ROTEM and Dietary Supplements

NCT03125551 | Withdrawn DMC

• 1 other identifier: MMed Anaesthesiology -15402364
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Dietary Supplements can affect platelet activation and aggregation, which could result in bleeding tendencies. This study wishes to evaluate the influence that these supplements has on platelet function using Rotational thromboelastometry.

Conditions

Dietary Supplements; Bleeding Tendency; Due to Coagulation Defect

Keywords

Dietary supplements; Bleeding tendency

Outcome Measures

Primary Outcomes (1)

• Platelet dysfunction determined by ROTEM when consuming ginger, garlic, ginkgo biloba and ginseng.

  To determine if viscoelastic point-of-care coagulation monitoring (ROTEM) detects abnormalities in platelet function when subjects consume ginger, garlic, ginkgo biloba and ginseng within their recommended daily allowances. ExTEM and FibTEM analysis will be performed and difference in MCF values will determine if there is platelet dysfunction or not.

  2-4 weeks

Study Arms (5)

Ginger

ACTIVE COMPARATOR

Ginger ( Zingiber officinale) 4 grams po dly for 14 days

Dietary Supplement: Ginger

Garlic

ACTIVE COMPARATOR

Garlic (Allium sativum) 4-12 mg alliin po dly for 14 days

Dietary Supplement: Garlic

Ginkgo Biloba

ACTIVE COMPARATOR

Ginkgo Biloba 40mg po tds for 14 days

Dietary Supplement: Ginkgo Biloba

Ginseng

ACTIVE COMPARATOR

Ginseng 400mg po dly for 14 days

Dietary Supplement: Ginseng

Placebo

PLACEBO COMPARATOR

Placebo po dly for 14 days

Other: Placebo

Interventions

Ginger DIETARY_SUPPLEMENT

Ginger dosage at daily recommended allowance

Ginger

Garlic DIETARY_SUPPLEMENT

Garlic dosage at daily recommended allowance

Garlic

Ginkgo Biloba DIETARY_SUPPLEMENT

Ginkgo Biloba dosage at daily recommended allowance

Ginkgo Biloba

Ginseng DIETARY_SUPPLEMENT

Ginseng dosage at daily recommended allowance

Ginseng

Placebo OTHER

Daily dosage strategy

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-60 years
• Both males and females
• Healthy volunteers
• Smokers and Non-smokers
• Staff frequenting the theatre complex at Steve Biko Academic Hospital

You may not qualify if:

• History of any chronic medical or psychiatric illness.
• Current excessive alcohol intake - more than 14 units a week in woman and more than 21 units a week in men.
• Pregnant or lactating mothers.
• Possible planned surgery during the study period

Sponsors & Collaborators

• University of Pretoria: lead

MeSH Terms

Conditions

Hemostatic Disorders

Interventions

ginger extract; Ginkgo Extract; Asian ginseng

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Jayde V Wyngaard, MBCHB

  University of Pretoria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Each participant will be blinded to the dietary supplement which they will be taking. The medical technologist doing the ROTEM will be blinded to the dietary supplements as well.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: Five- armed, placebo- controlled ( 4 intervention groups and 1 placebo group)

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: April 24, 2017
• Study Start: June 1, 2017
• Primary Completion: July 1, 2017
• Study Completion: August 1, 2017
• Last Updated: May 9, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share