• Title/Summary/Keyword: Double-blind

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Effects of phylloquinone supplementation on lipid profile in women with rheumatoid arthritis: a double blind placebo controlled study

  • Kolahi, Sousan;Gargari, Bahram Pourghassem;Abbasi, Mehran Mesgari;Jafarabadi, Mohammad Asghari;Shishavan, Neda Ghamarzad
    • Nutrition Research and Practice
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    • v.9 no.2
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    • pp.186-191
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    • 2015
  • BACKGROUND/OBJECTIVES: Rheumatoid arthritis (RA) is associated with an excess mortality from cardiovascular disease which is likely attributed to an atherogenic lipid profile. Among nutritional factors vitamin K has been recently focused as a pivotal nutrient in improvement of lipid related markers. Thus, this study was designed to determine the effects of vitamin K on lipid profile in this disease. SUBJECTS/METHODS: Fifty eight patients with definitive RA were participated in the present double blind placebo controlled study. They were randomly allocated into two groups to receive vitamin $K_1$ as phylloquinone [10 mg/day] (n = 30) or placebo pills (n = 28), for eight weeks. In order to control the effects of probable confounders dietary intakes, anthropometric measurements including weight and height, clinical status using disease activity score-28 (DAS-28), physical activity and anxiety status were evaluated at baseline. Moreover, serum levels of lipid related markers including total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C) and triglyceride (TG) were measured at baseline and at the end of intervention. RESULTS: There were no significant differences between the two groups regarding any of the baseline characteristics. After adjusting for some relevant confounders, in comparison between two groups, we observed no significant changes in lipid related markers at the end of intervention. Also, there was no significant difference between before and after intervention values within groups (P > 0.05). CONCLUSIONS: Function of vitamin $K_1$ in lipid profile modification remains still controversial. This study showed that vitamin $K_1$ has no effect on lipid profile in women with rheumatoid arthritis. Further studies with a longer follow-up are required to determine the effects of vitamin K on atherogenic lipid profile.

Effects of a Herbal Medicine, Yukgunja-Tang Extract Granule, on Functional Dyspepsia Patients by Sasang Constitution: Placebo-Controlled, Double-Blind, Randomized Trial (기능성 소화불량에 대한 육군자탕 엑스과립의 사상체질별 치료효과: 위약 대조, 이중 맹검, 무작위 시험)

  • Jeon, Su-Hyeong;Kim, Jong-Won
    • 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.

Omega 3 fatty acids as a host modulator in chronic periodontitis patients: a randomised, double-blind, palcebo-controlled, clinical trial

  • Deore, Girish D.;Gurav, Abhijit N.;Patil, Rahul;Shete, Abhijeet R.;NaikTari, Ritam S.;Inamdar, Saurabh P.
    • Journal of Periodontal and Implant Science
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    • v.44 no.1
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    • pp.25-32
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    • 2014
  • Purpose: Periodontitis is an infectious disease caused predominantly by gram-negative anerobes. The host inflammatory response to these bacteria causes alveolar bone loss that is characterized as periodontitis. Omega-3 fatty acids (${\omega}$-3 FAs) have anti-inflammatory properties, thus have been used to treat some chronic inflammatory diseases such as cardiovascular disease and rheumatoid arthritis. We aimed to evaluate the effect of dietary supplementation with ${\omega}$-3 FAs as a host modulating agent in patients with chronic periodontitis. Methods: Sixty otherwise healthy subjects with moderate and severe chronic periodontitis were enrolled in our randomised, double-blind, placebo-controlled trial. The control group (CG, n=30) was treated with scaling and root planing (SRP) and given a placebo; the treatment group (TG, n=30) was treated with SRP and dietary supplementation of ${\omega}$-3 FAs (one 300 mg tablet daily for 12 weeks). Periodontal clinical parameters and serum C-reactive protein (CRP) levels were evaluated in all patients at baseline, a 6-week and 12-week period after treatment. Results: A significant reduction in the gingival index, sulcus bleeding index, pocket depth, and clinical attachment level was found in the TG compared to the CG at a 12-week period. However, no statistically significant changes in serum CRP levels were found. Conclusions: Our findings suggest that ${\omega}$-3 FAs can successfully reduce gingival inflammation, pocket depth, and attachment level gain. Dietary supplementation with ${\omega}$-3 FAs may have potential benefits as a host modulatory agent in the prevention and/or C management of chronic periodontitis.

The Effects of Korean Ginseng and American Ginseng on Body Temperature in Koreans and Chineses -Double-blind Randomized Controlled Trials- (한국인과 중국인에서 체온에 대한 고려삼과 화기삼의 영향 -이중맹컴 무작위배정 임상시험-)

  • Seo Jung Chul;Heo Zheng Jie;Han Sang Won;Lee Kyung Lim;Byun Joon Seok;Kim Myung Soo;Ha Il Do;Leem Kang hyun
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.17 no.3
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    • pp.837-841
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    • 2003
  • In East-South Asia it has been widely known that Korean ginseng(Panax ginseng) increases body temperature, whereas American ginseng(Panax quinquefolius) decreases it. This study was designed to find out if Korean ginseng could increase body temperature comparing with American ginseng. Double-blind randomized controlled trials on body temperature of Korean ginseng and American ginseng in Koreans and Chineses was performed by using electronic thermometer at the ear. There was no significant difference between Korean ginseng and American ginseng in Koreans as well as Chineses by repeated-measures ANOVA. It was revealed that Korean ginseng does not increase body temperature. Maybe the concept that Korean ginseng increase body temperature is concerned with commercial interests dealing with American Ginseng.

The Clinical Effect of Oxiracetam in Patients with Organic Brain Syndrome-Double Blind, Placebo-Controlled Study (기질성 뇌증후군에서 Oxiracetam의 임상적 효과에 대한 이중맹검 대조연구)

  • 이병철;권기한;권기한;송홍기;김성민;유경호;이현미;강경수;윤여훈
    • 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.

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Efficacy and safety of Panax ginseng berry extract on glycemic control: A 12-wk randomized, double-blind, and placebo-controlled clinical trial

  • Choi, Han Seok;Kim, Sunmi;Kim, Min Jung;Kim, Myung-Sunny;Kim, Juewon;Park, Chan-Woong;Seo, Daebang;Shin, Song Seok;Oh, Sang Woo
    • 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.

A Randomized Study, Double-Blind, Placebo-Controled Study to Herbal Shampoo & Essence about Dandruff (한방 샴푸/에센스의 비듬에 대한 무작위배정, 이중맹검, 위약 대조군 연구)

  • Kim, Chagn-Hun;Hwang, Dong-Sung;Kim, Jung-Tae;Jung, Hyeon-A;Roh, Seok-Seon;Lim, Nam-Kyoo
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.20 no.3
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    • pp.222-235
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    • 2007
  • Background : Dandruff is a chronic scalp condition characterized by scaling. The common causative agent is now accepted to be the lipophilic Pityrosporum ovale. Obstecive : We conducted a randomized, double-blind, parallel-group study to investigate the efficacy of Herbal Shampoo & Essense and placebo in patients with mild to moderate dandruff. Mathods : Forth-seven patients with dandruff were assigned to one of two treatment goups: Test (contaning the medication) or control (vehicle). After administering through randomizion, two groups were used with Negative sampoo for first two weeks, and used with test or control products for second two weeks. Results : 1. After 2 weeks of treatment, the numbers of P. ovale in test groups were decreased in a statistically meaningful way(p<0.01) compared with control groups. 2. After 2 weeks of treatment, average of sebum-amount in test groups were decreased from 117.55 to 92.88, in a statistically meaningful way(P<0.05, paired t-test) compared with control groups that were decreased from 115.53 to 112.46. 3. In clinical score, average of control groups is decreased from 2.82 to 1.09. on the other sides, average of test groups is decreased from 3.88 to 2.44. The change of test groups is bigger than that of control groups, both two groups was decreased in a statistically way(<0.01) Conclusion : The study demonstrated that Herbal Shampoo & Essense can be used by patients with scalf safely and effectively with almost no side-effect.

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Randomized, Double-blind, Comparative Clinical Trial on the Efficacy of 4% Articaine and 2% Lidocaine in Inferior Alveolar Nerve Block Anesthesia (하치조신경 전달마취 시 4% 아티카인과 2% 리도카인의 임상적 효과에 관한 비교연구)

  • Im, Tae-Yun;Hwang, Kyung-Gyun;Park, Chang-Joo;Kim, Kwang-Soo;Oh, Young;Han, Ji-Young;Shim, Kwang-Sup
    • Journal of The Korean Dental Society of Anesthesiology
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    • v.10 no.1
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    • pp.1-6
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    • 2010
  • Background: Articaine, commercially available in South Korea from 2004, is widely being used for dental treatments. In the surgical extraction of impacted mandibular third molars, one of the most common procedures in oral and maxillofacial surgery, the anesthetic efficacy of 4% articaine and 2% lidocaine, both with 1:100,000 epinephrine, was compared. Methods: A randomized double-blind clinical trial was conducted of 80 patients for bilateral surgical extraction of mandibular third molars with informed consents. One operator carried out the routine surgical procedures using local anesthetic 4% articaine or 2% lidocaine with the same concentration of vasoconstrictor. Latency, duration of anesthesia and the amount of anesthetic solution were recorded. A visual analog scale (VAS) was used to evaluate the intraoperative pain. Results: The pain VAS scores reported similar anesthetic effect with both local anesthetics. Not in the latency of anesthesia and the amount of anesthetic solution, statistically significant difference was found in the mean duration of anesthesia. Conclusions: It was concluded that 4% articaine could offer better or at least the same clinical feasibility compared to 2% lidocaine, particularly in terms of the duration of the local anesthesia for common dental treatments.

Effects of Ephedra on Weight Loss and Heart Rate Variability: A Double-Blind Randomized Controlled Pilot Study (마황복용이 정상성인의 체중 감소와 심박변이도에 미치는 영향에 관한 예비 연구: 무작위배정 이중맹검시험)

  • Yang, Chang-Sop;Hsing, Li-Chang;Yeo, Jin-Ju;Seo, Eui-Seok;Jang, In-Soo
    • The Journal of Internal Korean Medicine
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    • v.27 no.4
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    • pp.836-844
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    • 2006
  • Background: Mahuang (Ephedra sinica STAPF) is well known as an herbal medicine and has been widely used to reduce body weight and increase athletic ability. However, as a result of reporting many cases of adverse effects on the cardiovascular system, use of dietary supplements containing ephedra was prohibited by the FDA. Objectives : The object of this study was to find the effectiveness of ephedra on weight loss without severe adverse effect. Methods : 16 healthy volunteers consisting of an ephedra group (N=8) and a placebo group (N=8) were investigated. Study form was a randomized, controlled, double-blind clinical trial. The ephedra group took 12g of ephedra while the placebo group took 12g of glutinous rice powder. Both groups were measured with BCA (body composition analysis) on weight loss and with HRV (heart rate variability) on its adverse effect before and after medication. Results : The following results were obtained after taking 12g of ephedra for 14 days. In the ephedra group, body weight reduced significantly. In the placebo group, there were no significant differences of body weight between before and after placebo treatment. There was a slight increase of heart beat rate and deactivation of cardiac activity. Parasympathetic nerves were deactivated, but balances of autonomic nervous system were well maintained. Conclusions : The results suggest that ephedra in healthy adults tends to reduce body weight and deactivation of autonomic nervous system and cardiac activity.

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Effects of Ephedra on the State-Trait Anxiety in Female Adults: A Double-Blind Randomized Controlled Study (마황복용이 성인여성의 상태-특성 불안에 미치는 영향: 무작위배정 이중맹검 임상연구)

  • Yang, Chang-Sop;Hsing, Li-Chang;Jeong, Hyun-Suk;Kim, Lak-Hyung;Kwak, Min-Jung;Seo, Eui-Seok;Jang, In-Soo
    • The Journal of Internal Korean Medicine
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    • v.28 no.2
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    • pp.346-353
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    • 2007
  • Background : Over a thousand years of clinical preparation of Ephedrain traditional Korean medicine has confirmed effectiveness and security. Recently. Ephedra-containing herbal preparations to treat obesity are common. The aim of this study is to identify effects of Ephedra on psychological anxiety. Objectives : To determine effects of Ephedraon psychoactivity and autonomic nervous system. Methods : The study design was a double-blind randomized controlled trial. The subjects of this study were healthy adults. They were allocated to either the Ephedragroup (N =66) or the placebo group (N =32), Ephedra(8 g) or a placebo in similar opaque capsules was given twice a day for 2 weeks. Anxiety score was estimated with State-Trait Anxiety Inventory before first and after last medication. 36 of the Ephedragroup and 24 of the placebo group finished the trial and were analyzed. Paired samples T-test and independent samples T-test were applied to statistical analysis. Results : The following result was obtained: After taking Ephedra. state anxiety increased significantly. In the placebo group. both state and trait anxiety increased although significance was not reached. Conclusions : It is concluded that the intake of Ephedraplays a significant role in the increase of anxiety in healthy adults. It is suggested that anxiety level change should be considered when using Ephedra in clinics.

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