwood is approved herbal medicine for the treatment of reduced appetite in Germany (Registration No.: 1339.99.99). Reduced appetite is observed in many chronic health disorders such as old age, immune disorders and cancer.
Trial aims at observing beneficial effects of wormwood supplementation in various chronic disorders associated with reduced appetite
Read the detailed description
Supplementation with wormwood in chronic disorders associated with reduced appetite.
Examples:
- Cancer
- Autoimmune diseases such as Crohns disease and IgA Nephropathy
- Old age
- Chronic stress and depression
- Conditions
- Cancer
- Keywords
- Crohn disease, Involuntary weight loss in cancer, IgA nephropathy, Depression with reduced appetite
- Medical subject headings
- Neoplasms, Crohn Disease, Glomerulonephritis, IGA
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in appetite
Measured: 6-12 months
Secondary outcomes (1)
Improvement in quality of life
Measured: 12-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2010 (estimated)
- Study startFeb 2006
- Primary completionAug 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CancerStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Freiburg
- Sponsor type
- University, hospital or other
- Investigators
- Simone S Krebs, MD, PhD, Principal investigator, University of Freiburg, Nuclear Medicine, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01126931
- Sponsor's protocol ID
- Appetite and Weight Loss
- Status last verified
- Feb 2008
- First submitted
- 17 May 2010
- Last updated
- 20 May 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Omer B, Krebs S, Omer H, Noor TO. Steroid-sparing effect of wormwood (Artemisia absinthium) in Crohn's disease: a double-blind placebo-controlled study. Phytomedicine. 2007 Feb;14(2-3):87-95. doi: 10.1016/j.phymed.2007.01.001. Epub 2007 Jan 19.
PubMed 17240130Krebs S, Omer TN, Omer B. Wormwood (Artemisia absinthium) suppresses tumour necrosis factor alpha and accelerates healing in patients with Crohn's disease - A controlled clinical trial. Phytomedicine. 2010 Apr;17(5):305-9. doi: 10.1016/j.phymed.2009.10.013. Epub 2009 Dec 3.
PubMed 19962291Krebs S, Omer B, Omer TN, Fliser D. Wormwood (Artemisia absinthium) for poorly responsive early-stage IgA nephropathy: a pilot uncontrolled trial. Am J Kidney Dis. 2010 Dec;56(6):1095-9. doi: 10.1053/j.ajkd.2010.06.025. Epub 2010 Sep 16.
PubMed 20843592
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial With Wormwood to Improve Appetite in Cancer, Autoimmune Diseases, Depression and Old Age
- ClinicalTrials.gov ID
- NCT01126931
- Acronym / sponsor ID
- Appetite and Weight Loss
- Conditions
- Cancer
- Keywords
- Crohn disease, Involuntary weight loss in cancer, IgA nephropathy, Depression with reduced appetite
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital FreiburgUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 20 May 2010 (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.
Wormwood is approved herbal medicine for the treatment of reduced appetite in Germany (Registration No.: 1339.99.99). Reduced appetite is observed in many chronic health disorders such as old age, immune disorders and cancer.
Trial aims at observing beneficial effects of wormwood supplementation in various chronic disorders associated with reduced appetite
Detailed description
Supplementation with wormwood in chronic disorders associated with reduced appetite.
Examples:
- Cancer
- Autoimmune diseases such as Crohns disease and IgA Nephropathy
- Old age
- Chronic stress and depression
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with reduced appetite and reduced quality of life as a result of chronic progressive disorders such as cancer, autoimmune diseases (Crohn, IgA-Nephropathy), old age and depression
Key inclusion criteria (2 listed)
- Appetite and weight loss
- Chronic progressive disease
Key exclusion criteria (1 listed)
- Life expectancy less than 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Improvement in appetite
Time frame: 6-12 months
1 secondary outcome
Improvement in quality of life
Time frame: 12-24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2010.
- Background: PubMed 17240130Omer B, Krebs S, Omer H, Noor TO. Steroid-sparing effect of wormwood (Artemisia absinthium) in Crohn's disease: a double-blind placebo-controlled study. Phytomedicine. 2007 Feb;14(2-3):87-95. doi: 10.1016/j.phymed.2007.01.001. Epub 2007 Jan 19.
- Background: PubMed 19962291Krebs S, Omer TN, Omer B. Wormwood (Artemisia absinthium) suppresses tumour necrosis factor alpha and accelerates healing in patients with Crohn's disease - A controlled clinical trial. Phytomedicine. 2010 Apr;17(5):305-9. doi: 10.1016/j.phymed.2009.10.013. Epub 2009 Dec 3.
- Derived from this study: PubMed 20843592Krebs S, Omer B, Omer TN, Fliser D. Wormwood (Artemisia absinthium) for poorly responsive early-stage IgA nephropathy: a pilot uncontrolled trial. Am J Kidney Dis. 2010 Dec;56(6):1095-9. doi: 10.1053/j.ajkd.2010.06.025. Epub 2010 Sep 16.
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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.
Simone S Krebs, MD, PhD principal investigator
University of Freiburg, Nuclear Medicine, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 20 May 2010. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simone S Krebs, MD, Ph.D ((+49) -761-27-3913, simone.krebs@uniklinik-freiburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in appetite (time frame: 6-12 months). 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 NCT01126931, which also lists 3 linked publications.
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 20 May 2010.