A Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Comparative Clinical Study to Evaluate the Efficacy and Safety of OLNP-06 <i>versus</i> Placebo in Subjects with Functional Dyspepsia

MPharm, Sanjib Kumar Panda; Nirvanashetty, Somashekara; BTech, Vivek A Parachur; MPharm, Chakravarthy Krishnamoorthy; Dey, Shemanti

doi:10.1080/19390211.2020.1856996

Cited by 7 publications

(3 citation statements)

References 20 publications

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“…In comparison to the placebo, which was found to be just 21% effective, zingiber officinale supplementation was found to be successful in 79% of the individuals. (19) Section C: Association of level of dyspepsia with selected demographic and clinical variables.…”

Section: Resultsmentioning

confidence: 99%

A study to assess the effectiveness of ginger tea on symptoms of dyspepsia among adults

Cecyli¹,

Soundariya²,

Jagadeeswari³

et al. 2023

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Introduction: Dyspepsia is a common gastrointestinal (GI) condition around the world. Dyspepsia is a symptom complex that includes a variety of upper GI symptoms such as epigastric pain or burning, early satiety, and post-prandial fullness. Treatment with complementary and alternative medicines, particularly herbal remedies, is one option for treating dyspepsia symptoms. Objectives: The objectives of the study were to evaluate the effectiveness of ginger tea on symptoms of dyspepsia among adults Methods: A one-group pre-test and post-test research design with 30 samples who met the inclusion criteria was used. Demographic and clinical data were collected using a self-structured questionnaire. During the pre-test, a questionnaire (LDQ) was used to assess the severity of dyspepsia symptoms using an interview method. Following the pre-test, 100ml of freshly prepared ginger tea was given once a day, seven days a week, in the morning before meals. The same tool was used for the post-test after seven days of ginger tea administration. Data has been subjected to descriptive and inferential statistics Result: During the pre-test, 13(43.33 %) of the 30 samples had moderate dyspepsia, 9(30%) had severe dyspepsia, and 8(26.67%) had mild dyspepsia, whereas in the post-test, 14(46.67%) had moderate dyspepsia, 12(40%) had mild dyspepsia, and 4(13.33%) had severe dyspepsia. Ginger tea is effective when the pre-test and post-test values are compared. At the p<0.001 level, the calculated paired ‘t’ test value of t = 9.104 was found to be statistically highly significant. Demographic variables such as marital status and clinical variables such as dyspepsia duration and smoking history show a significant association with post-test dyspepsia level at p<0.05. Conclusion: According to the study findings, the overall pre-test symptom score was mild to moderate. The post-test symptom score of dyspepsia patients who were given ginger tea showed a significant reduction in symptom severity. It was concluded that ginger had a greater impact on symptom relief in dyspepsia patients than other foods.

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Section: Resultsmentioning

confidence: 99%

A study to assess the effectiveness of ginger tea on symptoms of dyspepsia among adults

Cecyli¹,

Soundariya²,

Jagadeeswari³

et al. 2023

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“…Only one recent systematic review and meta-analysis specifically focused on intervention studies regarding dietary interventions and GERD [10]. Only two studies evaluating ginger supplements could be identified for inclusion in that meta-analysis [43,44]. These studies showed a significant improvement of GERD symptoms (OR 7.50 (95% CI: 3.62-15.54)).…”

Section: Discussionmentioning

confidence: 99%

The Efficacy of Dietary Interventions in Patients with Gastroesophageal Reflux Disease: A Systematic Review and Meta-Analysis of Intervention Studies

Lakananurak,

Pitisuttithum,

Susantitaphong

et al. 2024

Nutrients

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Background: International guidelines recommend dietary interventions as one of the most important treatments for patients with gastroesophageal reflux disease (GERD). Evidence to confirm the efficacy of these treatment modalities is lacking. The present study aims to evaluate the efficacy of dietary interventions on GERD-related outcomes evaluated in intervention studies on GERD patients. Methods: A systematic review and meta-analysis was performed according to PRISMA. The PubMed/MEDLINE, Web of Sciences, and Scopus databases were utilized for the literature search. Two independent researchers searched for relevant publications published up until June 2023. Intervention studies evaluating the efficacy of dietary interventions in patients with GERD were included. Results: A total of 577 articles were identified during the initial literature search. After reviewing, 21 studies with 16 different types of dietary interventions were included in the analysis. The interventions were divided into low-carbohydrate diets (3 studies), high-fat diets (2 studies), speed of eating studies (3 studies), low-FODMAP diets (2 studies), and other interventions (12 studies). A meta-analysis could be performed for low-carbohydrate diets and speed of eating interventions. Low-carbohydrate diets resulted in a significant reduction in esophageal acid exposure time (mean difference = −2.834%, 95% confidence interval (CI): −4.554 to −1.114), while a slow speed of eating did not lead to a lower percentage of reflux events compared to fast eating (risk ratio = 1.044, 95% CI: 0.543–2.004). Most other interventions showed positive effects in only a single study. Conclusion: Low-carbohydrate diets showed a significant improvement in GERD-related outcomes, while a slow eating speed did not result in a reduction in reflux events. The overall evidence regarding dietary interventions in GERD remains scarce. High-quality, long-term RCTs are still required to confirm the effects of dietary interventions in GERD patients.

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“…Zingiber officinale , otherwise known as ginger, was studied in patients suffering from Rome III criteria FD via a double‐blind, placebo‐controlled clinical trial 152 . A significant number of patients responded or had eliminated their FD symptoms compared to placebo without an increase in adverse events.…”

Section: Management Of Pre‐existing Functional Dyspepsia In Pregnancymentioning

confidence: 99%

Review article: Functional dyspepsia and pregnancy—Effects and management in a special population

Liu

Starkey

Virani

et al. 2023

Aliment Pharmacol Ther

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Background: Around 10% of Americans meet the Rome IV criteria for functional dyspepsia (FD), with a significantly higher rate in women. FD also has a higher prevalence in women below the age of 50, suggesting that women who are affected are likely to be of reproductive age. Unfortunately, there is a lack of research or evidence-based guidelines on managing FD in pregnancy. Aims and Methods:To address this issue, we aimed to perform a systematic review of the interactions between FD and pregnancy and managing pre-existing FD in the peripartum and post-partum phases using current lifestyle, pharmacological, nonpharmacological and alternative medicine interventions. Results: Due to the lack of Rome IV FD-specific data in pregnancy, we instead performed a narrative review on how existing FD interventions could be extrapolated to the pregnant population. Where possible we use the highest level of available evidence or official guidelines to answer these questions, which often involves synthesising treatment and safety evidence of these interventions in other diseases during pregnancy. Finally, we highlight current substantial knowledge gaps requiring further research for the safe management of a pregnant patient with pre-existing FD. Conclusions: Overall, despite the paucity of knowledge of treating FD during pregnancy, providers can mitigate this uncertainty by planning ahead with the patient. Patients should ideally minimise treatment until after breastfeeding. However, interdisciplinary resources are available to ensure that minimal-risk interventions are maximised, while interventions with more risks, if necessary, are justifiable by both the patient and the care team. Future investigations should continue to elicit the mechanistic relationship between FD and pregnancy while cautiously expanding prospective research on promising and safe therapies in pregnant patients with preexisting FD.

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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

Cited by 7 publications

References 20 publications

A study to assess the effectiveness of ginger tea on symptoms of dyspepsia among adults

A study to assess the effectiveness of ginger tea on symptoms of dyspepsia among adults

The Efficacy of Dietary Interventions in Patients with Gastroesophageal Reflux Disease: A Systematic Review and Meta-Analysis of Intervention Studies

Review article: Functional dyspepsia and pregnancy—Effects and management in a special population

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