• 한방비만학회지
• /
• 제24권1호
• /
• pp.87-93
• /
• 2024

Objectives: Obesity is a globally prevalent public health issue. Hence, there is a need for the development of safer and more effective anti-obesity drugs. Lythrum salicaria, a traditional medicinal herb used for centuries, has been reported to improve lipid metabolism and fat accumulation. It also has a low toxicity profile. Therefore, its potential as a functional ingredient in health functional foods needs to be evaluated. Methods: In this randomized, double-blind, placebo-controlled clinical trial, 90 participants will be randomly assigned to either the experimental or control group. Each subject will orally receive L. salicaria extract (1,350 mg/day) (500 mg L. salicaria+850 mg lactose as vehicle) or lactose (1,350 mg/day) as a hard capsule formula for 84 days (12 weeks). The primary outcome will be body fat mass (kg), which will be assessed using dual-energy x-ray absorptiometry (DXA) (performed only at visits 2 and 4). Secondary outcomes include body mass index, body weight, waist-to-hip ratio, body fat percentage (%) measured using DXA, lean body mass (kg) measured using DXA (assessed only at visits 2 and 4), lipids (total cholesterol, triglyceride, high-density lipoprotein cholesterol, and calculated low-density lipoprotein cholesterol), free fatty acid, high sensitivity C-reactive protein, adiponectin, and leptin. Conclusions: This protocol will be implemented after approval of Institutional Review Board of Pusan National University Korean Medicine Hospital (approval number: PNUKHIRB-2022-08-002) and registration with the Korean National Clinical Research Information Service (CRIS) (CRIS-KCT0008060). The results of this trial will provide potential of L. salicaria as a new anti-obesity functional food with fat-reducing effects and low toxicity.

• Journal of Acupuncture Research
• /
• 제26권3호
• /
• pp.59-65
• /
• 2009

Objectives : This survey was done in order to find out how Korean medical doctors derive pattern identification for acupuncture prescriptions in treating knee pain in real clinical practice. Methods : The survey questionnaire was developed by the committee of experts who major in acupuncture & moxibustion or statistics for acupuncture clinical trial protocol development. The questionnaires were distributed via e-mail to 75 members of Korean Acupuncture & moxibustion society from March 26th to April 14th in 2009. 57 members completed answers, and the computerized data were analyzed by SPSS 17.0 statistical program. Results : 1.54 Korean medical doctors selected meridian pattern identification based on the course of the meridians(52.5%), visceral pattern identification(27.1%), pattern identification based on cause of disease(8.5%) as the most commonly used pattern identification methods for acupuncture prescription when treating knee pain patients in real clinical practice. 2. In meridian pattern identification based on the course of the meridians, liver meridian of the medial knee region(13.2%), bladder meridian of the posterior knee region(12.0%), spleen meridian of the lateral knee region(11.7%), stomach meridian of the anterior knee region(9.8%) and kidney meridian of the medial knee region(8.6%) were selected. 3. In visceral pattern identification, blood stasis of sinews due to liver and kidney deficiency(5.3%), damp joint with yang deficiency of liver and kidney(4.9%), kidney qi deficiency with congealing cold(4.5%), yin deficiency of liver and kidney(4.1%) were selected. Conclusions : In our e-mail survey, Korean medical doctors answered that Meridian Pattern Identification based on the course of the meridians is the most often used diagnosis method. Visceral pattern identification, pattern identification based on cause of disease, pattern identification based on symptom and pattern identification based on qi-blood-yin-yang theory in order of frequency used, were selected for knee pain diagnosis in real clinical practice.

• 대한기관윤리심의기구협의회지
• /
• 제2권1호
• /
• pp.23-31
• /
• 2020

Purpose: To obtain opinions from Korean Institutional Review Board (IRB) members' self-evaluation on ability to conduct fairness review of clinical trial protocol with presence of conflict of interest and from investigators and IRB members on financial conflict of interest through surveying. Methods: IRB members and researchers in 9 different hospitals were asked to answer survey questions via email. Results: Responders were 115 personnel (IRB Chair/vice 18, medical member 30, non-medical member 28, and researcher 39) from 9 centers. Compared to IRB medical members, IRB chair/vice respondents scored higher with statistically significance on 10 point scale (8.44±1.381 vs. 7.30±1.685, p=0.005) when asked to self-evaluate fairness reviewing a protocol proposed by an investigator from the same department and a protocol from the company that supports the scientific committee of responders. When reviewing a protocol proposed by a hospital director, non-medical members scored statistically significantly higher than medical-members (7.47±1.76 vs. 8.07±2.70, p=0.034). When asked about the limitation of labor fee for principal investigator on phase 3 Human clinical trials of the Investigational new drug, while the responses range was wide, 60% answered that labor cost of principal investigator should be less than 30% of total budget for clinical trials with a budget of 100 million won. 51.3% answered that there is no need to disclose the labor cost of the principal investigator in the consent form. Since every investigator can be influenced unconsciously by conflict of interest, the answer that 'responder agrees that there is need for management' was the most chosen answer (IRB member 61.8%, investigator 64.1%, multiple answers allowed). Conclusion: Considering scores on questions of fairness by IRB members were between 7.23-8.56 on scale of 0 to 10 point when IRB members were asked about reviewing a clinical trial protocol, it cannot be said with absolute certainty that there is no issue regarding fairness in the review process. Therefore, there should be more ways to safeguard fairness for these issues. There is a need that the disclosure amount of honorarium from sponsor should be lower than 100 million Korean won. Considering the results of the survey in which respondents expressed their thoughts, it is likely that more education on the concept of conflict of interest is needed.

• 구강회복응용과학지
• /
• 제20권2호
• /
• pp.95-107
• /
• 2004

물론 과학적인 연구가 더 필요하겠지만, 적절한 교합고경은 주위 저작근과 조화를 이루면서, 최적의 기능을 발휘할 수 있어야 하며, 오랜기간 일정하게 유지를 할 수 있는 위치여야 한다. 가끔은 높아진(길어진) 치관 때문에 근육기능에 직접 영향을 미치거나, 치아나 주변지지 조직에 유해한 영향을 미치기도 한다. 적절한 교합고경을 찾기 위한 방법으로 rest position만을 활용하는 것은 상당히 조심할 필요가 있다. 자세나 개인에 따라서 freeway space가 상당히 가변적이기 때문이다. 연하작용 또한 근신경계의 기능에 중요한 역할을 하지만, 정상적인 범주를 찾기란 쉽지 않다. 그러므로 이런 경우에는, 환자가 스스로 생리적으로 적응할 수 있는 방법과 기간을 부여해 줄 필요가 있다. 레진 임시수복물의 일시적 사용이 그 해결책이 될 수 있다. 가철성 혹은 고정성 형태를 판단하는 것은 환자의 치료 범주에 따라 달라질 수 있을 것이다.

• Journal of Pharmaceutical Investigation
• /
• 제30권2호
• /
• pp.139-143
• /
• 2000

Gene therapy is becoming a very promising and feasible medical intervention as the understanding of human diseases extends to their molecular levels. Since the first US Food and Drug Administration (FDA)-approved human gene therapy protocol was approved in 1990, over 300 human clinical trial protocols had been approved worldwide so far. Even though some of the domestic gene therapy clinical trials also proved promising and more are awaiting, it should be emphasized that many safety aspects as well as effectiveness aspects should be considered during the development process. Moreover, there seems to be less restricted guidelines from the National Control Authority (NCA) in initiating human clinical trials. This article is intended to suggest some basis and points to consider in the development and evaluation of gene therapy products including antisense oligonucleotides pharmaceuticals.

• Korean Journal of Acupuncture
• /
• 제25권4호
• /
• pp.205-217
• /
• 2008

Background : One of the characteristics of acupuncture, a popular modality for treating musculoskeletal pain, is a plurality in diagnosis and treatment that can profoundly influence the treatment outcome. This multiplicity in treatment modality has to be considered in any research on the effectiveness of acupuncture. Many practitioners stress the necessity for individualized patient treatment, including acupuncture point selection and manipulation technique. However, the importance of individualization in acupuncture treatment, compared with standardization, has received little attention in clinical trials. The aim of the future study described here is therefore to compare the effectiveness of individualized acupuncture for knee osteoarthritis with standardized acupuncture and no acupuncture in patients with knee osteoarthritis. Methods : A total of 195 patients aged 50 years and over with knee pain, will be randomly divided into three treatment groups: individualized acupuncture, standardized acupuncture, and waiting list. Outcome data will be collected through patient.completed questionnaires before randomization, and at 4, 8 and 12 weeks after randomization. The questionnaires will be investigated demographic details as well as information on pain, movement and function of the affected knee, general health and quality of life. Discussion : This paper presents details on the rationale, design, and methods of the trial.

• 대한간호학회지
• /
• 제53권3호
• /
• pp.275-294
• /
• 2023

Purpose: This study aimed to develop an evidence-based extracorporeal membrane oxygenation (ECMO) nursing protocol for critically ill patients receiving ECMO treatment by using an adaptation process, and to verify the effects of the protocol. Methods: The protocol was developed according to the adaptation guidelines. A non-randomized controlled trial was conducted to test the protocol's effects. Data were collected between April 2019 and March 2021. The differences in physiological indicators and complication rates between the two groups were investigated using a chart review to evaluate patient outcomes. The nurses' outcome variables were evaluated using a questionnaire. Results: First, after reviewing 11 guidelines by appraisal of the guidelines for research and evaluation collaboration II, 5 guidelines with a standardization grade of over 50 points were selected. An ECMO nursing protocol was developed based on these guidelines. Second, there were no statistically significant differences in physiological indicators between the two groups of patients. However, the experimental group showed a statistically significant decrease in the infection rate (p = .026) and pressure injury rates (p = .041). The levels of satisfaction with ECMO nursing care, and empowerment and performance of the nurses who used the ECMO nursing protocol were higher than those of nurses who did not (p < .001). Conclusion: This protocol may help prevent infections and pressure injuries in patients, and improve nurses' satisfaction and empowerment. The nursing protocol developed for critically ill patients receiving ECMO treatment can be utilized in evidence-based nursing practice.

• Clinical Endoscopy
• /
• 제56권2호
• /
• pp.214-220
• /
• 2023

Background/Aims: This study aimed to determine whether vitamin C in addition to indomethacin decreases the occurrence and severity of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) occurrence and severity. Methods: This randomized clinical trial included patients undergoing ERCP. The participants were administered either rectal indomethacin (100 mg) plus an injection of vitamin C (500 mg) or rectal indomethacin (100 mg) alone just before ERCP. The primary outcomes were PEP occurrence and severity. The secondary amylase and lipase levels were determined after 24 hours. Results: A total of 344 patients completed the study. Based on intention-to-treat analysis, the PEP rates were 9.9% for indomethacin plus vitamin C plus indomethacin and 15.7% for indomethacin alone. Regarding the per-protocol analysis, the PEP rates were 9.7% and 15.7% in the combination and indomethacin arms, respectively. There was a remarkable difference between the two arms in PEP occurrence and severity on intention-to-treat and per-protocol analyses (p=0.034 and p=0.031, respectively). The post-ERCP lipase and amylase concentrations were lower in the combination arm than in the indomethacin alone arm (p=0.034 and p=0.029, respectively). Conclusions: Vitamin C injection in addition to rectal indomethacin reduced PEP occurrence and severity.

• Journal of Periodontal and Implant Science
• /
• 제44권6호
• /
• pp.280-287
• /
• 2014

Purpose: The purpose of this randomized single-blind controlled trial was to elucidate the clinical and antimicrobial effects of daily phototherapy (PT) as an adjunct to scaling and root planing (SRP) in patients with chronic periodontitis. Methods: The study was conducted from December 2013 to May 2014 at Ewha Womans University Mokdong Hospital, Seoul, Korea. Forty-one patients with mild to moderate chronic periodontitis were randomly divided into two therapeutic groups in a 1:1 ratio: SRP+PT and SRP (control) groups. All participants underwent full-mouth SRP. PT was performed thrice a day for a month by using electric toothbrushes with embedded light-emitting diodes. Plaque index, gingival index, probing pocket depth (PPD), clinical attachment level (CAL), and bleeding on probing were assessed before (baseline) and four weeks after (follow-up) the treatment. Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Prevotella intermedia, Fusobacterium nucleatum, Parvimonas micra, Campylobacter rectus, Eikenella corrodens, Streptococcus mutans, and Streptococcus sobrinus levels were detected by a real-time polymerase chain reaction at the same points in time. Results: The clinical parameters improved in both the groups. At the follow-up assessment, PPD was significantly decreased in the SRP+PT group (P=0.00). Further, PPD and CAL showed significantly greater changes in the SRP+PT group than in the SRP group (PPD, P=0.03; CAL, P=0.04). P. gingivalis and T. forsythia levels decreased in this group, but no significant intergroup differences were noted. Conclusions: Adjunctive PT seems to have clinical benefits, but evidence of its antimicrobial effects is not sufficient. Long-term studies are necessary to develop the most effective PT protocol and compare the effectiveness of PT with and without exogenous photosensitizers.

• Clinical and Experimental Reproductive Medicine
• /
• 제45권3호
• /
• pp.135-142
• /
• 2018

Objective: To prospectively evaluate the efficacy and safety of a fixed early gonadotropin-releasing hormone (GnRH) antagonist protocol compared to a conventional midfollicular GnRH antagonist protocol and a long GnRH agonist protocol for in vitro fertilization (IVF) in patients with polycystic ovary syndrome (PCOS). Methods: Randomized patients in all three groups (early antagonist, n = 14; conventional antagonist, n = 11; long agonist, n = 11) received 21 days of oral contraceptive pill treatment prior to stimulation. The GnRH antagonist was initiated on the 1st day of stimulation in the early antagonist group and on the 6th day in the conventional antagonist group. The GnRH agonist was initiated on the 18th day of the preceding cycle. The primary endpoint was the number of oocytes retrieved, and the secondary endpoints included the rate of moderate-to-severe ovarian hyperstimulation syndrome (OHSS) and the clinical pregnancy rate. Results: The median total number of oocytes was similar among the three groups (early, 16; conventional, 12; agonist, 19; p= 0.111). The early GnRH antagonist protocol showed statistically non-significant associations with a higher clinical pregnancy rate (early, 50.0%; conventional, 11.1%; agonist, 22.2%; p= 0.180) and lower incidence of moderate-to-severe OHSS (early, 7.7%; conventional, 18.2%; agonist, 27.3%; p= 0.463), especially among subjects at high risk for OHSS (early, 12.5%; conventional, 40.0%; agonist, 50.0%; p= 0.324). Conclusion: In PCOS patients undergoing IVF, early administration of a GnRH antagonist may possibly lead to benefits due to a reduced incidence of moderate-to-severe OHSS in high-risk subjects with a better clinical pregnancy rate per embryo transfer. Further studies with more subjects are required.