NCT02882776

Brief Summary

This study aims to examine the effect of ginger beverage consumption on platelets activity in apparently healthy Saudi adult volunteers. As for the Saudi population, consumption of powdered ginger dissolved in hot water is a common practice. Accordingly, in this study, it is tempting to speculate the effect of this form of ginger consumption, given in separate time points per day, on platelet aggregation profile by using platelet aggregation analogues. If positive results were obtained, the herb could provide natural protection against the development of platelet aggregation complications and could be a potential alternative to aspirin, used for improving blood circulation and hematological pathophysiologies in diseased individuals.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 10, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 30, 2016

Completed
Last Updated

August 30, 2016

Status Verified

August 1, 2016

Enrollment Period

2.6 years

First QC Date

August 10, 2016

Last Update Submit

August 24, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • The effect of ginger beverage consumption on platelets activity will be examined in apparently healthy, Saudi adult volunteers.

    1 year

Secondary Outcomes (4)

  • The demographic characteristics of the sample under study will be identified.

    1 year

  • Any change in platelet morphology before and after ginger consumption will be studied

    1 year

  • Platelets' count before and after ginger consumption will be compared.

    1 year

  • Any change in platelets function after ginger consumption via addition of aggregation analogues will be studied.

    1 year

Study Arms (2)

Ginger drink once daily

OTHER

this group will receive ginger drink made by dissolving 4g ginger powder in plain water once a day for continuous 5 days.

Dietary Supplement: Ginger drink

Ginger drink twice daily

OTHER

this group will receive ginger drink made by dissolving 4g ginger powder in plain water twice a day for continuous 5 days.

Dietary Supplement: Ginger drink

Interventions

Ginger drinkDIETARY_SUPPLEMENT

Ginger powder dissolved in water

Ginger drink once dailyGinger drink twice daily

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Apparently healthy Saudi volunteers of either sex
  • Age group = 18-60 years.

You may not qualify if:

  • History of organ abnormalities or concomitant illnesses.
  • Abnormal platelets count or function.
  • Individuals with bleeding disorder as Von Willebrand Disorder or Hemophilia.
  • Known allergy to ginger.
  • Concurrent warfarin ingestion.
  • History of ingestion of asprin,clopidogrel, nifedipine, non-steroid anti-inflammatory drugs (NSAIDs) or ethanol within the past two week.
  • Any volunteer ingests ethanol, aspirin, clopidogrel, wine, beer and contraceptive pills during the study duration will be excluded from the study.
  • pregnant \& lactating women.
  • Individuals on herbal treatment.
  • Active G.I ulcers/ recently diagnosed G.I ulcers within one month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Abdulaziz Medical City - National Guard Hospital

Riyadh, Central, 11426, Saudi Arabia

Location

MeSH Terms

Conditions

Hematologic Diseases

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Study Officials

  • Dr. Askar S. Alaskar, MD,FACP,FRCP

    King Abdullah Medical research Center - King Abdulaziz Medical City - Riyadh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2016

First Posted

August 30, 2016

Study Start

December 1, 2013

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

August 30, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share

Undecided

Locations