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一项评价 OLNP-06 安慰剂在功能性消化不良受试者中的疗效和安全性的随机、双盲、安慰剂对照、平行分组、对照临床研究。

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

机构信息

Olene Life Sciences Private Limited, Chennai, India.

出版信息

J Diet Suppl. 2022;19(2):226-237. doi: 10.1080/19390211.2020.1856996. Epub 2020 Dec 11.


DOI:10.1080/19390211.2020.1856996
PMID:33305631
Abstract

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 ( < .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 ( < .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. Clinical Trial Registry-India, CTRI/2019/09/021019, Registered on 2 Sep 2019.

摘要

OLNP-06 是一种姜提取物产品,其总姜酚含量标准化,采用专有的 Aqueosome 技术配方。OLNP-06 的安全性和疗效在一项随机、双盲、安慰剂对照、平行组比较临床试验中进行了评估,该试验纳入了功能性消化不良(FD)患者。在试验过程中观察到临床终点有显著改善,同时具有极好的安全性。

该研究纳入了 50 名年龄在 18 至 55 岁之间、符合罗马 III 标准的 FD 患者。他们被随机分为两组,一组接受 OLNP-06,每日两次,每次 200 毫克;另一组接受安慰剂,每日两次,每次 200 毫克。主要疗效终点是整体治疗疗效(OTE)的综合评估。次要疗效终点是三种主要症状(餐后饱胀、上腹胀满和早饱)的消除率以及每种症状评分的消除率。进行了生化和血液学参数(包括尿液分析)检查,以评估 OLNP-06 的安全性。

在 50 名受试者中,有 48 名完成了研究。根据 OTE 评估,接受 OLNP-06 的受试者中有 79%( < .05)和接受安慰剂的受试者中有 21%被归类为应答者。接受 ONLP-06 的受试者餐后饱胀、上腹胀满和早饱的消除率(评分 0)为 64%,而安慰剂组为 13%( < .05)。

OLNP-06 被发现是安全且耐受良好的,因为没有发生与治疗相关的不良事件。在 FD 患者中,补充 OLNP-06 4 周可显著减轻消化不良症状。

印度临床试验注册处,CTRI/2019/09/021019,于 2019 年 9 月 2 日注册。

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