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Evidence
This information is provided for educational purposes only and is not intended to promote the product as a treatment or cure for any disease. The statements about EmetoGard have not been evaluated by the Food and Drug Administration (FDA). This product is not intended to diagnose, treat, cure, or prevent any disease.
OLNP-06 is ginger extract product standardized to higher amount of total gingerols formulated with proprietary Aqueosome technology. The safety and efficacy of OLNP-06 were evaluated in a randomized, double blind, placebo controlled, parallel group comparative clinical study in subjects with functional dyspepsia (FD). Significant improvements in clinical endpoints were observed during the trial along with excellent safety profile. Fifty subjects aged between 18 and 55 years suffering from FD as per ROME III criteria were enrolled into the study. They were randomized into two treatment groups, one group received OLNP-06, 200 mg twice daily and other group received placebo 200 mg twice daily. The primary efficacy end point was global assessment of overall treatment efficacy (OTE). Secondary efficacy endpoints were elimination rate of three major symptoms (postprandial fullness, upper abdominal bloating and early satiation) and elimination rate for each individual symptom scores. Biochemical and hematological parameters including urine analysis were performed to evaluate the safety of OLNP-06. Out of 50 subjects, 48subjects completed the study. Total 79% of the subjects receiving OLNP-06 and 21% of the subjects receiving placebo (p < .05) were classified as responders according to the assessment of OTE. Elimination rate (score 0) of postprandial fullness, upper abdominal bloating and early satiation was 64% in subjects receiving ONLP-06 compared with 13% in the placebo group (p < .05). OLNP-06 was found to be safe and well tolerated as there was no incidence of treatment-related AE's. Supplementation of OLNP-06 for 4 weeks significantly reduced dyspeptic symptoms in subjects suffering from FD.
Summary
In this 28-day, double-blind, randomized controlled trial, Ginfort (OLNP-06), the patented ginger extract in EmetoGard, was evaluated in a randomized, double-blind, placebo-controlled clinical trial in 50 adults. OLNP-06 (Ginfort) 200 mg, twice daily was evaluated in patients (n=50) with dyspepeptic symptoms. Patients experienced significant improvement in:
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Nausea
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Bloating
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Upper abdominal discomfort
Results demonstrated significant improvement in those treated with active Ginfort compared to placebo. After 28 days, nausea improved in over 80% of patients compared to less than 40% with placebo (* p<0.05).
Disclosure: The study was funded by Olene Life Sciences who manufactured
OLNP-06. Several authors were also employees of Olene Life Sciences.
Participants rated symptoms of upper abdominal pain, upper abdominal discomfort, postprandial fullness, bloating, early satiation, excessive belching, nausea, vomiting, and heartburn on a 0–3 scale (none, mild, moderate, severe).
The daily diary cards were completed after their evening meals throughout the 4-week treatment period.
Based on diary entries, investigators evaluated the elimination rate for each symptom, defined as the proportion of participants reporting a score of zero.
Only nausea and abdominal pain results are shown here. For full article, see:
Safety & Tolerability
The study using EmetoGard (Ginfort®) showed that it was safe and well-tolerated in adults.
In the active group, reported adverse events included:
• Heaviness in head (1 patient, 4%)
• Dark yellow urine (1 patient, 4%)
In the placebo group, reported adverse events included:
• Dark yellow urine (1 patient, 4%)
• Constipation (1 patient, 4%)
Overall, no serious adverse events or safety concerns were identified:
*Based on a 4-week randomized placebo-controlled trial in subjects with nausea and epigastric discomfort. OLNP-06 is the unique formulation of ginger extract now known as Ginfort®. This has not evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.
