Back to resultsThe Effect of the Nutraceutical "Hemofix" on the Coagulation System
Primary Purpose
Von Willebrand Disease, Menorrhagia
Status
Withdrawn
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
HEMOFIX
Sponsored by
About this trial
This is an interventional supportive care trial for Von Willebrand Disease focused on measuring mild bleeding disorder
Eligibility Criteria
Inclusion Criteria:
- Healthy volunteers and volunteers with a mild bleeding disorder
Exclusion Criteria:
- people with thrombophilic and cardiovascular complications,
- people who are treated with anti-coagulants,
- women taking birth control pills
- people with a history hypercoagulability
Sites / Locations
- Hadassah Medical Organization
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HEMOFIX
Arm Description
3 grams a day
Outcomes
Primary Outcome Measures
bleeding and blood test results
Secondary Outcome Measures
Full Information
NCT ID
NCT01651468
First Posted
July 25, 2012
Last Updated
November 26, 2017
Sponsor
Hadassah Medical Organization
Collaborators
HEMOFIX, Yocheved Grossman, Idan Grossman
1. Study Identification
Unique Protocol Identification Number
NCT01651468
Brief Title
The Effect of the Nutraceutical "Hemofix" on the Coagulation System
Official Title
Phase 1 Study of the Nutraceutical "Hemofix" Safety and Effect on the Coagulation System
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Withdrawn
Why Stopped
The collaborator lost interest in a clinical study.
Study Start Date
September 2016 (undefined)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hadassah Medical Organization
Collaborators
HEMOFIX, Yocheved Grossman, Idan Grossman
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Von Willebrand Disease, Menorrhagia
Keywords
mild bleeding disorder
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HEMOFIX
Arm Type
Experimental
Arm Description
3 grams a day
Intervention Type
Dietary Supplement
Intervention Name(s)
HEMOFIX
Intervention Description
unique complex herbal mixture
Primary Outcome Measure Information:
Title
bleeding and blood test results
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy volunteers and volunteers with a mild bleeding disorder
Exclusion Criteria:
people with thrombophilic and cardiovascular complications,
people who are treated with anti-coagulants,
women taking birth control pills
people with a history hypercoagulability
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Varon, Prof
Organizational Affiliation
HMO
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
The Effect of the Nutraceutical "Hemofix" on the Coagulation System
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