• Title/Summary/Keyword: double-blind

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Efficacy and Safety of Cheong-A-Won Gagambang (JCE003) on Knee Osteoarthritis: Randomized Controlled Pilot Trial

  • Kong, Haejin;Kang, Jaehui;Lee, Hyun
    • Journal of Acupuncture Research
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    • v.39 no.3
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    • pp.202-212
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    • 2022
  • Background: The aim of this study was to evaluate the effectiveness and safety of Cheong-A-Won Gagambang (JCE003) treatment for degenerative knee osteoarthritis. Methods: This was a single-center, randomized, double-blind, placebo-controlled pilot clinical trial. There were 36 adults with degenerative knee osteoarthritis who were randomly allocated into JCE003 1,000 mg, JCE003 2,000 mg, or the placebo group (in a 1:1:1 ratio). The participants received 12 weeks of treatment and had scheduled tests every 6 weeks. The primary outcomes were measured using the Korean Western Ontario and McMaster Universities scale, and the secondary outcomes were measured using the visual analog scale, European quality of life-5-dimensions, patient global impression of change, C-reactive protein, and erythrocyte sedimentation rate. Changes between baseline scores and scores following study completion were analyzed. Results: There were 29 participants whose data were analyzed in this study. The change of Korean Western Ontario and McMaster Universities, visual analog scale, European quality of life-5-dimensions scores showed significant improvement in the JCE003 1,000 mg group. The change of patient global impression of change was significantly improved in the placebo group. There were 14 adverse events, but there was no clinically significant relationship with the intake of JCE003 compared with the placebo. Conclusion: Taking JCE003 may be effective at improving knee pain in patients with degenerative knee osteoarthritis and appears to be safe. Based on this study, the concentration and feasibility of the test group may be used when conducting a large-scale clinical trial of degenerative knee osteoarthritis in the future.

Evaluation of the efficacy and safety of epidural steroid injection using a nonparticulate steroid, dexamethasone or betamethasone: a double-blind, randomized, crossover, clinical trial

  • Lee, Guen Young;Lee, Joon Woo;Lee, Eugene;Yeom, Jin S.;Kim, Ki-Jeong;Shin, Hyung-Ik;Kang, Heung Sik
    • The Korean Journal of Pain
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    • v.35 no.3
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    • pp.336-344
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    • 2022
  • Background: The U.S. Food and Drug Administration has prohibited epidural steroid injection (ESI) with particulate steroids. Thus, this study aimed to compare the efficacy and safety of ESI with two nonparticulate steroids, dexamethasone and betamethasone. Methods: The eligible patients (n = 600) who received ESI (0 week) with dexamethasone (ESI-dexa) or betamethasone (ESI-beta) had follow-up visits at 2, 4, and 8 weeks with a phone interview at 12 weeks. The primary endpoint was the proportion of effective responders without pain or who were much improved at 2 weeks. The secondary endpoints were the proportion of crossover injections at 2 weeks; changes in the visual analog scale (VAS) and disability index scores at 2, 4, and 8 weeks; the number of additional ESIs in 12 weeks; the number of participants having spinal surgery, as well as the incidence of adverse events over the 12 weeks. Results: The proportion of effective responders at 2 weeks was not different between ESI-beta (72/216, 33.3%) and ESI-dexa (63/200, 31.5%; P = 0.670). Adverse events were more common with ESI-dexa (40/200, 20.0%) than with ESI-beta (24/216, 11.1%; P = 0.012). VAS scores decreased more with ESI-beta than with ESI-dexa at 2 weeks (difference, 0.35; P = 0.023) and 4 weeks (difference, 0.42; P = 0.011). The disability score improved significantly more with ESI-beta compared with ESI-dexa at 2 weeks (difference, 3.37; P = 0.009), 4 weeks (difference, 4.01; P = 0.002), and 8 weeks (difference, 3.54; P = 0.007). Conclusions: Betamethasone would be more appropriate for ESI.

A plant-based multivitamin, multimineral, and phytonutrient supplementation enhances the DNA repair response to metabolic challenges

  • Yeo, Eunji;Hong, Jina;Kang, Seunghee;Lee, Wonyoung;Kwon, Oran;Park, Eunmi
    • Journal of Nutrition and Health
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    • v.55 no.4
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    • pp.450-461
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    • 2022
  • Purpose: DNA damage and repair responses are induced by metabolic diseases and environmental stress. The balance of DNA repair response and the antioxidant system play a role in modulating the entire body's health. This study uses a high-fat and high-calorie (HFC) drink to examine the new roles of a plant-based multivitamin/mineral supplement with phytonutrients (PMP) for regulating the antioxidant system and cellular DNA repair signaling in the body resulting from metabolic stress. Methods: In a double-blind, randomized, parallel-arm, and placebo-controlled trial, healthy adults received a capsule containing either a PMP supplement (n = 12) or a placebo control (n = 12) for 8 weeks. Fasting blood samples were collected at 0, 1, and 3 hours after consuming a HFC drink (900 kcal). The blood samples were analyzed for the following oxidative stress makers: areas under the curve reactive oxygen species (ROS) levels, plasma malondialdehyde (MDA), erythrocytes MDA, urinary MDA, oxidized low-density lipoprotein, and the glutathione:oxidized glutathione ratio at the time points. We further examined the related protein levels of DNA repair signaling (pCHK1 (Serine 345), p-P53 (Serine 15), and 𝛄H2AX expression) in the plasma of subjects to evaluate the time-dependent effects of a HFC drink. Results: In a previous study, we showed that PMP supplementation for eight weeks reduces the ROS and endogenous DNA damage in human blood plasma. Results of the current study further show that PMP supplementation is significantly correlated with antioxidant defense. Compared to the placebo samples, the blood plasma obtained after PMP supplementation showed enhanced DNA damage response genes such as pCHK1(Serine 345) (a transducer of DNA response) and 𝛄H2AX (a hallmark of DNA damage) during the 8 weeks trial on metabolic challenges. Conclusion: Our results indicate that PMP supplementation for 8 weeks enhances the antioxidant system against oxidative stress and prevents DNA damage signaling in humans.

Fermented Whey Protein Supplementation Improves Muscular Strength, Muscle Parameters, and Physical Performance in Middle-Aged Korean Adults: An 8-Week Double Blind Randomized Controlled Trial

  • Cheol Hyun Kim;Yu Bin Jeon;Dong Gyu Yoo;Ki-Hong Kim;Hwan-Jong Jeong;Byung-Kwan Kim;Mi-Houn Park;Ki-Hwan Kim;Joon-Ho Hwang;Gun Hee Cho;Sung-Kyu Kim;Ki-Woong Lee;Sung-Han Kim
    • Food Science of Animal Resources
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    • v.43 no.3
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    • pp.512-530
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    • 2023
  • The present study evaluated the effects of fermented whey protein using kimchi lactic acid bacteria Lactobacillus casei DK211 on skeletal muscle mass, muscle strength, and physical performance in healthy middle-aged males performing regular resistance exercises. Effective protein supplementation and regular exercise are two important factors for improving muscle health. Therefore, in this study, the effects of consuming fermented whey protein twice a day were investigated and compared with that of non-fermented supplementation. Forty-eight males (average age 44.8) were randomly assigned to two groups: Fermented whey protein supplementation (FWPS) and non-fermented whey protein concentration supplementation (WPCS) groups. Each group ingested 37 g of FWPS or WPCS twice a day for eight weeks. Body composition, muscle strength, and physical performance were assessed pre- and post-intervention. Independent t-tests or chi-square tests for the categorical variables were performed for analyzing the observations. FWPS was effective in promoting the physical performance in dynamic balance measurement and muscle health, indicated through the increment in grip strength (left), upper arm circumference, and flat leg circumference from the baseline. However, similar improvements were not observed in the WPCS group. These results imply that whey protein fermented by L. casei DK211 is an effective protein supplement for enhancing muscle health in males performing regular resistance exercises.

Dental plaque removal efficiency of a smart toothbrush based on augmented reality in children (증강현실 기반 스마트 칫솔의 치면세균막 제거효과 평가)

  • Min-Ji Park;Suk-Bin Jang;Jae-Young Lee
    • Journal of Korean society of Dental Hygiene
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    • v.23 no.1
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    • pp.33-42
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    • 2023
  • Objectives: Based on the strengths of augmented reality (AR), this study aimed to determine the dental plaque removal efficiency of a guided brushing program in children. Methods: This randomized, controlled, double-blind crossover clinical trial evaluated the plaque removal rate after regular brushing versus AR-based guided toothbrushing in 20 children aged 5-12 years. Results: Overall, the dental plaque removal efficiency of AR-based brushing was superior to that of regular brushing (p<0.05). When classified in detail, no significant difference was noted in the plaque removal rate between the two brushing methods in the anterior region (p=0.056), whereas a significant difference in the plaque removal rate was observed in the posterior region (p<0.05). Conclusions: Based on these results, the efficacy of dental plaque removal for brushing using an AR-based smartphone application was confirmed; thus, this can be used for oral health education incorporating ICT technology in the future.

A Study on Thermal Effect and Medication Compliance of Red Ginseng Extract (홍삼의 온열 효과와 복약 순응도에 관한 연구)

  • Choi, Min-Sun;Jeong, Jae-Cheol;Park, Jang-Kyung;Ahn, Hong-Yeop;Kim, Dong-Il
    • The Journal of Korean Obstetrics and Gynecology
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    • v.22 no.3
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    • pp.223-235
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    • 2009
  • Purpose: To evaluate thermal effect and medication compliance of red ginseng extract. Methods: Randomized, double-blind, placebo-controlled, cross-over clinical study was performed. Twenty four healthy, married women aged 30-45 years with FSFI score below 25 were randomly divided into two groups; red ginseng group(N=12) and placebo group(N=12). During the first 6-week period (Study1), each group was dosed with red ginseng or placebo twice a day. Before starting the second 6-week period(Study2), a crossover design was chosen with a 2-week break(Washout period). Interchanging two groups after Washout period, red ginseng and placebo were dosed to each group. The efficacy of thermal effect was measured with subjective warm sensation scale and lower abdomen temperature by Digital Infrared Thermographic imaging(DITI) before and after each 6-week period. A medication compliance was assessed after each 6-week period and the correlation medication compliance between Sasang Constitution and subjective warm sensation was analyzed. Results: Overall 23 participants completed the study. In subjective warm sensation scale, after taking placebo, all participants exhibited an improving trend, but there was no significant difference. In lower abdomen temperature by DITI, statistically significant objective thermal effect of red ginseng was also not shown. A medication compliance was higher in Yin constitution(Taeumin, Soeumin), and showed an upward trend with decreasing subjective warm sensation. But no statistically significant difference was exhibited. Conclusion: Statistically significant thermal effect of red ginseng was not shown in this study. We anticipate if a long-term clinical trial is practiced, significant thermal effect of red ginseng will be shown.

A Clinical Study of InGaAlP Laser Transcutaneous Blood Irradiation on Heart Rate Variability in Healthy Adults (II) (InGaAlP 레이저 경피혈액조사가 정상성인의 심박변이도에 미치는 영향에 대한 임상적 연구(II))

  • Yeo, Jinju;Lee, Taeho;Son, Donghyuk;Hsing, Lichang;Lee, Inhwan;Jang, Insoo
    • The Journal of the Society of Stroke on Korean Medicine
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    • v.6 no.1
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    • pp.9-16
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    • 2005
  • Objective : The heart rate variability is very useful indicator to study the function of the autonomic nervous system(ANS), and the physiologic signals can be observed based on the changes of the ANS of the heart. In order to assay the effects of the laser exposing to healthy subjects, the double blind test has been performed. Methods : This study included 62 healthy adults who have not any ANS disease and had normal sinus rhythm in electrocardiogram. The control group consisted of 31 subjects, laser group consisted of 31 subject. HRV was measured for 5 minutes before laser irradiation, sham and real laser irradiated for 30 minutes and than HRV remeasured for 5 minutes. Statistical significance was evaluated by independent T-test. Results : Mean HRV, Ln(VLF), Ln(HF), Ln(TP) of both groups at post-laser period decreased compared with that of the pre-laser period. Ln(LF) of both groups at post-laser period increased compared with that of the pre-laser period. LF/HF, SDNN of real laser group decreased and sham group decreased. Conclusions : There is no difference between two groups. The reason is presumed that all the studied subjects are healthy adults, and also the short and single transcutaneous laser irradiation would not influence upon changes of the ANS. The further study must be followed.

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Efficacy of buccal piroxicam infiltration and inferior alveolar nerve block in patients with irreversible pulpitis: a prospective, double-blind, randomized clinical trial

  • Saurav Paul;Sridevi Nandamuri;Aakrati Raina;Mukta Bansal
    • Restorative Dentistry and Endodontics
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    • v.46 no.1
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    • pp.9.1-9.9
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    • 2021
  • Objectives: This randomized clinical trial aimed to assess the effectiveness of buccal infiltration with piroxicam on the anesthetic efficacy of inferior alveolar nerve block (IANB) with buccal infiltration in irreversible pulpitis, with pain assessed using the Heft-Parker visual analogue scale (HP-VAS). Materials and Methods: This study included 56 patients with irreversible pulpitis in mandibular molars, randomly distributed between 2 groups (n = 28). After evaluating the initial pain score with the HP-VAS, each patient received IANB followed by buccal infiltration of 2% lignocaine with adrenaline (1:80,000). Five minutes later, the patients in groups 1 and 2 were given buccal infiltration with 40 mg/2 mL of piroxicam or normal saline, respectively. An access opening procedure (AOP) was performed 15 minutes post-IANB once the individual showed signs of lip numbness as well as 2 negative responses to electric pulp testing. The HP-VAS was used to grade the patient's pain during caries removal (CR), AOP, and working length measurement (WLM). Successful anesthesia was identified either by the absence of pain or slight pain through CR, AOP, and WLM, with no requirement of a further anesthetic dose. A statistical analysis was done using the Shapiro-Wilk and Mann-Whitney U tests. Results: The piroxicam group presented a significantly lower (p < 0.05) mean pain score than the saline group during AOP. Conclusions: Buccal infiltration with piroxicam enhanced the efficacy of anesthesia with IANB and buccal infiltration with lignocaine in patients with irreversible pulpitis.

Proficiency test for analyzing illegal compounds in food (식품 중 부정유해물질의 분석 능력평가)

  • Chang, Moonik;Yoon, Taehyung;Hong, Mooki;Choi, Dongmi
    • Analytical Science and Technology
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    • v.20 no.1
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    • pp.78-83
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    • 2007
  • To perform proficiency test for determining anti-impotence drug-like compounds in food, interlaboratory test has been done. Targets were 6 such as sildenafil, tadalafil, vardenafil, homosildenafil, hydroxy-homosildenafil and pseudo-vardenafilI. Total 13 institutes were participated and all is in charging of food analysis. To do double blind test, the reference materials were made as 13 different ginseng drink samples and each sample had random 3 targets. By the official method for anti-impotence drug-like compounds in food code, sample was just diluted in water, extracted in organic solvents, determined by HPLC/UV and then confirmed by LC/MS. The analytical duration was 60 days after receiving sample. Ten out of 13 institutes were satisfied by evaluation of Z-score and RSZ according to the regulation for managing analytical quality assurance.

Effectiveness of dexamethasone or adrenaline with lignocaine 2% for prolonging inferior alveolar nerve block: a randomized controlled trial

  • Deo, Saroj Prasad;Ahmad, Md Shakeel;Singh, Abanish
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
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    • v.48 no.1
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    • pp.21-32
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    • 2022
  • Objectives: Inferior alveolar nerve block (IANB) is commonly used for mandibular dentoalveolar surgery. The objective of this study was to evaluate and compare the effectiveness of coadministration of dexamethasone (4 mg/mL) or adrenaline (0.01 mg/mL) as an adjuvant with lignocaine 2% in IANB during third molar surgery (TMS). Patients and Methods: This double-blind, randomized controlled trial was conducted between March and August 2020. The investigators screened patients needing elective TMS under local anesthesia. Based on strict inclusion and exclusion criteria, patients were enrolled in this study. These patients were assigned randomly into two study groups: dexamethasone group (DXN) or adrenaline group (ADN). Outcome variables were postoperative edema, trismus, visual analogue scale (VAS), perioperative analgesia, onset time, and duration of IANB. Results: Eighty-three patients were enrolled in this study, of whom 23 (27.7%) were eliminated or excluded during follow-up. This study thus included data from 60 samples. Mean age was 32.28±11.74 years, including 28 females (46.7%) in the ADN (16 patients, 57.1%) and DXN (12 patients, 42.9%) groups. The duration of action for DXN (mean±standard deviation [SD], 4:02:07±0:34:01 hours; standard error [SE], 0:06:00 hours; log-rank P=0.001) and for ADN (mean±SD, 1:58:34±0:24:52 hours; SE, 0:04:42 hours; log-rank P=0.001) were found. Similarly, time at which 1st analgesic consume and total number of nonsteroidal antiinflammatory drugs need to rescue postoperative analgesia was found statistically significant between study groups (t (58)=-11.95; confidence interval, -2:25:41 to -1:43:53; P=0.001). Early-hours VAS was also significantly different between the study groups. Conclusion: A single injection of dexamethasone prolongs the duration of action of lignocaine 2% IANB. Additionally, it can be used in cases where adrenaline is contraindicated.