• Title/Summary/Keyword: Clinical safety

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Low-level Laser Therapy with Novel Array of Light Source and Individualized Program for Treatment of Androgenetic Alopecia: A 16-week, Randomized, Double-blind, Sham Device-controlled Study

  • Kim, Jee-Woo;Kwon, Yeo-Seon;Chang, Yoon-Young;Hong, Sung-Ho;Shin, Jung-Won;Na, Jung-Im;Huh, Chang-Hun
    • Medical Lasers
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    • v.9 no.2
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    • pp.150-158
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    • 2020
  • Background and Objectives Low-level laser therapy (LLLT) is used widely to promote hair growth in androgenetic alopecia (AGA). This study examined the clinical efficacy and safety of a home-use LLLT device with a newly designed array of light sources and software optimized for individual types of AGA. Materials and Methods The study was a randomized, double-blind, sham device-controlled trial. Forty-eight subjects (39 men and nine women) were assigned randomly in a 2:1 ratio to use either the test device (LG Pra'L HGN1, LG electronics, Korea) or sham device. The subjects used the LLLT device three times a week for 16 weeks. Phototrichogram was used to measure the hair density and hair thickness at 0, 8, and 16-weeks. Adverse events were closely monitored. Results After 16 weeks of using the device, the test group showed a significant increase in hair density and hair thickness compared to the control. In the test group, the hair density increased 6.96 counts/cm2 at eight weeks and 13.67 counts/cm2 at 16 weeks from the baseline. The hair thickness increased 7.21 ㎛ at eight weeks and 11.80 ㎛ at 16 weeks compared to the baseline. Conclusion The home-use LLLT device with a novel array of light sources and an individualized program according to the types of hair loss appears to be an effective and safe treatment modality for both male and female AGA patients.

Gamitaeeumjowee-Tang for weight loss in diabetic patients: A retrospective chart review (당뇨 환자의 체중감량을 위한 가미태음조위탕의 임상적 활용: 후향적 차트 리뷰)

  • Lee, A-Reum;Lee, Da-Yeon;Kim, Min-Ji;Lee, Hyang-Sook;Choi, Ka-Hye;Kim, Seo-Young;Lim, Young-Woo;Park, Young-Bae
    • The Journal of Korean Medicine
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    • v.42 no.1
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    • pp.46-58
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    • 2021
  • Objectives: The purpose of this study is to report weight changes and analyze adverse events in diabetic patients with Gamitaeeumjowee-Tang for weight loss. Methods: A retrospective chart review of weight change and adverse events was performed during the 10-week weight loss program using Gamitaeeumjowee-tang with low-calorie diets for diabetics(n=61). Weight and BMI changes were compared before and after the program and calculated the percentage of people who lost more than 5% of their weight, also identified whether subjects felt satiated or not. Adverse events were evaluated in terms of causality, severity and system-organ classes. Results: After 10-week weight loss program, significant weight loss (5.9±2.32kg, 7.73% reduction from baseline) and BMI reduction (2.9±0.86) were reported (n=61). Those who lost more than 5 percent of their body weight accounted for 88.5%, and also 88.5% of the participants felt full to help control their appetite. In assessing the causality of adverse events, 'Unlikely' was the most common (66%) and in severity evaluations, almost all symptoms were mild. Insomnia was the most frequently reported during the first 8 weeks, and constipation was reported the most afterwards. Conclusions: A combination of Gamitaeeumjowee-tang and low-calorie diets for 10 weeks appears to help weight reduction without serious adverse events in diabetic patients. Future well-designed prospective clinical studies testing the effectiveness and safety of this weight loss program are warranted.

A comparison of different O-antigen serogroups of Escherichia coli in semen samples of fertile and infertile men

  • Nabi, Ali;Khalili, Mohammad Bagher;Eslami, Gilda;Vakili, Mahmood;Anbari, Fatemeh;Torki, Alireza
    • Clinical and Experimental Reproductive Medicine
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    • v.49 no.1
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    • pp.33-39
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    • 2022
  • Objective: Male genital tract infections have been associated with infertility, and Escherichia coli has drawn increasing attention as an important bacterium in this context. This investigation aimed to characterize and compare the distributions of O-antigen serogroups of E. coli in the semen samples of fertile and infertile men. Methods: In this case-control study, semen samples were collected from 618 fertile and 1,535 infertile men. The E. coli-positive samples were evaluated in terms of concentration, morphology, viability, and motility parameters according to the World Health Organization 2010 guidelines. Finally, different serogroups of E. coli were identified by multiplex polymerase chain reaction targeting the O-antigen variations of the bacterium. Results: The prevalence of E. coli among fertile men was significantly higher than among infertile men (p<0.001). The sperm morphology, viability, and motility in the E. coli-positive fertile group were significantly higher than in the E. coli-positive infertile group (p<0.001). E. coli O6 was the most prevalent serogroup found in both groups. However, there was no significant difference in the frequency of different serogroups of E. coil between the two groups (p=0.55). Conclusion: Despite the higher prevalence of E. coli among fertile men, E. coli had more detrimental effects on semen parameters in infertile men. There was no significant difference in E. coli serogroups between the fertile and infertile groups.

Study on Effect of Human Hair by Deer Antler Fermented Keratin Peptide (녹용 발효 케라틴 펩타이드에 의한 인체 모발 연구)

  • Gaewon, Nam
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.48 no.4
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    • pp.385-392
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    • 2022
  • In this study, keratin peptides were produced through high-temperature anaerobic fermentation of keratin, a protein contained in deer antler, with Fervidobacterium islandicum AW-1, and factors related to human hair, confirming the possibility of keratin peptides as cosmetic ingredients. As a result of the cytotoxicity and proliferation of deer antler fermented keratin peptide according to the concentration in the dermal papilla cell line, cytotoxicity was not observed and the cell proliferation effect was shown. For human dermal papilla cells, statistically significant increasing in growth factors according to the deer antler fermented keratin peptide was determined possiblity of effects on hair growth. Cosmetic products containing deer antler fermented keratin peptides were manufactured and skin safety and anti hair loss efficacy clinical tests were conducted. As a result, after 12 weeks of use, the total number of hairs statistically significant increased compared to before using the product and the difference in total number of hairs compared to the control group was found. In conclusion, we suggest that the possibility of fermented deer antler keratin peptide as a cosmeceutical ingredient as well as a health functional food material was confirmed.

Analysis of Clinical Research Trends for Thread Embedding Acupuncture of Cervical Radiculopathy

  • Eun Sil, Heo;Hyun-Jong, Lee;Jung Hee, Lee;Sang Ha, Woo;Yun Kyu, Lee;Seong Hun, Choi;Jae Soo, Kim
    • Journal of Acupuncture Research
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    • v.39 no.4
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    • pp.283-296
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    • 2022
  • In this study, the evidence of thread embedding acupuncture (TEA) in treating cervical radiculopathy in randomized controlled trials was investigated. We searched 16 databases up to August 22, 2022. Of the 2,644 studies retrieved, 22 randomized controlled trials (2,483 participants) were selected. Quality assessments were performed using Cochrane's risk-of-bias tool and RevMan 5.4 software. Outcome measures in the included studies typically showed TEA had a significant therapeutic effect compared with simple acupuncture and other remedies, and TEA was better than sham TEA. Catgut and polydioxanone had no difference in effectiveness, however, catgut was considered to be less safe. TEA was shown to be more therapeutic when inserted deeper into the skin. Ultrasound guided TEA was more effective and safer than conventional TEA, and using a flat blade needle was better than conventional needles for TEA. No serious adverse events were reported from using TEA, and only a few mild side effects were observed. However, the limited number and heterogeneity of the included studies, together with the unclear methodological quality, indicate that higher-quality studies need to be conducted to determine the effectiveness and safety of TEA for cervical radiculopathy.

Single Oral Dose Toxicity Test of HBX-6 in Sprague-Dawley Rat (HBX-6의 Sprague-Dawley rat를 이용한 단회경구투여 독성시험)

  • Jin, Bo-Ram;Seo, Dong-Wook;Kim, Myoung-Seok;Lee, Kwang-Ho;Yoon, Il-Joo;Kim, Chang Eun;An, Hyo-Jin
    • The Korea Journal of Herbology
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    • v.33 no.1
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    • pp.71-76
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    • 2018
  • Objectives : This study was performed to investigate the single oral toxicity of HBX-6 in Sprague-Dawley (SD) rats. Methods : Twenty SD rats were randomly assigned to four groups of 5 rats each and were administrated singly to female and male SD rats, as an oral dose of 2000 mg/kg. HBX-6 is a newly combined Korean herbal medicine formula 30 % Ethanol extract derived from The Dongui Bogam. Now we are developing the prescription for the aim of improving benign prostatic hyperplasia (BPH) without undesirable side effects. HBX-6 is composed of nine medicinal herbs: Aconiti Lateralis Radix Preparata, Corni Fructus, Cistanchis Herba, Psoraleae Semen, Dendrobii Herba, Morindae Radix, Cuscutae Semen, Trigonellae Semen, Foeniculi Fructus. Animals were monitored for the mortality and changes in the body weight, clinical signs, gross observation and necropsy findings for the 14 days according to "Standard for Toxicity Study of Pharmaceuticals" of Korea Food and Drug Administration (KFDA) guideline and "Acute Oral Toxicity - Fixed Dose Procedure" of OECD Test Guideline. Results : We could not find any mortality. Compared with the control group, significant weight change was not observed in the experimental group. After administration, the more common symptoms were not observed. There were no gross abnormalities in all cases. Conclusions : Taken together, these results suggest that the approximate lethal dose of HBX-6 in both female and male SD rats were considered as over 2000 mg/kg.

Function of Blending Essential Oil in the Development of Anti-Dandruff Products

  • Yuk, Young Sam
    • International Journal of Internet, Broadcasting and Communication
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    • v.14 no.3
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    • pp.171-181
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    • 2022
  • Purpose: In this paper, we show our blending ratio of 10 types of Essential Oils that survives beneficial bacteria and kills harmful bacteria in the scalp, and we investigate the possibility of application of our blending ratio to the development of anti-dandruff products and the possibility of being used as a raw material for clinical beauty and customized cosmetics. Methods: The scalp microorganisms used in our study were M. furfur, S. epidermidis, E. coli, and P. nitroreducens. There are a total of 10 Essential Oils such as True Lavender, Lime, Roman chamomile, Rosemary camphor, Cedarwood, Geranium, Clove, Tea tree, Palmalosa, and Peppermint. The antibacterial test of the blended Essential Oil was carried out according to the test method of the standardized evaluation methodology of "Food and Food Additives Code". Since M. furfur is related to the growth of sebum in the scalp, in this study we used the fnLNB and the fnLNA with 20 ㎖ of whole fat cow milk added. Results: The blending ratio of EO, which inhibits dandruff-causing bacteria such as M. furfur, S. epidermidis, E. coli, and does not inhibit P. nitroreducens showing dominant growth in a healthy scalp, was B8(Clove 0.2%, Roman chamomile 0.5%, Tea tree 0.3%), B9(Geranium 0.1%, Palmarosa 0.1%, Roman chamomile 0.5%, Tea tree 0.3%), B10(Clove 0.1%, Geranium 0.1%, Palmarosa 0.1%, Roman chamomile 0.5%, Tea tree 0.2%). Conclusion: It is thought that the blending ratio of BEO obtained as a result of this study can provide a basis for use as an alternative to antibiotics in developing anti-dandruff drugs and emerge as a new alternative to solve scalp microbial imbalance. In order for EO to be used as a useful raw material for anti-dandruff preparation, researches on 1) Standardization (the effects of products differ according to the types, regions, climate, extraction methods, etc.), 2) Antimicrobial effects, 3) Safety, etc., must be established.

Integrated Rehabilitation for Children with Cerebral palsy: A Prospective Observational Study

  • Lee, Hye-Yoon;Yun, Young-Ju;Shin, Yong-Beom;Kim, Soo-Yeon;Han, Jun-hee;Yu, Sun-ae
    • The Journal of Korean Medicine
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    • v.42 no.4
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    • pp.61-74
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    • 2021
  • Objectives: This study aimed to analyse: 1) the clinical effectiveness and safety of traditional Korean Medicine (TKM) and frequency of TKM therapies used and their relationship with conventional treatments. Methods: This prospective observational study enrolled children with cerebral palsy (CP) aged 6-78 months (n=126). The children who used herbal medication for >30 days or acupuncture treatment >12 sessions within 6 months were defined as the integrated rehabilitation (IR) group; the remaining participants were included in the conventional rehabilitation (CR) group. Results: Changes in the Gross Motor Function Measure-66 (GMFM-66) were greater in the IR group (6.4±6.1) than in the CR group (4.6±5.8). The reduction in the number of other health problems was greater in the IR group than in the CR group. The GMFM-66 improvement was greatest in gross motor function classification system level 1. There was no between-group difference in the frequency of rehabilitation therapy (10.9±6.6 and 12.0±9.9 in the IR and CR groups, respectively). Conclusion: TKM may offer additional benefits in terms of the GMFM-66 score and other health problems. However, there is a need for further randomized controlled trials involving a restricted CP type and a controlled treatment type and intensity to confirm these findings.

Potential application of herbal medicine treatment based on pattern identification for canine cognitive dysfunctional syndrome: a comparative analysis of Korea medicine therapy for patients with dementia (반려견 인지기능장애증후군에 대한 한의 진단 및 한약치료 적용 가능성 고찰: 치매환자 국내한의치료기술과 비교 분석)

  • Jung, Kyungsook;Zhao, HuiYan;Choi, Yujin;Jang, Jung-Hee
    • Korean Journal of Veterinary Research
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    • v.62 no.3
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    • pp.25.1-25.9
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    • 2022
  • Canine cognitive dysfunction syndrome (CDS) is a neurodegenerative disease that causes cognitive and behavioral disorders and reduces the quality of life in dogs and their guardians. This study reviewed the complementary and alternative medicine (CAM) for CDS and compared the diagnosis and therapy of CAM between CDS in canines and dementia in humans. The evaluation tools for the diagnosis of CDS and dementia were similar in the neurological and neuropsychiatric examinations, daily life activity, cognitive tests, and neuroimaging, but the evaluation for dementia was further subdivided. In CAM, pattern identification is a diagnostic method for accurate, personalized treatment, such as herbal medicine. For herbal medicine treatment of cognitive impairment in canines and humans, a similar pattern identification classified as deficiency (Qi, blood, and Yin) and Excess (phlegm, Qi stagnation, and blood stasis) is being used. However, the veterinary clinical basis for verifying the efficacy and safety of CAM therapies for CDS is limited. Therefore, based on CAM evidence in dementia, it is necessary to establish CDS-targeted CAM diagnostic methods and therapeutic techniques considering the anatomical, physiological, and pathological characteristics of dogs.

Antibacterial activity of florfenicol composite nanogels against Staphylococcus aureus small colony variants

  • Liu, Jinhuan;Ju, Mujie;Wu, Yifei;Leng, Nannan;Algharib, Samah Attia;Luo, Wanhe
    • Journal of Veterinary Science
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    • v.23 no.5
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    • pp.78.1-78.13
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    • 2022
  • Background: Florfenicol might be ineffective for treating Staphylococcus aureus small colony variants (SCVs) mastitis. Objectives: In this study, florfenicol-loaded chitosan (CS)-sodium tripolyphosphate (TPP) composite nanogels were prepared to allow targeted delivery to SCV infected sites. Methods: The formulation screening, the characteristics, in vitro release, antibacterial activity, therapeutic efficacy, and biosafety of the florfenicol composite nanogels were studied. Results: The optimized formulation was obtained when the CS and TPP were 10 and 5 mg/mL, respectively. The encapsulation efficiency, loading capacity, size, polydispersity index, and zeta potential of the optimized florfenicol composite nanogels were 87.3% ± 2.7%, 5.8% ± 1.4%, 280.3 ± 1.5 nm, 0.15 ± 0.03, and 36.3 ± 1.4 mv, respectively. Optical and scanning electron microscopy showed that spherical particles with a relatively uniform distribution and drugs might be incorporated in cross-linked polymeric networks. The in vitro release study showed that the florfenicol composite nanogels exhibited a biphasic pattern with the sustained release of 72.2% ± 1.8% at 48 h in pH 5.5 phosphate-buffered saline. The minimal inhibitory concentrations of commercial florfenicol solution and florfenicol composite nanogels against SCVs were 1 and 0.25 ㎍/mL, respectively. The time-killing curves and live-dead bacterial staining showed that the florfenicol composite nanogels were concentration-dependent. Furthermore, the florfenicol composite nanogels displayed good therapeutic efficacy against SCVs mastitis. Biological safety studies showed that the florfenicol composite nanogels might be a biocompatible preparation because of their non-toxic effects on the renal tissue and liver. Conclusions: Florfenicol composite nanogels might improve the treatment of SCV infections.