Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01651468
Recruitment Status : Withdrawn (The collaborator lost interest in a clinical study.)
First Posted : July 27, 2012
Last Update Posted : November 28, 2017
Sponsor:
Collaborators:
HEMOFIX
Yocheved Grossman
Idan Grossman
Information provided by (Responsible Party):
Hadassah Medical Organization

Tracking Information
First Submitted Date  ICMJE July 25, 2012
First Posted Date  ICMJE July 27, 2012
Last Update Posted Date November 28, 2017
Study Start Date  ICMJE September 2016
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2012)
bleeding and blood test results [ Time Frame: one year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of the Nutraceutical "Hemofix" on the Coagulation System
Official Title  ICMJE Phase 1 Study of the Nutraceutical "Hemofix" Safety and Effect on the Coagulation System
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Von Willebrand Disease
  • Menorrhagia
Intervention  ICMJE Dietary Supplement: HEMOFIX
unique complex herbal mixture
Study Arms  ICMJE Experimental: HEMOFIX
3 grams a day
Intervention: Dietary Supplement: HEMOFIX
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: February 22, 2017)
0
Original Estimated Enrollment  ICMJE
 (submitted: July 26, 2012)
40
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01651468
Other Study ID Numbers  ICMJE HEMOFIX- HMO-CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hadassah Medical Organization
Study Sponsor  ICMJE Hadassah Medical Organization
Collaborators  ICMJE
  • HEMOFIX
  • Yocheved Grossman
  • Idan Grossman
Investigators  ICMJE
Principal Investigator: David Varon, Prof HMO
PRS Account Hadassah Medical Organization
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP