• Title/Summary/Keyword: Clinical trial,

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Study on the Anti-stress Effect of Chenwangbosim-Dan Extract∘Fermented Rice Extract (GABA ː gamma-aminobutyric acid 30%) Complex : A double-blind, randomized, placebo-controlled study (천왕보심단(天王補心丹)∘쌀발효추출물(GABAːgamma-aminobutyric acid 30%) 복합물의 항(抗)스트레스에 대한 유효성 연구ː무작위 배정 및 이중맹검)

  • Choyoung, Hong;Seo, Sang Gwon;Seunggon, Na;Hosong, Cho;Mi-Kyung, Lee;Mu Hyun, Jin;Seok-Seon, Roh;Youngsung, Ju
    • The Korea Journal of Herbology
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    • v.38 no.2
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    • pp.1-7
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    • 2023
  • Objectives : From this study, we sight to identify Anti-stress effect of Chenwangbosim-Dan (Tianwangbuxin-Dan) Extract∘Fermented Rice Extract (GABA : gamma-aminobutyric acid 30%) Complex Methods : In order to measure the degree of functional evaluation of tension relief due to stress, it was evaluated whether the psychological indicators VAS(Visual Analog Scale) and POMS(Profile Of Mood State) were improved. Which is generally used for stress measurement and has a high frequency of clinical use. All clinical trial subjects were required to take the drug once a day at 9 ± 30 min in the morning for 2 weeks. Results : After intake, the group that Chenwangbosim-Dan(Tianwangbuxin-Dan) Extract∘Fermented Rice Extract (GABA : gamma-aminobutyric acid 30%) Complex had a statistically significant improvement effect compared to before intake due to an improved 30.81% of the VAS scores. The POMS-T score improved 54.13%, the POMS-V score improved 117.5% and the POMS-F score improved 59%, which had a statistically significant effect compared to Placebo group (p<0.001). There is a significant difference between two group, so even considering the placebo effect, the anti stress effect was confirmed in the Chenwangbosim-Dan (Tianwangbuxin-Dan) Extract∘Fermented Rice Extract (GABA : gamma-aminobutyric acid 30%) Complex intake group. Conclusions : The above results showed that the Chenwangbosim-Dan(Tianwangbuxin-Dan) Extract∘Fermented Rice Extract (GABA : gamma-aminobutyric acid 30%) Complex had an anti-stress effect. Therefore, it is expected to be developed as a safe and comfortable mental care health functional food that can reduce the risk of drug abuse.

Case Series of Patients with Parkinson Syndrome visited in Oriental Medicine Hospital (한방병원에 내원한 파킨슨 증후군 환자 증례군 보고)

  • Lee, Seung-yeop;Kim, Mi-young;Kim, Young-jee;Choi, Won-woo;Min, In-kyu;Sun, Jong-joo;Hong, Jin-woo;Na, Byong-jo;Jung, Woo-sang;Moon, Sang-kwan;Cho, Ki-ho;Kim, Young-suk
    • The Journal of the Society of Stroke on Korean Medicine
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    • v.8 no.1
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    • pp.34-39
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    • 2007
  • Objective : To report cases of patients with Parkinson's syndrome. Design : Case-series Patients and methods : 35 of patients with Parkinson's syndrome who visited Department of Cardiovascular and Neurologic Diseases of Kyunghee Oriental Medical Center were treated by acupuncture and herbal medicine from May until December 2007. 35 patients were participated in this study. 21 patients were dropped out during the trial, and we evaluated symptom progress of 14 patients by using several questionnaires such as Unified Parkinson's Disease Rating Scale(UPDRS), modified Hoehn & Yahr stage (H&Y stage) and Schwab & England ADL scale(S&E ADL scale). Results : The whole group consists of 14 male patients and 21 female patients. Mean±SD age range is 64.5±8.4. There were no significant differences of the demographic and clinical characteristics between the case group and drop-out group. The mean±SD medical treatment period of the Case group were 8.4±6.3weeks, the mean±SD of the total score in first medical treatment UPDRS section 1~3 were 29.6±11.0, the mean±SD of the final score were 27.1±12.6, all of which showed significant improvement(p=0.007). There were no significant changes on the H&Y stage and S&E ADL scale. Conclusion : Patients with Parkinson's syndrome who visited Department of Cardiovascular and Neurologic diseases of Kyunghee Oriental Medical Center had a tendency of showing improvement in clinical symptoms.

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Indigo Naturalis in Inflammatory Bowel Disease: mechanisms of action and insights from clinical trials

  • Hyeonjin Kim;Soohyun Jeong;Sung Wook Kim;Hyung-Jin Kim;Dae Yong Kim;Tae Han Yook;Gabsik Yang
    • Journal of Pharmacopuncture
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    • v.27 no.2
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    • pp.59-69
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    • 2024
  • This study investigates the therapeutic potential of Indigo Naturalis (IN) in treating a Inflammatory Bowel Disease (IBD). The objective is to comprehensively examine the effects and pharmacological mechanisms of IN on IBD, assessing its potential as an novel treatment for IBD. Analysis of 11 selected papers is conducted to understand the effects of IN, focusing on compounds like indirubin, isatin, indigo, and tryptanthrin. This study evaluates their impact on Disease Activity Index (DAI) score, colon length, mucosal damage, and macrophage infiltration in Dextran Sulfate Sodium (DSS)-induced colitis mice. Additionally, It investigate into the anti-inflammatory mechanisms, including Aryl hydrocarbon Receptor (AhR) pathway activation, Nuclear Factor kappa B (NF-κB)/nod-like receptor family pyrin domain containing 3 (NLRP3)/Interleukin 1 beta (IL-1β) inhibition, and modulation of Toll-like receptor 4 (TLR4)/myeloid differentiation primary response 88 (MYD88)/NF-κB and Mitogen Activated Protein Kinase (MAPK) pathways. Immunomodulatory effects on T helper 17 (Th17)/regulatory T cell (Treg cell) balance and Glycogen synthase kinase-3 beta (GSK3-β) expression are also explored. Furthermore, the study addresses the role of IN in restoring intestinal microbiota diversity, reducing pathogenic bacteria, and increasing beneficial bacteria. The findings reveal that IN, particularly indirubin and indigo, demonstrates significant improvements in DAI score, colon length, mucosal damage, and macrophage infiltration in DSS-induced colitis mice. The anti-inflammatory effects are attributed to the activation of the AhR pathway, inhibition of inflammatory pathways, and modulation of immune responses. These results exhibit the potential of IN in IBD treatment. Notably, the restoration of intestinal microbiota diversity and balance further supports its efficacy. IN emerges as a promising and effective treatment for IBD, demonstrating anti-inflammatory effects and positive outcomes in preclinical studies. However, potential side effects necessitate further investigation for safe therapeutic development. The study underscores the need for future research to explore a broader range of active ingredients in IN to enhance therapeutic efficacy and safety.

Importance of an Integrated Assessment of Functional Disability and Work Ability in Workers Affected by Low Back Pain

  • Fabrizio Russo;Cristina Di Tecco;Simone Russo;Giorgia Petrucci;Gianluca Vadala;Vincenzo Denaro;Sergio Iavicoli
    • Safety and Health at Work
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    • v.15 no.1
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    • pp.66-72
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    • 2024
  • Background: This study examines the relationship between functional disability and work ability in workers affected by low back pain (LBP) through an analysis of correlations between the Oswestry Disability Index (ODI) and Work Ability Index (WAI). The role of personal and work factors on functional disability/work ability levels has also been studied. LBP is the most common musculoskeletal problem and a major disabling health problem worldwide. Its etiology is multifactorial. Multidisciplinary approaches may help reduce the burden of pain and disability and improve job continuity and reintegration at work. Methods: A cohort of 264 patients affected by LBP from an Italian outpatient clinic were included in a clinical diagnostic/therapeutic trial aiming at rehabilitation and return to work through an integrated investigation protocol. Data were collected during the first medical examination using anamnestic and clinical tools. The final sample is composed of 252 patients, 57.1% man, 44.0 % blue collars, 46.4% with the high school degree, 45.6% married. Results: WAI and ODI reported a negative and fair correlation (r = -0.454; p = .000). Workers with acute LBP symptoms have a higher probability of severe disability than those with chronic LBP symptoms. White collars without depressive symptoms reported higher work ability - even in chronic disability conditions-than those with depressive symptoms. Conclusion: The study found that ODI and WAI have a convergent validity and this suggests that the two tools measure capture distinctive aspects of disability related to personal, environmental, and occupational characteristics. The most important and modifiable prognostic factors found for ODI and WAI were depressive symptoms, workday absence, and intensity of back pain. The study also found a mild association between age and ODI. The study's findings highlight the importance of using a multidisciplinary approach to manage and prevent disability due to LBP.

Association Between Body Mass Index and Cognitive Function in Mild Cognitive Impairment Regardless of APOE ε4 Status

  • Ye Sol Mun;Hee Kyung Park;Jihee Kim;Jiyoung Yeom;Geon Ha Kim;Min Young Chun;Hye Ah Lee;Soo Jin Yoon;Kyung Won Park;Eun-Joo Kim;Bora Yoon;Jae-Won Jang;Jin Yong Hong;Seong Hye Choi;Jee Hyang Jeong
    • Dementia and Neurocognitive Disorders
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    • v.21 no.1
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    • pp.30-41
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    • 2022
  • Background and Purpose: In this study we aimed to find the association between neuropsychological performance and body mass index (BMI) in patients with mild cognitive impairment (MCI). In addition, we investigated the effects of the apolipoprotein E (APOE) genotype in the relationship between the BMI and cognition in MCI. Methods: We enrolled a cohort of 3,038 subjects with MCI aged 65-90 from the Clinical Research Center for Dementia of South Korea and a dementia cohort of the Ewha Womans University Mokdong Hospital. MCI patients were classified into three subgroups according to the Asian standard of BMI. We compared cognitive performances between groups by one-way analysis of variance. To investigate the effects of the APOE genotype, we used multivariate linear regression models after adjusting for possible confounders. Results: Even though normal BMI groups were younger, had more females, and had less comorbidities, the higher BMI groups had better cognitive functions. Among subjects with APOE ε4 carriers, there was a positive relationship between the BMI and the memory task alone. Conclusions: Our findings suggested that higher BMI in patients with MCI were associated with better cognitive performance. The effects of the APOE ε4 genotype in the associations between BMI and cognition were distinguishing. Therefore, according to physical status, APOE ε4 genotype-specific strategies in the assessments and treatments may be necessary in elderly patients with MCI.

A Prospective Randomized Comparative Clinical Trial Comparing the Efficacy between Ondansetron and Metoclopramide for Prevention of Nausea and Vomiting in Patients Undergoing Fractionated Radiotherapy to the Abdominal Region (복부 방사선치료를 받는 환자에서 발생하는 오심 및 구토에 대한 온단세트론과 메토클로프라미드의 효과 : 제 3상 전향적 무작위 비교임상시험)

  • Park Hee Chul;Suh Chang Ok;Seong Jinsil;Cho Jae Ho;Lim John Jihoon;Park Won;Song Jae Seok;Kim Gwi Eon
    • Radiation Oncology Journal
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    • v.19 no.2
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    • pp.127-135
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    • 2001
  • Purpose : This study is a prospective randomized clinical trial comparing the efficacy and complication of anti-emetic drugs for prevention of nausea and vomiting after radiotherapy which has moderate emetogenic potential. The aim of this study was to investigate whether the anti-emetic efficacy of ondansetron $(Zofran^{\circledR})$ 8 mg bid dose (Group O) is better than the efficacy of metoclopramide 5 mg lid dose (Group M) in patients undergoing fractionated radiotherapy to the abdominal region. Materials and Methods : Study entry was restricted to those patients who met the following eligibility criteria: histologically confirmed malignant disease; no distant metastasis; performance status of not more than ECOG grade 2; no previous chemotherapy and radiotherapy. Between March 1997 and February 1998, 60 patients enrolled in this study. All patients signed a written statement of informed consent prior to enrollment. Blinding was maintained by dosing identical number of tablets including one dose of matching placebo for Group O. The extent of nausea, appetite loss, and the number of emetic episodes were recorded everyday using diary card. The mean score of nausea, appetite loss and the mean number of emetic episodes were obtained in a weekly interval. Results : Prescription error occurred in one patient. And diary cards have not returned in 3 patients due to premature refusal of treatment. Card from one patient was excluded from the analysis because she had a history of treatment for neurosis. As a result, the analysis consisted of 55 patients. Patient characteristics and radiotherapy characteristics were similar except mean age was $52.9{\pm}11.2$ in group M, $46.5{\pm}9.5$ in group O. The difference of age was statistically significant. The mean score of nausea, appetite loss and emetic episodes in a weekly interval was higher in group M than O. In group M, the symptoms were most significant at 5th week. In a panel data analysis using mixed procedure, treatment group was only significant factor detecting the difference of weekly score for all three symptoms. Ondansetron $(Zofran^{\circledR})$ 8 mg bid dose and metoclopramide 5 mg lid dose were well tolerated without significant side effects. There were no clinically important changes In vital signs or clinical laboratory parameters with either drug. Conclusion : Concerning the fact that patients with younger age have higher emetogenic potential, there are possibilities that age difference between two treatment groups lowered the statistical power of analysis. There were significant difference favoring ondansetron group with respect to the severity of nausea, vomiting and loss of appetite. We concluded that ondansetron is more effective anti-emetic agents in the control of radiotherapy-induced nausea, vomiting, loss of appetite without significant toxicity, compared with commonly used drug, i.e., metoclopramide. However, there were patients suffering emesis despite the administration of ondansetron. The possible strategies to improve the prevention and the treatment of radiotherapy-induced emesis must be further studied.

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Clinical Study of the Patients, in Whom Pulmonary Embolism was Suspected by Lung Perfusion Scan (폐 관류주사검사상 폐동맥 색전증 소견을 보인 환자의 임상적 고찰)

  • Lee, Gwi-Lae;Kim, Jae-Yeol;Park, Jae-Suk;Yoo, Chul-Gyu;Kim, Young-Whan;Shim, Young-Soo;Han, Sung-Koo
    • Tuberculosis and Respiratory Diseases
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    • v.44 no.4
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    • pp.889-898
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    • 1997
  • Pulmonary Embolism can develop in variable conditions, and presents with nonspecific symptoms and signs. If diagnosis is delayed, it can be resulted in catastrophic results. Therefore, early diagnosis and adequate treatment is crucial in Pulmonary Embolism. Lung Perfusion Scan is useful screening test. Negative result can exclude pulmonary embolism. But, perfusion defects don't always mean pulmonary embolism. To find the better methods of interpretation of lung perfusion scan and To evaluate the clinical course and outcomes of the patients, in whom pulmonary embolism was suspected by lung perfusion scan, we reviewed the clinical records of 49 cases suspected by lung perfusion scan at Seoul National University Hospital during the period of January, 1995 to July, 1996. The results are as follows. First impression of cases in which PE was present at time of admission were pulmonary embolism (63%), heart diseases (26%), and pneumonia (11%) in orders. Underlying diseases of cases in which PE developed during admission were malignancy (36.5%), ICH (22.7%), sepsis (13.7%), and SLE (9.1%) in orders. The predisposing factors were operation (20%), cancer (16%), immobility (16%), connective tissue disease (16%), heart dis. (10%), old age (10%), and preg/pelvic dis. (8%) The results, of lung perfusion scan were HPPE 40 cases(26.8 %), IPPE 21 cases(14.1%), LPPE 88 cases (59.1%), and cases(%) of treatment in these cases were HPPE 34 cases(85%), IPPE 9 cases(42.9%), LPPE 0 case(0.0%). Treatments were heparin and warfarin (69.5%), heparin alone (8.2%), warfarin alone (2.0%), embolectomy (4.1%), thrombolytics (2.0%), IVC filter (2.0%), and no treatment (12.2%) In 34 cases (69.4%), follow up could be done, and 5 cases were recurred (10.2%). The causes of recurrence was incomplete anticoagulant therapy (3 cases) and recurrence of predisposing factor (2 cases). Expired case due to pulmonary embolism was one who was expired just before trial of thrombolytic therapy. Conclusion : Efforts should be made to shorten the interval from onset of Sx to Dx, ie, high index of suspision.

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A Review of Questionnaire for the Clinical Trials on Chronic Low Back Pain (만성 요통 임상연구에 사용된 설문지 현황 고찰)

  • Kim, Doo-Hee;Shin, Woo-Suk;Lee, Jin-Won;Park, Won-Hyung;Cha, Yun-Yeop;Ko, Youn-Seok;Lee, Jung-Han;Chung, Won-Suk;Shin, Byung-Cheul;Song, Yun-Kyung;Go, Ho-Yeon;Sun, Seong-Ho;Jeon, Chan-Yong;Jang, Bo-Hyoung;Ko, Seong-Gyu
    • Journal of Korean Medicine Rehabilitation
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    • v.23 no.4
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    • pp.95-115
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    • 2013
  • Objectives The aim of this review is to provide fundamental data for low back pain scales which can be used in clinical trial. Methods We investigated the latest studies on chronic low back pain via PubMed. And we also investigated domestic studies through "http://oasis.kiom.re.kr". 95 research papers were analyzed. Scales were classified into pain scale, function scale, generic health status scale and psychological scale. Results 1) According to foreign clinical studies, Visual Analog Scale (VAS) and Numerical Rating Scale (NRS) were used 18 times as pain scale. Oswestry Disability Index (ODI) was used 20 times as function scale, Roland-Morris Disability Questionnaire (RMDQ) was 17, and Hannover Functional Ability Questionnaire (HFAQ) was used 3 times. 36-item Short Form Health Survey (SF-36) was used 13 times as generic health status scale, Euroqol-5 Dimentions Questionnaire (EQ-5D) was 11, and 12-item Short Form Health Survey (SF-12) was used 3 times. Fear-Avoidance Beliefs Questionnaire (FABQ) was used 9 times as psychological scale, Pain Catastrophizing Scale (PCS) and Tampa Scale for Kinesiophobia (TSK-R) both were used 3 times. 2) According to domestic clinical studies, VAS was used 37 times as pain scale, NRS was 11, and Short Form McGill Pain Questionnaire (SF-MPQ) was used 6 times. ODI was used 30 times as function scale, RMDQ was 2 times only. SF-36 was used once as generic health status scale and Beck's Depression Inventory (BDI) was used 3 times as psychological scale. Conclusions We recommend VAS or NRS as a measure to evaluate pain, and ODI as a measure to evaluate functional disability. And we also recommend SF-36 or SF-12 and EQ-5D as a measure to evaluate generic health status. Finally, we recommend FABQ for use in measuring psychological scale.

The E-mail Survey on the Neck Pain for Acupuncture and Moxibustion Clinical Guideline (경항통에 관한 침구임상 진료지침 개발을 위한 전자우편 설문조사)

  • Kim, Hyun-Wook;Kim, Sung-Soo;Nam, Dong-Woo;Kim, Eun-Jung;Hong, Kwon-Eui;Kim, Sung-Chul;Kim, Sun-Woong;Lee, Jae-Dong;Kim, Kap-Sung;Lee, Geon-Mok
    • Journal of Acupuncture Research
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    • v.26 no.3
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    • pp.67-80
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    • 2009
  • Objectives : The purpose of this survey is the development on the neck pain for acupuncture and moxibustion clinical guideline. 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. 57 members completed answers, and the computerized data were analyzed by SPSS 17.0 statistical program. Results and Conclusions : 1. The first selected pattern identification on the neck pain This study shows that the meridian pattern identification was selected 35 times(61.4%), the pattern identification based on cause of disease was selected 8 times(14.0%), the visceral pattern identification was selected 7 times(12.3%), the other pattern identification was selected 4 times(7.0%), Qi blood yin yang pattern identification was selected 2 times(3.5%), according to symptoms was selected 1 time(2.4%). 2. Meridian pattern identification Small intestine meridian of hand Taeyang was used 39 times(18.1%), Large intestine meridian of hand Yangmyeong and Bladder meridian of foot Taeyang was used 34 times(15.7%), Gall-bladder meridian of foot Soyang was 32 times(14.8%), Tripple energizer meridian of hand Soyang was used 31 times(14.4%), Governor meridian was used 30 times(13.9%), Lung meridian of hand Taeeum was used 8 times(3.7%), Heart meridian of hand Soeum and Pericarduim meridian of hand Gworeum was used 4 times(1.9%). 3. Pattern identification based on cause of disease Wind-Cold-Dampness was used 31 times(17.5%), Accumulation of the collateral by Phelgm-Dampness was used 16 times(14.0%), affection by exopathogen Wind-Cold(stiff neck, sprain of cervical) was used 13 times (11.4%), Defecient-Cold was used 10 times(8.8%), affection by exopathogen Wind-Dampness was used 9 times(7.9%), Deep Invasion by Wind-Cold was used 8 times(7.0%), Wind-Cold was used 7 times (6.1%), Wind-Cold was used 6 times(5.3%), Accumulation in the Center by Phelgm-Dampness, Imparement of bou fluid by Pathogenic Heat, Wind-Heat with Dampness was used 5 times(4.4%), affection by exopathogen Wind-Dampness and Accumulation of the collateral by Wind-Cold was used 4 times(3.5%), Invasion of Dampness-Heat was used 2 times(1.8%). 4. Visceral pattern identification Rising of the Liver yang was used 16 times(41%), Yin deficiency of Liver and Kidney+pathogens was used 15 times(38.5%), Yin deficiency of Liver and Kidney was used 8 times(20.5%) on this survey.

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Fermented Jeju Soybean Extract Promotes Hair Growth in Human Hair Follicle Organ Culture and Clinical Trial (모낭기관배양과 임상에서 제주푸른콩발효추출물의 육모 효능에 미치는 영향)

  • Lee, Yonghee;Shin, Seung Hyun;Kim, Sehyun;Jeong, Gyusang;Hong, Min Jung;Park, Hyeokgon;Kim, Seung Hun;Kim, Eun Joo;Kang, Young-Gyu;Park, Byung Cheol;Park, Won Seok;Kim, Su Na;Kim, Hyoung-June
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.47 no.3
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    • pp.255-263
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    • 2021
  • Soybean extract is known to play an important role in preventing and treating diseases associated with aging, cancer, obesity, and cardiovascular disease. A recent has revealed that soybean extract has a potent effect on hair growth in in vitro, in vivo, and clinical studies. Recently, it has been reported that their fermented extracts exhibit numerous and high efficacy, as compared to general extracts. However, the underlying mechanisms that induce hair growth after using fermented soybean extract are not well understood. The present study aimed to determine the effects of fermented Jeju soybean (FJS) extract on hair growth, with a focus on the underlying mechanisms similar to those of minoxidil. We conducted in vitro and ex vivo investigations and clinical studies. FJS extract enhanced dermal papilla cell proliferation, VEGF levels, and potassium channel opening. Moreover, it promoted human hair follicle elongation. These effects were comprehensively demonstrated in the clinical results, in which FJS extract-containing shampoo improved hair density after 24 weeks of utilization. Collectively, the results of this study demonstrate that FJS extract promotes hair growth and inhibits hair loss through a mechanism similar to that of minoxidil in hair follicles.