ROTEM and Dietary Supplements

NCT03125551 — Not applicable, Withdrawn, University of Pretoria

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Viscoelastic Point-of-Care Coagulation Monitoring and Dietary Supplements: A Randomized, Double-blind, Placebo-controlled Trial

Registry	NCT03125551
Status	Withdrawn - Study requires Medicines Control council approval
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, diagnostic
Sponsor	University of Pretoria (Other)
Conditions	Dietary Supplements, Bleeding Tendency; Due to Coagulation Defect
Interventions	Ginger, Garlic, Ginkgo Biloba, Ginseng, Placebo (Dietary supplement, other)
Dates	start 2017-06-01 (estimated), primary completion 2017-07-01 (estimated), completion 2017-08-01 (estimated), first posted 2017-04-24, last updated 2018-05-09

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Ginger	Active comparator	Dietary Supplement: Ginger	Ginger ( Zingiber officinale) 4 grams po dly for 14 days
Garlic	Active comparator	Dietary Supplement: Garlic	Garlic (Allium sativum) 4-12 mg alliin po dly for 14 days
Ginkgo Biloba	Active comparator	Dietary Supplement: Ginkgo Biloba	Ginkgo Biloba 40mg po tds for 14 days
Ginseng	Active comparator	Dietary Supplement: Ginseng	Ginseng 400mg po dly for 14 days
Placebo	Placebo comparator	Other: Placebo	Placebo po dly for 14 days

Ginger (Dietary supplement): Ginger dosage at daily recommended allowance
Garlic (Dietary supplement): Garlic dosage at daily recommended allowance
Ginkgo Biloba (Dietary supplement): Ginkgo Biloba dosage at daily recommended allowance
Ginseng (Dietary supplement): Ginseng dosage at daily recommended allowance
Placebo (Other): Daily dosage strategy

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 60 Years, accepts healthy volunteers

Inclusion Criteria:

1. Age 18-60 years
2. Both males and females
3. Healthy volunteers
4. Smokers and Non-smokers
5. Staff frequenting the theatre complex at Steve Biko Academic Hospital

Exclusion Criteria:

1. 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.
2. History of any chronic medical or psychiatric illness.
3. Current excessive alcohol intake - more than 14 units a week in woman and more than 21 units a week in men.
4. Pregnant or lactating mothers.
5. Possible planned surgery during the study period

+Investigators

Jayde V Wyngaard, MBCHB, Principal investigator, University of Pretoria