Functional dyspepsia (FD) is a common disorder characterized by a cluster of symptoms largely affecting the upper digestive system.
The symptoms include epigastric pain, burning, and an uncomfortable sense of fullness. FD affects close to 20% of the global population, with no clear-cut conventional treatment. Lifestyle-related factors are believed to contribute to the onset of functional dyspepsia, including cigarette smoking, alcohol, stress, certain medications, infections, and obesity. Dysfunction in the gut-associated nervous system is also believed to impair gastric motor function.
The current randomised, double-blind, placebo-controlled clinical study was conducted at the Maharaja Agrasen Hospital, New Delhi, India, and included 57 participants suffering from FD. They were allocated either 200mg of ginger extract (Ginfort by DolCas Biotech), twice daily, or the equivalent dose in a dibasic calcium-inactive placebo.
Overall treatment efficacy was rated on a seven-point Likert scale where subjects were asked to complete a weekly questionnaire over the course of the 4-week trial. Nine functional dyspepsia related symptoms were assessed including upper abdominal pain, upper abdominal discomfort, postprandial fullness, upper abdominal bloating, early satiety, excessive belching, nausea, vomiting, and heartburn.
At two weeks into the trial, 41% of subjects in the treatment group reported a statistically significant positive response which was maintained throughout the trial period. Ginger extract supplementation was found to be effective in 79% of the subjects, while the placebo was found to be 21% effective. Moreover, responder rate in the ginger treated group was 58% higher than placebo group at Visit 4.
In an assessment at Week 4 of secondary efficacy endpoints, the collective elimination score for three major symptoms — postprandial fullness, upper abdominal bloating, and early satiation — was 64% for the treated subjects, whereas only 13% of the placebo group said their symptoms were eliminated. Most of the nine individual symptoms also showed statistically significant rates of elimination over the placebo group. Examination of blood labs and of vital signs determined Ginfort to be an effective and safe option for the treatment of FD.
Dr. Shavon Jackson-Michel, Director of Medical & Scientific Affairs at DolCas Biotech, LLC. “The ginger rhizome’s (underground stem) use in support of digestive health has been promising and anecdotally rewarding yet has evaded rigorous scientific evaluation in terms of producing consistently, positive results.”
A 2019 review on the role of ginger in gastrointestinal disorders provided recommendations for improving the evidence profile for ginger ingredients, establishing effective dose recommendations and optimizing ginger preparations to ensure stability and bioavailability of known ginger actives, specifically the volatile oils gingerols and shagaols.
Ginfort’s Aqueosome technology delivers 26% of active gingeroid compounds, including the gingerols and shagaols. Its proprietary solvent-free extraction process produces a powder from ginger oleoresin containing high concentrations of pure ginger polyphenols and essential oils in their native, naturally stable matrix. This enables low clinical doses and less restrictive storage conditions and enhances the stability and bioavailability of the rhizome’s particularly volatile bioactives.
Source: Journal of Dietary Supplements
Panda. S. K., et al
“A Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Comparative Clinical Study to Evaluate the Efficacy and Safety of OLNP-06 versus Placebo in Subjects with Functional Dyspepsia”