• Title/Summary/Keyword: randomized clinical controlled trial

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Effect of Lythrum salicaria Extract on Body Fat Reduction: A Protocol for a Randomized, Double-Blinded, Placebo-Controlled Clinical Trial (체지방 감소에 대한 털부처꽃 추출물의 효과: 무작위배정, 이중눈가림, 대조군 비교 인체적용시험 프로토콜)

  • Hye-Jin Park;In Heo;Yea-Jin Park;Hyo-Jin An;Su Shin;Yun-Yeop Cha
    • Journal of Korean Medicine for Obesity Research
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    • v.24 no.1
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    • pp.87-93
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    • 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.

A Clinical Research Analysis of the Korean Medicine for Peroneal Nerve Palsy (비골신경마비에 대한 국내 한의치료 임상연구 동향 분석)

  • Hong, Su Min;Lee, Eun Jung
    • Journal of Korean Medicine Rehabilitation
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    • v.29 no.3
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    • pp.61-74
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    • 2019
  • Objectives This study aimed to review clinical studies about Korean medicine used in peroneal nerve palsy. Methods In 11 online databases (Earticle, Research Information Sharing Service, Oriental Medicine Advanced Searching Integrated System, KMbase, Korean Traditional Knowledge Portal, National Digital Science Library, MEDLINE/Pubmed, Ebscohost, Cochrane CENTRAL, EMBASE, China National Knowledge Infrastructure), we searched clinical studies about Korean medicine. Among the studies that we've searched, we excluded the studies that are not related to Korean medicine, case reports, randomized controlled trials and retrospective studies. As a result, 16 case studies and 1 randomized controlled trial are included. Results Total number of patients was 123. In these studies, acupuncture (100%), herbal medicine (58.8%), pharmacopuncture (58.8%), Korean physical therapy (58.8%), moxibustion (41.1%), cupping (41.1%) etc. were used. In acupuncture, GB34 and ST36 were most frequently used. Most of the herbal medicines used in these studies were different. Range of movement were most frequently used in outcome measure. Conclusions In this study, we reviewed studies about Korean medicine used in peroneal nerve palsy. It was difficult to clearly determine which intervention has improved the symptom. In the future, Further clinical studies will be needed to retain the evidence for the treatment of peroneal nerve palsy. And also more randomized controlled clinical trials to prove the efficacy of Korean medicine will be needed.

The Effects of Coenzyme Q10 Supplementation on Oxidative Status and Lipid Profile in Migraine Patients: A Randomized Double-Blinded Controlled Clinical Trial

  • Monireh Dahri;Atefeh Sarafan Sadeghi;Naseh Pahlavani;Elyas Nattagh-Eshtivani;Mazyar Hashemilar;Mohammad Asghari-Jafarabadi;Hanieh Barghchi;Ali Tarighat-Esfanjani
    • Clinical Nutrition Research
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    • v.12 no.4
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    • pp.257-268
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    • 2023
  • Migraine is a common neurological disease correlated with oxidative stress and lipid profile disorders. The present study was designed to determine the effects of Coenzyme Q10 (Co-Q10) supplementation on oxidative status and lipid profile in migraine individuals. This clinical trial was conducted on 84 females aged 18-50 years, diagnosed for episodic migraine according to the International Headache Society. Subjects were randomized to receive either Co-Q10 supplement (400 mg/day) or placebo for 12 weeks. Lipid profile and oxidative stress indices including malondialdehyde (MDA) and total antioxidant capacity (TAC) were measured before and after intervention in both groups. Also, anthropometric indices, dietary intakes, and clinical features were collected. Data analysis was conducted using SPSS version 16. Seventy-seven of the participants, with mean age of 33.70 ± 7.75 years, completed the study. After 12-week intervention, Co-Q10 led to a significant decrease in MDA levels compared to placebo (p = 0.009), with no effect on TAC levels (p = 0.106). A significant increase in serum Co-Q10 concentration and high-density lipoprotein cholesterol (HDL-C) level in Co-Q10 group was observed, but no significant differences were found in other lipid profile variables (low-density lipoprotein cholesterol, triglycerides and total cholesterol). Among anthropometric variables, Co-Q10 only caused a significant reduction in body fat percentage (BFP), but we did not find any significant changes in others. A 12-week Co-Q10 supplementation led to significant improvement in clinical features, BFP, and HDL-C level among migraine individuals.

Neoadjuvant Chemotherapy for Resectable Esophageal Carcinoma: A Meta-analysis of Randomized Clinical Trials

  • Xu, Xiao-Hua;Peng, Xue-Hong;Yu, Ping;Xu, Xiao-Yuan;Cai, Er-Hui;Guo, Pi;Li, Ke
    • Asian Pacific Journal of Cancer Prevention
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    • v.13 no.1
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    • pp.103-110
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    • 2012
  • Neoadjuvant chemotherapy for resectable esophageal carcinoma has been a focus of study, but no agreement has been reached on clinical randomized controlled trials and relevant systematic evaluation. The purpose of this study was to perform a meta-analysis on published randomized controlled trials (RCTs) that compared neoadjuvant chemotherapy and surgery with surgery alone for resectable esophageal carcinoma. Medline and manual searches was conducted in PubMed, ASCO (American Society of Clinical Oncology) meeting summary, Embase, the Cochrane Library (up to October 2010), Chinese Biomedical Literature Database, China National Knowledge Infrastructure, VIP Database, Wanfang Database. The selection contents were to identify all published and unpublished RCTs that compared neoadjuvant chemotherapy and surgery with surgery alone for resectable esophageal carcinoma. Sixteen RCTs which included 2,594 patients were selected. The risk ratio (RR) (95% confidence interval [CI]; P value), expressed as neoadjuvant chemotherapy and surgery versus surgery alone (treatment versus control), was 1.02 (0.95, 1.10; P=0.54) for 1-year survival, 1.29 (1.13, 1.47; P=0.0001) for 3-year survival, 1.31 (1.13, 1.51; P=0.0003) for 5-year survival, 1.00 (0.95, 1.04; P= 0.85) for rate of resection and 0.89 (0.64, 1.23; P=0.48) for operative mortality. The results showed that neoadjuvant chemotherapy for resectable esophageal carcinoma can raise the overall survival rate of patients with esophageal carcinoma, but it does not affect treatment-related mortality.

Current Status of N-of-1 Trials for Herbal Medicine -Literature Review (한약에 대한 N-of-1 임상시험의 현황 - 문헌 고찰)

  • Jeung, Chang-woon;Jeon, Sun-woo;Jo, Hee-Geun
    • The Journal of Korean Medicine
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    • v.41 no.1
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    • pp.107-116
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    • 2020
  • Objectives: To overcome the limitations of randomized controlled trials, many other trials design is tested. The n-of-1 trial is a promising research method in the field of Korean medicine because of this methodology can examine the optimal treatment for each patient strictly. Therefore, we reviewed the status of N-of-1 studies on herbal medicine. Methods: A systematic literature review was conducted based on the pubmed database. The search term were 'N-of-1 Trial', 'Chinese Medicine', 'Herbal Medicine', 'Kampo'. There was no restriction in year. Results: Four clinical trials have been identified to demonstrate the effectiveness of herbal medicines for Kidney-yin-deficiency syndrome, bronchiectasis and gastric cancer. These studies suggest that the N-of-1 design is a study that encourages patient involvement, demonstrates the effectiveness of herbal medicines and helps reduce unnecessary medication. Conclusion: The N-of-1 clinical trial may be a rigorous methodology suitable for the clinical setting and may help the development of evidence-based Korean medicine. Attention is also needed in this research method in Korea.

Research Trends on the Thread Embedding Therapy of Low back pain in Traditional Chinese Medicine - Focusing on published articles in China (요통에 대한 매선 임상연구의 중국 현황 분석 - 중국 내(內) 출판 저널을 중심으로)

  • Jun, Purumea;Liu, Yan;Park, Ji-Eun;Jung, So-Young;Han, Chang-Hyun
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.31 no.1
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    • pp.25-35
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    • 2017
  • About 60% to 90% of a total population experience low back pain at least once of life, and about 35% to 79% among them experience a recurrent and chronic low back pain. thread-embedding therapy is mainly used to improve appearance or treat obesity in early stage, but recently it is also used to treat musculoskeletal pain. This study aimed to search Chinese study using thread-embedding therapy on low back pain and to analyse their methodology. Three Chinese database(CNKI(www.cnki.net), WANFANG(www.wanfangdata.com), WEIPU(www.cqvip.com)) were searched for clinical study of thread-embedding therapy up to March 2016. The characteristics of included studies and regimen of thread-embedding in those studies were analyzed. The total 21 studies (4 case studies, 16 non-randomized controlled trials, 1 randomized controlled trial) were included. All studies on thread embedding treatment of low back pain reported that its effectiveness was very good. The most frequently used acupoints was Ashi acupoints and acupoints on bladder meridian(BL) or governor vessel(GV). Thread-embedding therapy is considered very useful for low back pain in Traditional Chinese medicine. Further studies are needed to investigate the effect of thread-embedding therapy and to expand its application. This study is limited in that the literature search in the Chinese database were restricted.

The effects of Sa-am Acupuncture Simpojeongkyeok Treatment on Hwa-byung : Randomized, patient-assessor blind, placebo-controlled acupuncture, pilot clinical trial (화병에 대한 사암침 심포정격의 치료 효과 : 환자-평가자 눈가림, 무작위배정 대조군 임상시험)

  • Choi, Woo-Jin;Lee, Seung-Gi;Son, In-Bong;Sun, Seung-Ho
    • Journal of Oriental Neuropsychiatry
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    • v.22 no.2
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    • pp.1-13
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    • 2011
  • Objectives : The purpose of this research is to examine the effects of Sa-am acupuncture Simpojeongkyeok treatment on Hwa-byung. Methods : The study was performed through a patient-assessor blind, randomized, placebo-controlled trial in which the volunteers, data collector and analyst were unaware of individuals which were receiving the treatment. Fifty volunteers were divided into a trial and a control group, each of which consisted of 25 subjects. The trial group was treated with Sa-am acupuncture Simpojeongkyeok, while needle insertion at non-acupoints was given to the control group. The Likert scale for major symptoms of Hwa-byung was measured as the 1st evaluative instrument, and then a comparative analysis was conducted by comparing the results with those measured by of STAXI-K, STAI-K and BDI-K. Results : In the Likert scale comparison of major symptoms, total scores in both groups were decreased after treatment. However, a more significant decrease was found in those of trial group compared to those of the control group from a statistical perspective. The results measured by BDI scores also decreased significantly in the trial group after treatment. In comparison of STAXI and STAI scores, there were no significant differences found between the groups. Conclusions : The results suggest that Sa-am Acupuncture Simpojeongkyeok treatment is effective in the treatment of Hwa-byung.

The Effects of Acupuncture Treatment on Hwa-byung patient's Insomnia: Patient-assessor blind, Randomized, Placebo-controlled Clinical trial (화병환자의 불면증상에 대한 침치료 유효성 평가연구: 환자-평가자 눈가림, 무작위배정, 일반대조군 임상시험)

  • Lee, Go-Eun;Kim, Nam-Kwon;Kim, Hang-Yi;Kang, Hyung-Won
    • Journal of Oriental Neuropsychiatry
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    • v.23 no.1
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    • pp.31-48
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    • 2012
  • Objectives: The purpose of this research is to examine the effects of acupuncture treatment on Hwa-byung patient's insomnia. Methods: The study was performed through a patient-assessor blind, randomized, placebo-controlled trial in which the volunteers, data collectors and analysts were unaware of individuals who were receiving the treatment. A total of thirty-seven volunteers were divided into 2 groups. 18 subjects were placed into a trial group and 19 subjects into a control group by a randomization table. The trial group was treated on bilateral Shigu, Ahnmyun, B62 (Shinmaek), and K6 (Chohae), while the control group was not given any other treatment. The ISI(Insomnia Severity Scale) was measured as the 1st evaluative instrument, and then a comparative analysis was conducted by comparing the results with those measured by a Likert scale for major symptoms of Hwa-byung, PSQI, Hwa-byung scale, BDI, STAI, and STAXI. Results: In the ISI, PSQI, and the Likert scale regarding major symptoms of Hwa-byung, Hwa-byung scale, BDI, and STAI, more significant decreases were found in those concerning the trial group compared to those of the control group from a statistical perspective. However, in the STAXI, regarding the trial group, there was no significant decrease compared to the control group. Conclusions: The results suggest that acupuncture treatment is effective in the treatment regarding Hwa-byung patients who suffer from insomnia.

The Effect of Virtual Reality Based Rehabilitation Program on Balance of Patient with Stroke: A Meta-analysis of Studies in Korea (가상현실기반 재활프로그램이 뇌졸중환자의 균형에 미치는 영향 : 국내연구에 대한 메타분석)

  • Roh, Jung-suk
    • Journal of Korean Physical Therapy Science
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    • v.24 no.1
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    • pp.59-68
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    • 2017
  • Purpose : The aims of this study was to conduct a systematic literature review with meta-analysis to investigate the effect of virtual reality based rehabilitation program on balance of patient with stroke in Korean studies. Method : The studies for analysis were searched in electronic databases(Research Information Sharing Service; RISS, Korean Studies Information Service; KISS, DBpia, e-articles, National Assembly Library). The key words for search were 'virtual reality', 'stroke', and 'balance' and only randomized controlled trials and clinical controlled trials were included. Of 40 studies identified in the search, 20 studies met the criteria of this study and included in this meta-analysis. Result : The results were as follows: 1) The overall effect size of virtual reality based rehabilitation program was 0.557(95% critical interval; 0.340~0.774). 2) In the analysis of sub-categorical variables, effect size was as follows; the commercial game type(0.621) > virtual environment type(0.335); the dynamic balance measurement(0.750) > static balance measurement(0.226); randomized controlled trial(0.653) > clinical controlled trial(0.275); and thesis type(0.706) > article of journal type(0.339). 3) In the analysis of sub-continuous variables, as time of program(per session) increased, the balance increased(p<0.05). Conclusion : The results of this study showed that virtual reality based rehabilitation program moderately improves the balance of stroke patient. Further studies are recommended to investigate the effect of sub-variables related to virtual reality programs on motor functions of patient with stroke.

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Evaluation of the clinical and radiographic effectiveness of treating peri-implant bone defects with a new biphasic calcium phosphate bone graft: a prospective, multicenter randomized controlled trial

  • Jae-Hong Lee;Hyun-wook An;Jae-Seung Im;Woo-Joo Kim;Dong-Won Lee ;Jeong-Ho Yun
    • Journal of Periodontal and Implant Science
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    • v.53 no.4
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    • pp.306-317
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    • 2023
  • Purpose: Biphasic calcium phosphate (BCP), a widely used biomaterial for bone regeneration, contains synthetic hydroxyapatite (HA) and β-tricalcium phosphate (β-TCP), the ratio of which can be adjusted to modulate the rate of degradation. The aim of this study was to evaluate the clinical and radiographic benefits of reconstructing peri-implant bone defects with a newly developed BCP consisting of 60% β-TCP and 40% HA compared to demineralized bovine bone mineral (DBBM). Methods: This prospective, multicenter, parallel, single-blind randomized controlled trial was conducted at the periodontology departments of 3 different dental hospitals. Changes in clinical (defect width and height) and radiographic (augmented horizontal bone thickness) parameters were measured between implant surgery with guided bone regeneration (GBR) and re-entry surgery. Postoperative discomfort (severity and duration of pain and swelling) and early soft-tissue wound healing (dehiscence and inflammation) were also assessed. Data were compared between the BCP (test) and DBBM (control) groups using the independent t-test and the χ2 test. Results: Of the 53 cases included, 27 were in the test group and 26 were in the control group. After a healing period of 18 weeks, the full and mean resolution of buccal dehiscence defects were 59.3% (n=16) and 71.3% in the test group and 42.3% (n=11) and 57.9% in the control group, respectively. There were no significant differences between the groups in terms of the change in mean horizontal bone augmentation (test group: -0.50±0.66 mm vs. control groups: -0.66±0.83 mm, P=0.133), postoperative discomfort, or early wound healing. No adverse or fatal complications occurred in either group. Conclusions: The GBR procedure with the newly developed BCP showed favorable clinical, radiographic, postoperative discomfort-related, and early wound healing outcomes for peri-implant dehiscence defects that were similar to those for DBBM.