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The Effect of the Nutraceutical "Hemofix" on the Coagulation System

This study is not yet open for participant recruitment.
Verified July 2012 by Hadassah Medical Organization
Sponsor:
Collaborators:
HEMOFIX
Yocheved Grossman
Idan Grossman
Information provided by (Responsible Party):
David Varon, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01651468
First received: July 25, 2012
Last updated: July 28, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Von Willebrand Disease
Menorrhagia
 Dietary Supplement: HEMOFIX
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Phase 1 Study of the Nutraceutical "Hemofix" Safety and Effect on the Coagulation System

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • bleeding and blood test results [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: September 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HEMOFIX
3 grams a day
 Dietary Supplement: HEMOFIX
unique complex herbal mixture

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01651468

Locations
Israel
Hadassah Medical Organization Not yet recruiting
Jerusalem, Israel
Contact: Hadas Lemberg, PhD     00 972 2 6777572     lhadas@hadassah.org.il    
Principal Investigator: David Varon, Prof            
Sponsors and Collaborators
Hadassah Medical Organization
HEMOFIX
Yocheved Grossman
Idan Grossman
Investigators
Principal Investigator: David Varon, Prof HMO
  More Information

No publications provided

Responsible Party: David Varon, Director of coagulation unit, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01651468     History of Changes
Other Study ID Numbers: HEMOFIX- HMO-CTIL
Study First Received: July 25, 2012
Last Updated: July 28, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
mild bleeding disorder

Additional relevant MeSH terms:
Menorrhagia
Von Willebrand Diseases
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Menstruation Disturbances
Pathologic Processes
 Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Blood Platelet Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on May 23, 2013