Annex A: Summary of Studies COT/2025/01

Traditional/culinary uses of ginger

COT/2025/01

Last updated: 22 May 2025

Human Studies

Author/Date

Study type

Study size/No. of Patients at End

Exposure (ginger dose/day)

Study period

Length of Treatment (days)

Main outcome measures

 Main results

Chittumma et al., 2007

Randomized double-blind controlled trial.

126/123

Ginger powder
capsules (325 mg ×2,
3x/d, =
1950 mg/day).

4 days

4

Change in nausea and vomiting scores (3 symptoms on Rhodes index);
occurrence of side-effects.

Only minor side effects observed. No difence between the groups.

Ensiyeh et al., 2005

Double-blind randomised controlled trial.

70/69

Ginger powder
capsules (500 mg
2×/d =1000 mg/day)

3 months

4

Severity of nausea (VAS 0–10); number of vomiting episodes; general response to treatment (5-item Likert scale); occurrence of side-effects or adverse
pregnancy outcome.

Two spontaneous abortions in ginger group, 1 in B6 group; no congenital anomalies observed in babies brough to term.

Fischer-Rassmussen et al., 1991

Double-blind randomised crossover trial.

30/27

Ginger powder
capsules (250 mg
4 times per day =
1000 mg/day).

11 days

4

Preference of treatment period; relief scores (4-point scoring system); outcome of pregnancy.

One spontaneous abortion, One elected. No adverse effects were observed in remaining 25 subjects.

Portnoi, 2003

Not specified.

187 pregnant women.

Various, not specified.

up to 12 months post birth.

Minimum of 3 days.

Safety and effectiveness of ginger for nausea and vomiting of pregnancy (NVP).

Three major malformations were reported in the ginger group, ventricular septal defect (VSD), right lung abnormality, and kidney abnormality (pelviectasis).  One incidence of idiopathic central precocious puberty at age 2 years. No significant difference between the two groups in terms of live births, spontaneous abortions, stillbirths, therapeutic abortions, birth weight, or gestational age.

Smith, 2004

Randomized, controlled equivalence trial.

291 women, less than 16 weeks pregnant.

1.05 g ginger.

3 weeks.

3 weeks.

Ginger verses B6 for the treatment of nausea or vomiting in pregnancy.

Three spontaneous abortions in ginger group, 9 abortions in B6 group.

Vutyavanich, 2001

Double blind

32

Ginger powder
capsules (250 mg
4x/day =1000
mg/day).

5 months.

4

Severity of nausea (VAS 0–10); number of vomiting episodes; general response to treatment after 1 week (5-item Likert
scale); occurrence of side-effects and adverse pregnancy outcomes.

No significant adverse effects of ginger on pregnancy outcome.

Human studies – Platelet Aggregation

Author/date

Study design

Population/study size

Study Duration

Exposure

Outcome

 Results

Comment

Bordia
et al., 1997

Placebo controlled
trial.

Patients with
confirmed
myocardial
infarction N = 60.

3 months. Outcomes
measured at: baseline, 1.5
months and 3 months.

Dose: 4g per day Unstandardised
capsules.

Platelet aggregation—
Agonist(s): ADP and Epi.

Ginger had no
significant effect on
both measures of
aggregation.

Ginger had no significant effect on blood lipids or blood sugar.

Bordia
et al., 1997

NA

NA

NA

NA

Fibrinogen;

NA

No mention of
randomisation.

Bordia
et al., 1997

NA

NA

NA

NA

Fibrinolytic activity.

 

P value not reported.

Lumb.
1994

Randomised,
double-blinded
placebo-controlled
crossover
trial.

Healthy male
volunteers N=8.

Total study period:
2 x 1 day, at least 14
days washout period. Outcomes measured
immediately before,
3 hrs, and 24 hrs post
consumption of ginger.

Dose: 2g (4 x 500 mg) dried ginger per day Unstandardized
capsules.

Platelet aggregation; - Agonist(s): AA, ADP, collagen, ristocetin, ADP; Bleeding time; Platelet count; Thromboelastography.

No significant
changes in any
outcome at any time
point.

NA

Srivastava
1989

Open-label
single-arm trial.

Healthy female
volunteers, N = 7.

Total study period: 7
days. Outcomes
measured at
baseline and 7days post-consumption.

Dose: 5g raw ginger
per day.

Platelet thromboxane B2 production.

Ginger consumption
resulted in a 37%
inhibition of
thromboxane B2
production (p<0.01).

NA

Young et al., 2006

Not specified.

20

72 days.

1 g ginger (+ 10 mg nifedipine).

Synergistic effect of ginger and nifedipine on anti-platelet aggregation in normal human volunteers and hypertensive patients.

Ginger and nifedipine had synergistic
effect on anti-platelet aggregation; Ginger increased anti-platelet aggregation effect of nifedipine in all patients.

 NA

In vivo studies

Author

Test System

Study size

Exposure

Characterisation of test substance

Duration

Main outcome measure

Outcome

Wilkinson 2000

Sprague-Dawley rats, F.

43

Oral, drinking water on days 6-15.

20 g/L or 50 g/L ginger tea.

20 days.

Reproductive and developmental toxicity.

Embryonic loss in the treated groups 2 times that of the controls. Exposed fetuses found to be significantly heavier than control. No gross structural malformations observed.

Effect on Platelet Aggregation

Author

Test System

Study size

Exposure

Characterisation of test substance

Main outcome measure

Outcome

Srivastava
1989

Open-label
single-arm trial.

Healthy female
volunteers, N = 7.

Total study period: 7
days. Outcomes
measured at
baseline and 7 days
post-consumption.

Dose: 5g raw ginger
per day.

Platelet thromboxane B2 production.

Ginger consumption
resulted in a 37%
inhibition of
thromboxane B2
production (p<0.01).