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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 2012 by Hadassah Medical Organization.
Recruitment status was Not yet recruiting

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:

Genetics Home Reference related topics: von Willebrand disease

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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 September 26, 2016

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