• 대한한방소아과학회지
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• 제35권2호
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• pp.11-20
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• 2021

Objectives The purpose of the study is to evaluate the safety of the Allium Fistulosum extract in children and its effectiveness in height growth. Methods This study is randomized, double-blind, placebo-controlled trial. The participants are children between the 3rd and 25th percentiles in height, and between the ages of 5 and 12 years. They are randomly assigned to treatment group or control group. The treatment group will take 5 g (1 g as Allium Fistulosum extract) for 24 weeks, 1 time a day. The control group will take the 5 g (0 g as Allium Fistulosum extract) of placebo for 24 weeks, 1 time a day. The primary outcome is change in height, and the secondary outcomes are growth rate, height standard deviations, Insulin-like growth factor-1 (IGF-1), Insulin-like growth factor binding protein-3 (IGFBP-3), IGF1-1/IGFBP-3 ratio, growth hormone, bone age, osteocalcin, and Z-score for growth. Results This protocol has been approved by the institutional review board (IRB) of Daejeon Korean Medicine Hospital of Daejeon University (IRB No. DJDSKH-20-BM-15), and registered in the Clinical Research Information Service (CRIS) (Registry No. KCT0005981). Conclusions This study will provide clinical information about the effectiveness and safety of Allium Fistulosum extract in children for their growth.

• 대한한의학회지
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• 제28권1호통권69호
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• pp.105-116
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• 2007

Objectives : Mahuang (Ephedra sinica), well known as an herbal medicine in the East and West, contains a relatively high percentage of ephedrine known as sympathomimetic alkaloid. We investigated the effects of Mahuang on sympathetic nervous system with heart rate variety (HRV). Time and frequency domain analysis of HRV is a noninvasive technique capable of providing information on autonomic modulation of the sinus node. Methods : We investigated 57 healthy volunteers consisting of 37 subjects in the Mahuang group and 20 subjects in the placebo group. Study form was a randomized, placebo-controlled, double-blind clinical trial. The 37 subjects in the Mahuang group took 3 Mahuang capsules (1 capsule equivalent to 2g herb Mahuang) twice a day at 10 a.m. and 2 p.,., while the 20 subjects in the placebo group took 3 placebo-capsules filled with glutinous rice powder at the same times. Mahuang medicine and placebo medicine were made into opaque capsules. We measured HRV at 3 p.m. 1 or 2 days before medication and at 3 p.m. after medication. Results : Mean-RR and SDNN of the Mahuang group significantly decreased compared with that of the placebo group, but the heart rate of the Mahuang group significantly increased compared with the placebo. HRV-Index, RMSSD and SDSD of the Mahuang group significantly decreased compared with that of the placebo group, but PNN50 of the Mahuang group significantly increased compared with placebo. Ln(TP), Ln(VLF), Ln(LF) and Ln(HF) of the Mahuang group significantly decreased compared with those of the placebo group. There were no significant differences in normalized LF, normalized HF and LF/HF ratio between the Mahuang and placebo groups. Conclusion : The results suggest that Mahuang in healthy adults tends to reduce the autonomic nervous system within the normal range.

• 약학회지
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• 제37권5호
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• pp.442-452
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• 1993

Previous experimental and clinical investigations suggest a possible role of new nootropic drug, oxiracetam, in improving cognitive performances in patients affected by organic brain syndrome. In this study, the cognitive and behavioral effects of oxiracetam treatment in patients with clinical symptoms of organic brain syndrome were evaluated. Sixty-six patients were enrolled and assigned to either oxiracetam or placebo, according to a randomized, double-blind design between two patient-groups. Either oxiracetam or placebo was orally given bid for 8 weeks ; daily dose of oxiracetam was 1600mg. All the patients, enrolled in this study, were diagnosed as having mild to moderate cognitive dysfunction as defined by a baseline Mini Mental State ExaminationKorean version (MMSE-K) score between 14 and 25. The patients under-went, at baseline, 4 weeks and 8 weeks after, routine laboratory study (CBC, SMA12, U/A, EKG) and the following neuropsychological tests ; MMSE-K, modified Korean Wechsler Intelligence Scale(MKWIS), Nurses' Observation Scale for Geriatric patients(NOSGER). Fifteen patients of whom were dropped out or excluded from the analysis because of poor compliance or violation of the protocol. Fiftyone patients (aged 54~78 years, male 25, female 26) were analyzed (vascular dementia, 30 ; senile dementia of Alzheimer type, 9 ; mixed type, 5 ; other cause, 7). Statistical analysis of the data demonstrated that the two groups were comparable at baseline. At the end of each study period the oxiracetam group scored significantly better on the majority of the tests evaluating cognitive function, psychometricity and the improvement rating scale of subjective symptoms than placebo group, in which worsening trends or no changes were seen on the whole. No side effects were noted during oxiracetam treatment. The present study, showing positive clinical findings after oxiracetam therapy, confirmed that this drug can be useful pharmacological treatment in organic brain syndrome.

• Journal of the Korean Academy of Child and Adolescent Psychiatry
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• 제2권1호
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• pp.87-96
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• 1991

자폐증의 임상증상 완화에 대한 Carbamazepine의 효과를 평가하기 위하여 위약으로 대조한 이중맹(placebo controlled double blind) 연구를 실시하였다. 연구대상 아동은 1989년 10월부터 1991년 11월까지 서울대학병원 어린이병원 소아정신과 외래를 방문한, DSM-III-R의 전반적 발달장애의 진단기준을 만족시키면서, 부모가 연구에 동의한 23명의 남아로 하였다. 또한 다른 내과적 혹은 정신과적 질환력을 갖지 않으며, 연구 시작전 적어도 2개월이상의 약물복용이 없는 기간을 갖도록 하였다. 연구 대상군의 Cabamazepine치료군과 위약군으로 할당을 무작위적 할당표에 의해 할당하였는데, 각각 12명, 11명이 해당되었다. 연구 대상 아동의 상태를 모르는(blind) 2명의 평가자에 의하여, 기초관찰 기간과 12주의 약물치료 기간후에 측정한 검사도구의 측정값의 변화와 약물에 대한 부작용을 보았다. 두 검사자간의 신뢰도는 .4875-.6613이었다. 기초 관찰기간시 두군사이의 사회 인구학적 변인 및 검사도구의 값은 유의한 차이가 없었다. 약물 치료 기간 종결시 측정한 검사도구의 값과 기초 관찰기간의 값을 비교한 결과, Autism Behavior Checklist상 전체 점수의 유의한 차이(P<.05), 즉 Carbamazepine치료군이 위약군보다 자폐증 증상의 완화정도가 큰 소견을 보였다. Vineland Social Maturation Scale에서는 두군 모두에서 약물 치료 기간동안 사회성숙도상의 발달이 유의한 정도(P<.005)로 있었다.

• International Journal of Contents
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• 제7권2호
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• pp.59-63
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• 2011

The aim of our study was to evaluate the immediate effects of an 830-nm Aluminium gallium arsenide (GaAlAs) laser, by examining the changes, in pressure-pain threshold (PPT) and tenderness at 3 kg of the myofascial trigger point (MTrP) of the upper trapezius muscle in visual display terminal (VDT) workers in comparison with placebo treatment. Thirty VDT workers (13 males, 17 females) with complaints of upper trapezius muscle were recruited. All participants were given either active GaAlAs laser (830 nm wavelength, 450 mW, 9 J at point) or placebo GaAlAs laser, according to the double-blinded and placebo-controlled trial. Both active and placebo low-level laser therapy (LLLT) treatments showed no significant effect on PPT and tenderness at 3 kg. These results suggest that a higher dosage may be necessary to produce immediate effects when applying LLLT to the MTrP of relatively large muscles such as the upper trapezius muscle.

• 한방재활의학과학회지
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• 제30권1호
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• pp.105-113
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• 2020

Objectives Excess weight and obesity are a crucial public health problem worldwide and are considered as the main cause of many chronic diseases. The present study evaluated the effects of Aronia melanocarpa extract (AMEX) supplementation on body compositions in overweight or obese people. Methods This randomized, double-blind, placebo-controlled clinical trial was carried out on 66 healthy overweight or obese peoples. The eligible subjects were divided into AMEX and placebo supplement treatment for 12 weeks. Anthropometrics, body composition (dual-energy X-ray absorptiometry), and blood analysis were performed preand post intervention. Results We observed significant reductions in the body weight and body mass index in both groups; however, the decrease was higher in the AMEX group. Body fat mass and percent body fat showed a tendency to decreases after AMEX supplementation. No clinically significant changes were observed for any safety parameter. Conclusions In conclusion, the data of this trial indicate that AMEX were not effective in reducing body compositions, but as a safe supplement, it may help weight loss in overweight or obese people.

• Journal of Periodontal and Implant Science
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• 제46권1호
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• pp.46-56
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• 2016

Purpose: We evaluated the efficacy of a mouthwash containing potassium nitrate ($KNO_3$) as its main component, along with sodium fluoride (NaF) and cetylpyridinium chloride (CPC). The primary endpoint was the relief of dentin hypersensitivity (DH) against the cold stimuli. The effects on other DH tests and periodontal inflammation were also evaluated. Methods: We used a single-center, double-blind, placebo-controlled, randomized design. A total of 82 patients with DH (40 in the test group, 42 placebo controls) were analyzed using visual analog scales (VASs) for a cold test, a tactile test, a compressive air test, and self-reported pain during daily activities, as well as clinical parameters including plaque index, gingival index, modified sulcular bleeding index (mSBI), gingival recession, and probing depth, which were collected at baseline and after four and six weeks of mouthwash use. Results: VAS scores for cold sensations, tactile sensations, the compressive air test, and self-reported pain significantly decreased from baseline during the six weeks in both groups (P<0.01), and no significant differences between the groups were found. In male patients (10 in the test group and 7 in the control group), both groups showed significant reductions in VAS scores for the cold test over the six weeks, and greater reductions were found in the test group than in the control group between four and six weeks (P=0.01) and between baseline and six weeks (P<0.01). In addition, the mSBI in the test group significantly decreased from baseline during the six weeks (P<0.01), and the changes at four and six weeks from baseline were significantly greater in the test group compared to the control group (P=0.03 and P=0.02, respectively). Conclusions: A mouthwash containing a mixture of $KNO_3$, NaF, and CPC reduced DH and gingival inflammation, however, the efficacy was comparable to the control group.

• Journal of the Korean Association of Oral and Maxillofacial Surgeons
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• 제34권2호
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• pp.157-165
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• 2008

The aim of this study was to evaluate the efficacy of a topical 0.2% hyaluronic acid (HA) preparation in the management of wound after removal of arch bar for facial bone fracture and a suture site after orthognatic, oral cancer or oral surgery. Forty patients participated in a randomized, placebo controlled, double-blind trial to evaluate the efficacy of the topical HA and preparation. HA topically applied to the wound after removal of arch bar or stitch out, 3 times a day for 4 weeks. Evaluation is performed once a week for 4 weeks. For subjective evaluation, relative pain reduction in visual analog scale (VAS) and existence of heat sensation was accessed. For objective evaluation, gross evaluation, papilla index, existence of wound dehiscence, redness and swelling was checked. The same evaluation was performed in each arch bar group and suture group. For whole subject, 0.2% HA group resulted higher reduction than placebo group in pain of site in first week with significancy. Same findings were seen other weeks but there was no significancy. 0.2% HA group had better result than placebo in objective evaluation (papilla index, wound dehiscence, redness and swelling), but in gross evaluation placebo had better result than 0.2% HA group with no significancy. Subject was divided into suture group and arch bar group. Same aspect was seen, but only suture group had significancy not arch bar group in pain reduction score. 0.2% HA group resulted higher reduction than placebo group in pain of site in first week with significancy, especially in suture group. It reveals topical application of HA in wound especially suture site reduced pain in early stage. And 0.2% HA group had better result than placebo in papilla index, redness and swelling with no statistical significancy. In conclusion, HA has effect of pain reduction and healing promotion in the mucosal wound after oral surgery.

• Nutrition Research and Practice
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• 제11권4호
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• pp.290-299
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• 2017

BACKGROUND/OBJECTIVES: Spirulina is a known a functional food related to lipid profiles, immune functions, and antioxidant capacity. Circulating monocyte chemoattractant protein-1 (MCP-1) level is associated with inflammation markers. Single nucleotide polymorphism in the MCP-1 promoter region -2518 have been identified and shown to affect gene transcription. Gene variation may also impact functional food supplementary effects. The current study investigated the interaction of MCP-1 -2518 polymorphism with spirulina supplements on anti-inflammatory capacity in Korean elderly. SUBJECTS/METHODS: After genotyping, healthy elderly subjects (n = 78) were included in a randomized, double blind, and placebo controlled study. Baseline characteristic, body composition, and dietary intake were measured twice (baseline vs. week 16). For 16 weeks, subjects consumed 8 g either spirulina or placebo daily. Plasma MCP-1, interleukin (IL) -2, IL-6, tumor necrosis factor (TNF)-${\alpha}$, complement (C) 3, immunoglobulin (Ig) G, and Ig A concentrations and lymphocyte proliferation rate (LPR) were analyzed as inflammatory markers. RESULTS: In the placebo group with A/A genotype, MCP-1 level was significantly increased, but the spirulina group with A/A genotype was unchanged. IL-2 was significantly increased only in subjects with spirulina supplementation. TNF-${\alpha}$ was significantly reduced in subjects with the G carrier. C3 was significantly increased in the placebo group, particularly when A/A increased more than G, but not when spirulina was ingested. LPR was significantly different only in subjects with A/A genotype; there was a significant increase in phytohemagglutinin and lipopolysaccharide induced LPR in the spirulina group. CONCLUSION: In healthy Korean elderly, spirulina supplementation may influence different inflammatory markers by the MCP-1 genotype. These results may be useful for customized dietary guidelines to improve immune function in Koreans.

• Journal of Gastric Cancer
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• 제17권2호
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• pp.120-131
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• 2017

Purpose: Tumor bleeding is a major complication in inoperable gastric cancer. The study aim was to investigate the effects of proton pump inhibitor (PPI) treatment for the prevention of gastric tumor bleeding. Materials and Methods: This study was a prospective double-blind, randomized, placebo-controlled trial. Patients with inoperable gastric cancer were randomly assigned to receive oral lansoprazole (30 mg) or placebo daily. The primary endpoint was the occurrence of tumor bleeding, and the secondary endpoints were transfusion requirement and overall survival (OS). Results: This study initially planned to enroll 394 patients, but prematurely ended due to low recruitment rate. Overall, 127 patients were included in the analyses: 64 in the lansoprazole group and 63 in the placebo group. During the median follow-up of 6.4 months, tumor bleeding rates were 7.8% and 9.5%, in the lansoprazole and placebo groups, respectively, with the cumulative bleeding incidence not statistically different between the groups (P=0.515, Gray's test). However, during the initial 4 months, 4 placebo-treated patients developed tumor bleeding, whereas there were no bleeding events in the lansoprazole-treated patients (P=0.041, Gray's test). There was no difference in the proportion of patients who required transfusion between the groups. The OS between the lansoprazole (11.7 months) and the placebo (11.0 months) groups was not statistically different (P=0.610). Study drug-related serious adverse event or bleeding-related death did not occur. Conclusions: Treating patients with inoperable gastric cancer with lansoprazole did not significantly reduce the incidence of tumor bleeding. However, further studies are needed to evaluate whether lansoprazole can prevent tumor bleeding during earlier phases of chemotherapy (ClinicalTrial.gov, identifier No. NCT02150447).