• Title/Summary/Keyword: randomized clinical trial

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Development and Tree-Dimensional Kinematic Analysis of the Dual Chamber-based Drinking Aid for Stroke Patients: A Prospective Pilot Study (이중 체임버 구조가 내장된 뇌졸중 환자용 컵의 개발과 3차원 동작분석을 통한 운동 형상학적 유용성 검증: 전향적 예비연구)

  • Heo, Seo Yoon;Kim, Kyeong-Mi
    • Journal of the Institute of Electronics and Information Engineers
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    • v.53 no.12
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    • pp.180-190
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    • 2016
  • This prospective pilot clinical trial mainly focuses on developing dual chamber-based assistive cups which are suitable for stroke patients who have struggled with using there affected arms. It is unable to provide motor and sensory enhancement during drinking activities and to examine the feasibility of the devices for acute phase, even for chronic stroke survivors. The stroke patients(n=16; male=8, female=8), in this trial, were provided informed consent to the investigation. All the individuals participated in 1 weeks of training for using cups, randomized over dedicated dual chamber based assistive cups(DC) or placebo-cups(PC) training. All the participants were assessed within 1 week before and after the intervention period. 3-dimensional motion analysis, sEMG(surface electromyography) and 3-dimensional trunk movement were assessed. The result presents DC data group compared with PC showed, they needed lesser ROM(range of motion) at the phase of drinking in shoulder movements and lesser muscle activities on upper trapezius, deltoid middle fiber and triceps brachii muscles, lesser tilting movement on front and back side in drinking phase, the differences were statistically significant(p<.05). Dual chamber-based assistive cup could be one of efficient way to complete ADLs(activities of daily living), especially drinking tasks, and these evidence data may contribute to determine certain rehabilitation policies related to assistive devise usage.

The Effect of korean, Chinese and American Ginseng on Blood Pressure of Hypertensive Patients (한국삼, 중국삼, 서양삼이 고혈압 환자의 혈압에 미치는 영향)

  • Lee Cha-ro;Lee Sang-Ho;Rhee Jun-Woo;Na Byong-Jo;Kim Tae-Hun;Jung Woo-Sang;Moon Sang-Ho;Cho Ki-Ho;Bae Hyung-Sup;Kim Young-Suk
    • The Journal of Korean Medicine
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    • v.26 no.3 s.63
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    • pp.228-238
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    • 2005
  • Objectives : We conducted a randomized, double-blinded clinical trial to assess the anti-hypertensive effect of Ginseng and to know the difference of the effect according to it's growing districts md species by 24-hour ambulatory blood pressure measurement (ABPM). Methods : We allocated 96 hypertensive patients enrolled in this trial to Korean ginseng(KG), American ginseng (AG), Chinese ginseng (CG), and Korean red ginseng (KRG) groups by randomization. Each subject was administered 4.5mg/day of encapsulated ginseng for 4 weeks. We assessed anti-hypertensive effect, blood pressure variability using ABPM and toxicity by blood chemistry before and after treatment. We also evaluated changes of symptoms due to hypertension and adverse effect in all groups at the first visit, 2 weeks later and 4 weeks later. Results : Blood pressure after treatments showed significant decrease of systolic blood pressure (sBP) in the CG-group (p<0,05) and diastolic blood pressure (dBP) in the KRG-group (p<0.05). However, there were no significant changes of sBP (or dBP) after treatment in the other groups and no significant difference in changes of BP between before and after treatment among the 4 groups. Blood pressure variability in the CG-group showed significant decrease after treatment but not in the KRG-group. Symptoms such as headache or neck stiffness and heating sensation due to hypertension improved significantly in all groups, especially in the KRG-group. A3l patients had no adverse effect after treatment and there was no liver or kidney toxicity. Conclusions : CG and KRG seem to have anti-hypertensive effects, but there was no significantly different effect depending on growing district and species of Ginseng.

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Research on Subjective Symptoms of Cancer Patients Using Questionnaire - Based on the 48 Patients Who Have Participated in Clinical Trial about Korean Red Ginseng - (설문지를 이용한 암환자의 동반 자각 증상에 관한 연구 - 홍삼투여 인체적용시험에 참여한 48명 환자를 중심으로 -)

  • Kim, Eun Jung;Jung, Chan Yung;Kim, Kap Sung;Lee, Seung Deok
    • The Journal of Korean Medicine
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    • v.33 no.3
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    • pp.1-9
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    • 2012
  • Objectives: This research was aimed 1) to find out various subjective symptoms cancer patients had, 2) to find out the quantitative difference of symptoms occurring according to the area of cancer, current treatment methods, and relapse of the cancer and 3) to analyze the relationship between the occurrence of symptoms. Methods: This study was a survey about the various subjective symptoms cancer patients had. The subjects were 48 cancer patients in a double-blinded randomized controlled trial about the effectiveness of Korean Red Ginseng (KRG) treatments. Surveys were examined before Korean Red Ginseng (KRG) treatments. The questionnaire consisted of demographic research, patient history and accompanying symptoms. The symptoms part consisted of 4 questions on general symptoms (vertigo, hot flush, rash, insomnia), 2 questions on digestion symptoms (anorexia, dyspepsia), 2 questions on excretions (diarrhea, constipation), and 5 questions on symptoms in different body parts (headache, dryness of lips, chest pain, aphthous ulcer, nose bleeding). The questionnaire was used to research presence of symptoms and relationships between the occurrence of symptoms. Results: A total of 48 patients took part in this survey. Dizziness was the most frequent subjective symptom patients had (64.58%), followed by dry mouth (43.75%), headache (43.75%), insomnia (41.67%), anorexia (37.5%) and chest discomfort (37.5%). The presence of these subjective symptoms was partially related to the patient's history details - type of cancer, method of cancer treatment (chemotherapy, radiotherapy), termination of treatment, presence of pain, fatigue and recurrence, etc. Factor analysis was conducted to analyze the relationship between the occurrence of symptoms. It suggested 5 factors as a result, but there was a limitation that only a low level of correlation was shown among them. Conclusions: We were able to analyze the occurrences and the relationships among them for accompanying subjective symptoms in cancer patients. However the results of the study are limited in that only 48 patients participated. The symptoms in cancer patients showed a tendency for clustering, occurring simultaneously or continuously rather than occurring alone. The study of these symptom clusters is worth further study, for it is similar to the Symptom Differentiation System in Traditional Korean Medicine. For effective approach to the treatment of cancer in Traditional Korean Medicine, further research on the Korean traditional view of cancer patients should be done based on this research, regarding various symptoms and those relationships on a larger scale.

The Effects of Cervi Pantotrichum Cornu Pharmacopuncture and Bovis calculus.Fel Ursi Pharmacopuncture on the Heart Rate Variability (녹용약침과 웅담.우황(BU)약침이 정상인의 심박변이도(HRV)에 미치는 영향)

  • Lee, Hwi-Yong;Lee, Jin-Bok;Cho, Yi-Hyun;Song, Beom-Yong;Yook, Tae-Han
    • Journal of Acupuncture Research
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    • v.27 no.1
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    • pp.65-74
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    • 2010
  • Objectives : This study was to investigate the effects of Cervi Pantotrichum Cornu Pharmacopuncture and Bovis calculus Fel Ursi Pharmacopuncture on autonomic nervous system with Heart Rate Variability(HRV). Purpose of the trial was to observe what influence Cervi Pantotrichum Cornu Pharmacopuncture and Bovis calculus Fel Ursi pharmacopuncture have on the autonomic nervous system. Methods : 40 healthy male volunteers were divided into two experimental groups, such as Cervi Pantotrichum Cornu Pharmacopuncture group and Bovis calculus Fel Ursi Pharmacopuncture group. Study design was a randomized, double-blind clinical trial. 20 subjects in one experimental group were injected Cervi Pantotrichum Cornu Pharmacopuncture, 20 subjects in other experimental group were injected hydrolyzed Bovis calculus Fel Ursi Pharmacopuncture at GB21(Kyonjong). We measured HRV 7 times : baseline measurement and every 5 minutes for 30 minutes after injection. The SPSS 15.0 for Windows was used to analyze the data by the paired t-test(in group) and independent sample t-test(between the groups). Results A. Time Domain Analysis 1. Analysis of Mean HRV, SDNN and Complexity After injection of Cervi Pantotrichum Cornu Pharmacopuncture, Mean HRV was significantly decreased all the times after injection. SDNN was significantly increased at immediate and 25 minute after injection. Complexity was significantly decreased only at 15 minute after injection. After injection of Bovis calculus Fel Ursi Pharmacopuncture, Mean HRV was significantly decreased all the times after injection. Complexity was significantly decreased at 15 minutes after injection. 2. Analysis of HRV index, pNN50 After injection of Cervi Pantotrichum Cornu Pharmacopuncture, HRV index was significantly increased immediately after injection. pNN50 was significantly decreased at immediately, 20 and 25 minutes after injection. After injection of Bovis calculus Fel Ursi Pharmacopuncture, HRV index was significantly increased immediately after injection. pNN50 was significantly decreased at immediate and 25 minutes after injection. B. Frequency Domain Analysis 1. Analysis of Ln(TP), Ln(HF), Ln(LF), Ln(VLF) After injection of Cervi Pantotrichum Cornu Pharmacopuncture, Ln(TP) was significantly increased at immediate and 25 after injection. Ln(HF) was significantly increased all the times after injection. Ln(LF) was significantly increased at 15, 20 and 25 minutes after injection. Ln(VLF) was significantly increased at immediate and 25 minutes after injection. After injection of Bovis calculus Fel Ursi Pharmacopuncture, Ln(TP) was significantly increased at immediately and 25 after injection. Ln(LF) was significantly increased at 20 and 25 minutes after injection. Ln(VLF) was significantly increased at immediate and 25 minutes after injection. Conclusions : We results suggest that Cervi Pantotrichum Cornu Pharmacopuncture and Bovis calculus Fel Ursi Pharmacopuncture in healthy adult men tend to activate the autonomic nervous system and sympathetic nervous system within normal range.

Effects of Transcranial Direct-Current Stimulation Therapy on Primary Chronic Insomnia: A Proof-of Concept Clinical Trial (일차성 만성불면증 환자에서 경두개 직류전기자극법 치료 효과: 개념 증명 연구)

  • Jun, Jin-Sun;Kim, Tae-Joon;Koo, Sun A;Park, Ji-Sook;Kim, Keun Tae;Yang, Tae-Won;Lim, Jung-Ah;Byun, Jung-Ick;Sunwoo, Jun-Sang;Jung, Ki-Young
    • Journal of Sleep Medicine
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    • v.15 no.2
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    • pp.37-42
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    • 2018
  • Objectives: To assess the effect and safety of transcranial direct-current stimulation (tDCS) in primary chronic insomnia. Methods: A one-month, double-blind, randomized, sham-controlled trial was performed. A total of 7 patients with primary chronic insomnia received tDCS using anodal (n=3), cathodal (n=2), or sham stimulation (n=2). They were followed up at 1 week and 1 month after treatment. The primary outcome measures included improvement in total sleep time (TST), sleep latency (SL), and sleep efficiency (SE) at 1 month follow-up. Results: TST and SE were improved with tDCS at 1 month follow-up in all patients (100%) of the anodal group, one (50%) of the cathodal group, and one (50%) of the sham group. tDCS improved SL at 1 month follow-up in two patients (67%) of the anodal group, one (50%) of the cathodal group, and none (0%) of the sham group. With respect to adverse events, transient itching sensation occurred in one patient of the anodal group. None of the other groups reported adverse events. Conclusions: Our results suggest that tDCS may be effective and safe for treatment of primary chronic insomnia. A larger controlled study needs to be further investigated.

A Randomized Phase III Study of Patients With Advanced Gastric Adenocarcinoma Without Progression After Six Cycles of XELOX (Capecitabine Plus Oxaliplatin) Followed by Capecitabine Maintenance or Clinical Observation

  • Guk Jin Lee;Hyunho Kim;Sung Shim Cho;Hyung Soon Park;Ho Jung An;In Sook Woo;Jae Ho Byun;Ji Hyung Hong;Yoon Ho Ko;Der Sheng Sun;Hye Sung Won;Jong Youl Jin;Ji Chan Park ;In-Ho Kim;Sang Young Roh;Byoung Yong Shim
    • Journal of Gastric Cancer
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    • v.23 no.2
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    • pp.315-327
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    • 2023
  • Purpose: Oxaliplatin, a component of the capecitabine plus oxaliplatin (XELOX) regimen, has a more favorable toxicity profile than cisplatin in patients with advanced gastric cancer (GC). However, oxaliplatin can induce sensory neuropathy and cumulative, dose-related toxicities. Thus, the capecitabine maintenance regimen may achieve the maximum treatment effect while reducing the cumulative neurotoxicity of oxaliplatin. This study aimed to compare the survival of patients with advanced GC between capecitabine maintenance and observation after 1st line XELOX chemotherapy. Materials and Methods: Sixty-three patients treated with six cycles of XELOX for advanced GC in six hospitals of the Catholic University of Korea were randomized 1:1 to receive capecitabine maintenance or observation. The primary endpoint was progression-free survival (PFS), analyzed using a two-sided log-rank test stratified at a 5% significance level. Results: Between 2015 and 2020, 32 and 31 patients were randomized into the maintenance and observation groups, respectively. After randomization, the median number of capecitabine maintenance cycles was 6. The PFS was significantly higher in the maintenance group than the observation group (6.3 vs. 4.1 months, P=0.010). Overall survival was not significantly different between the 2 groups (18.2 vs. 16.5 months, P=0.624). Toxicities, such as hand-foot syndrome, were reported in some maintenance group patients. Maintenance treatment was a significant factor associated with PFS in multivariate analysis (hazard ratio, 0.472; 95% confidence interval, 0.250-0.890; P=0.020). Conclusions: After 6 cycles of XELOX chemotherapy, capecitabine maintenance significantly prolonged PFS compared with observation, and toxicity was manageable. Maintenance treatment was a significant prognostic factor associated with PFS.

Review of the Radiation Risk and Clinical Efficacy Associated with Computed Tomography Cancer Screening (암의 조기발견을 위한 CT촬영에서의 임상적 효능과 방사선위해에 대한 고찰)

  • Kim, Hyun Ja
    • Journal of Radiation Protection and Research
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    • v.38 no.4
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    • pp.214-227
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    • 2013
  • Computed tomographic scan as a screening procedures in asymptomatic individuals has seen a steady increase with the introduction of multiple-raw detector CT scanners. This report provides a brief review of the current controversy surrounding CT cancer screening, with a focus on the radiation induced cancer risks and clinical efficacy. 1. A large study of patients at high risk of lung cancer(the National Lung Screening Trial[NLST]) showed that CT screening reduced cancer deaths by 20%(1.33% in those screened compared with 1.67% in those not screened). The rate of positive screening tests was 24.2% and 96.4% of the positive screening results in the low-dose CT group were false-positive. Radiation induced lung cancer risk was estimated the most important in screening population because ERR of radiation induced lung cancer does not show the decrease with increasing age and synergistic connection between smoking and radiation risk. Therefore, the radiation risk may be on the same order of magnitude as the benefit observed in the NLST. Optimal screening strategy remain uncertain, CT lung cancer screening is not yet ready for implementation. 2. Computed tomographic colonography is as good as colonoscopy for detecting colon cancer and is almost as good as colonoscopy for detecting advanced adenomas, but significantly less sensitive and specific for smaller lesions and disadvantageous for subsequent therapeutic optical colonoscopy if polyps are detected. The average effective dose from CT colonography was estimated 8-10 $mS{\nu}$, which could be a significant dose if administered routinely within the population over many years. CT colonography should a) achieve at least 90% sensitivity and specificity in the size category from 6 and 10 mm, b) offer non-cathartic bowl preparation and c) be optimized and standardized CT parameters if it is to be used for mass screening. 3. There is little evidence that demonstrates, for whole-body scanning, the benefit outweighs the detriment. This test found large portion of patient(86~90.8%) had at least one abnormal finding, whereas only 2% were estimated to have clinically significant disease. Annual scans from ages 45 to 75 years would accrue an estimated lifetime cancer mortality risk of 1.9%. There is no group within the medical community that recommends whole-body CT. No good studies indicate the accuracy of screening CT, at this time. The benefit/risk balance for any of the commonly suggested CT screening techniques has yet to be established. These areas need further research. Therefore wild screening should be avoided.

Optimal Scheme of Postoperative Chemoradiotherapy in Rectal Cancer : Phase III Prospective Randomized Trial (직장암의 근치적 수술 후 화학요법과 방사선치료의 순서)

  • Kim Young Seok;Kim Jong Hoon;Choi Eun Kyung;Ahn Seung Do;Lee Sang-Wook;Kim Kyoung-Ju;Lee Je Hwan;Kim Jin Cheon;You Chang Sik;Kim Hee Cheol
    • Radiation Oncology Journal
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    • v.20 no.1
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    • pp.53-61
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    • 2002
  • Purpose : To determine the optimal scheme of postoperative chemoradiotherapy in rectal cancer by comparing survival, Patterns of failure, toxicities in early and late radiotherapy groups using a Phase III randomized prospective clinical trial. Materials and Methods : From January 1996 to March 1999, 307 patients with curatively resected AJCC stage II and III rectal cancer were assigned randomly to an 'early (151 patients, arm 1)' or a 'late (156 patients, arm II)' and were administered combined chemotherapy (5-FU $375\;mg/m^2/day$, leucovorin $20\;mg/m^2$, IV bolus daily, for 3 days with RT, 5 days without RT, 8 cycles with 4 weeks interval) and radiation therapy (whole pelvis with 45 Gy/25 fractions/5 weeks). Patients of arm I received radiation therapy from day 1 of the first cycle of chemotherapy and those of arm II from day 57 with a third cycle of chemotherapy. The median follow-up period of living patients was 40 months. Results : Of the 307 patients enrolled, fifty patients did not receive scheduled radiation therapy or chemotherapy. The overall survival rate and disease free survival rate at 5 years were $78.3\%\;and\;68.7\%$ in arm I, and $78.4\%\;and\;67.5\%$ in arm II. The local recurrence rate was $6.6\%\;and\;6.4\%$ (p=0.46) in arms I and II, respectively, no significant difference was observed between the distant metastasis rates of the two arms ($23.8\%\;and\;29.5\%$, p=0.16). During radiation therapy, grade 3 diarrhea or more, by the NCI common toxicity criteria, was observed in $63.0\%\;and\;58.2\%$ of the respective arms (p=N.S.), but most were controlled with supportive care. Hematologic toxicity (leukopenia) greater than RTOG grade 2 was found in only $1.3\%\;and\;2.6\%$ of patients in each respective arm. Conclusion : There was no significant difference in survival, patterns of failure or toxicities between the early and late radiation therapy arms. Postoperative adjuvant chemoradiation was found to be a relatively safe treatment but higher compliance is needed.

The effect of Light Emitting Diode electric toothbrush on gingivitis: a randomized controlled trial (발광 다이오드(Light Emitting Diode) 전동칫솔의 치은염에 대한 효과: 무작위 배정 임상시험)

  • Lee, Sung-Jo
    • Journal of Dental Rehabilitation and Applied Science
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    • v.33 no.2
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    • pp.119-126
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    • 2017
  • Purpose: The aim of the present study was to compare clinical antiplaque and antigingivitis effect between Light Emitting Diode (LED) electronic toothbrush and electronic toothbrush without LED for gingivitis and mild periodontitis patients. Materials and Methods: 30 patients included in this study. 15 patients in experimental group used LED electronic tooth brush which has red and white LED within its head, and other 15 patients in control group used same product which specially modified that function without LED. Clinical parameters ($L{\ddot{o}}e-Silness$ gingival index (GI), Quigley-Hein plaque index (PI)) were measured at the baseline, 2 weeks and 4 weeks later. Wilcoxon signed rank test and Mann-Whitney test were used for statistical analysis. Results: Compare of GI change between experimental and control group with time, both groups showed that reduced GI, but lower GI values detected at 2 weeks and 4 weeks later in experimental group than control group. And lower PI values detected at 4 weeks later in experimental group than control group, but not statistically significant. Conclusion: Based on these results and within the limits of this study, the electronic toothbrush with LED could reducing gingivitis in a short period and infer that decreasing plaque accumulation in a long period.

Chunghyul-dan for the Prevention of Stroke Progression in Silent Brain Infarction (무증후성 뇌경색 환자에 대한 청혈단(淸血丹)의 중풍예방효과)

  • Cho Ki-Ho;Ji Nam-Gue;Jung Woo-Sang;Park Seong-Uk;Moon Sang-Kwan;Ko Chang-Nam;Kim Young-Suk;Bae Hyung-Sup
    • The Journal of Korean Medicine
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    • v.26 no.2 s.62
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    • pp.77-84
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    • 2005
  • Objectives: Chunghyul-dan is a combinatorial herbal medicine, and previous studies reported it had therapeutic effects for microangiopathy, which is a major part. in the progression of stroke, as well as having anti-hypertensive, anti-hyperlipidemic, anti-apoptotic, anti-oxidative, and anti-inflammatory activities, Therefore, we examined the inhibitory effect of Chunghyul-dan on stroke occurrence in patients with silent brain infarction. Methods: We prescribed Chunghyul-dan at 600 mg a day to patients with silent brain infarction confirmed by brain MRI, and monitored stroke occurrence, drug compliances, and adverse effects for 1 year, We then performed follow-up brain MRI to detect new vascular lesions after 1 year of Chunghyul-dan medication. As for the subjects lost to follow-up, we assessed their prognosis after 1 year by telephone. Results: There were twenty-one subjects who were treated with Chunghyul-dan for more than 1 year, None of them experienced new clinical syndromes characterized by rapidly developing clinical symptoms and signs of focal and at times global loss of brain function, which could be accompanied with evidence of stroke occurrence, or any adverse effects during the Chunghyul-dan medication period. These results might be explained by various biochemical effects of Chunghyul-dan on microangiopathy, which is closely related with cell cycle progression, hypertension, hyperlipidemia, vascular inflammation, and oxidative damage. Of the 10 subjects lost to follow-up, six were reached; two of them had stroke occurrence. Conclusions: We suggest Chunghyul-dan could be useful for prevention of stroke occurrence in patients with silent brain infarction by preventing the progression of microangiopathy. Further study with a randomized controlled trial is needed to confirm this suggestion.

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