• Title/Summary/Keyword: Double blind test

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Analysis of Plasma Proteome before and after Oral Administration of Acidic Polysacharide from Panax Ginseng, Double-blind, Placebo-controlled, Randomised Trial (인삼 다당체 경구 투여 전 ${\cdot}$ 후 혈장의 proteome 분석;무작위배정, 이중 맹검, 위약비교시험)

  • Lee, Seon-Goo;Cho, Young-Ho;Kang, Tae-Gyu;Yang, Ha-Young;Yoo, Byong-Chul;Cho, Chong-Kwan;Yoo, Hwa-Seung
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.21 no.5
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    • pp.1185-1193
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    • 2007
  • Ginsing polysaccharide, known to have an immune regulating effect, was administered to 23 randomly selected healthy male subjects with a mean age of 23 years in accordance with an IRB approval. Then, these subjects underwent physico-chemical tests and serum proteome was analyzed from the blood sample taken from these subjects. Analyses of proteome involved image analysis, protein sections and protein identification in sequence after two-dimensional electrophoresis was carried out. During the physico-chemical test, 4 subjects were excluded from the study. In the proteome analysis, identified were 5 spots such as SP40, 40, Cytokeratin 9, hypothetical protein LOC544932, Apolipoprotein E ,similar to Human albumin, which showed differences in the amount of protein expression. In conclusion, changes of 5 proteins were remarkable before and after administration of ginsing polysaccharides. In certain cases, hepatic and renal slight injury occurred. Thus, further clinical study on dosage regimen would be necessary for securing the basis for concentration-dependent effectiveness and safety.

Evaluations on Salivary Flow Induction and Dissolution Patterns in Saliva of Pilocarpine Chewing Tablet in Healthy Human Volunteers (건강한 성인 지원자를 대상으로 한 필로칼핀 저작정의 타액분비 유도 및 타액중 용출패턴 평가)

  • Park, Kyoung-Ho
    • Journal of Pharmaceutical Investigation
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    • v.27 no.4
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    • pp.331-335
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    • 1997
  • Xerostomia is caused by organic or functional changes affecting the salivary system at different levels. Patients suffering from xerostomia may also complain of an oral burning sensation, ulceration or soreness, difficulty in swallowing, and poor denture retention. And pilocarpine is administered orally to induce salivary secretion. In Seoul National University Hospital(SNUH) pharmacy, the pilocarpine chewing tablets are prepared and supplied to patients of xerostomia in request of the dental hospital in SNUH. And we tested the salivary flow induction and the dissolution patterns of these products in saliva by a double-blind, sequential cross-over trials to eight healthy human volunteers with placebo. The pilocarpine chewing tablet contained 5 mg of pilocarpine, and placebo consisted of same materials as test drug, but didn't contain pilocarpine. In vivo experiment, all subjects were instructed to chew as 60-80 times/min. Mixed saliva was collected in the ranges of intervals such as 0-2, 2-5, 5-10, 10-15, 15-20, 20-30, 30-45 and 45-60 min after pilocarpine chewing tablet or placebo administration. Saliva volume was measured in each collecting time interval, and saliva pilocarpine concentrations were determined by reversed phase HPLC. The 82.5 percent $(4.13{\pm}0.69\;mg)$ of pilocarpine was extracted from chewing tablets during mastication of 60-80 times per minute for 60 minutes. Among these dissolved amounts, 90 percent was extracted within 20 minutes. The salivary flow rates were more increased in a group who administered pilocarpine chewing tablet at the interval of 5-10, 10-15, 20-30 and 45-60 min rather than a placebo-group, but only extracted amount of pilocarpine at 45-60 min interval is significanly different between two groups (p<0.05). But total amounts of saliva secreted for 1 hour in two group-pilocarpine and placebo treated- were $46.36{\pm}9.72\;ml\;and\;39.09{\pm}7.81\;ml$, respectively, and were not significantly different between two groups.

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Effects of Caffeine on Auditory- and Vestibular-Evoked Potentials in Healthy Individuals: A Double-Blind Placebo-Controlled Study

  • Tavanai, Elham;Farahani, Saeid;Ghahraman, Mansoureh Adel;Soleimanian, Saleheh;Jalaie, Shohreh
    • Journal of Audiology & Otology
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    • v.24 no.1
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    • pp.10-16
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    • 2020
  • Background and Objectives:The blockage of adenosine receptors by caffeine changes the levels of neurotransmitters. These receptors are present in all parts of the body, including the auditory and vestibular systems. This study aimed to evaluate the effect of caffeine on evoked potentials using auditory brainstem responses (ABRs) and cervical vestibular-evoked myogenic potentials (cVEMPs) in a double-blind placebo-controlled study. Subjects and Methods: Forty individuals (20 females and 20 males; aged 18-25 years) were randomly assigned to two groups: the test group (consuming 3 mg/kg pure caffeine powder with little sugar and dry milk in 100 mL of water), and the placebo group (consuming only sugar and dry milk in 100 mL water as placebo). The cVEMPs and ABRs were recorded before and after caffeine or placebo intake. Results: A significant difference was observed in the absolute latencies of I and III (p<0.010), and V (p<0.001) and in the inter-peak latencies of III-V and I-V (p<0.001) of ABRs wave. In contrast, no significant difference was found in cVEMP parameters (P13 and N23 latency, threshold, P13-N23 amplitude, and amplitude ratio). The mean amplitudes of P13-N23 showed an increase after caffeine ingestion. However, this was not significant compared with the placebo group (p>0.050). Conclusions: It seems that the extent of caffeine's effects varies for differently evoked potentials. Latency reduction in ABRs indicates that caffeine improves transmission in the central brain auditory pathways. However, different effects of caffeine on auditory- and vestibular-evoked potentials could be attributed to the differences in sensitivities of the ABR and cVEMP tests.

Fermented Laminaria japonica improves working memory and antioxidant defense mechanism in healthy adults: a randomized, double-blind, and placebo-controlled clinical study

  • Kim, Young-Sang;Reid, Storm N.S.;Ryu, Jeh-Kwang;Lee, Bae-Jin;Jeon, Byeong Hwan
    • Fisheries and Aquatic Sciences
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    • v.25 no.8
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    • pp.450-461
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    • 2022
  • A randomized, double-blind, and placebo-controlled clinical study was used to determine the cognitive functions related to working memory (WM) and antioxidant properties of fermented Laminaria japonica (FLJ) on healthy volunteers. Eighty participants were divided into a placebo group (n = 40) and FLJ group (n = 40) that received FLJ (1.5 g/day) for 6 weeks. Memory-related blood indices (brain-derived neurotrophic factor, BDNF; angiotensin-converting enzyme; human growth hormone, HGH; insulin-like growth factor-1, IGF-1) and antioxidant function-related indices (catalase, CAT; malondialdehyde, MDA; 8-oxo-2'-deoxyguanosine, 8-oxo-dG; thiobarbituric acid reactive substances, TBARS) were determined before and after the trial. In addition, standardized cognitive tests were conducted using the Cambridge Neuropsychological Test Automated Batteries. Furthermore, the Korean Wechsler Adult Intelligence Scale (K-WAIS)-IV, and the Korean version of the Montreal Cognitive Assessment (MoCA-K) were used to assess the pre and post intake changes on WM-related properties. According to the results, FLJ significantly increased the level of CAT, BDNF, HGH, and IGF-1. FLJ reduced the level of TBARS, MDA, and 8-oxo-dG in serum. Furthermore, FLJ improved physical activities related to cognitive functions such as K-WAIS-IV, MoCA-K, Paired Associates Learning, and Spatial Working Memory compared to the placebo group. Our results suggest that FLJ is a potential candidate to develop functional materials reflecting its capability to induce antioxidant mechanisms together with WM-related indices.

Effects of Caffeine on Auditory- and Vestibular-Evoked Potentials in Healthy Individuals: A Double-Blind Placebo-Controlled Study

  • Tavanai, Elham;Farahani, Saeid;Ghahraman, Mansoureh Adel;Soleimanian, Saleheh;Jalaie, Shohreh
    • Korean Journal of Audiology
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    • v.24 no.1
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    • pp.10-16
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    • 2020
  • Background and Objectives:The blockage of adenosine receptors by caffeine changes the levels of neurotransmitters. These receptors are present in all parts of the body, including the auditory and vestibular systems. This study aimed to evaluate the effect of caffeine on evoked potentials using auditory brainstem responses (ABRs) and cervical vestibular-evoked myogenic potentials (cVEMPs) in a double-blind placebo-controlled study. Subjects and Methods: Forty individuals (20 females and 20 males; aged 18-25 years) were randomly assigned to two groups: the test group (consuming 3 mg/kg pure caffeine powder with little sugar and dry milk in 100 mL of water), and the placebo group (consuming only sugar and dry milk in 100 mL water as placebo). The cVEMPs and ABRs were recorded before and after caffeine or placebo intake. Results: A significant difference was observed in the absolute latencies of I and III (p<0.010), and V (p<0.001) and in the inter-peak latencies of III-V and I-V (p<0.001) of ABRs wave. In contrast, no significant difference was found in cVEMP parameters (P13 and N23 latency, threshold, P13-N23 amplitude, and amplitude ratio). The mean amplitudes of P13-N23 showed an increase after caffeine ingestion. However, this was not significant compared with the placebo group (p>0.050). Conclusions: It seems that the extent of caffeine's effects varies for differently evoked potentials. Latency reduction in ABRs indicates that caffeine improves transmission in the central brain auditory pathways. However, different effects of caffeine on auditory- and vestibular-evoked potentials could be attributed to the differences in sensitivities of the ABR and cVEMP tests.

The Verify of Memory Improvement by Gastrodia Elata Blume (천마를 이용한 기억력 향상 효과 연구)

  • Kim, Woo-Chul;Jeong, Jong-Kil;Kim, Jeong-Sang;Kim, Kyeong-Ok
    • Journal of Oriental Neuropsychiatry
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    • v.24 no.1
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    • pp.27-44
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    • 2013
  • Objectives : This study was designed to investigate the effects of Gastrodia elata Blume on the improvement of memory. Methods : This study was a 12 week, double blind, comparative clinical study. There were eligible who worked with a group of healthy seniors, all 60 years of age or older. 50 subjects were randomized either to Gastrodia elata Blume in powder form and steep in hot water or placebo. We measured the faculty of memory by using K-DRS, MMSE-K, Digit Span, Letter Fluency Test, Word List Memory Test, and the Trail Making Test, and after 12 weeks we measured the faculty of memory again using the same methods. Results : Gastrodia elata Blume steeps in the hot water group significantly increased. Initiation, perseveration level, and Memory level of K-DRS and MMSE-K score. There were no considerable differences between three groups in Digit Span and Trail Making Test score. Gastrodia elata Blume group showed significant advances in Letter Fluency Test and recognition of Word List Memory Test. Conclusions : The results suggest that Gastrodia elata Blume may have positive effects on memory improvement and function of the frontal lobe activation.

Clinical Studies on the Anti-Irritation Effects of Mung Bean (Phaseolus aureus) Extract in Cosmetics (녹두추출물의 자극완화 효과에 관한 임상 연구)

  • 안기웅;강태원;정지헌;조병기
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.30 no.1
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    • pp.23-28
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    • 2004
  • The aim of this study is to assess the anti-irritation activities of mung bean (Phaseolus aureus) extract against various irritants used in cosmetics. For its antidotal activity, mung bean has been used as a medicinal or cosmetic material since ancient times. However, there have been few reports describing the biological activities of these beans and no comprehensive surveys of the constituents. We obtained an ethanolic extract of mung bean and isolated the major constituents, such as vitexin and isovitexin. And we previously reported that the mung bean extract containing vitexin and isovitexin had excellent antioxidant and anti-inflammatory activities. To investigate the mechanisms of anti-inflammatory activity of mung bean extract, we examined the inhibitory effects on histamine release from rat peritoneal mast cells and lipoxygenase activity. Mung bean extract inhibited histamine release in a concentration dependent manner but showed no inhibitory activity in the 5-lipoxygenase assay. And, clinical studies were conducted to evaluate the anti-irritation effects of mung bean extract against various irritants used in cosmetics such as lactic acid, retinol, and preservatives. When 2.0% of mung bean extract was applied to cosmetic formulae containing each of irritants, it revealed considerable anti-irritation efficacy. Our results of the human patch test with 20 volunteers showed that this extract reduced skin irritations caused by 5.0% lactic acid, 4000 IU retinol, and 1.0% preservative mixture by about 60%, 30%, and 50% respectively. The stinging potential test for assessing subjective irritation also showed that the extract reduced the unpleasant sensations by about 50∼30%. Finally, we performed a double-blind usage test with 30 subjects to compare formulae containing mung bean extract with placebo. From the results of questionnaires for 4 weeks of use, we confirmed the excellent anti-irritation effect of mung bean extract. Conclusively, we could discover new material that had anti-irritation effects and apply this mung bean extract to the final cosmetic products successfully.

A Research to Evaluate the Safety and Efficacy of Yukwool-tang (Liuyu-tang) for Major Depression in Women: A Study Protocol for a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Clinical Trial (여성의 주요우울증에 대한 노에스액(육울탕)의 안전성, 유효성 평가 : 무작위배정, 양측눈가림, 위약대조, 평행설계 임상시험 프로토콜)

  • Seo, Young Kyung;Lee, Eun Hee;Kim, Hwan;Lee, Ji-yoon;Park, Chae Rin;Choi, Sunyoung;Jang, Eunsu;Kwon, Ojin;Kim, Hyungjun;Jung, In Chul
    • Journal of Oriental Neuropsychiatry
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    • v.29 no.1
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    • pp.35-46
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    • 2018
  • Objectives: The aim of this trial is to evaluate the efficacy and safety of Yukwool-tang (Liuyu-tang) for the treatment of major depression in women by comparing the Yukwool-tang (Liuyu-tang)-treated group with the placebo-treated group and assessing the association of various biological factors related to depression through various outcome measures. Methods: This study is a single-center, randomized, double-blind, placebo-controlled, parallel-design clinical trial. The subjects to be selected are women between the ages of 19 and 65, and the registered subjects are to be randomly assigned to treatment with Yukwool-tang or the placebo control. The Yukwool-tang group will take 1 bottle of Yukwool-tang (30 mg) for 8 weeks, 3 times a day, before meals. The control group will take the placebo in the same way. The primary outcome to be examined will be the change between the total score after 8 weeks and the total score before the start of the study of the K-HDRS score. Secondary outcomes are assessed by the change in total score after 12 weeks of K-HDRS, K-HDRS remission rate, K-HDRS improvement rate, BDI-K, PITD, KSCL-95, ISI, STAI-K, EQ-5D, VAS, Emotional Stimulation Test, BDNF test, inflammatory cytokine and tumor necrosis factor test, intestinal microbiome test, dietary report and Beck's hopelessness scale. Results: This protocol has been approved by the IRB of Dunsan Korean Medicine Hospital of Daejeon University and is registered in the CRIS, and it is made public in advance to ensure transparency of the research process and conduct ethical clinical trials. Conclusions: Based on this protocol, when the trial is completed, its data can be used to access the validity and safety of Yukwool-tang for major depression in women, and it is also expected to be helpful in the study of the correlation between future treatment of Korean medicine for depression and related biological factors, and quality of life.

The Clinical Effect of Bosingunyang-tang on Chronic Non-bacterial Prostatitis/Chronic Pelvic Pain Syndrome : Randomized Double-blind, Placebo-controlled Clinical Trial

  • Song, Moon-Koo;Kang, Ji-Suck;Kang, Cheol-Ho;Ahn, Young-Min;Ahn, Se-Young;Doo, Ho-Kyung;Lee, Byung-Cheol
    • The Journal of Internal Korean Medicine
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    • v.29 no.3
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    • pp.800-809
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    • 2008
  • Objective : Although chronic prostatitis/chronic pelvic pain syndrcme(CP/CPPS) is a common disease, there is no consensus on the etiology or pathology and treatment. This was a double-blinded, placebo-controlled, randomized clinical trial, investigating the therapeutic effects of the traditional Korean medicine, Bosingunyang-tang(BSGYT). Method : Participants who met US National Institutes of Health (NIH) consensus criteria for CP/CPPS were entered after applying inclusion/exclusion criteria. They were randomized to the BSGYT or placebo group. and treated three times a day for 6 weeks. NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) was used to estimate the clinical symptoms of CP/CPPS. Prostaglandin E2 and ${\beta}$-endorphin in prostatic fluid, collected by 2-glass pre-massage and post-massage test, were analyzed as factors associated with pain and inflammation. Result : The mean decrease in NIH-CPSI total score of the BSGYT group was 11.0 points, which is 5.7 points more than the placebo group. (Mann Whitney test P=0.038) Also the BSGYT group showed three times higher response rate than the placebo group in NIH-CPSI pain subscale score. (Fisher's exact test P=0.027) In those responders, prostaglandin E2 decreased significantly. (Wilcoxon's signed-ranks test P=0.037). No specific side effects were observed. Conclusion : After a 6-week treatment period, BSGYT improved clinical symptoms of CP/CPPS patients by decreasing PGE2 level in prostatic fluid.

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CLINICALI MPROVEMENT OF SKIN AGING BY RETINOL CONTAINING PRODUCTS: WITH NON- INVASIVE METHODS

  • Sun, B.K.;Lee, H.K.;Cho, J.C.;Kim, J.I.
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.23 no.3
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    • pp.39-47
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    • 1997
  • Retinol as well as RA is well known to have many beneficial effects on aged skin. But the skin irritation potential and unstable condition of the products containing them have been some problems in their cosmetic uses. So, retinol containing gel product was developed for less skin irritancy and more stability in cosmetic products. To examine the clinical effects of retinlo containing product, we used cilnicla non-invasive assessment techniques on 40 volunteers for 6 months maintaining double-blind test conditions. According to our results, the use of retinol containing product improved skin color and hydration level slightly. But there was no statistical differences. There was no erythema reaction compared to the use of RA. Especially, the skin elasticity increased above 20% and skin wrinkles of crows' feet region decreased more than 10%. Besides the instrumental analysis, a large majority of volnteers felt that their skin were improved in the case of wrunkles, elasticity, hydration and color.

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