• 동의신경정신과학회지
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• 제32권2호
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• pp.81-93
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• 2021

Objectives: Mild cognitive impairment (MCI) is condition of cognitive decline shown in transition from normal aging to dementia. Hominis placenta pharmacopuncture (HPP) is a treatment that combines effects of medication and acupuncture by injecting Hominis placenta into acupoints. The objective of this study was to evaluate the efficacy and safety of HPP for MCI. Methods: This was a randomized, double-blind, placebo-controlled, two-center clinical trial. Eligible patients were randomly allocated to either the HPP group or the placebo group. HPP or saline as placebo was administered to participants for eight weeks. Changes in symptoms were observed. The primary outcome was difference in mean change of Korean Version of the Montreal Cognitive Assessment (MoCA-K) score between the HPP group and the placebo group. Cognitive function, overall status of mood and sleep, and quality of life (QoL) were also assessed. Safety assessment and economic analysis were then conducted. Results: Thirty participants were enrolled. One participant in the placebo group dropped out. The score of MoCA-K increased after treatment. Its mean change was smaller in the HPP group than in the control group. HPP ameliorated Global Deterioration Scale and Korean Dementia Rating Scale subtests for attention, organization, and memory compared to the placebo. However, none of them was significantly different between the two groups. Mood, sleep, and QoL all improved more in the HPP group than in the placebo group, although differences between the two groups were not statistically significant. There was no adverse event probably related to the drug. HPP treatment needed KRW 345,000 more than the placebo group in improving Geriatric Quality of Life scale-Dementia score by one point for one year. Conclusions: Although HPP treatment did not significantly improve cognition, it changed behavioral and psychological symptoms in MCI.

• Journal of Ginseng Research
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• 제43권4호
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• pp.676-683
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• 2019

Background: Korean Red Ginseng (KRG) is widely used for strengthening the immune system and fighting fatigue, especially in people with deficiency syndrome. However, there is concern that the long-term application or a high dose of KRG can cause "fireness" (上火 in Chinese) because of its "dryness" (燥性 in Chinese). The aim of this study was to assess the safety and efficacy of a 4-week treatment with KRG in participants with deficiency syndrome. Methods: This was a 4-week, randomized, double-blind, placebo-controlled clinical trial. A total of 180 Chinese participants were randomly allocated to three groups: placebo control group, participants were given a placebo, 3.6 g/d; KRG 1.8 g and 3.6 g groups. The primary outcomes were the changes in fireness and safety evaluation (adverse events, laboratory tests, and electrocardiogram). The secondary outcomes were the efficacy of KRG on fatigue, which include the following: traditional Chinese medicine (TCM) symptom scale and fatigue self-assessment scale. Results: Of the 180 patients, 174 completed the full study. After 4 weeks of KRG treatment, the Fire-heat symptoms score including Excess fire-heat score and Deficient fire-heat score showed no significant change as compared with placebo treatment, and no clinically significant changes in any safety parameter were observed. Based on the TCM syndrome score and fatigue self-assessment score, TCM symptoms and fatigue were greatly improved after treatment with KRG, which showed a dose- and time-dependent effect. The total effective rate was also significantly increased in the KRG groups. Conclusion: Our study revealed that KRG has a potent antifatigue effect without significant adverse effects in people with deficiency syndrome. Although a larger sample size and longer treatment may be required for a more definite conclusion, this clinical trial is the first to disprove the common conception of "fireness" related to KRG.

• Nutrition Research and Practice
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• 제11권6호
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• pp.525-525
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• 2017

• 고려인삼학회:학술대회논문집
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• 고려인삼학회 2005년도 춘계 학술대회 및 총회
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• pp.8-11
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• 2005

• 대한약학회:학술대회논문집
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• 대한약학회 2001년도 Proceedings of International Convention of the Pharmaceutical Society of Korea
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• pp.318.1-318.1
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• 2001

• Pediatric Gastroenterology, Hepatology & Nutrition
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• 제24권5호
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• pp.423-431
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• 2021

Purpose: To assess the effect of combination probiotic Saccharomyces boulardii CNCM-I 3799 and Bacillus subtilis CU-1 in outpatient management of acute watery diarrhea in children. Methods: A randomized double-blind placebo-controlled study was conducted in 180 participants aged six months to five years with acute mild to moderate diarrhea. All were enrolled from six centers across India and centrally randomized to receive S. boulardii CNCM-I 3799 and B. subtilis CU-1 or a placebo along with oral rehydration salts and zinc supplementation. Each participant was followed up for three months to assess recurrence of diarrhea. Results: The mean duration of diarrhea in the probiotic and placebo groups were 54.16 hours and 59.48 hours, respectively. The difference in the duration of diarrhea in those administered with probiotic or placebo within 24 hours of diarrhea onset was 25.21 hours. Furthermore, the difference in duration of diarrhea was 13.84 hours (p<0.05) for participants who were administered with probiotics within 48 hours. There were no significant differences in the stool frequencies between the two arms. After three months, 15% in the probiotic group and 18.5% in the placebo group reported episodes of diarrhea. The mean duration of diarrhea was considerably lower in the probiotic group, 31.02 hours versus 48 hours in placebo (p=0.017). Conclusion: S. boulardii CNCM-I 3799 and B. subtilis CU-1 combination was effective in reducing the duration of diarrhea when administered within 48 hours of diarrhea onset. Similarly, it reduced recurrence of diarrhea and its intensity in the subsequent three months.

• Asian Pacific Journal of Cancer Prevention
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• 제15권14호
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• pp.5733-5739
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• 2014

Background: Breast cancer is the most common female malignancy in the world. Beta glucan can be a hematopoietic and an immune modulator agent in cancer patients. The aim of this trial was to determine the effect of beta glucan on white blood cell counts and serum levels of IL-4 and IL-12 in women with breast cancer undergoing chemotherapy. Materials and Methods: This randomized double-blind placebo-controlled clinical trial was conducted on 30 women with breast carcinoma aged 28-65 years. The eligible participants were randomly assigned to intervention (n=15) or placebo (n=15) groups using a block randomization procedure with matching based on age, course of chemotherapy and menopause status. Patients in the intervention group received two 10-mg capsules of soluble 1-3, 1-6, D-beta glucan daily and the control group receiving placebo during 21 days, the interval between two courses of chemotherapy. White blood cells, neuthrophil, lymphocyte and monocyte counts as well as serum levels of IL-4 and IL-12 were measured at baseline and at the end of the study as primary outcomes of the study. Results: In both groups white blood cell counts decreased after 21 days of the intervention, however in the beta glucan group, WBC was less decreased non significantly than the placebo group. At the end of the study, the change in the serum level of IL-4 in the beta glucan group in comparison with the placebo group was statistically significant (p=0.001). The serum level of IL-12 in the beta glucan group statistically increased (p=0.03) and comparison between two groups at the end of the study was significant after adjusting for baseline values and covariates (p=0.007). Conclusions: The findings suggest that beta glucan can be useful as a complementary or adjuvant therapy and immunomodulary agent in breast cancer patients in combination with cancer therapies, but further studies are needed for confirmation.

• Nutrition Research and Practice
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• 제11권1호
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• pp.43-50
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• 2017

BACKGROUND/OBJECTIVES: The present study investigated the hypothesis that a highly pure linear ${\beta}$-1,3-glucan produced by Agrobacterium sp. R259 enhances human natural killer (NK) cell activity and suppresses pro-inflammatory cytokines. SUBJECTS/METHODS: In an eight-week, double-blind, randomized, placebo-controlled clinical trial, 83 healthy adults with white blood cell counts of $4,000-8,000cells/{\mu}L$ were participated and randomly assigned to take two capsules per day containing either 350 mg ${\beta}$-1,3-glucan or placebo. Six participants withdrew their study consent or were excluded due to NK cell activity levels outside the normal range. NK cell activity and serum levels of immunoglobulin G (IgG) and cytokines, such as interferon (IFN)-${\gamma}$, interleukin (IL)-2, IL-4, IL-6, IL-10, IL-12 and tumor necrosis factor (TNF)-${\alpha}$ were measured. RESULTS: NK cell activity and the serum levels of IL-10 were significantly higher from baseline to week 8 in the ${\beta}$-glucan group compared with the placebo group (P = 0.048, P = 0.029). Consumption of ${\beta}$-1,3-glucan also significantly increased NK cell activity compared with placebo after adjusting for smoking and stress status (P = 0.009). In particular, the effect of ${\beta}$-1,3-glucan on NK cell activity was greater in participants with severe stress than in those experiencing mild stress. However, the administration ${\beta}$-1,3-glucan did not significantly modulate the levels of IFN-${\gamma}$, IL-2, IL-4, IL-6, IL-12, TNF-${\alpha}$ and IgG compared with the placebo. CONCLUSION: The results showed that supplementation with bacterial ${\beta}$-1,3-glucan significantly increased NK cell activity without causing any adverse effects. Additionally, the beneficial effect of ${\beta}$-1,3-glucan on NK cell activity was greater in participants experiencing severe stress.

• Preventive Nutrition and Food Science
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• 제10권3호
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• pp.285-289
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• 2005

In this double-blind, placebo-controlled trial, we assessed the efficacy and safety of beef tallow extract (BTE) including Cis-9-cetylmyristoleate in patients with arthritis. Between May and December 2003, we selected 80 patients (n=80) who showed/manifested arthritic symptoms and whose radiological findings were suggestive of arthritis, and randomly assigned them to placebo-controlled (n=40) and treatment group (n=40). The placebo (corn starch 350 mg) and BTE (208 mg) were orally administered to placebo-controlled and treatment group three times a day, respectively. We assessed the efficacy and safety based on the visual analogue scale (V AS) and modified knee society knee scores (MKSKS) at baseline and endpoint, respectively. To assess the safety, we monitored the adverse effects noted in liver, kidney, cardiovascular and gastrointestinal system for 3 weeks. Then, we performed not only a questionnaire study but also laboratory tests (e.g., liver function test, kidney function test, urinalysis, electrocardiography [EKG], complete blood cell counts [CBC] and chest X-ray). For statistical analysis, Student (-test and paired (-test were done using SPSS■ Version 11.0. Statistical significance was set at p < 0.05. The scores between V AS and MKSKS showed statistical significance (p < 0.05) with an improvement of $69.2\%$ (27/39) and $3.8\%$ (21/39) of treatment-group patients, respectively. Abnormal laboratory findings were noted in neither placebo-controlled nor treatment group. In conclusion, our results indicate that the administration of BTE was a safe and effective treatment regimen for patients with arthritis. In addition, the efficacy of BTE was more remarkable in alleviating the symptoms rather than improving the function.

• Journal of Ginseng Research
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• 제46권4호
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• pp.585-591
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• 2022

Background: Korean Red Ginseng (KRG) extract has been shown to have beneficial effects in patients with atherosclerosis, suggesting that KRG extract may be effective in preventing subsequent ischemic stroke in patients with severe atherosclerosis. Methods: This double-blind, placebo-controlled trial randomized patients with severe atherosclerosis in major intracranial arteries or extracranial carotid artery, to ginseng group and placebo group. They were given two 500-mg KRG tablets or identical placebo tablets twice daily for 12 months according to randomization. The primary endpoint was the composite of cerebral ischemic stroke and transient ischemic attack during 12 months after randomization. The secondary endpoints were change in volumetric blood flow of the intracranial vessels and the incidence of newly developed asymptomatic ischemic lesions. Any adverse events were monitored. Results: Fifty-eight patients were randomized from June 2016 to June 2017, 29 to ginseng and 29 to placebo, and 52 (28 and 24, respectively) completed the study. One patient in the placebo group, but none in the ginseng group, experienced ischemic symptoms (p = 0.46). Changes in volumetric blood flow and the presence of ischemic brain lesions did not differ significantly in the two groups, and none of these patients experienced adverse drug reactions. Conclusion: Ginseng was well tolerated by patients with severe atherosclerosis, with these patients showing good compliance with ginseng dosing. Ginseng did not show significant effects compared with placebo, although none of the ginseng-treated patients experienced ischemic events. Long-term studies in larger patient populations are required to test the effect of ginseng.