• Title/Summary/Keyword: Double blind test

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Low-level Laser Therapy with Novel Array of Light Source and Individualized Program for Treatment of Androgenetic Alopecia: A 16-week, Randomized, Double-blind, Sham Device-controlled Study

  • Kim, Jee-Woo;Kwon, Yeo-Seon;Chang, Yoon-Young;Hong, Sung-Ho;Shin, Jung-Won;Na, Jung-Im;Huh, Chang-Hun
    • Medical Lasers
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    • v.9 no.2
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    • pp.150-158
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    • 2020
  • Background and Objectives Low-level laser therapy (LLLT) is used widely to promote hair growth in androgenetic alopecia (AGA). This study examined the clinical efficacy and safety of a home-use LLLT device with a newly designed array of light sources and software optimized for individual types of AGA. Materials and Methods The study was a randomized, double-blind, sham device-controlled trial. Forty-eight subjects (39 men and nine women) were assigned randomly in a 2:1 ratio to use either the test device (LG Pra'L HGN1, LG electronics, Korea) or sham device. The subjects used the LLLT device three times a week for 16 weeks. Phototrichogram was used to measure the hair density and hair thickness at 0, 8, and 16-weeks. Adverse events were closely monitored. Results After 16 weeks of using the device, the test group showed a significant increase in hair density and hair thickness compared to the control. In the test group, the hair density increased 6.96 counts/cm2 at eight weeks and 13.67 counts/cm2 at 16 weeks from the baseline. The hair thickness increased 7.21 ㎛ at eight weeks and 11.80 ㎛ at 16 weeks compared to the baseline. Conclusion The home-use LLLT device with a novel array of light sources and an individualized program according to the types of hair loss appears to be an effective and safe treatment modality for both male and female AGA patients.

The Effects of SBD-1 on Hangover Syndrome : a Randomized Double-blind Crossover Preliminary Study (신선불취단(神仙不醉丹) 가감방(加減方)의 숙취 예방효과에 대한 이중맹검 무작위배정 교차임상 예비연구)

  • Jeong, Hyun-Suk;Kang, Sei-Young;Han, Hyun-Jin;Jang, In-Soo
    • The Journal of Internal Korean Medicine
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    • v.33 no.4
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    • pp.511-519
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    • 2012
  • Objectives : This study investigated the effect of Sinseonbulchuidan (SBD-1) on hangover syndrome. We undertook this study to test whether SBD-1 is effective in preventing the signs and symptoms of alcohol-induced hangover. Methods : Fifteen healthy volunteers participated in this double-blind randomized crossover study. All participants received either SBD-1 or indistinguishable placebo capsules before alcohol consumption. The primary outcome measure was the difference in hangover severity scores between SBD-1 and placebo intervention. Secondary outcome measure was the difference in profile of mood states (POMS) between SBD-1 and placebo intervention. Results : After alcohol exposure, the overall symptom scores were significantly decreased in the SBD-1 group compared with those given a placebo. The mean scores for the hangover symptoms were high in the placebo group, and statistical significance was observed in 4 symptom scores (loss of appetite, stomachache, nausea, and total score). There were no differences in the POMS and cognitive performance test results between SBD-1 and placebo intervention. Conclusions : We conclude that the SBD-1 is effective in preventing the signs and symptoms of alcohol-induced hangover. Larger studies are required to confirm these findings.

Effect of Saengmaeg-san Extract on Xerostomia in Stroke Patients : A Double-Blind Randomized Controlled Study (중풍환자의 구강건조증에 대한 생맥산의 효과 : 무작위배정 이중맹검 연구)

  • Lee, Dae-Hyun;Han, Hyun-Jin;Kim, Lak-Hyung;Kang, Sei-Young;Jang, In-Soo
    • The Journal of Internal Korean Medicine
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    • v.32 no.4
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    • pp.542-549
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    • 2011
  • Objectives : The present study was made to evaluate the clinical effectiveness of Saengmaeg-san (生脈散) extract to treat xerostomia in stroke patients. Methods : The study design was a double-blind randomized controlled trial. Subjects were stroke patients with xerostomia. They were allocated to either the Saengmaeg-san (n=12) or placebo group (n=12). Saengmaeg-san extract or a placebo in similar opaque capsules was given three times a day for a week. The improvement of xerostomia was measured by the xerostomia-evaluating questionnaire, developed by the school of dentistry in Seoul National University, before baseline and one week later. Eleven of the Saengmaeg-san group and ten of the placebo group finished the trial and were analyzed. Paired samples t-test and Mann-Whitney test were applied to statistical analysis. Results : On three of the six questions, the Saengmaeg-san group improved significantly. On two of the six questions, the Saengmaeg-san group improved significantly more than the placebo group. On the other questions, the Saengmaeg-san group improved more than the placebo group, although significance was not reached. Conclusions : These results demonstrate that Saengmaeg-san extract is effective for treating xerostomia in stroke patients, and further studies should be conducted to provide more valuable information.

봉약침(Bee Venom)과 Sweet Bee Venom의 Allergy 반응에 대한 비교연구

  • Lee, Jin-Seon;Lee, Jong-Young;Kwon, Ki-Rok;Lee, Hee-Choon
    • Journal of Pharmacopuncture
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    • v.9 no.3 s.21
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    • pp.61-77
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    • 2006
  • Objectives : Sweet bee venom is made by removing allergen from the bee venom through gel filtration chromatography and propionic acid/urea polyacrylamide gel electrophoresis. The aim of this study was to verify allergy inhibitory action in Sweet Bee Venom in which the allergy causing enzyme is removed. Methods : 95 healthy adult men and women were selected through a survey whom had never received the bee venom therapy in the past. The concentration of bee venom pharmacopuncture and Sweet BV pharmacopuncture was equally at 0.1mg/ml and the experiment was conducted as the double blind test. Experiment groups were classified into low dosage groups(0.1ml for both bee venom pharmacopuncture and Sweet BV) and high dosage groups where 0.4ml of respective administrations were rendered made observations for allergic responses. Results : Participants of the study was comprised of 71 men and 24 women with the average age of 29.0 years. According to results of the low dosage groups, Sweet BV group showed significant reduction in pain after 4 hours and 24 hours compared to the bee venom pharmacopuncture group. Other allergic responses were insignificant between the groups. For the high dosage groups, Sweet bee venom group showed reduction in pain after 30 minutes and 4 hours. Other allergic responses such as edema, itchiness, dizziness from hypersensitivity, and fatigue were significantly lower in the Sweet bee venom administered group after 30 minutes. Conclusions : As a result of removed allergen, Sweet bee venom significantly inhibits allergic responses both locally and throughout the body. This indicates wider and easier application of Sweet bee venom for the symptoms applicable to the bee venom pharmacopuncture. Further comparative studies should be conducted to yield more objective verification.

Clinical Studies of Sweet Bee Venom to the Effect of Abdominal Fat Accumulation (Sweet BV의 침감비교 연구)

  • Lim, Chung-San;Park, Won-Pil;Jang, Seong-Bong;Choi, Young-Chon;Park, Do-Il;Kwon, Ki-Rok;Lee, Hee-Choon
    • Journal of Pharmacopuncture
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    • v.11 no.2
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    • pp.55-62
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    • 2008
  • Objective Sweet bee venom is made by removing allergen from the bee venom through gel filtration chromatography and propionic acid/urea polyacrylamide gel electrophoresis. The aim of this study was to verify allergy inhibitory action in Sweet Bee Venom(SBV) and New Sweet Bee Venom(NSBV) removed enzymes and compounds of low molecular weight. Methods 84 healthy adult men and women were selected through a survey whom had never received the bee venom therapy in the past. The concentration of Normal Saline, SBV and NSBV pharmacopuncture was equally at 0.1mg/mL and the experiment was conducted as the double blind test. Results Participants of the study was comprised of 63 men and 21 women with the average age of 28.3 years. According to results of pain sense, SBV group showed significant higher score compared with NS group and NSBV group using VAS in treating time. And SBV and NSBV group showed significant higher score compared with NS group after 30 minutes. Other allergic responses were insignificant between the groups. Conclusions As a result of removed allergen and compounds of low molecular weight, NSBV significantly inhibits pain sense in treating time compared with SBV. This indicates wider and easier application of NSBV for the useful application in clinical treatment. Further comparative studies should be conducted to yield more objective verification.

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.

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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Tooth whitening effect of toothpaste containing hydrogen peroxide (과산화수소가 배합된 제제의 치아미백효과에 관한 연구)

  • Ahn, Jae-Hyun;Kim, Ji-Hye;Kim, Jong-Hoon;Jang, Jong-Hwa;Oh, Yoon-Jong;Park, Yong-Duk
    • Journal of Korean society of Dental Hygiene
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    • v.14 no.1
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    • pp.101-108
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    • 2014
  • Objectives : The purpose of this study was to evaluate the tooth whitening effect of 0.74% and 2.80% hydrogen peroxide toothpastes and safety on tooth and gingival tissue. Methods : Toothpastes containing 0.74% and 2.80% hydrogen peroxide were evaluated. In in-vitro test, some additives (sodium metaphosphate, sodium pyrophosphate and titanium dioxide) were added to the toothpastes. Hydroxyapatite specimens (HAPs) were made and stained using modified Stookey's methods. HAPs were treated for 1 hour at shaking incubator and brushed for 1,000 times as 250 gF with each diluted toothpaste. Before and after color was measured by colorimeter. Using double blind method, 99 Korean with natural maxillary anterior teeth were selected and the initial brightness (baseline) was measured by SHADEEYE-EX. Based on this measurement they were crossly distributed into control group (0% hydrogen peroxide), test 1 (0.74% hydrogen peroxide) and test 2 (2.80% hydrogen peroxide). After 2 weeks, people of each group were provided toothpaste and told to use 3 times a day right after every meal for 3 minutes. The brightness of teeth was measured 3 times for every one month. Results : ${\Delta}L$ was statistically significant among three groups in shaking test. ${\Delta}L$ of two test groups was statistically significant compared with control group but not between each test group in brushing test. After using toothpaste for 3 months, test 1 group and test 2 group were 15.89% and 31.23% more whitened compared with control group respectively (p<0.05). Rate of more whitened person of each test group was 24.2% and 40.5% more than control group respectively (p<0.05). There was no difference in the hypersensitivity during 3 months using toothpastes and no side effect on teeth or gums. Conclusions : Toothpastes containing 0.74% and 2.80% hydrogen peroxide showed tooth whitening effect and both were safe enough to use for tooth whitening.

The Effect of Sweet Bee Venom Pharmacopuncture(SBVP) on Cancer-Related Pain : A Randomized Controlled Trial and Double Blinded - Pilot study (암성통증에 대한 SBVP 효과 - 무작위대조시험, 이중맹검)

  • Yoo, Hwa-Seung;Kim, Jung-Sun
    • Journal of Pharmacopuncture
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    • v.11 no.1
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    • pp.21-29
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    • 2008
  • Objectives : To investigate the therapeutic effects of SBVP in the treatment of patients with cancer-related pain. Design : A prospective randomized, double-blind, placebo-controlled study of SBVP. Setting : The study was conducted at the East West Cancer Center of Daejeon University Dunsan Oriental Hospital from March 1, 2007 to June 20, 2007. Patients : 11 patients diagnosed with cancer-related pain of over 3rd degree on the Numeric Rating Scale(NRS)(0, no pain at all, 10, worst pain imaginable) were entered into a double-blind, placebo-controlled trial of SBVP. They were randomized into Groups A and B(SBVP and control group, respectively) using the table of random sampling numbers and never informed of their affiliation by the coordinator. 5 of 6 patients in Group A and 4 of 5 patients in Group B completed the clinical trial. Intervention : SBVP(1ml/day) for group A and Normal Saline Placebo(1ml/day) for group B was injected into the abdomen acupoint, Zhong Wan(CV 12). The treatment was administered daily for five days. Outcome Measures : Degree of cancer-related pain was measured using the Numeric Rating Scale(NRS) before and after each treatment for "Pain right now" and "Average pain in last 24 hours". Statistical Analysis : Analysis regarding variations in NRS was carried out by applying t-tests(independent sample t-test and paired sample t-test) and Wilcoxon signed rank test with level of significance at 5%. Results : Differences in NRS of "Pain right now" for the two groups were statistically significant. The mean improvement point of SBVP was significantly higher than the control group($2.48^{\circ}{\pm}1.52$ vs $0.97^{\circ}{\pm}1.88$, p<0.05). Differences in average pain score before and after treatment in SBVP group were also significant($5.13^{\circ}{\pm}1.77$ vs $2.65^{\circ}{\pm}0.67$, p<0.05) compared with control group. The two groups showed no significant differences for long term effects in "Average pain in last 24 hours." Conclusion : Although further study will be needed on the large scale, SBVP shows potential as an effective treatment for immediate relief of cancer-related pain.

APPLICATION OF 0.2% HYALURONIC ACID GEL IN ORAL SURGICAL WOUND : A RANDOMIZED DOUBLE-BLIND STUDY (구강내 외과적 창상 치유에서 0.2% hyaluronic acid gel의 유효성에 대한 이중 맹검 연구)

  • Kim, Jae-Yoon;Lee, Jin-Yong;Bae, Kwang-Hak;Lee, Jong-Ho
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
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    • v.34 no.2
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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.