Dietary SupplementsNCT03125551
ROTEM and Dietary Supplements
A study testing Ginger, Garlic and Ginkgo Biloba in people with Dietary Supplements and Bleeding Tendency; Due to Coagulation Defect, run by University of Pretoria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Supplements, Bleeding Tendency; Due to Coagulation Defect
- What is being tested?
- Ginger, Garlic and Ginkgo Biloba
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2017to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-60 years
- Both males and females
- Healthy volunteers
- Smokers and Non-smokers
- Staff frequenting the theatre complex at Steve Biko Academic Hospital
Who cannot join
- Use of any medication, excluding oral contraceptive pills, in the two week period prior to commencement of the study. Medicines excluded, include aspirin, dietary supplements, herbal teas, anticoagulants and other non-steroidal anti-inflammatory medications. . Oral contraceptive pills were omitted as an exclusion criteria, taking into account that the majority of woman use these. The results of the study will be a better reflection of the effect of these dietary supplements in the modern day woman. Its coagulant properties will be taken into account during data analysis.
- 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
About this study
Official title: Viscoelastic Point-of-Care Coagulation Monitoring and Dietary Supplements: A Randomized, Double-blind, Placebo-controlled Trial
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.
Read the detailed description
The WHO informs us that more than 80% of patients in Africa use traditional/herbal medicines as their primary source of health care. The Mayo Clinic stated that nearly 40% of adults reported using complementary and alternative medicine (CAM). Many of these herbal medicines as well as dietary supplements have effects on the coagulation cascade and have been identified as such using laboratory tests including aPTT, PT, INR, light transmission aggregometry and impedence aggregometry to mention but a few.
This study wishes to evaluate coagulation abnormalities using viscoelastic point-of-care coagulation monitoring in this population. This test is readily available in large hospitals and academic settings and is increasingly being used in perioperative medicine. It provides information on coagulation and thrombolysis with minimal delay when compared to other laboratory-based coagulation tests.
The dietary supplements which will be evaluated in this study are ginger, garlic, gingko biloba and ginseng. These four herbal supplements were identified as the most commonly used substances known to modulate the coagulation system. These herbal supplements will be investigated within their maximum daily allowance dosages.
A five-armed placebo-controlled study will be undertaken and study subjects will be recruited on a volunteer basis. Subjects will be divided into five groups and each group will receive one of the four dietary supplements and the fifth group placebo, for a two week period. Rotational thromboelastometry (ROTEM) studies will be performed on blood samples obtained from each participant at baseline and at the end of the treatment period to identify coagulation abnormalities. Most of these herbal medicines have been identified to affect platelet function and this study will specifically look at platelet function determined by maximum clot firmness (MCF) in the ROTEM analysis.
Viscoelastic point-of-care coagulation monitoring in patients using herbal medicines and dietary supplements will aid decision making regarding cause of perioperative haemorrhage and need for specific blood products. It will therefore assist with goal-directed management of perioperative haemorrhage. It will also aid the anaesthetist wishing to employ a regional anaesthetic technique in this patient group.
- Being tested
- Ginger, Garlic, Ginkgo Biloba, Ginseng, Placebo
- Keywords
- Dietary supplements, Bleeding tendency
- Medical subject headings
- Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GingerDietary supplement
Ginger dosage at daily recommended allowance
GarlicDietary supplement
Garlic dosage at daily recommended allowance
Ginkgo BilobaDietary supplement
Ginkgo Biloba dosage at daily recommended allowance
GinsengDietary supplement
Ginseng dosage at daily recommended allowance
PlaceboOther
Daily dosage strategy
| Study group | Role | What they receive |
|---|---|---|
| Ginger | Active comparator | Ginger ( Zingiber officinale) 4 grams po dly for 14 days Receives: Dietary Supplement: Ginger |
| Garlic | Active comparator | Garlic (Allium sativum) 4-12 mg alliin po dly for 14 days Receives: Dietary Supplement: Garlic |
| Ginkgo Biloba | Active comparator | Ginkgo Biloba 40mg po tds for 14 days Receives: Dietary Supplement: Ginkgo Biloba |
| Ginseng | Active comparator | Ginseng 400mg po dly for 14 days Receives: Dietary Supplement: Ginseng |
| Placebo | Placebo comparator | Placebo po dly for 14 days Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study startJun 2017 (estimated)
- Primary completionJul 2017 (estimated)
- Study completionAug 2017 (estimated)
Why it stopped: Study requires Medicines Control council approval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary SupplementsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Five- armed, placebo- controlled ( 4 intervention groups and 1 placebo group)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pretoria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jayde Wyngaard, University of Pretoria
- Investigators
- Jayde V Wyngaard, MBCHB, Principal investigator, University of Pretoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03125551
- Sponsor's protocol ID
- MMed Anaesthesiology -15402364
- Status last verified
- May 2018
- First submitted
- 27 Mar 2017
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Viscoelastic Point-of-Care Coagulation Monitoring and Dietary Supplements: A Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03125551
- Acronym / sponsor ID
- MMed Anaesthesiology -15402364
- Keywords
- Dietary supplements, Bleeding tendency
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study requires Medicines Control council approval
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PretoriaUniversity, hospital or other
- Study start
- Jun 2017 (estimated)
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 24 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The WHO informs us that more than 80% of patients in Africa use traditional/herbal medicines as their primary source of health care. The Mayo Clinic stated that nearly 40% of adults reported using complementary and alternative medicine (CAM). Many of these herbal medicines as well as dietary supplements have effects on the coagulation cascade and have been identified as such using laboratory tests including aPTT, PT, INR, light transmission aggregometry and impedence aggregometry to mention but a few.
This study wishes to evaluate coagulation abnormalities using viscoelastic point-of-care coagulation monitoring in this population. This test is readily available in large hospitals and academic settings and is increasingly being used in perioperative medicine. It provides information on coagulation and thrombolysis with minimal delay when compared to other laboratory-based coagulation tests.
The dietary supplements which will be evaluated in this study are ginger, garlic, gingko biloba and ginseng. These four herbal supplements were identified as the most commonly used substances known to modulate the coagulation system. These herbal supplements will be investigated within their maximum daily allowance dosages.
A five-armed placebo-controlled study will be undertaken and study subjects will be recruited on a volunteer basis. Subjects will be divided into five groups and each group will receive one of the four dietary supplements and the fifth group placebo, for a two week period. Rotational thromboelastometry (ROTEM) studies will be performed on blood samples obtained from each participant at baseline and at the end of the treatment period to identify coagulation abnormalities. Most of these herbal medicines have been identified to affect platelet function and this study will specifically look at platelet function determined by maximum clot firmness (MCF) in the ROTEM analysis.
Viscoelastic point-of-care coagulation monitoring in patients using herbal medicines and dietary supplements will aid decision making regarding cause of perioperative haemorrhage and need for specific blood products. It will therefore assist with goal-directed management of perioperative haemorrhage. It will also aid the anaesthetist wishing to employ a regional anaesthetic technique in this patient group.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
- Model description
- Five- armed, placebo- controlled ( 4 intervention groups and 1 placebo group)
| Arm | Type | Receives |
|---|---|---|
| Ginger | Active comparator | Dietary Supplement: GingerGinger ( Zingiber officinale) 4 grams po dly for 14 days |
| Garlic | Active comparator | Dietary Supplement: GarlicGarlic (Allium sativum) 4-12 mg alliin po dly for 14 days |
| Ginkgo Biloba | Active comparator | Dietary Supplement: Ginkgo BilobaGinkgo Biloba 40mg po tds for 14 days |
| Ginseng | Active comparator | Dietary Supplement: GinsengGinseng 400mg po dly for 14 days |
| Placebo | Placebo comparator | Other: PlaceboPlacebo po dly for 14 days |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18-60 years
- Both males and females
- Healthy volunteers
- Smokers and Non-smokers
- Staff frequenting the theatre complex at Steve Biko Academic Hospital
Key exclusion criteria (5 listed)
- Use of any medication, excluding oral contraceptive pills, in the two week period prior to commencement of the study. Medicines excluded, include aspirin, dietary supplements, herbal teas, anticoagulants and other non-steroidal anti-inflammatory medications. . Oral contraceptive pills were omitted as an exclusion criteria, taking into account that the majority of woman use these. The results of the study will be a better reflection of the effect of these dietary supplements in the modern day woman. Its coagulant properties will be taken into account during data analysis.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GingerGinger dosage at daily recommended allowance | Dietary supplement | Ginger |
| GarlicGarlic dosage at daily recommended allowance | Dietary supplement | Garlic |
| Ginkgo BilobaGinkgo Biloba dosage at daily recommended allowance | Dietary supplement | Ginkgo Biloba |
| GinsengGinseng dosage at daily recommended allowance | Dietary supplement | Ginseng |
| PlaceboDaily dosage strategy | Other | Placebo |
Primary outcome
Platelet dysfunction determined by ROTEM when consuming ginger, garlic, ginkgo biloba and ginseng.
Time frame: 2-4 weeks
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2018.
- Individual participant dataSharing planned: No
Related trials for Dietary Supplements
RecruitingPhase 2
FAST for DM - Fatty Acid Supplementation Trial (FAST) for Dermatomyositis (DM)
Dermatomyositis (DM), Juvenile Dermatomyositis (JDM)
Recruiting
Impact of Food Supplementation on Quality of Life in Patients With Endometriosis and Pelvic Pain.
Endometriosis (Diagnosis)
Not yet recruiting
Effect of HMB Supplementation and Vivifrail Exercise on Body Composition, Handgrip Strength and Physical Performance in Women Over 60 Years of Age
Aging, Muscle Strength
Not yet recruiting
A Clinical Trial to Evaluate the Effects of A Supplement on Symptoms of Menopause and Overall Well-being
Menopause, Menopausal Symptoms
Not yet recruiting
Hop Extract Versus Soy Isoflavone Extract for Menopausal Symptoms (HOPES)
Menopause, Perimenopause
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jayde V Wyngaard, MBCHB principal investigator
University of Pretoria
Questions about this trial
What is this clinical trial studying?
A study testing Ginger, Garlic and Ginkgo Biloba in people with Dietary Supplements and Bleeding Tendency; Due to Coagulation Defect, run by University of Pretoria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet dysfunction determined by ROTEM when consuming ginger, garlic, ginkgo biloba and ginseng. (time frame: 2-4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2018.