Supplementary MaterialsSupplemental Digital Content medi-99-e19910-s001
August 14, 2020
Supplementary MaterialsSupplemental Digital Content medi-99-e19910-s001. score to confirm the efficacy of NHT. The secondary outcomes include overall total effect, single dyspepsia symptom scale, food retention questionnaire, questionnaire, FD-related quality of life, electrogastrography, TKI-258 kinase inhibitor and safety assessments. TKI-258 kinase inhibitor Adverse events will be evaluated at every visit. The primary endpoint will be measured at week 4, and then re-evaluated at week 8 through a follow-up phone visit. Discussion: This trial will evaluate the safety and efficacy of NHT as a treatment of FD. The results of this trial will not only verify whether NHT boosts FD gastric and symptoms myoelectrical activity, but clarify those correlations also. Trial registration amount: CRIS KCT0003405. infections.[11C14] Due to the complications and limitations of the medications, many FD individuals have a tendency to prefer substitute treatment options, such as for example herbal medicine.[15C17](NHT) is among the most regularly prescribed herbal medicine for treating FD in traditional Korean medicine. Even though some scholarly research have got demonstrated that NHT works well in the treating FD,[18,19] randomized TKI-258 kinase inhibitor controlled studies to provide clinical evidence of NHT as a treatment option for patients with FD have not yet been performed. The goal of this study is TKI-258 kinase inhibitor usually to propose a protocol of randomized, placebo-controlled trial aimed to evaluate the security and efficacy of NHT in patients with FD. 2.?Methods and design 2.1. Objective This study aims to assess the security and efficacy of NHT in patients with FD. 2.2. Hypothesis We hypothesize that this administration of NHT for 4 weeks will relieve the symptoms of FD. 2.3. Design This study is usually a prospective, multi-center, randomized, double-blind, and placebo-controlled trial. It will be conducted at Kyung Hee University or college Korean Medicine Hospital and Kyung Hee University or college Hospital at Gangdong, Seoul, Korea, from May 2019 to December 2020. This trial has been registered with the Clinical Research Information Support (CRIS) (KCT0003405, on December 24 registered, 2018). Total 116 individuals who meet up with the research requirements and consent to take part in trial will end up being randomly designated into either NHT or placebo group using a ratio of just one 1:1. They shall undergo four weeks of administration and another four weeks of follow-up period. The scholarly research stream graph illustrating the complete research method is certainly proven in Body ?Figure and Figure11 ?Figure22 displays the timetable of final result measurements, following Standard Process Items: Tips for Interventional Studies (Heart) checklist (see Additional document 1). Open up in another window Body 1 Flow graph from the trial procedure. NHT?=?questionnaire, ECG?=?electrocardiography, EGG?=?electrogastrography, FD-QoL?=?useful dyspepsia-related standard of living, FRQ?=?meals retention questionnaire, KRAS2 OTE?=?general total effect, PIFD?=?design identification of useful dyspepsia, SDS?=?one dyspepsia symptom, TDS?=?total dyspepsia symptom, VAS?=?visible analogue scale. 2.4. Ethics acceptance THE STUDY Ethics Committees at Kyung Hee School Korean Medicine Medical center (approval number is certainly KOMCIRB-2017C08-030) and Kyung Hee School Medical center at Gangdong (No. KHNMCOH 2019-01-003-003) possess approved this process. Before enrollment, all individuals will indication a created up to date consent type after completely up to date of the reason, process and risks associated with the trial by the investigators. The protocol is usually in accordance with the revised version of the Declaration of Helsinki and Good Clinical Practice guidelines approved by the Korea Food and Drug Administration. 2.5. Sample size calculation We hypothesize that oral administration of NHT is more effective than that of placebo in relieving FD symptoms. As TKI-258 kinase inhibitor the first randomized clinical trial of NHT in patients with FD, we referred to a previous study with a altered.