Von Willebrand DiseaseNCT01651468
The Effect of the Nutraceutical "Hemofix" on the Coagulation System
A study testing HEMOFIX in people with Von Willebrand Disease and Menorrhagia, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Hemofix is a herbal formula based on traditional Jewish and far eastern medicine created to assist in wound healing and bleeding arrest. It contains herbs such as Red Clover, Liquorice, Raspberry, Ginger and more. The present study will evaluate the formula on the coagulation system. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Von Willebrand Disease, Menorrhagia
- What is being tested?
- HEMOFIX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2016to Dec 2023
- Phase
- Interventional
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers and volunteers with a mild bleeding disorder
Who cannot join
- people with thrombophilic and cardiovascular complications,
- people who are treated with anti-coagulants,
- women taking birth control pills
- people with a history hypercoagulability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study of the Nutraceutical "Hemofix" Safety and Effect on the Coagulation System
Hemofix is a herbal formula based on traditional Jewish and far eastern medicine created to assist in wound healing and bleeding arrest. It contains herbs such as Red Clover, Liquorice, Raspberry, Ginger and more. The present study will evaluate the formula on the coagulation system.
- Conditions
- Von Willebrand Disease, Menorrhagia
- Being tested
- HEMOFIX
- Keywords
- mild bleeding disorder
- Medical subject headings
- von Willebrand Diseases, Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEMOFIXDietary supplement
unique complex herbal mixture
| Study group | Role | What they receive |
|---|---|---|
| HEMOFIX | Experimental | 3 grams a day Receives: Dietary Supplement: HEMOFIX |
What is being measured
The primary outcome is the main question the study is designed to answer.
bleeding and blood test results
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2012 (estimated)
- Study startSep 2016
- Primary completionJan 2020 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: The collaborator lost interest in a clinical study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Von Willebrand DiseaseStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Collaborators
- HEMOFIX, Yocheved Grossman, Idan Grossman
- Responsible party
- Sponsor
- Investigators
- David Varon, Prof, Principal investigator, HMO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01651468
- Sponsor's protocol ID
- HEMOFIX- HMO-CTIL
- Status last verified
- Feb 2017
- First submitted
- 25 Jul 2012
- Last updated
- 28 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of the Nutraceutical "Hemofix" Safety and Effect on the Coagulation System
- ClinicalTrials.gov ID
- NCT01651468
- Acronym / sponsor ID
- HEMOFIX- HMO-CTIL
- Conditions
- Von Willebrand Disease, Menorrhagia
- Keywords
- mild bleeding disorder
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The collaborator lost interest in a clinical study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Collaborators
- HEMOFIX, Yocheved Grossman, Idan Grossman
- Study start
- Sep 2016
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 27 Jul 2012 (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.
Hemofix is a herbal formula based on traditional Jewish and far eastern medicine created to assist in wound healing and bleeding arrest. It contains herbs such as Red Clover, Liquorice, Raspberry, Ginger and more. The present study will evaluate the formula on the coagulation system.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HEMOFIX | Experimental | Dietary Supplement: HEMOFIX3 grams a day |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy volunteers and volunteers with a mild bleeding disorder
Key exclusion criteria (4 listed)
- people with thrombophilic and cardiovascular complications,
- people who are treated with anti-coagulants,
- women taking birth control pills
- people with a history hypercoagulability
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 |
|---|---|---|
| HEMOFIXunique complex herbal mixture | Dietary supplement | HEMOFIX |
Primary outcome
bleeding and blood test results
Time frame: one year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2017.
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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.
David Varon, Prof principal investigator
HMO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HEMOFIX in people with Von Willebrand Disease and Menorrhagia, run by Hadassah Medical Organization at 1 site in Israel.
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: withdrawn, as of the sponsor's last update on 28 Nov 2017. 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 Israel. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
bleeding and blood test results (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Nov 2017.