• Title/Summary/Keyword: Double-blind

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The Effects of distilled Rehmannia glutinosa Herbal Acupuncture on the Heart Rate Variability(HRV) (생지황 약침이 정상인의 심박변이도(HRV)에 미치는 영향)

  • Shin, Jin-Cheol;Kim, Lak-Hyung;Song, Beom-Yong;Yook, Tae-Han
    • Journal of Pharmacopuncture
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    • v.11 no.1
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    • pp.83-97
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    • 2008
  • Objectives : We investigated the effects of distilled Rehmannia glutinosa Herbal Acupuncture on autonomic nervous system with the Heart Rate Variability(HRV) in adult man. as well as we tried to observe how distilled Rehmannia glutinosa Herbal Acupuncture on the balance of the autonomic nervous system. Methods : We investigated on 58 healthy volunteers consisted of 28 subjects in experiment(distilled Rehmannia glutinosa Herbal Acupuncture) group and 30 subjects in control(Normal Saline) group. Study form was a randomized, placebo-controlled, double-blind clinical trial. 28 subjects in experiment group were injected distilled Rehmannia glutinosa Herbal Acupuncture at $GB_{21}$(Kyonjong) and 30 subjects in control group were injected Normal Saline at $G_{21}$(Kyonjong). except of 2 subjects(in control group) who can't be measured and 6 subjects(2 in experiment group and 4 in control group) who move or make unforceable error during measuring. Finally 26 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 : 1. After distilled Rehmannia glutinosa Herbal Acupuncture injection, Mean HRV is significantly low only for first 5 minute, SDNN is significantly high after 5 minute, Complexity is significantly low only from 20 minute to 25 minute. HRV index is significantly high for first 5minute and from 10 minute to after 10 minute. 2. HRV index of distilled Rehmannia glutinosa Herbal Acupuncture Group significantly increased from 25 minute to 30 minute, and pNN50 of Rehmannia glutinosa Herbal Acupuncture Group significantly decreased from 20 minute to 30 minute compared with those of Normal Saline group. 3. After distilled Rehmannia glutinosa Herbal Acupuncture injection, Ln(TP) and Ln(VLF) are significantly high after injection. Normalized LF is significantly high from 5 minute to 20 minute and from 25 minute and 30 minute. Normalized HF is significantly low from 5minute to 20 minute and from 25 minute and 30 minute. 4. Ln(TP) and Ln(VLF) of distilled Rehmannia glutinosa Herbal Acupuncture Group significantly increased from 20 minute to 25 minute compared with those of Normal Saline group. Conclusions : The results suggest that Rehmannia glutinosa Herbal Acupuncture in healthy adult man tend to activate the autonomic nervous system and parasympathetic nervous system compared to Normal Saline within normal range.

Chicken Egg Yolk Antibodies (IgY) for Prophylaxis and Treatment of Rotavirus Diarrhea in Human and Animal Neonates: A Concise Review

  • Thu, Hlaing Myat;Myat, Theingi Win;Win, Mo Mo;Thant, Kyaw Zin;Rahman, Shofiqur;Umeda, Kouji;Nguyen, Sa Van;Icatlo, Faustino C. Jr.;Higo-Moriguchi, Kyoko;Taniguchi, Koki;Tsuji, Takao;Oguma, Keiji;Kim, Sang Jong;Bae, Hyun Suk;Choi, Hyuk Joon
    • Food Science of Animal Resources
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    • v.37 no.1
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    • pp.1-9
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    • 2017
  • The rotavirus-induced diarrhea of human and animal neonates is a major public health concern worldwide. Until recently, no effective therapy is available to specifically inactivate the rotavirion particles within the gut. Passive immunotherapy by oral administration of chicken egg yolk antibody (IgY) has emerged of late as a fresh alternative strategy to control infectious diseases of the alimentary tract and has been applied in the treatment of diarrhea due to rotavirus infection. The purpose of this concise review is to evaluate evidence on the properties and performance of anti-rotavirus immunoglobulin Y (IgY) for prevention and treatment of rotavirus diarrhea in human and animal neonates. A survey of relevant anti-rotavirus IgY basic studies and clinical trials among neonatal animals (since 1994-2015) and humans (since 1982-2015) have been reviewed and briefly summarized. Our analysis of a number of rotavirus investigations involving animal and human clinical trials revealed that anti-rotavirus IgY significantly reduced the severity of clinical manifestation of diarrhea among IgY-treated subjects relative to a corresponding control or placebo group. The accumulated information as a whole depicts oral IgY to be a safe and efficacious option for treatment of rotavirus diarrhea in neonates. There is however a clear need for more randomized, placebo controlled and double-blind trials with bigger sample size to further solidify and confirm claims of efficacy and safety in controlling diarrhea caused by rotavirus infection especially among human infants with health issues such as low birth weights or compromised immunity in whom it is most needed.

Effect of YGF251 on Secretion Of IGF-1 in Human Blood (YGF251 투여에 의한 인체내 혈중의 IGF-1 분비량 변화 효과)

  • 김재수;박준홍;조한성;박점석;홍억기
    • KSBB Journal
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    • v.17 no.4
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    • pp.403-408
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    • 2002
  • For stimulating the in vivo secretion of IGF-1 (insulin-like growth factor-1) which is well known to promote the various physiological actions in human body, the natural herbal extract, YGF251 (young growth factor 251), was developed and evaluated for its effect as IGF-1 secretagogue in this study. The clinical study was peformed as double blind test, and 31 adult female and male volunteers between the age of 40 and 70 were investigated for their changes of concentration of IGF-1 , insulin level, weight, blood pressure, and liver and kidney functions. As the result of paired sample test on the change of the concentration of IGF-1, in YGF251 treated group, it was 245.6 ng/mL before dosing. The concentration of IGF-1 was increased to 269.3 ng/mL after a month and to 275.6 ng/mL after two months, and both were statistically significant (p〈0.05). While in control group, the concentration of IGF-1 was 280.0 ng/mL before dosing, but decreased to 239.2 ng/mL after a month and to 230.2 ng/mL after two months, and both were also statistically significant (p〈0.05). In YGF251 treated group, the concentration of insulin in blood increased about 2 times after a month dosing as an average level, but in control group, it showed a decrease of 36% compared with before dosing. And there were little changes regarding to the measured weight and blood pressure. Various measured data in order to observe the alteration in liver and kidney functions by the administration of YGF251 showed a little change within measuring error range.

Efficacy and Adverse Events of Bangpungtongseong-san(Bofutsusho-san) and Bangkihwangki-tang(Boiogiot-tang) by Oriental Obesity Pattern Identification on Obese Subjects : Randomized, Double Blind, Placebo-controlled Trial (비만 환자에서 한방 비만 변증에 따른 방풍통성산과 방기황기탕의 치료효과 및 부작용 비교 : 무작위 배정, 이중 맹검, 위약-대조군 임상시험)

  • Park, Jung-Hyun;Lee, Myeong-Jong;Kim, Ho-Jun;Hong, Sun-woo;Lee, Dong-Ki;Yoo, Jae-Wook;Choi, Sun-Mi;Moon, Jin-Seok;Lim, Chi-Yeon;Lee, Jung-bok
    • Journal of Korean Medicine Rehabilitation
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    • v.21 no.2
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    • pp.265-278
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    • 2011
  • Objectives : This trial were conducted to evaluate the efficacy and adverse events of Bofutsusho-san(BTS) and Boiogiot-tang(BOT) by oriental obesity pattern identification on obese subjects, as compared to placebo. Methods : 166 subjects(body mass index ${\geq}25kg/m^2$) were recruited and randomized to receive BT(n=55), FH(n=55) or placebo(n=56) for 8 weeks. Anthropometric factors, serum lipid, glucose, blood pressure(BP), pulse rate, resting metabolic rate and oriental obesity pattern identification questionnaire were measured at baseline and 8 weeks. Adverse events and safety outcome variables were also checked during trials. Results : The frequency of top-scored oriental obesity pattern was ordered by indigestion(食積) > stagnation of the liver qi(肝鬱) > yang deficiency(陽虛) > spleen deficiency(脾虛) > phlegm(痰飮) > blood stasis(瘀血) in subjects. BTS group significantly decreased body weight, body mass index(BMI), waist circumference(WC), body fat mass, total cholesterol and HDL-cholesterol in stagnation of the liver qi(肝鬱) and WC in indigestion(食積). BOT group showed significant decrease of body weight, BMI, WC, and body fat mass in indigestion(食積) not in deficiency(虛症). Adverse events were reported most frequently in yang deficiency(陽虛) by BT group and stagnation of the liver qi(肝鬱) by BOT group. Conclusions : Bofu-tsusho-san was effective in treating obesity with stagnation of the liver qi(肝鬱). Obesity pattern identification could be a useful diagnostic tool predicting treatment effects and adverse events.

A COMPARATIVE STUDY OF CHLORAL HYDRATE/HYDROXYZINE VERSUS MIDAZOLAM/MEPERIDINE AS ORAL CONSCIOUS SEDATIVE REGIMENS (Chloral hydrate/Hydroxyzine과 Midazolam/Meperidine의 경구 투여 진정효과에 관한 비교 연구)

  • Kim, Yong-Heon;Kim, Ji-Yeon;Park, Ki-Tae
    • Journal of the korean academy of Pediatric Dentistry
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    • v.32 no.2
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    • pp.262-269
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    • 2005
  • The purpose of this study was to compare the efficacy and complications of two oral sedative regimens, chloral hydrate (60mg/kg)/hydroxyzine(25mg) versus midazolam(1mg/kg)/meperidine(1mg/kg) for the sedation of pediatric dental patients. Fifteen patients(mean age 36.2months, range 24-47months), ASA Class I or II, who needed at least two restorative dental procedures were selected in this double-blind, randomized study. All subjects were randomly assigned to receive either chloral hydrate/hydroxyzine or midazolam/meperidine and 50% $N_2O/O_2$ was administered at each appointment. Behavior assessment(sleep, movement, crying, overall behavior) was made using Houpt Sedation Rating Scale and physiologic parameters(pulse rate, oxygen saturation) were monitored using pulse oximeter. The incidence of hypoxia($SpO_2$ 90% or less, at least 10s duration) and vomiting was recorded. Patients sedated with chloral hydrate/hydroxyzine showed significantly better overall behavior score than patients sedated with midazolam/meperidine. There was no clinically significant difference in the incidence of hypoxia and vomiting. It was concluded that oral administration of chloral hydrate/hydroxyzine is more effective than midazolam/meperidine for the sedation of pediatric dental patients.

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A CONTROL OF PLAQUE, GINGIVITIS AND ANTI-CARIES EFFECT OF DENTIFRICE CONTAINING HORSERADISH EXTRACTS (서양산 고추냉이 추출물이 함유된 세치제의 효능에 대한 임상적 실험연구)

  • Seo, Hyun-Woo;Park, Ho-Won;Kim, Jong-Soo;Lee, Si-Young;Shin, Il-Shik
    • Journal of the korean academy of Pediatric Dentistry
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    • v.39 no.1
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    • pp.26-33
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    • 2012
  • The purpose of this study was to find out the effect of dentifrice containing Horseradish (Armoracia rustica) root extracts on improvement of oral hygiene. The clinical evaluation was done participated by 80 adults volunteers who provided a informed consent for their participation. The participants were divided into two groups ; control group (using toothpaste without Horseradish extracts) and experimental group (using toothpaste containing Horseradish extracts). The checklist of the experiment includes the plaque index, gingival index and anti-caries activity. The anti-caries activity was measured by cultivating Streptococcus mutans for 48 hours then estimating the number of increased bacteria using Dentocult SM. The double-blind method was used in this study. The results of this study can be summarized as follows; 1. The plaque formation decreased 28% in control group, 58% in experimental group using dentifrice with Horseradish extracts compared to baseline data. 2. For gingival index, control group and experimental group showed 26% and 40% decrease compared to baseline data, respectively. 3. The score of caries activity test decreased by 4% for control group and 69% for experimental group compared to baseline data. According to the results, a dentifrice containing Horseradish extracts can improve oral hygiene.

A single-center, randomized, double-blind, placebo-controlled study on the efficacy and safety of "enzyme-treated red ginseng powder complex (BG11001)" for antiwrinkle and proelasticity in individuals with healthy skin

  • Park, Sang-Yong;Shin, Yu-Kyong;Kim, Hee-Taek;Kim, Yong Min;Lee, Don-Gil;Hwang, Eunson;Cho, Byung-Goo;Yin, Chang Shik;Kim, Ki-Young;Yi, Tae Hoo
    • Journal of Ginseng Research
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    • v.40 no.3
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    • pp.260-268
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    • 2016
  • Background: During the aging process, skin shows visible changes, characterized by a loss of elasticity and the appearance of wrinkles due to reduced collagen production and decreased elasticity of elastin fibers. Panax ginseng Meyer has been used as a traditional medicine for various diseases due to its wide range of biological activities including skin protective effects. Ginsenosides are the main components responsible for the biological activities of ginseng. However, the protective activities of an enzymatic preparation of red ginseng against human skin aging have not been investigated. Methods: The efficacy of an enzyme-treated powder complex of red ginseng (BG11001) in preventing human skin aging was evaluated by oral administration to 78 randomized individuals. All patients were requested to take three daily capsules containing either 750 mg of BG11001 or a placebo vehicle for 24 wk; at the end of the testing period, skin roughness, elasticity, and skin water content were measured. Results: BG11001 significantly reduced the average roughness of eye wrinkles and the Global Photo Damage Score compared with the placebo, although there were no significant differences in arithmetic roughness average between the groups. In addition, gross elasticity and net elasticity values increased, and transepidermal water loss level decreased, indicating improved skin elasticity and moisture content. Conclusion: In conclusion, enzyme-treated red ginseng extract significantly improved eye wrinkle roughness, skin elasticity, and moisture content. Moreover, enzyme-treated red ginseng extract would be useful substance as a bio-health skin care product.

Effect of Ephedra Sinica and Evodia Rutaecarpa on Resting Metabolic Rate in Obese Premenopausal Women during Low-calorie Diet: A Randomized Controlled Clinical Trial (저열량 식이요법을 한 폐경 전 비만 여성의 휴식 대사량에 대한 마황과 오수유의 효과)

  • Kim, Su-Jin;Ko, Byung-Pyo;Kim, Hyung-Do;Kim, Jin-Ah;Park, Jeong-Mi;Choi, Seung-Ki;Jeon, Uoo-Hyun;Kim, Ho-Jun
    • Journal of Korean Medicine for Obesity Research
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    • v.4 no.1
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    • pp.45-54
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    • 2004
  • Objective: To evaluate the effect of Ephedra Sinica and Evodia Rutaecarpa on resting metabolic rate(RMR), weight and body composition in obese women during low-calorie diet. Methods: We recruited 90 healthy premenopausal women$(body\;mass\;index{\geq}25kg/m^2)$ and randomly assigned to three groups(ephedra group, evodia group and placebo group). Subjects were administered Ephedra Sinica(6g twice a day) or Evodia Rutaecarpa(6g twice a day) or placebo in a double-blind fashion and participated in low-calorie diet for 8 weeks. Resting metabolic rate and body composition were measured at baseline, 4 and 8 weeks. Results: RMR change for 4 weeks was significantly higher in the ephedra group compared with the placebo group(p<.05). But the change for 8 weeks was not significant and the Evodia group showed no significant RMR change. Weight and percent body fat changes for 4 weeks and 8 weeks were significantly higher than the placebo group in the ephedra group(p<.05), but the Evodia group didn't show significant level. Conclusions: This study supports and emphasizes the benefits of herbal medicine in maintaining or increasing RMR during low-calorie diet. Especially Ephedra treatment was effective on significant maintainment of RMR, loss of weight and percent body fat(P<.05).

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Effect of Korean Red Ginseng Extract on Blood Circulation in Healthy Volunteers: A Randomized, Double-Blind, Placebo-Controlled Trial (건강한 지원자에서 홍삼농축액의 혈행 개선 효과: 무작위, 이중맹검, 위약-대조 시험)

  • Shin, Kyeong-Seob;Lee, Jung-Jin;Kim, Yeong-Il;Yu, Ji-Yeon;Park, Eun-Seok;Im, Ji-Hyun;You, Soon-Hyang;Oh, Ki-Wan;Lee, Myung-Koo;Wee, Jae-Joon;Kim, Young-Sook;Yun, Yeo-Pyo
    • Journal of Ginseng Research
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    • v.31 no.2
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    • pp.109-116
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    • 2007
  • Korean red ginseng has broad efficacious effects against hypertension, diabetes, nociception, and cancer, and it counteracts weakness. It has been reported that Korean red ginseng is able to normalize blood pressure, improve cholesterol and lower blood glucose levels. We have recently reported that Korean red ginseng extract (KRGE) significantly prevented rat carotid arterial thrombosis in vivo, and inhibited platelet aggregation ex vivo and in vitro in a dose-dependent manner. The purpose of this study was to examine the effects of KRGE on blood circulation in human by measuring ex vivo platelet aggregation, plasma coagulation and serum lipid profiles in healthy volunteers. Subjects were randomly divided into three groups (placebo-group, KRGE-low dose group, KRGE-high dose group). Administration of KRGE to subjects significantly inhibited ADP-induced platelet aggregations both in KRGE-low dose group from $72.79{\pm}20.53$ to $62.00{\pm}23.06%$ (p=0.0009), and in KRGE-high dose group from $75.14{\pm}21.86$ to $64.52{\pm}24.72%$ (p=0.0039), respectively. Administration of KRGE to subjects also significantly inhibited collagen-induced platelet aggregations both in KRGE-low dose group from $85.52{\pm}12.57$ to $79.62{\pm}20.47%$ (p=0.0916), and in KRGE-high dose group from $80.24{\pm}18.11$ to $70.31{\pm}25.93%$ (p=0.0565), respectively. Whereas, KRGE has no significant effects on coagulation system, such as prothrombin time (PT) and activated partial thromboplastin time (APTT), and serum lipid profiles, such as total cholesterol, low density lipoprotein cholesterol, high density lipoprotein cholesterol and triglyceride. KRGE also has no significant effects on hematological and serum biochemical profiles. These results suggest that KRGE has a potential to improve blood circulation through antiplatelet activity in human, and KRGE intake may be beneficial for the individuals with high risks of thrombotic and cardiovascular diseases.

Safety and tolerability of Korean Red Ginseng in healthy adults: a multicenter, double-blind, randomized, placebo-controlled trial

  • Song, Sang-Wook;Kim, Ha-Na;Shim, Jae-Yong;Yoo, Byeong-Yeon;Kim, Dae-Hyun;Lee, Sang-Hyun;Park, Joo-Sung;Kim, Moon-Jong;Yoo, Jun-Hyun;Cho, BeLong;Kang, Hee-Cheol;Kim, Kwang-Min;Kim, Sung-Soo;Kim, Kyung-Soo
    • Journal of Ginseng Research
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    • v.42 no.4
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    • pp.571-576
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    • 2018
  • Background: Korean Red Ginseng (KRG) has been used in Asia for its various biological effects, but no studies have investigated the safety of its long-term intake. Therefore, the present study evaluated the safety of KRG intake for 24 weeks. Methods: We randomized 1,000 participants in a 1:1 ratio into two groups, which were treated daily with 2 g of KRG or a placebo for 24 weeks. The primary endpoint was all adverse events and adverse drug reactions (ADRs) that occurred after KRG or placebo administration, which were reported at week 4, 12, and 24 after the baseline visit. Results: In total, 192 and 211 participants experienced adverse events in the KRG and placebo groups (39.2% and 42.0%, respectively; p = 0.361), and 59 and 57 KRG- and placebo-treated individuals reported ADRs (12.0% and 11.4%, respectively; p = 0.737). The frequently occurring ADRs were pruritus (2.0%), headache (1.6%), diarrhea (1.4%), and dizziness (1.2%) in the KRG group and pruritus (2.0%), headache (1.8%), dizziness (1.6%), rash (1.4%), and diarrhea (1.2%) in the placebo group. Discontinuation of drug administration due to ADRs was reported in 13 participants, six (1.2%) and seven (1.4%) in the KRG and placebo groups, respectively (p = 0.814). No significant abnormal changes were revealed by anthropometric, laboratory, and vital sign measurements in the KRG group compared with those in the placebo group. Conclusion: The present study confirms the safety and tolerability of daily intake of 2 g of KRG for 24 weeks by healthy adults.