• Title/Summary/Keyword: randomized controlled trial

Search Result 1,224, Processing Time 0.032 seconds

Effect of Onkyung-tang on Cold Hypersensitivity on Feet: A Multi-center Double-blind Randomized Controlled Trial (온경탕이 족부냉증에 미치는 영향에 대한 다기관 이중맹검 무작위 대조군 연구)

  • Kwon, Na-Yoen;Yoo, Joon-Sang;Kim, Hyeong-Jun;Lee, Dong Nyung
    • The Journal of Korean Obstetrics and Gynecology
    • /
    • v.33 no.3
    • /
    • pp.149-174
    • /
    • 2020
  • Objectives: This study was aimed to figure out the effect of Onkyung-tang (OKT) on cold hypersensitivity on feet in female patients. Methods: This study was designed to implement multi-center randomized clinical trial in three korean medical hospitals. The female patients who were enrolled in this study were 112 women who suffered from cold hypersensitivity on feet. They were randomly allocated into OKT group or control group in 1:1 ratio. The primary outcome was change in score of visual analogue scale of hypersensitivity on feet, and the secondary outcomes were thermometer of LU4, PC8, ST32, LR3, visual analogue scale of hypersensitivity on hands, result of cold stress test, and score of World Health Organization Quality of Life-BREF. Results: In both group, the VAS of hypersensitivity on feet and hands was decreased while taking the medicine, and the effect of decreasing the VAS continues for the 4 weeks after the end of medication (p<0.001, 0.003, 0.001). In OKT group, the body temperature difference in lower extremity (ST32-LR3) was steadily decreased at every visit and it was statistically significant(p=0.003, <0.001). On the other hand, in control group, the body temperature difference in lower extremity was decreased only while taking the medicine (p<0.001). Conclusions: OKT significantly reduced discomfort coldness on feet in patients, and the effect of treatment was maintained at least for four weeks after medication.

Innovative customized CAD/CAM nickel-titanium lingual retainer versus standard stainless-steel lingual retainer: A randomized controlled trial

  • Gelin, Emilie;Seidel, Laurence;Bruwier, Annick;Albert, Adelin;Charavet, Carole
    • The korean journal of orthodontics
    • /
    • v.50 no.6
    • /
    • pp.373-382
    • /
    • 2020
  • Objective: To compare computer-aided design and computer-aided manufacturing (CAD/CAM) customized nitinol retainers with standard stainless-steel fixed retainers over a 12-month study period. Methods: This randomized controlled trial (RCT) was conducted on 62 patients randomly allocated to a control group that received stainless-steel retainers or a test group that received customized CAD/CAM nickel-titanium retainers. Four time points were defined: retainer placement (T0) and 1-month (T1), 6-month (T2), and 12-month (T3) follow-up appointments. At each time point, Little's irregularity index (LII) (primary endpoint) and dental stability measurements such as intercanine width were recorded in addition to assessment of periodontal parameters. Radiological measurements such as the incisor mandibular plane angle (IMPA) were recorded at T0 and T3. Failure events (wire integrity or debonding) were assessed at each time point. Results: From T0 to T3, LII and other dental measurements showed no significant differences between the two groups. The data for periodontal parameters remained stable over the study period, except for the gingival index, which was slightly, but significantly, higher in the test group at T3 (p = 0.039). The IMPA angle showed no intergroup difference. The two groups showed no significant difference in debonding events. Conclusions: This RCT conducted over a 12-month period demonstrated no significant difference between customized CAD/CAM nickel-titanium lingual retainers and standard stainless-steel lingual retainers in terms of dental anterior stability and retainer survival. Both retainers eventually appeared to be equally effective in maintaining periodontal health.

A 8-Week, Randomized, Double-Blind, Placebo-Controlled Human Trial to Evaluate the Efficacy and Safety of Punica granatum L.·Actinidia chinensis Planch. Mixed Extract on Body Fat (석류·참다래 혼합추출물의 체지방 감소에 대한 유효성 및 안전성을 평가하기 위한 8주, 무작위 배정, 이중눈가림, 위약-대조 인체적용시험)

  • Choi, Jin-Bong;Lee, Ji-Eun;Do, Yun-Kyoung
    • Journal of Korean Medicine for Obesity Research
    • /
    • v.17 no.2
    • /
    • pp.87-95
    • /
    • 2017
  • Objectives: This study was conducted to evaluate efficacy and safety of Punica granatum L. Actinidia chinensis Planch. mixed extract on body fat. Methods: Thirty women were recruited ($25kg/m^2{\leq}body$ mass index [BMI]${\leq}29.9kg/m^2$) ($19yr{\leq}age{\leq}38yr$) and randomized to receive Punica granatum L. Actinidia chinensis Planch. mixed extract or placebo for 8 weeks. During the test, they visited four times including screening. Body fat mass, body fat rate, anthropometric dimensions at waist and hip, waist-hip ratio, total cholesterol, triglyceride, low density lipoprotein-cholesterol (LDL-C), and high density lipoprotein-cholesterol (HDL-C) were measured at screening and 8 weeks after screening. Adverse reaction were also checked each visit. Results: There were no significant differences in all index. But when divide experimental group by BMI index, age, and compliance, less than BMI $27kg/m^2$ group decreased body weight, body fat mass and more than BMI $27kg/m^2$ group also decreased body weight, body fat mass and waist circumference. Less than age 30 years group showed decline of waist circumference, fat free rate and T-cholesterol and more than age 30 years group showed decline of fat free mass. Group with compliance more than 95% was decreased BMI, fat free mass, and hip circumference. Conclusions: There was no significant efficacy as compared with placebo group, but as divide experimental group according to BMI index, age, compliance, mixed extract might be effective to reduce obesity index.

Hyaluronic acid reduces inflammation and crevicular fluid IL-1β concentrations in peri-implantitis: a randomized controlled clinical trial

  • Sanchez-Fernandez, Elena;Magan-Fernandez, Antonio;O'Valle, Francisco;Bravo, Manuel;Mesa, Francisco
    • Journal of Periodontal and Implant Science
    • /
    • v.51 no.1
    • /
    • pp.63-74
    • /
    • 2021
  • Purpose: This study investigated the effects of hyaluronic acid (HA) on peri-implant clinical variables and crevicular concentrations of the proinflammatory biomarkers interleukin (IL)-1β and tumor necrosis factor (TNF)-α in patients with peri-implantitis. Methods: A randomized controlled trial was conducted in peri-implantitis patients. Patients were randomized to receive a 0.8% HA gel (test group), an excipient-based gel (control group 1), or no gel (control group 2). Clinical periodontal variables and marginal bone loss after 0, 45, and 90 days of treatment were assessed. IL-1β and TNF-α levels in crevicular fluid were measured by enzyme-linked immunosorbent assays at baseline and after 45 days of treatment. Clustering analysis was performed, considering the possibility of multiple implants in a single patient. Results: Sixty-one patients with 100 dental implants were assigned to the test group, control group 1, or control group 2. Probing pocket depth (PPD) was significantly lower in the test group than in both control groups at 45 days (control 1: 95% CI, -1.66, -0.40 mm; control 2: 95% CI, -1.07, -0.01 mm) and 90 days (control 1: 95% CI, -1.72, -0.54 mm; control 2: 95% CI, -1.13, -0.15 mm). There was a trend towards less bleeding on probing in the test group than in control group 2 at 90 days (P=0.07). Implants with a PPD ≥5 mm showed higher levels of IL-1β in the control group 2 at 45 days than in the test group (P=0.04). Conclusions: This study demonstrates for the first time that the topical application of a HA gel in the peri-implant pocket and around implants with peri-implantitis may reduce inflammation and crevicular fluid IL-1β levels.

A Randomized Controlled Trial To Motivate Worksite Fecal Occult Blood Testing (암위험사정이 직장인의 혈변검사에 미친 영향에 관한 실험연구)

  • 이정렬
    • Journal of Korean Academy of Nursing
    • /
    • v.20 no.3
    • /
    • pp.300-306
    • /
    • 1990
  • Colorectal cancer is second only to lung cancer as a cause of death due to cancer in the united States. Studies have shown that fecal occult blood(FOB) tests are effective in detecting colorectal cancer in its early stages. To motivate worksite FOB testing, a randomized controlled trial was conducted. Employees 40 years or older from three federal agencies in Washington State were randomized to a control group(n=139) which received a letter stating the availability of the FOB test at the worksite clinic or to an intervention group(n=139) which received the letter about facts on colorectal cancer and a Colorectal Cancer Risk Appraisal. The Colorectal Cancer Risk Appraisal included a feedback on an individual's risk of developing colorectal cancer compared to his / her peers in terms of ‘normal’, ‘moderate’, or ‘high’ risk status. After 3 months, a follow-up questionnaire was sent to all participants to measure the effectiveness of the intervention. In the analysis of the three major outcomes, two possible confounding factors(dietary fat and family history of colorectal cancer) were controlled by logistic regression. Based on a review of the worksite clinic records, the Intervention group had 4.3% higher compliance rate with the FOB test during the follow-up period compared to the control group(p=.10). The largest effect of the intervention was on the employees' intention to get a FOB test within the next year(62.6% in the intervention group vs. 36.2% in the control group, OR=3.18, p<.001). In the final Multivariate logistic model, the employees who were more likely to intend to get a FOB test within the next year were in the intervention group ; were at ‘moderate’ or ‘high’ risk of colorectal cancer ; knew more about the availability of the FOB test at the worksite clinic ; and had a FOB test during the last three years.

  • PDF

A Literature Study of Topical Application of Chinese Herbal Medicine for Allergic Rhinitis (국소한약외용제의 알레르기성 비염 치료 효과에 대한 문헌 고찰)

  • Bang, Mi Ran;Kim, Jang Hyun;Min, Sang Yeon
    • The Journal of Pediatrics of Korean Medicine
    • /
    • v.30 no.3
    • /
    • pp.52-60
    • /
    • 2016
  • Objectives The purpose of this study is to analyze studies about the effects of topical application of Chinese herbal medicine for allergic rhinitis within randomized controlled trials (RCT). Methods The search database includes KJTK (Korean Traditional Knowledge Portal), OASIS (Oriental Medicine Advanced Searching Integrated system), CNKI (China National Knowledge Infrastructure), PubMed, and EMBASE. We used the following key search terms: "allergic rhinitis", "traditional Chinese medicine", "traditional Korean medicine", "Chinese herbal medicine", "randomized controlled trial", "clinical study", "nasal spray", and "nasal drop" Results Five studies were selected for analysis. Three studies used nasal spray of Chinese herbal medicine and two studies used nasal drops of Chinese herbal medicine for the intervention. Frequently used herbs were Magnoliae Flos (辛夷), Scutellariae Radix (黃芩), Coptidis Rhizoma (黃連), and Astragali Radix (黃芪). For the outcome measures, studies used symptom score, questionnaire of Quality of Life, nasal airway resistance, or laboratory studies. From all 5 studies, it has been shown that topical application of Chinese herbal medicine was effective for improving symptoms of allergic rhinitis. Two out of five studies showed statistical difference between study group and control group. Conclusions This study shows that topical application of Chinese herbal medicine can improve symptoms of allergic rhinitis. Well-designed RCT studies with low risk of bias and studies with outcome measures for assessing the immunomodulatory effects are necessary to confirm these findings.

Effectiveness of tramadol compared to lignocaine as local anesthesia in the extraction of firm teeth: a randomized controlled trial

  • Goel, Manu;Sen, Pinaki;Maturkar, Tushar;Latke, Siddhesh;Dehankar, Tejasvini
    • Journal of Dental Anesthesia and Pain Medicine
    • /
    • v.21 no.3
    • /
    • pp.245-252
    • /
    • 2021
  • Background: The aim of this study was to compare the local anesthetic effect of tramadol with that of lignocaine in the extraction of immobile (grade 0) maxillary first molars. Methods: This was a randomized, double-blind, equally balanced, controlled trial conducted on a sample population of 116 patients. The patients were randomly divided into two groups: group A (control) and group B (study). Group A and group B participants received 1.8 ml of 2% lignocaine without adrenaline and 1.8 ml of 5% tramadol, respectively through the supra-periosteal infiltration technique before extraction. Intraoperative pain was recorded on the Visual Analog Scale (VAS) and was evaluated using two unpaired t-tests. Results: Intraoperative pain was evaluated in both the control and study groups. In the control group, the mean VAS score was 0.71 ± 0.81, while in the study group, the mean intraoperative VAS score was 1.21 ± 0.86, with the difference between the two mean values being statistically significant (P = 0.001). Conclusion: Tramadol has a less potent local anesthetic effect than lignocaine. As a higher dose of tramadol is required to obtain the desired anesthetic effect, it should be used as a supplement to lignocaine in extensive surgical procedures. It can also be used in patients allergic to lignocaine.

Randomized Controlled Trials of Acupuncture for Healthy Volunteers in Korea: A Systematic Review (국내에서 수행된 건강인 대상 침 관련 무작위 대조 임상연구에 대한 체계적 문헌 고찰)

  • Sagong, Hye-Seon;Kim, Hyun-Tae;Heo, In;Shin, Byung-Cheul
    • Journal of Korean Medicine Rehabilitation
    • /
    • v.31 no.1
    • /
    • pp.137-147
    • /
    • 2021
  • Objectives Domestic acupuncture research is being actively conducted in various fields. The aim of this study is to systematically analyze the current acupuncture randomized controlled trials (RCTs) conducted on healthy volunteers. Methods We searched RCTs by the search terms of (acupuncture & random & healthy) in 10 electronic databases and related journals. Then, we analyzed the characteristics and assessed the risk of bias by Cochrane tool. Results Finally, 49 acupuncture RCTs on health volunteers were included in our analysis. The purpose of research could be classified into five major categories: (1) checking the effects on physiological function, (2) comparing the effects of different acupuncture/acupuncture methods, (3) a study confirming improvement after inducing a specific condition, (4) a sham acupuncture study, and (5) a comparison of acupuncture sense. The Cochrane risk of bias was generally high, especially only 1 trial adopted allocation concealment (1/49, 2.0%) and 9 ones with assessor blinding (9/49, 18.4%). Conclusions Acupuncture RCTs in healthy subjects have confirmed various effects in various age/sex groups. However the research quality should be updated for future clinical research and to draw clear conclusion within rigorous methodology.