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.
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 functio...
| Published in: | Journal of Dietary Supplements Vol. 19; no. 2; pp. 226 - 238 |
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| Main Authors: | , , , , |
| Format: | research tables/charts randomized controlled trial Journal Article |
| Published: |
Taylor & Francis Ltd
2022
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| Online Access: | View this record in EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=155402847&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 155402847 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 19390211 2Y62 jtl: Journal of Dietary Supplements issn: 19390211 maglogo: N pubinfo: dt: 2022 vid: 19 iid: 2 pid: 377 pub: Taylor & Francis Ltd place: Philadelphia, Pennsylvania artinfo: ui: 155402847 147517177 155402847 155402847 10.1080/19390211.2020.1856996 155402847 ppf: 226 ppct: 12 formats: fmt: – @attributes: type: T – @attributes: type: P tig: atl: 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. aug: au: Panda, MPharm, Sanjib Kumar Nirvanashetty, PhD, Somashekara Parachur, BTech, Vivek A. Krishnamoorthy, MPharm, Chakravarthy Dey, MSc, Shemanti affil: Olene Life Sciences Private Limited, Chennai, India sug: subj: Dyspepsia Diet Therapy Dietary Supplements Drug Efficacy Patient Safety Dyspepsia Symptoms Human India Randomized Controlled Trials Double-Blind Studies Random Assignment Placebos Comparative Studies Urinalysis Drug Elimination Routes Satiation ab: 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. Trial Registration: Clinical Trial Registry-India, CTRI/2019/09/021019, Registered on 2 Sep 2019. pubtype: Academic Journal doctype: research tables/charts randomized controlled trial Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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