• Journal of Korean Medicine for Obesity Research
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• v.11 no.1
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• pp.1-14
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• 2011

Objectives This trial was conducted to evaluate the efficacy of Red Ginseng by oriental medical obesity syndrome differentiation on obese women as compared to placebo. Methods 50 obese women were recruited and randomized to receive Korean Red Ginseng(n=24) or placebo(n=26) for 8 weeks. Anthropometric factors, serum lipid, glucose, blood pressure, pulse rate, resting metabolic rate, Korean version of obesity-related quality of life(KOQOL) scale and oriental medical obesity syndrome differentiation questionnaire were measured at baseline and 8 weeks. Adeverse events and safety outcomes variables were also checked during trials. Results and Conclusion There was significant efficacy of Red Ginseng on obese women in body weight, body fat mass, waist-hip ratio, food intake, KOQOL as compared with baseline. But there was no efficacy as compared with placebo group except KOQOL. There was no difference of efficacy compared with the oriental medical obesity syndrome differentiation.

• Journal of Nutrition and Health
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• v.36 no.9
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• pp.918-923
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• 2003

L-theanine Is an amino acid in green tea and has been known to decrease serotonin and increase norepinephrine in rat brains, and also reported to produce mental relaxation, lower blood pressure and improve learning ability in human beings. But, few studies on these effects for human beings have been conducted so far. This study was conducted to evaluate the effect of L-theanine on the release of brain alpha waves known to be related with mental relaxation and concentration. Twenty healthy male volunteers aged 18 to 30 years without any Physical and Psychological diseases were recruited through written advertisement. Alpha power values of EEG as a surrogate marker of mental relaxation and concentration were measured in frontal and occipital regions for 40 minutes after administration of four placebo or test tablets and 20 minute resting period. The same procedure crossed over at 7-day intervals. We analyzed average alpha power values in frontal and occipital regions at 10 minute intervals. Repeated ANOVA revealed that there were significant differences of occipital alpha power values between placebo and test groups with high anxiety (p < 0.05). The mean values at 20,30,40,50 and 60 minute intervals were 0.23, 024, 0.28, 0.25 and 0.34 in placebo, respectively and 0.23, 0.29, 0.40, 0.34, and 0.45 in test, respectively. But there were no significant differences of frontal and occipital alpha power values between placebo and test groups with low anxiety (p > 0.05) . The results of this study suggest that L-theanine containing tablets promote the release of alpha waves related to mental relaxation and concentration in young adult males.

• Biomedical Science Letters
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• v.17 no.3
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• pp.245-251
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• 2011

This study was conducted to investigate the effect of soybean peptide on muscle damage index and hormone (testosterone and cortisol) concentration. Subjects of this study were 23 high school male taekwondo players who had participated in regular exercise. They were randomly divided into two groups, one group took soybean peptide (S-peptide, n=13) 4 g a day for 4 weeks and the other took placebo (placebo, n=10) for the same time. We obtained blood samples before and after experiment and analyzed for CPK (Creatine phosphokinase), LDH (Lactate dehydrogenase), ALD (Aldolase), myoglobin, testosterone and cortisol. As for body composition, there was no significant difference in weight, body fat rate and LBM (lean body mass) between the S-peptide and the S-peptide group and placebo group. In CPK, LDH, ALD and myoglobin, S-peptide group was significantly lower than the placebo group and showed significant decrease before and after intaking soybean peptide (P<0.05~0.01). In the concentration of plasma testosterone, S-peptide group was increased from two weeks but not significant difference. The concentration of plasma cortisol showed significantly decrease in the S-peptide (P<0.01). These results indicate that the intake of soybean peptide have positive effect on index of muscle damage and changes of hormone concentration.

• Nutrition Research and Practice
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• v.9 no.4
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• pp.393-399
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• 2015

BACKGROUND/OBJECTIVES: Thin children may have insufficient intake of energy and nutrients, resulting in reduced immune function and growth. This study aimed to identify the effects of multiple herb formula SEC-22 supplementation on growth, dietary changes, and picky eating behaviors in thin children. SUBJECTS/METHODS: A double-blind, randomized clinical trial was conducted on 79 children aged 2-5 years with poor appetites, BMI percentile < 25, and without any illness. Subjects were given either SEC-22 (n = 35) or placebo (n = 44) for 2 months and followed for an additional 2 months. Three-day dietary records, questionnaires on picky eating behaviors, and anthropometric measures were collected. RESULTS: Energy, carbohydrate intake, and feeding difficulty improved in both groups during the intervention period. However, changes were maintained only in the SEC-22 group after 2 months of follow-up post-supplementation. 'Frequency of trying to feed' was improved in the SEC-22 group compared to the placebo group after the first month of follow-up (P < 0.05). Intakes of potassium and thiamine were improved in the SEC-22 group compared to the placebo group after the first month of intervention (P < 0.05). 'Frequency of food reward', eating amount, and intakes of carbohydrate, potassium, and vitamin C showed significant improvement compared to the placebo group after the second month of follow-up (P < 0.05). CONCLUSIONS: These results suggest that SEC-22 supplementation can improve parental feeding difficulty resulting from insufficient eating amount or picky eating as well as increase nutrient intake in thin children. Although these improvements were observable at least 2 months after supplementation, effects beyond this time frame need to be confirmed.

• Journal of Sasang Constitutional Medicine
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• v.30 no.2
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• pp.42-54
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• 2018

Objectives This study was aimed to compare effects of Yukgunja-tang (YGJT) extract granule on functional dyspepsia (FD) by sasang constitution. Methods A placebo-controlled, double-blind, randomized, two-center trial was performed. We obtained 3D face images of FD patients participating in this study using face-only scanner and classified them into two types as narrow face and wide face by 3D facial shape diagnosis system (3-FSDS). 96 subjects (48 subjects per type) were enrolled and were randomly allocated into treatment or control groups in a 2:1 ratio. YGJT extract granule or placebo were administered to each group during the 8 week treatment period. One of sasang constitutional specialist diagnosed their constitutions by referring to questionnaires and 3D face images. The primary outcome was total dyspepsia symptom scale (TDS scale), the secondary outcomes were single dyspepsia symptom scale (SDS scale), visual analog scale (VAS) and so on. This trial was registered with clinical research information service identifier: KCT0001920, 15 May, 2016. Results In the Taeeumin treatment group, the TDS scale was significantly decreased after 8 weeks compared to the control group (t=2.331, p=0.025) and the SDS scale also significantly decreased. (t=2.042, p=0.048). The specific effects of the YGJT extract granule without the placebo effect on the Taeeumin with functional dyspepsia were 30.61% in TDS scale and 28.33% in SDS scale. Conclusions The effects of Yukgunja-tang extract granule on functional dyspepsia was different according to Sasang constitution. So the constitution should be considered in randomized controlled trials using herbal extract granules.

• Tuberculosis and Respiratory Diseases
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• v.80 no.3
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• pp.265-269
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• 2017

Background: The first line of anti-tuberculosis (TB) drugs are the most effective standard of drugs for TB. However, the use of these drugs is associated with hepatotoxicity. Silymarin has protective effects against hepatotoxicity of anti-TB drugs in animal models. This study aims to investigate the protective effect of silymarin on hepatotoxicity caused by anti-TB drugs. Methods: This is a prospective, randomized, double-blind and placebo-controlled study. Patients were eligible if they were 20 years of age or order and started the first-line anti-tuberculosis drugs. Eligible patients were randomized for receiving silymarin or a placebo for the first 4 weeks. The primary outcome was the proportion of patients who showed elevated serum liver enzymes more than 3 times the upper normal limit (UNL) or total bilirubin (TBil) > $2{\times}UNL$ within the first 8 weeks of anti-TB treatment. Results: We enrolled a total of 121 patients who silymarin or a placebo to start their anti-TB treatment, for the first 8 weeks. The proportions of elevated serum liver enzymes more than 3 times of UNL at week 2, week 4, and week 8 did not show any significant difference between the silymarin and placebo groups, at 0% versus 3.6% (p>0.999); 4.4% versus 3.6% (p>0.999); and 8.7% versus 10.8% (p=0.630), respectively. However, patients with TBil >$2{\times}UNL$ at week 8 were significantly low in the silymarin group (0% versus 8.7%, p=0.043). Conclusion: Our findings did not show silymarin had any significant preventive effect on the hepatotoxicity of anti-TB drugs.

• YAKHAK HOEJI
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• v.37 no.5
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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 Ginseng Research
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• v.42 no.1
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• pp.90-97
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• 2018

Background: Antihyperglycemic effects of Panax ginseng berry have never been explored in humans. The aims of this study were to assess the efficacy and safety of a 12-wk treatment with ginseng berry extract in participants with a fasting glucose level between 100 mg/dL and 140 mg/dL. Methods: This study was a 12-wk, randomized, double-blind, placebo-controlled clinical trial. A total of 72 participants were randomly allocated to two groups of either ginseng berry extract or placebo, and 63 participants completed the study. The parameters related to glucose metabolism were assessed. Results: Although the present study failed to show significant antihyperglycemic effects of ginseng berry extract on the parameters related to blood glucose and lipid metabolism in the total study population, it demonstrated that ginseng berry extract could significantly decrease serum concentration of fasting glucose by 3.7% (p = 0.035), postprandial glucose at 60 min during 75 g oral glucose tolerance test by 10.7% (p = 0.006), and the area under the curve for glucose by 7.7% (p = 0.024) in those with fasting glucose level of 110 mg/dL or higher, while the placebo group did not exhibit a statistically significant decrease. Safety profiles were not different between the two groups. Conclusion: The present study suggests that ginseng berry extract has the potential to improve glucose metabolism in human, especially in those with fasting glucose level of 110 mg/dL or higher. For a more meaningful benefit, further research in people with higher blood glucose levels is required.

• Archives of Plastic Surgery
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• v.44 no.5
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• pp.378-383
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• 2017

Background This study aimed to assess the effects of the topical application of tamoxifen on wound healing of burned skin in Wistar rats by evaluating 3 healing characteristics: fibrotic tissue thickness (FTT), scar surface area (SSA), and angiogenesis in the healed scar tissue. Methods Eighteen male Wistar rats were used in this study. A third-degree burn wound was made on the shaved animals' back, measuring $2{\times}2{\times}2cm$. In the first group, a 2% tamoxifen ointment was applied to the wound twice daily for 8 weeks. The second group received a placebo ointment during the same period. The third group did not receive any treatment and served as the control group. Results The median (interquartile range=[Q1, Q3]) FTT was 1.35 (1.15, 1.62) mm, 1.00 (0.95, 1.02) mm, and 1.25 (0.8, 1.5) mm in the control, tamoxifen, and placebo groups, respectively (P=0.069). However, the FTT in the tamoxifen group was less than in the placebo and control groups. The median angiogenesis was 3.5 (3.00, 6.25), 8.00 (6.75, 9.25), and 7.00 (5.50, 8.25) vessels per high-power field for the control, tamoxifen, and placebo groups, respectively (P=0.067). However, the median angiogenesis was higher in the tamoxifen group than in the control group. No significant difference was observed in the mean SSA between the tamoxifen group and the control group (P=0.990). Conclusions Local application of tamoxifen increased angiogenesis and decreased the FTT, with no change in the SSA in burned skin areas. These effects are expected to expedite the wound healing process, reducing contracture and preventing hypertrophic scar and keloid formation.

• Asian Pacific Journal of Cancer Prevention
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• v.14 no.10
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• pp.5753-5759
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• 2013

Curcumin and curcumin containing polyherbal preparations have demonstrated anti-microbial and antiviral properties in pre-clinical studies. Till date no therapeutic intervention has been proved to be effective and safe in clearing established cervical human papillomavirus (HPV) infection. The present study evaluated the efficacy of Basant polyherbal vaginal cream (containing extracts of curcumin, reetha, amla and aloe vera) and of curcumin vaginal capsules to eliminate HPV infection from cervix. Women were screened by Pap smear and HPV DNA test by PCR. HPV positive women without high grade cervical neoplasias (N=287) were randomized to four intervention arms to be treated with vaginal Basant cream, vaginal placebo cream, curcumin vaginal capsules and placebo vaginal capsules respectively. All subjects were instructed to use one application of the assigned formulation daily for 30 consecutive days except during menstruation and recalled within seven days of the last application for repeat HPV test, cytology and colposcopy. HPV clearance rate in Basant arm (87.7%) was significantly higher than the combined placebo arms (73.3%). Curcumin caused higher rate of clearance (81.3%) than placebo though the difference was not statistically significant. Vaginal irritation and itching, mostly mild to moderate, was significantly higher after Basant application. No serious adverse events were noted.