• Title/Summary/Keyword: Double-blind

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Improvement of Skin Moisture Capacity through Dietary Beauty Supplement Containing Ceramides Derived from Rice (쌀 유래 세라마이드를 함유한 미용보조제의 피부미용개선 효과)

  • Kim, Tae-Su;Lee, Sung-Pyo;Park, So-I;Yang, Woong-Suk;Kang, Myung-Hwa;Murai, Hiromichi;Okada, Tadashi;Lee, Jae-Hwan;Park, Il-Bum;Park, Hyun-Jun
    • Korean Journal of Food Science and Technology
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    • v.44 no.4
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    • pp.434-440
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    • 2012
  • A placebo-controlled double-blind ingestion study of a beauty supplement containing rice-derived ceramide was performed. Thirty three subjects who always tended to have rough skin due to dryness participated in the study. Dermatological diagnosis by physicians showed that the supplement significantly improved dryness and itching of the skin. On measurement of water content in the skin, the supplement was shown to significantly increase water content in the skin. On microscopic three-dimensional analysis of the epidermis, the supplement was shown to improve smoothness, exfoliation, and short-term ingestion of the supplement containing rice derived ceramide, which is very effective as skin beautifying food.

Cranberry Juice to Reduce Bladder Biofilms and Infection in Geriatric and Spinal Cord Injured Patients with Dysfunctional Bladders

  • Reid, Gregor;Potter, Patrick;Lam, Dominique;Warren, Diny;Borrie, Michael;Hayes, Keith
    • Preventive Nutrition and Food Science
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    • v.8 no.1
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    • pp.24-28
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    • 2003
  • There is evidence to suggest that cranberry juice supplements improve the health of the urinary tract by inhibiting the binding of fimbriated uropathogenic E. coli to the bladder mucosa. In patients with neurogenic bladders, urinary tract infections (UTI) are particularly common and often poorly managed by antibiotic treatment. A double-blind, randomized, placebo-controlled trial was undertaken on 29 geriatric and spinal cord injured patients with dysfunctional bladders. They received three times daily at mealtimes a 4 oz bottle of cranberry juice (Ocean Spray Cranberries, USA) or a specially prepared synthetic placebo drink. Two episodes of UTI arose in week one of cranberry intake and none thereafter, compared to four episodes of UTI in 4 placebo patients in weeks four, six and 10. Mean bacterial adhesion counts on bladder cells of the patients rose during the first month of treatment in 71 % of the placebo patients compared to only 31 % of cranberry patients (p < 0.001). The difference persisted to some extent for the second and third months. Bacterial adhesion levels correlated with culture findings (higher adhesion and higher viable counts in urine) (p < 0.001), positive leukocyte nitrite tests (136$\pm$131 bacteria per cell versus 52$\pm$86 in negative tests) (p < 0.001), and higher white blood cell counts (> 10) per high power field (126$\pm$125 versus 48$\pm$85 bacteria per cell) (p<0.001). E. coli was the most frequently isolated organism (40% samples) followed by K. pneumoniae (17%) and a number of other uropathogens. Group B Streptococci, and coagulase negative Staphylococcus were recovered from urine in 4 samples but were not associated with any red blood cell presence. The daily intake of cranberry juice, in amounts which are not detrimental to long term compliance, appeared to have a role in reducing the risk of bladder colonization and infection in a highly susceptible patient population.

A Clinical Trial of Dextranase-Containing Mouthwash on the Inhibition of Plaque Formation and Gingivitis (Dextranase 함유 구강 세정액의 치태 억제 및 치은염 예방 효과에 관한 임상적 연구)

  • Song, Woo-Sung;Son, Eun-Ju;Kim, Do-Man;Chung, Hyun-Ju
    • Journal of Periodontal and Implant Science
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    • v.31 no.2
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    • pp.371-388
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    • 2001
  • A novel glucanhydrolase(DXAMase) from a mutant of Lipomyces starkeyi(KSM 22) has been shown effective in hydrolysis of mutan, reduction of mutan formation by Streptococcus mutans and removal pre-formed sucrose-dependentadherent microbial film and DXAMase has been strongly bound to hydroxyapatitie. These in vitro properties of Lipomyces starkeyi DXAMase are desirable for its application as a dental plaque control agent. This study was performed to determine the adjunctive oral hygiene benefits and safety of dextranase(Lipomyces starkeyi KSM 22 DXAMase)-containing mouthwash when used alongside normal tooth-brushing. This 6-month clinical trial was placebo-controlled double-blind design evaluating 1U/ml dextranase mouthwash and 0.12% chlorhexidine mouthwash. A total 39 systemically healthy subjects, who had moderate levels of plaque and gingivitis were included. At baseline, 1, 3 and 6 months, subjects were scored for plaque accumulation(Turesky modification of Quingley-Hein's plaque index), gingivitis status($L\ddot{o}e$ and Silness gingival index), and tooth stain(Area and severity index system by Lang et al). Additionally, oral mucosal examinations were performed and subjects questioned for adverse symptoms. Two weeks after pre-experiment examinations and a professional prophylaxis, the subjects provided with allocated mousewash and instructed to use 20-ml volumes for 30s twice daily after toothbrushing. All the groups showed significant increase in plaque accumulation since 1 month of experiment. During 6 months' period, the Dextranase mouthwash group showed the least increase in plaque accumulation, compared to the Chlorhexidine mouthwash and placebo groups. As for gingival inflammation, all the groups showed significant increase during 6 months of experiment. The Experimental group(Dextranase mouthwash) also showed the least increase in gingival index score, compared to the Positive control(Chlorhexidine mouthwash)as well as the Negative control(placebo)groups. Whereas the tooth stain was increased significantly in the Positive control group, compared to the baseline score and the Negative controlgroup since 3 months of mouthrinsing. It was significantly increased after 6 months in the Experimental group, still less severe than the Positive control group. As for the oral side effect, the Experimental group showed less tongue accumulation, bad taste, compared to the Positive control group. From these results, mouthrinsing with Lipomyces starkeyi KSM 22 dextranase provided adjunctive benefits to toothbrushing, comparable to 0.12% chlorhexidine mouthwash in inhibition of plaque accumulation and gingival inflammation and local side effects were if anything less frequent and less intense than chlorhexidine, with long-term use of the mouthwash. All data had provided positive evidence for Lipomyces starkeyi KSM 22 dextranase as an antiplaque agent and suggested that further development of dextranase formulations for plaque control are warranted.

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A Study on Efficacy of Preemptive Analgesia - A Comparison on Efficacy of Preoperative and Postoperative Analgesic Administration - (선행적 진통 요법의 효과성에 대한 연구 -발치 전과 후 진통 요법의 효과 비교-)

  • Jung, Young-Soo;Kim, Moon-Key;Park, Hyung-Sik;Lee, Eui-Wung;Kang, Jeong-Wan
    • Journal of The Korean Dental Society of Anesthesiology
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    • v.3 no.1 s.4
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    • pp.10-18
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    • 2003
  • Background: Studies on the pain have been dealing with many different ways for last several centuries. Especially, preemptive analgesia is being used as a method to control the postoperative pain. Many studies on its efficacy have been processed in different ways about various drugs, administration methods and times for various operations. And the value of preemptive analgesia are still controversial regarding the results of other clinical studies. The authors performed a clinical study on efficacy of preemptive analgesia using an non-steroidal anti-inflammatory drug (NSAID) for the surgical extraction of impacted third molar teeth and present the more effective pain treatment after oral surgery with literature review. Methods: Using a randomized double blind test design, this study compared the analgesic efficacies of an NSAID, Talniflumate 370 mg. This drug administrated first either 1 hour preoperatively (experimental group) or when the pain developed moderately to severely over 5 scale of verbal rating scales (0-10) to respective 30 patients undergoing the removal of impacted third molars. Pain intensity and the time from the end of surgery were assessed postoperatively whenever the patients demanded additional drug over 5 scale for forty eight hours using same verbal rating scales. Results: The sex distribution, the age of the patients. and the time required for surgery in two groups were similar. The average first time for demanding additional drug after surgery was 163.9 minutes in experimental group and 191.5 minutes in control group. At this time, the average pain intensity was 5.8 in experimental group and 6.1 in control group. And the average second time for demanding additional drug was 365.5 minutes in experimental group and 351.8 minutes in control group. At this time. the average pain intensities were 6.6 in experimental group and 6.2 in control group. No statistically significant difference was found between the average first times and second times, and the average pain intensities at first and second times in two groups. Conclusions: From these results the efficacy of preemptive analgesia used in this study was not appeared. This clinical study indicates that many NSAIDs administrated preoperatively in present practices have weak efficacy of preemptive analgesia for postoperative pain, thus the authors recommend that only postoperative analgesics are adequate without preoperative use of analgesics.

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Patient Controlled Analgesia of Alfentanil after a Total Abdominal Hysterectomy: A Comparison of the Intravenous and Epidural Route (전자궁 적출술 후 자가통증조절장치를 이용하여 정맥과 경막외로 투여된 Alfentanil의 진통효과 비교)

  • Choi, Soo Kyeong;Yoon, Seok Hwa;Lee, Jun Hwa;Hwang, Jae Ha;Jung, Woo Suk;Kim, Yoon Hee;Lee, Won Hyung
    • The Korean Journal of Pain
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    • v.20 no.2
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    • pp.169-173
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    • 2007
  • Background: Although the use of intravenous patient controlled analgesia (IVPCA) has been compared to the use of patient conrolled epidural analgesia (PCEA), there is no optimal administration route of alfentanil for the treatment of postoperative pain. This randomized double-blind study compared the efficacy of the use of IVPCA and PCEA for postoperative pain and the side effects after a total abdominal hysterectomy (TAH). Methods: Sixty patients undergoing a TAH were randomly assigned to receive either IVPCA (Group I) or PCEA (Group E) for the infusion of alfentanil for postoperative pain control. In both groups, a loading dose of $750{\mu}g$ alfentanil was administered. All patients received the same continuous infusion rate (0.3 mg/h), bolus dose (0.15 mg), and lockout time (15 min). The incidence of side effects, the VAS (visual analog scale) of pain, blood pressure, and heart rate were checked for 20 hours after the loading dose injection. Results: The VAS of pain was not significantly different between the two groups of patients. The onset of the analgesic effect was significantly more rapid in the Group I patients than in the Group E patients. There was no difference in side effects for either group. Conclusions: When considering multiple factors such as the onset of analgesia, technical difficulties or infection after the procedure, IVPCA using alfentanil is more useful than PCEA for postoperative pain control after a TAH.

Incidence of Paresthesia Related to the Insertion Length of Catheter during the Epidural Catheterization (경막외강 카테터 삽입 시 삽입 길이와 감각이상의 빈도)

  • Lim, Jun Goo;Kim, Young Jae;Cho, Jae Heung;Lee, Sang Eun;Kim, Young Hwan;Lim, Se Hoon;Lee, Jeong Han;Lee, Kun Moo;Cheong, Soon Ho;Choi, Young Kyun;Shin, Chee Mahn
    • The Korean Journal of Pain
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    • v.20 no.1
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    • pp.50-53
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    • 2007
  • Background: Continuous epidural catheterization is a popular and effective procedure for postoperative analgesia. However, continuous epidural catheterization has associated complications such as venous puncture, dural puncture, subarachnoid cannulation, suboptimal catheter placement, and paresthesia because the tip of the epidural catheter touches thenerves of the dura in the epidural space. In this study, we compared the incidence of paresthesia in two different lengths of epidural catheter insertion. Methods: One hundred women undergoing gynecologic or orthopedic surgery were enrolled in this prospective, double-blinded, randomized study. All patients were randomly divided into two groups based on the insertion length of the epidural catheter 2 cm (group A) or 4 cm (group B). A Tuohy needle was inserted in the lumbarspinal region with a bevel directed cephalad by use of the median approach, and then the epidural space was confirmed by the loss of resistance technique with air. While the practitioner inserted an epidural catheter into the epidural space, a blind observer checked for paresthesia or withdrawal movement. Results: In 97 included patients, 30.6% of the patients in group A (n = 49) had paresthesia, versus 31.3% in group B (n = 48). Withdrawal movements were represented in 2% and 6% of the patients in group A and group B, respectively. There was no difference in the incidence of paresthesia and withdrawal movement between the two groups. Conclusions: There is no clear relationship for the incidence of catheter-related paresthesia according to the catheter length inserted into the epidural space for epidural analgesia.

A 4 week Randomized, Double-blind Human Trial to Compare the Efficacy and Safety of Aureobasidium pullulans Cultured Solution and Placebo on Improvement of Immune in Subjects (흑효모배양액 분말의 면역관련 사이토카인에 미치는 영향에 대한 무작위 배정 임상연구)

  • Choi, Hae-Yun;Kim, Jong-Dae;Park, Mee-Yeon
    • Korean Journal of Oriental Medicine
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    • v.15 no.3
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    • pp.83-91
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    • 2009
  • $\beta$-glucan is a fiber-type complex sugar (polysaccharide) derived from the cell wall of baker's yeast, oat and barley fiber, and many medicinal mushrooms, such as maitake. The primary uses of $\beta$-glucan are to enhance the immune system, to lower blood cholesterol levels and to treat tumor. $\beta$-glucan has no systemic toxicity in mice, therefore it needed clinical trail to prove efficacy and safety for human. The subjects total 56 healty volunteers were divided into two groups including taken $\beta$-glucan tablet group and placebo group. Subjects were taken two tablets per oral for 4 weeks. They had agreed to take part in this experiment, and didn't take any other clinical trail products. After 4 weeks blood of subjects were checked. The check list are TNF-$\alpha$, INF-$\gamma$, IL-2, IL-4, total WBC, differential WBC, RBC, hemoglobin, platelet, MCV, MCH, MCHC, HCT, Na, K, Ca, Cl, AST, ALT, ALP, $\gamma$-GTP, total protein, triglyceride, total cholesterol, total bilirubin, albumin, uric acid, creatinine, BUN, pH, protein, glucose, ketone body, blood, bilirubin. We evaluated efficacy by cytokines that compare before and after taking. Collected data were analyzed as two sample t-test, chi-square test and ANOVA using SAS V.9.1.This study results are that in TNF-$\alpha$ of $1^{st}$ efficacy measurement item, all of two groups figure were increased significantly compare to before figure. In IL4 of $2^{nd}$ efficacy measurement item, experimental group figure were decreased significantly but placebo group figure were increased. The conclusions show that based on the above results, $\beta$-glucan has favorable effect to enhance immune system, especially IL4 results showed that it has effect to improve the allergic immune system.

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The Effects of distilled Astragali Radix Herbal Acupuncture on the Heart Rate Variability(HRV) (황인 약침이 정산인의 심박변이도(HRV)에 미치는 영향)

  • Lim, Sung-Taek;Kim, Lak-Hyung;Song, Beom-Yong;Yook, Tae-Han
    • Journal of Oriental Neuropsychiatry
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    • v.19 no.1
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    • pp.107-124
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    • 2008
  • We investigated the effects of distilled Astragali Radix Herbal Acupuncture on autonomic nervous system with the Heart Rate Variability(HRV) in adult man. as well as we tried to observe how distilled Astragali Radix Herbal Acupuncture on the balance of the autonomic nervous system. Methods : We investigated on 61 healthy volunteers consisted of 31 subjects in experiment(distilled Astragali Radix Herbal Acupuncture) group and 30 subjects in control(Normal Saline) group. Study form was a randomized, placebo-controlled, double-blind clinical trial. 31 subjects in experiment group were injected distilled Astragali Radix Herbal Acupuncture at GB21(Kyonjong) and 30 subjects in control group were injected Normal Saline at GB21(Kyonjong). except of 2 subjects(in control group) who can't be measured and 10 subjects(6 in experiment group and 4 in control group) who move or make unforceable error during measuring. Finally 25 subject in experiment group and 24 subject in control group are studied. We measured HRV by PolyG-I on 7 times : before and after injection per 5 minutes during 30 minutes. The SPSS 10.0 for windows was used to analyze the data and the paired t test(in group) and Student t test(between two groups) were used to verify the result. Results : I. After distilled Astragali Radix Herbal Acupuncture injection, SDNN is significantly high from 5 minute to 10 minute and from 15 minute to 30 minute, Complexity is significantly low from 20 minute to 30minute. HRV index is significantly mgb for first 20 minute and from 25 minute to 30 minute, RMSSD is significantly high only from 15 minute to 20 minute. 2. HRV index of distilled Astragali Radix Herbal Acupuncture Group significantly increased from 25 minute to 30 minute, pNN50 of distilled Astragali Radix Herbal Acupuncture Group significantly decreased from 25 minute to 30 minute and RMSSD of distilled Astragali Radix Herbal Acupuncture Group significantly increased from 25 minute to 30 minute compared with those of Normal Saline group. 3. After distilled Astragali Radix Herbal Acupuncture injection, Ln(TP) is significantly high from 5 minute to 10 minute and from 15 minute to 30 minute. Ln(VLF) is significantly high after 5 minute, Ln(LF) is significantly high after 15 minute and Ln(HF) is significantly high from 5 minute to 10 minute and 25 minute to 30 minute, but significantly low for first 5 minute and from 10 minute to 20 minute. Normalized LF is significantly high after 20 minute and Normalized LF is significantly low after 20 minute. Conclusions : The results suggest that distilled Astragali Radix Herbal Acupuncture in healthy adult man tend to activate the autonomic nervous system within normal range. This result is derived from that parasympathetic nervous system was continuously activated and sympathetic nervous system was activated a little later.

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Efficacy and safety of vitamin D3 B.O.N intramuscular injection in Korean adults with vitamin D deficiency

  • Choi, Han Seok;Chung, Yoon-Sok;Choi, Yong Jun;Seo, Da Hea;Lim, Sung-Kil
    • Osteoporosis and Sarcopenia
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    • v.2 no.4
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    • pp.228-237
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    • 2016
  • Objective: There has been no prospective study that examined intramuscular injection of high-dose vitamin D in Korean adults. The aim of this study was to assess the efficacy and safety of high-dose vitamin $D_3$ after intramuscular injection in Korean adults with vitamin D deficiency. Method: This study was a 24-week, prospective, multicenter, randomized, double-blind, placebo-controlled trial. A total of 84 subjects ${\geq}19$ and <65 years of age were randomly allocated to either the vitamin $D_3$ or placebo group in a 2:1 ratio. After randomization, a single injection of plain vitamin $D_3$ 200,000 IU or placebo was intramuscularly administered. If serum 25-hydroxyvitamin D (25[OH]D) concentrations were <30 ng/mLon week 12 or thereafter, a repeat injection was administered. Results: After a single intramuscular injection of vitamin $D_3$ to adults with vitamin D deficiency, the proportion of subjects with serum 25(OH)D concentrations ${\geq}30ng/mL$ within 12 weeks was 46.4% in the vitamin $D_3$ group and 3.6% in the placebo group (p<0.0001). The proportion of subjects with serum 25(OH)D concentrations ${\geq}30ng/mL$ within 24 weeks was 73.2% in the vitamin $D_3$ group and 3.6% in the placebo group (p<0.0001). Mean change in serum 25(OH)D concentrations at weeks 12 and 24 after vitamin $D_3$ injection was $12.8{\pm}8.1$ and $21.5{\pm}8.1ng/mL$, respectively, in the vitamin $D_3$ group, with no significant changes in the placebo group. Serum parathyroid hormone concentrations showed a significant decrease in the vitamin $D_3$ group but no change in the placebo group. Conclusion: Intramuscular injection of vitamin $D_3$ 200,000 IU was superior to placebo in terms of its impact on serum 25(OH)D concentrations, and is considered to be safe and effective in Korean adults with vitamin D deficiency.

Effects of Unripe Rubus Coreanus Extract on Upper Body Obesity: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial (미숙과 복분자 추출물의 상체비만 개선 효과: 무작위배정, 이중눈가림, 위약-대조 임상연구)

  • Ha, Ki Chan;Kim, Hye Mi;Baek, Hyang Im;Jeong, Da Young;Kim, Eun;Lee, Ki Hoon;Kim, Ha Rim;Kwon, Kang Beom;Kim, Sunoh;Lee, Jung Han
    • Journal of Korean Medicine Rehabilitation
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    • v.31 no.4
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    • pp.117-127
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    • 2021
  • Objectives Previously, we demonstrated that a 5% ethanol extract of unripe Rubus coreanus (5-uRCK) and ellagic acid has hypocholesterolemic and antiobesity activity in high-fat diet-fed animals. Therefore, we conducted a clinical study on the anti-obesity effect of 5-uRCK in 140 Korean adults (aged 19-70 years, body mass index (BMI) ≥25 kg/m2). Methods The participants were randomly assigned to two groups and were administered the placebo (n=70) or 5-uRCK extract (800 mg, n=70) daily for 12 weeks. The subjects were instructed to maintain their usual dietary intake and normal physical activity. Anthropometrics, body composition (dual-energy X-ray absorptiometry), and blood parameters were compared between the two groups. Results Average body weight and BMI did not show any significant changes; however, changes in upper body fat mass between the two groups was significantly different, as determined using analysis of covariance adjusted for baseline of percent body fat and drinking units. Moreover, Although not significant, the trunk fat mass and percent trunk fat tended to decrease after 5-uRCK supplementation. There was no significant difference in other laboratory biomarkers between the two groups. All safety parameters were within normal ranges in the both group. Conclusions In the present study, 5-uRCK significantly reduced upper body fat in obese subjects after 12 weeks, which indicates that it may help improve android-type obesity. Furthermore, the supplement is safe and well tolerated.