The Effect of the Nutraceutical "Hemofix" on the Coagulat... | NCT01651468

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

NCT01651468

Sponsor

Hadassah Medical Organization

Status

Withdrawn

Last Update Posted

Nov 28, 2017Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Von Willebrand Disease
Menorrhagia

Interventions

HEMOFIX

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The collaborator lost interest in a clinical study.

Expanded Access Info

Start Date

Sep 2016

Primary Completion Date

Jan 2020Estimated

Completion Date

Dec 2023Estimated

First Submitted Date

Jul 25, 2012

First Submission Date that Met QC Criteria

Jul 26, 2012

First Posted Date

Jul 27, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 26, 2017

Last Update Posted Date

Nov 28, 2017Actual

Name	Class
HEMOFIX	UNKNOWN
Yocheved Grossman	UNKNOWN
Idan Grossman	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HEMOFIX	Experimental	3 grams a day	Dietary Supplement: HEMOFIX

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HEMOFIX	Dietary Supplement	unique complex herbal mixture	HEMOFIX

Measure	Description	Time Frame
bleeding and blood test results		one year

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Varon, Prof	HMO	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Organization		Jerusalem			Israel

Condition Browse Module

MeSH Terms

ID	Term
D014842	von Willebrand Diseases
D008595	Menorrhagia

Ancestor Terms

ID	Term
D025861	Blood Coagulation Disorders, Inherited
D001778	Blood Coagulation Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided