• 한방비만학회지
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• 제10권1호
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• pp.1-16
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• 2010

Objectives The clinical trial was designed to investigate the safety and effects of Bofu-tsusho-san extracts on the change of the weight, body compositions, serum in obese patients. Methods This study was a 4-weeks, double blind, comparative clinical trial. Eligible subjects had a body mass index(BMI) greater than $25\;kg/m^2$ and waist circumference(WC) longer than 85 cm in woman or 90 cm in man. Among 38 subjects, 36 subjects were randomized either to Bofu-tsusho-san or placebo. After 4 weeks of treatment, we measured anthropometric factors(weight, height, WC, BMI etc.), abdominal fat area by CT scanning, serum lipid(total cholesterol(TC), triglyceride(TG), HDL cholesterol, LDL cholesterol), blood level of variety(glucose, adiponectine, leptin, C-reactive protein(CRP) etc.), blood pressure(BP). Adverse events also evaluated. Results BMI, BP, TG, CRP were reduced and weight, WC, score of KOQOL(Korean version of obesity-related QOL scale), SRI(Stress response inventory) were significant changed in Bofu-tsusho-san. But there were no considerable difference between Bofu-tsusho-san and placebo. there were no serious adverse events in either group. Conclusion There were limitations in this study that it conducted within a short period of 4 weeks. but its weight and WC loss effect was significant and it had few adverse events.

• 대한한방내과학회지
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• 제29권3호
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• pp.778-786
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• 2008

Objectives : This study was to investigate the short time effect of caffeine on heart rate variability(HRV) and the effect of Neiguan(PC6) acupuncture stimulation on HRV. Methods : 27 healthy adult volunteers were randomly allocated to two groups: Neiguan group (N=13) or placebo group (N=14). The study was carried out under a randomized double-blinded placebo-controlled trial method. Each group orally received the same tablets with 200 mg caffeine. After 1 hour, acupuncture was applied to the Neiguan(PC6) points for the Neiguan group, and for the placebo group was applied to a non-acupuncture point. Both groups were estimated with HRV 3 times, before and after caffeine ingestion, 20 minutes after acupuncture stimulation. Results : After taking caffeine, pulse rate, mean-HRV, and pNN50(the proportion derived by dividing NN50 by the total number of NN intervals) decreased, SDNN(standard deviation of all normal-to-normal (NN) intervals), RMSSD (the root square of successive differences), TP log, HF(high frequency), and HRV index was increased. There were significant changes to the autonomic nervous system after taking caffeine. There were no significant differences between the two groups after acupuncture at Neiguan. Conclusion : Caffeine could induce general activation of the autonomic nervous system. Neiguan acupuncture stimulation may not have significant influence on the autonomic nervous system.

• Physical Therapy Rehabilitation Science
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• 제6권2호
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• pp.59-64
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• 2017

Objective: Elderly people with dementia experience not only cognitive dysfunction but also motor function deficits, such as balance and gait impairments. Recently, transcutaneous electrical nerve stimulation (TENS) has been used to reduce pain as well as to control muscle spasm, spasticity and motor performance in various types of subjects. The purpose of this study determined the effect of a single trial TENS on balance and gait function in elderly people with dementia. Design: A randomized controlled trial. Methods: Twenty-two subjects with dementia were assigned to the TENS group (n=12) and ten subjects were assigned to the control group (n=10) randomly. Subjects were classified into two groups: the TENS group (n=12) and the placebo-TENS group (n=10). The TENS group had electrical stimulation applied on the calf muscle for 15 minutes, while the placebo-TENS group had not received real electrical stimulation. The timed up and go test (TUG) and functional reach test (FRT) were used to measure the balance function, and the 10 meters walk test (MWT) and 6MWT were used to assess gait ability. All tests were performed before and after intervention under a single-blinded condition. Results: After intervention, there were significant improvements in TUG, FRT, 10MWT, and 6MWT results in the TENS group (p<0.05), while the placebo-TENS group did not show significant changes in all outcome measurements. There were also differences in all tests between the two groups at post-measurements (p<0.05). Conclusions: This study demonstrated that a single trial TENS application on the calf may be used to improve balance and gait function in elderly people with dementia.

• Journal of Ginseng Research
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• 제45권1호
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• pp.191-198
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• 2021

Background: Most clinical studies of immune responses activated by Korean Red Ginseng (KRG) have been conducted exclusively in patients. However, there is still a lack of clinical research on immune-boosting benefits of KRG for healthy persons. This study aims to confirm how KRG boosts the immune system of healthy subjects. Methods: A total of 100 healthy adult subjects were randomly divided into two groups that took either a 2 g KRG tablet or a placebo per day for 8 weeks. The primary efficacy evaluation variables included changes in T cells, B cells, and white blood cells (WBCs) before and after eight weeks of KRG ingestion. Cytokines (TNF-α, INF-γ, IL-2 and IL-4), WBC differential count, and incidence of colds were measured in the secondary efficacy evaluation variables. Safety evaluation variables were used to identify changes in laboratory test results that incorporated adverse reactions, vital signs, hematological tests, blood chemistry tests, and urinalysis. Results: Compared to the placebo group, the KRG intake group showed a significant increase in the number of T cells (CD3) and its subtypes (CD4 and CD8), B cells, and the WBC count before and after eight weeks of the intake. There were no clinically significant adverse reactions or other notable results in the safety evaluation factors observed. Conclusion: This study has proven through its eight-week intake test and subsequent analysis that KRG boosts the immune system through an increase in T cells, B cells, and WBCs, and that it is safe according to the study's safety evaluation.

• Journal of Nutrition and Health
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• 제55권4호
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• pp.450-461
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• 2022

Purpose: DNA damage and repair responses are induced by metabolic diseases and environmental stress. The balance of DNA repair response and the antioxidant system play a role in modulating the entire body's health. This study uses a high-fat and high-calorie (HFC) drink to examine the new roles of a plant-based multivitamin/mineral supplement with phytonutrients (PMP) for regulating the antioxidant system and cellular DNA repair signaling in the body resulting from metabolic stress. Methods: In a double-blind, randomized, parallel-arm, and placebo-controlled trial, healthy adults received a capsule containing either a PMP supplement (n = 12) or a placebo control (n = 12) for 8 weeks. Fasting blood samples were collected at 0, 1, and 3 hours after consuming a HFC drink (900 kcal). The blood samples were analyzed for the following oxidative stress makers: areas under the curve reactive oxygen species (ROS) levels, plasma malondialdehyde (MDA), erythrocytes MDA, urinary MDA, oxidized low-density lipoprotein, and the glutathione:oxidized glutathione ratio at the time points. We further examined the related protein levels of DNA repair signaling (pCHK1 (Serine 345), p-P53 (Serine 15), and 𝛄H2AX expression) in the plasma of subjects to evaluate the time-dependent effects of a HFC drink. Results: In a previous study, we showed that PMP supplementation for eight weeks reduces the ROS and endogenous DNA damage in human blood plasma. Results of the current study further show that PMP supplementation is significantly correlated with antioxidant defense. Compared to the placebo samples, the blood plasma obtained after PMP supplementation showed enhanced DNA damage response genes such as pCHK1(Serine 345) (a transducer of DNA response) and 𝛄H2AX (a hallmark of DNA damage) during the 8 weeks trial on metabolic challenges. Conclusion: Our results indicate that PMP supplementation for 8 weeks enhances the antioxidant system against oxidative stress and prevents DNA damage signaling in humans.

• 한국임상약학회지
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• 제15권1호
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• pp.9-20
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• 2005

Cholestatic liver disease is a frequent complication of prolonged parenteral nutrition, especially in premature infants. Numerous factors have been cited as contributing to TPN associated cholestasis. However the exact etiology remains obscure. Ursodeoxycholic acid (UDCA) has been reported to be beneficial far children and adults with various chronic cholestatic liver disease. The aim of this prospective, randomized, double-blind, placebo-controlled study was to determine the preventive effects of UDCA administration during TPN. Seventeen pediatric patients (8 boys and 9 girls) undergoing TPN were assigned randomly to two groups, UDCA and placebo group. UDCA group (n=9) received 15 mg/kg/day UDCA and placebo group (n=8) received 15 mg/kg/day placebo enterally during the TPN period. Liver function tests (total bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase) were per-formed before TPN and weekly or three times a week. The patients' weights, complete blood count, composition of TPN, and the infusion rate of TPN and lipid were monitored everyday. Calcium and phosphate were monitored twice a week. Between the UDCA and placebo groups, there were no differences in weight at the onset of TPN, birth weight, duration of TPN, respiratory distress syndrome associated with prematurity, age at the onset of TPN, gestational age, the number of days the patients received antibiotics, the number of patients received enteral nutritions and the composition of TPN. In contrast, there was a significant difference between the UDCA and placebo groups in alanine aminotransferase levels during TPN. It doesn't seem that UDCA administration during TPN correlates directly with improvement of liver function. But the preventive administration of UDCA may be effective in reducing liver enzyme, alanine aminotransferase and has no adverse effects.

• Journal of Periodontal and Implant Science
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• 제30권1호
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• pp.1-11
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• 2000

Although various analgesics have been administrated for postoperative pain control, postoperative pain has not been adequately controlled . The purpose of this study was to evaluate the effects and patient's satisfaction of $Myprodol^{(R)}$(combination analgesics with codeine, ibuprofen, paracetamol) compared to Acetamionphen and placebo drug after periodontal surgery and dental implant surgery. We studied 98 cases of outpatients which were composed of 67 cases of flap operation(which separated to 3 groups: Placebo group(n=25), $Myprodol^{(R)}$ group(n=22), Acetaminophen group(n=20)) and 21 cases of dental implant surgery(which separated to 3 groups : Placebo group(n=10), $Myprodol^{(R)}$ group(n=12), Acetaminophen group(n=9)). We evaluated the postoperative pain(Pain 1), Pain after first drug administraion(Pain 2), the degrees of pain reduction(pain 3), patient's satisfaction for drug, and side-effects. We obtained following results; 1. In Pain 1, making a comparison among groups, there was no significant difference in both cases of flap operation-group and dental implant surgery-group 2. In Pain 2, establishing a comparison among groups, there was no significant difference in flap operation-group, but significant difference was seen between placebo group and $Myprodol^{(R)}$ group in cases of dental implant surgery group(P<0.05). 3. In Pain 3, making a comparison among groups, $Myprodol^{(R)}$ group showed significant differences compared to placebo group and Acetaminophen group in both cases of flap operation group and dental implant surgery group(P<0.05). 4. In patient's satisfactory score, making a comparison among groups, there were significant differences between placebo group and $Myprodol^{(R)}$ group in cases of flap operation group and between $Myprodol^{(R)}$ group and Acetaminophen group in cases of dental implant surgery group(P<0.05). 5. Making a comparison in side-dffect, no significant differrence was seen. Our conclusion is that $Myprodol^{(R)}$ is a effective oral analgesics to the patients who underwent periodontal surgery or implant surgery for it's synergism among three dugs.

• The Korean journal of internal medicine
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• 제33권6호
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• pp.1224-1233
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• 2018

Background/Aims: The objective of this study was to determine the efficacy and safety of add-on therapy with certolizumab pegol (CZP) in active rheumatoid arthritis (RA) patients of a single ethnicity. Methods: In this 24-week, phase 3, randomized, double-blind, placebo-controlled trial, eligible patients (n = 127) were randomized 2:1 to subcutaneous CZP + methotrexate (MTX; 400 mg at week 0, 2, and 4 followed by 200 mg every 2 weeks) or placebo + MTX. Results: At week 24, the American College of Rheumatology criteria for 20% (ACR20) response rate was significantly greater with CZP + MTX than with placebo (66.7% vs. 27.5%, p < 0.001). Differences in ACR20 response rates for CZP vs. placebo were significant from week 1 (p < 0.05) and remained significant through week 24. The CZP group reported significant improvement in physical function and disability compared to the placebo group (p < 0.001) at week 24, as assessed by Korean Health Assessment Questionnaire-Disability Index (KHAQ-DI). Post hoc analysis indicated that the proportion of patients who had ACR70 responses, Disease Activity Score 28 (DAS28) low disease activity, and DAS28 remission at week 24 was greater in CZP + MTX-treated patients who achieved a decrease in DAS28 ${\geq}1.2$ (43.8%) at week 4 than in nonresponders. Among 18 (22.2%) and 14 patients (35.0%) in CZP and placebo groups who had latent tuberculosis (TB), none developed active TB. Most adverse events were mild or moderate. Conclusions: CZP treatment combined with MTX in active RA patients with moderate to severe disease activity and an inadequate response to MTX resulted in rapid onset of efficacy, which is associated with better clinical outcome at week 24 and has an acceptable safety profile, especially in an intermediate TB-burden population.

• 대한한의학회지
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• 제26권2호
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• pp.95-104
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• 2005

Objectives: This was a double blinded, randomized, placebo-controlled clinical study for evaluation of safety and effective dose finding of Cardiotonic Pills$^{(R)}$ in patients with chest pain and discomfort. Cardiotonic Pills$^{(R)}$ are composed of Salviae Miltiorrhizae Radix (丹蔘), Notoginseng Radix (三七根) and Borneolum (龍腦). Major effects of Salviae Miltiorrhizae Radix and Notoginseng Radix are vasodilatation, sedation and analgesic action. Borneolum has an antibacterial effect, and can stimulate the central nervous system. All of these substances are oriental herbs that have been used for a long time in east Asia. Cardiotonic Pills fi received Investigational New Drug (IND) approval from the Food and Drug Administration (FDA) in the USA and 40 million people in the world take this pill. We performed a phase IV clinical study to confirm its efficacy and safety in patients who have probable cardiogenic or psychogenic chest pain or chest stifling. Methods: This study was planned for a multi-center clinical trial including four university hospitals of oriental medicine in Korea. This was the first time to evaluate the 'planning treatment according to diagnosis (辨證施治)' of chest pain or chest discomfort according to oriental medical guidelines. The patients who were included in this trial were adult volunteers from 20 to 70 years old who had chest pain or chest discomfort more than twice during a recent month, and we received written consent to participate in this study from all of them. After administration of Cardiotonic Pills$^{(R)}$ for 8 weeks, number of occurrences, duration, appearance and degree of chest pain or chest discomfort was observed and degree of symptoms (severity of illness, global improvement) were measured using a patient's global assessment composite scale. Results: In the patient's global assessment scale, the severity of illness of the Cardiotonic Pills$^{(R)}$ group (n=25) was 14/25=0.56 but of the placebo group (n=25) was 7/25=0.28 (p-value=0.0449). This result indicates Cardiotonic Pills$^{(R)}$have a positive effect on the symptoms of chest pain and discomfort. However, the global improvement of the Cardiotonic Pills$^{(R)}$group was 23/25=0.92, and of the placebo group was 22/25=0.88 (p-value=0.6374). The total symptom score of the Cardiotonic Pills$^{(R)}$ group was $1.68\pm20.06$, and of the placebo group was $16.76\pm72.l4$(p-value=0.2285). The number of symptom events of the Cardiotonic Pills$^{(R)}$ group was $72\pm29.78$, and of the placebo group (n=25) was $10.80\pm38.42$ (p­value=0.3660). We could not find any effects on the other factors examined besides the severity of illness, beyond the difference of standard deviations. Conclusions: Cardiotonic Pills$^{(R)}$ significantly reduced chest pain and chest discomfort in patients. Therefore, we expect that Cardiotonic Pills$^{(R)}$ will be helpful for patients with chest pain and chest discomfort not only caused by heart disease but also by other diseases.

• 한국식품위생안전성학회:학술대회논문집
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• 한국식품위생안전성학회 2004년도 추계심포지움 및 학술발표회 : 건강기능식품의 안전성 평가와 개발
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• pp.50-58
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• 2004

성인을 대상으로 펩타이드의 강압효과를 검토하기 위해, 경증고혈압증군(輕症高血壓症群) (평균연령 50.2${\pm}$5.6세, 남9명, 여1명) 및 정상고혈압군 (평균연령 47.7${\pm}$2.8세, 남9명) 에 있어서, 플라시보를 이용한 2중맹검법(2重盲檢法)에 따른 비교대조시험을 실시했다. 경증고혈압증군에서는 Valy-Tyrosine(VY) 환산으로 125${\mu}$g/day의 '펩타이드 음료'에 의해 혈압 저하의 경향이 확인되었고 VY 환산250${\mu}$g/day의 펩타이드 음용량으로 플라시보군에 비해서 유의한 강압이 확인되었다. (음용개시 4주후에서 수축기혈압 17.8${\pm}$2.5mmHg: p <0.01, 확장기혈압 11.0${\pm}$2.0mmHg: p (0.05). 정상고치혈압군(正常高値血壓群)에서는 유의한 혈압강하를 확인하지 못했다. 양 군(群)에서 공히 심박수의 변화는 없었다. 경증고혈압군 (평균연령 50.6${\pm}$4.6세, 남10명) 에 있어서 VY 125${\mu}$g/day의 음용량에서는 전후기 각 4주간의 비교대조교차실험을 했다. 펩타이드 전기 음용군(0-4주)에서는, 음용개시 1주후에 수축기 · 확장기 혈압 모두 유의한 혈압저하작용이 확인되었다. (수축기혈압의 변화율-6.9%, 확장기혈압의 변화율-5.8%, p <0.05) 펩타이드 후기 음용군(10-14주)에서는, 수축기혈압이 음용개시 3주후(변화율-6.7%, p <0.05)에, 확장기혈압이 음용개시 2주후(변화율 6.0%, p <0.05)에 각각 유의한 강압이 확인되었다. 양 군 모두 음용 중지 후에 혈압의 완만한 복귀가 관찰되었다. 전 대상자에 있어서 자각증상, 타각소견(他覺所見)과 함께 이상(異常)은 확인되지 않았으며 부작용도 없었다. 이상의 결과로부터, ‘펩타이드 음료’는 경증고혈압 혹은 경계역고혈압자(境界域高血壓者)의 혈압을, 자각증상 및 혈액${\cdot}$뇨검사에도 전혀 영향을 미치지 않고 저하시킨다고 결론지었다.