• 제목/요약/키워드: randomized controlled double blind study

검색결과 209건 처리시간 0.03초

Non-inferiority study of the efficacy of two hyaluronic acid products in post-extraction sockets of impacted third molars

  • Yang, Hyunwoo;Kim, Junghun;Kim, Jihong;Kim, Dongwook;Kim, Hyung Jun
    • Maxillofacial Plastic and Reconstructive Surgery
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    • 제42권
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    • pp.40.1-40.5
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    • 2020
  • Background: Hyaluronic acid (HA) is well known to exert an anti-inflammatory effect during oral wound healing and is commonly applied after tooth extraction. However, no double-blind randomized controlled study comparing two hyaluronate mouthwash products has been conducted so far. The aim of this study was to comparatively analyze the efficacy of Mucobarrier® and Aloclair® in terms of clinical symptoms. Results: A total of 112 patients were randomly assigned to assess the degree of discomfort, pain reduction, redness, burning sensation, and swelling between two groups on the day of surgery and 7 days later in a double blind test, with a total 56 Aloclair patients and 56 Mucobarrier patients. There was no statistically significant difference in the overall discomfort, degree of pain reduction, redness, burning sensation, and swelling between the Mucobarrier and Aloclair groups. Conclusion: The local application of hyaluronic acid mouth wash after wisdom tooth extraction is beneficial in reducing overall discomfort and pain reduction, and the clinical utility of Mucobarrier® is no different from Aloclair®. Trial registration: Institutional Review Board of Yonsei University College of Dentistry, 2-2018-0036. Registered 10 September 2018-prospectively registered, https://eirb.yuhs.ac/

소아 안면 열상 봉합을 위한 케타민 진정시 국소 마취가 필요한가: 전향적 무작위대조, 이중맹검 연구 (Is Local Anesthesia Necessary in Ketamine Sedation for Pediatric Facial Laceration Repair?: A Double-Blind, Randomized, Controlled Study)

  • 고민정;최재형;조영순;이정원;임훈;문형준
    • Journal of Trauma and Injury
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    • 제27권4호
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    • pp.178-185
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    • 2014
  • Purpose: The aim of this study was to assess the clinical efficacy of combined treatment with local anesthesia and ketamine procedural sedation for pediatric facial laceration repair in the Emergency Department (ED). Methods: Patients aged 1 to 5 years receiving ketamine for facial laceration repair were prospectively enrolled in a double-blind, randomized, and controlled study at an ED. All patients were to receive intravenous ketamine (2 mg/kg). The local anesthesia group (LA group) received a local anesthetic along with ketamine, whereas the no local anesthesia group (NLA group) received only ketamine. The total time of sedation, the patients' movements and groans, adverse events, and the satisfaction ratings of physicians, nurses, and parents were recorded. Results: A total of 186 patients were randomized (NLA group: 90, LA group: 96). The total time of sedation (30.5 minutes for the NLA group, 32.6 minutes for the LA group; p=0.660), patients' groans (26 (28.9%) versus 23 (24.0%); 0.446) and movements (27 (30%) versus 35 (36.5%); p=0.350) was not affected by the addition of local anesthesia. Other adverse events were similar between the two groups. Also, the satisfaction ratings of physicians (median 4 for the NLA group versus 4 for the LA group (p=0.796)), nurses (2 versus 2.5 (p=0.400)), and parents (4 versus 4 (p=0.199)) were equivalent between the two groups. Conclusion: In this study, we found that local anesthesia was not required along with ketamine sedation for pediatric facial laceration repair.

풍한형 및 풍열형 감모에 대한 소청룡탕의 효과 - 이중맹검, 위약대조군연구 (Effect of Socheongryong-tang on Punghan and Pungyeol Type Common Cold : A Double Blind, Placebo Controlled Study)

  • 박양춘
    • 동의생리병리학회지
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    • 제19권2호
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    • pp.524-529
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    • 2005
  • Socheongryong-tang(SCRT) is widely used to treat the common cold. The purpose of this study was to evaluate the efficacy of SCRT on Punghan type(風寒型) and Pungyeol type(風熱型) common cold. 98 registered students with commom colds of recent onset were randomized to the double blind, placebo-controlled study. SCRT extract in capsule, $5.4g(1.8g{\times}3cap)$, orally dissolved 3 times a day. The severity of illness was assessed by the physician, using a 5-point scale on start and finish. In Pungyeol type common cold, no statistically significant differences were detected between the SCRT and placebo groups for any of the measured outcomes. In Punghan type common cold, SCRT significantly reduced rhinorrhea (p=0.034) and nasal stuffiness (p=0.048) compared with placebo. This study shows that SCRT is effective in treating cold symptoms in Punghan type common cold. If patients with cold are able to be administered SCRT according to common cold type, the benefit would be expected to increase.

The efficacy and safety of a Huanglian-jie-du decoction on Hwa-byung patients: A study protocol for a randomized controlled trial

  • Choi, Yu-Jin;Chung, Sun-Yong;Cho, Seung-Hun
    • 대한약침학회지
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    • 제21권1호
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    • pp.7-13
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    • 2018
  • Objective: Hwa-byung is one of the cultural concept of distress in Korea resulted from chronic accumulated anger. It is characterized by various symptoms like stuffy in the chest, hot or heat sensation, something pushing up in the chest, feeling of mortification, and a flush of anger. This protocol aims to explore the efficacy and safety of Huanglian-jie-du decoction on various somatic symptoms and insomnia in patients with Hwa-byung. Methods: This is study protocol for a randomized, double-blind, placebo-controlled trial. A total of 44 patients will be randomly assigned to the experimental group or the placebo group in a 1:1 ratio. All medications will be taken orally 3 times per day for 7 consecutive days. The primary outcomes are the mean changes in Patient Health Questionnaire of physical symptoms (PHQ-15) and Insomnia Severity Index (ISI) after the 7 days of administration. The secondary outcomes include the scales to assess stress response, symptoms of Hwa-byung, and state anger. Conclusion: The results of this study will provide high quality and explorative evidence to investigate the effect of Huanglian-jie-du decoction on Hwa-byung.

Efficacy and safety of low dose oral ketamine for controlling pain and distress during intravenous cannulation in children: a double-blind, randomized, placebo-controlled trial

  • Bagheri, Mahdi;Soltani, Alireza Ebrahim;Qorbani, Mostafa;Sureda, Antoni;Faghihi, Toktam
    • The Korean Journal of Pain
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    • 제35권3호
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    • pp.311-318
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    • 2022
  • Background: Ketamine is widely used in infants and young children for procedural sedation and anesthesia. The aim of this study was to evaluate the efficacy and safety of low dose oral ketamine to control pain and distress in children during intravenous (IV) cannulation. Methods: This is a prospective, randomized, double-blind study, including children aged between 3 and 6 years requiring a non-emergent IV-line placement. Children were randomly assigned to two groups, treated either with oral ketamine or a placebo. All patients were monitored for vital signs. Pain was assessed using the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) and Wong-Baker Faces Pain Rating Scale (WBFS) scales and sedation using a 5-point sedation score. The facility of IV-line placement was measured by a 3-point scale. Adverse effects were recorded after 1 and 24 hours. Results: A total of 79 and 81 children were entered in the ketamine and placebo groups, respectively. The heart and respiratory rates increased significantly in the placebo group. The median CHEOPS 4 (95% confidence interval [CI]: 3, 4, P < 0.001) and WBFS 6 (95% CI: 4, 6, P < 0.001) scores decreased statistically in the ketamine group. IV-line placement was 50% easier in the ketamine group (95% CI: 37%, 63%, P < 0.001). No serious adverse effects were observed in all cases. Conclusions: Low dose oral ketamine effectively decreased the pain and distress during IV cannulation in children without any significant adverse reactions.

A randomized, double-blind, placebo-controlled pilot study to assess the effects of protopanaxadiol saponin-enriched ginseng extract and pectinase-processed ginseng extract on the prevention of acute respiratory illness in healthy people

  • Hwang, Jeong-Hwan;Park, Soo-Hyun;Choi, Eun-Kyung;Jung, Su-Jin;Pyo, Mi Kyung;Chae, Soo-Wan
    • Journal of Ginseng Research
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    • 제44권5호
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    • pp.697-703
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    • 2020
  • Background: GS-3K8 and GINST, both of which are modified ginseng extracts, have never been examined in terms of their effectiveness for the prevention of acute respiratory illness (ARI) in humans. We conducted a pilot study to assess the feasibility of performing a large-scale, randomized, controlled trial. Methods: This study was a randomized, double-blind, placebo-controlled, pilot study at a single center from October 2014 to March 2015. The 45 healthy applicants were randomly divided into the GS-3K8 (n = 15), GINST (n = 15), and placebo groups (n = 15). The study drug was administered as a capsule (500 mg/cap and 3000 mg/day). GS-3K8 contained 6.31 mg/g of Rg1, 15.05 mg/g of Re, 30.84 mg/g of Rb1, 15.02 mg/g of Rc, 12.44 mg/g of Rb2, 6.97 mg/g of Rd, 1.59 mg/g of Rg3, 3.25 mg/g of Rk1, and 4.84 mg/g of Rg5. GINST contained 7.54 mg/g of Rg1, 1.87 mg/g of Re, 5.42 mg/g of Rb1, 0.29 mg/g of Rc, 0.36 mg/g of Rb2, 0.70 mg/g of Rd, and 6.3 mg/g of compound K. The feasibility criteria were the rates of recruitment, drug compliance, and successful follow-up. The primary clinical outcome measure was the incidence of ARI. The secondary clinical outcome measures were the duration of symptoms. Results: The rate of recruitment was 11.3 participants per week. The overall rate of completed follow-up was 97.8%. The mean compliance rate was 91.64 ± 9.80%, 95.28 ± 5.75%, and 89.70 ± 8.99% in the GS-3K8, GINST, and placebo groups, respectively. The incidence of ARI was 64.3% (9/14; 95% confidence interval [CI], 31.4-91.1%), 26.7% (4/15; 95% CI, 4.3-49.0%), and 80.0% (12/15; 95% CI, 54.8-93.0%) in the GS-3K8, GINST, and placebo groups, respectively. The average days of symptoms were 3.89 ± 4.65, 9.25 ± 7.63, and 12.25 ± 12.69 in the GS-3K8, GINST, and placebo groups, respectively. Conclusion: The results support the feasibility of a full-scale trial. GS-3K8 and GINST appear to have a positive tendency toward preventing the development of ARI and reducing the symptom duration. A randomized controlled trial is needed to confirm these findings.

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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    • 제42권1호
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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.

발효굴추출물의 경구 섭취가 소아 신장 성장에 미치는 효과 및 안전성 평가를 위한 무작위배정, 이중눈가림, 위약 대조 인체적용시험: 인체적용시험 프로토콜 (Randomized, Double-blind, and Placebo-controlled a Human Study for Growing of Stature via the Analysis of Effect of Ferment Oyster Extract: Study Protocol)

  • 김희연;박범찬;천진홍;최준용;안병민;박정현;이배진;김기봉
    • 대한한방소아과학회지
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    • 제33권4호
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    • pp.37-46
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    • 2019
  • Objectives The purpose of this study is to confirm the efficacy and safety of the treatment of with fermented oyster extract on height growth in children with short stature. Methods A total of 100 people, between 6 and 11 years old, will be participated in a randomized, double-blind, and placebo-controlled human study. The fermented oyster group will take 500 mg of fermented oyster extract once a day for 24 weeks. The placebo group will take 3400 mg of fructooligosaccharide as placebo once a day for 24 weeks. The outcomes of the intervention will be measured at the baseline, 6 week, 12 week, 18 week, and 24 week. The primary outcome is the changes in height from the baseline. The secondary outcomes are growth rate, height SDS, bone age, GH, IGF-1, IGFBP-3, osteocalcin, BALP, DPD, and LH. Results This trial was approved by the institutional review board of Pusan National University Korean Medicine Hospital (registry number: PNUKHIRB-2019002). Recruitment of the research participants will be opened from May 2019 till December 2019. Conclusions This study will provide clinical information to determine the efficacy and safety of the treatment with fermented oyster extract on height growth in children with short stature.

Herbal anti-inflammatory immunomodulators as host modulators in chronic periodontitis patients: a randomised, double-blind, placebo-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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    • 제44권2호
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    • pp.71-78
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    • 2014
  • Purpose: Host modulatory therapy has been proposed as a treatment for periodontal diseases. A class of herbal medicines, known to be immunomodulators, alters the activity of immune function through the regulation of informational molecules such as cytokines. In the current study, we tested the hypothesis that herbal immunomodulator drugs act as an adjuvant to scaling and root planing (SRP) in alleviating periodontal inflammation by improving clinical and biochemical parameters. Methods: Sixty healthy subjects (30 in each group) with moderate and severe chronic periodontitis were enrolled in a double-blind, placebo-controlled, double-masked randomised controlled trial. The control group was treated with SRP and a placebo, whereas the test group was treated with SRP followed by dietary supplementation of Septilin for 3 weeks. Periodontal clinical parameters and serum C-reactive protein (CRP) levels were evaluated for all patients at the baseline, 3 weeks, and 6 weeks. Results: Improved gingival index scores found in the test group as compared to the control group were found to be statistically significant only after 3 weeks (P<0.001). In contrast, the decrease in the sulcus bleeding index and pocket depth scores was statistically highly significant in the test group as compared to the control group after 3 weeks and 6 weeks (P<0.001). However, reduced clinical attachment level and CRP scores, as reflected in the test group as compared to the control group, were not found to be statistically significant after both 3 weeks (P>0.05) and 6 weeks (P>0.05). Conclusions: The results of this clinical-biochemical study suggest that dietary supplementation with herbal immunomodulatory agents may be a promising adjunct to SRP and may aid in improving periodontal treatment outcomes.