• Title/Summary/Keyword: Clinical trial center

Search Result 740, Processing Time 0.03 seconds

Effect of high-dose ginsenoside complex (UG0712) supplementation on physical performance of healthy adults during a 12-week supervised exercise program: A randomized placebo-controlled clinical trial

  • Lee, Eon Sook;Yang, Yun Jun;Lee, Jun Hyung;Yoon, Yeong Sook
    • Journal of Ginseng Research
    • /
    • v.42 no.2
    • /
    • pp.192-198
    • /
    • 2018
  • Background: Ginseng has been used as an ergogenic agent, although evidence for its effectiveness is weak. A randomized, double-blind, placebo-controlled clinical trial was conducted to evaluate the effect of a ginsenoside complex (UG0712) on changes in exercise performance. Methods: Sedentary individuals (n = 117) were randomly assigned into one of three groups: low-dose ginsenoside supplementation (100 mg/d, n = 39), high-dose ginsenoside supplementation (500 mg/d, n = 39), or a placebo group (500 mg/d, n = 39). All participants underwent a supervised 12-wk aerobic and resistance exercise training course. To assess the effects of supplementation on physical performance, maximal oxygen consumption ($VO_2max$), anaerobic threshold (AT), lactic acid, and muscle strength of the dominant knee were measured at baseline, every visit, and after the training program. Results: Both ginsenoside groups showed significant increases in $VO_2max$ and muscular strength during exercise training. There were no definite changes in AT and lactic acid levels over time. After exercise training, there were definite differences in the $VO_2max$ (28.64.9 to $33.7{\pm}4.9ml/kg/min$ in high-dose group vs. $30.4{\pm}6.7$ to $32.8{\pm}6.6ml/kg/min$ in placebo, p = 0.029) and AT ($19.3{\pm}4.2$ to $20.9{\pm}3.5ml/kg/min$ in high-dose group vs. $20.0{\pm}5.1$ to $20.0{\pm}4.9ml/kg/min$ in placebo, p = 0.038) between the high-dose ginsenoside and placebo groups. However, there was no difference in $VO_2max$ between the low-dose ginsenoside and placebo groups (p = 0.254). There were no differences in muscular strength during exercise training among the three groups. Conclusion: High-dose ginsenoside supplementation (UG0712) augmented the improvement of aerobic capacity by exercise training.

Acupuncture as an Additional Method of Rehabilitation Post-COVID-19: a randomized controlled trial

  • Indira Omarova;Assiya Akanova;Almagul Kurmanova;Gaukhar Kurmanova;Natalya Glushkova;Amina Seidanova;Kuatzhan Turysbekov
    • Journal of Pharmacopuncture
    • /
    • v.26 no.3
    • /
    • pp.238-246
    • /
    • 2023
  • Objectives: The purpose of this study was to evaluate the effectiveness of complex rehabilitation with and without acupuncture in a hospital setting. Methods: A randomized clinical trial was performed at Rehabilitation center "Kamenskoe Plato" in Almaty, Kazakhstan. 160 patients with Post COVID-19 condition were randomly equally divided into an acupuncture with complex rehabilitation methods and a only complex rehabilitation methods group in the period from March 1, 2022 to July 1, 2022. Either groups was performed for an 10-14 days period. The outcome measures were the Bartel index, the Borg scale, Modified Dyspnea Scale and the 6-minute walking test. Adverse events also were monitored and documented. Results: We found statistically significant improvement after the rehabilitation course with acupuncture in the all scales. And in the group without acupuncture, only on two scales: MDS and Borg scale. Conclusion: Rehabilitation with acupuncture is possible and effective in patients recovering from post-COVID-19. Our findings may be useful to guide clinicians taking care of patients with post-COVID-19.

Effects of the Fermented Milk Intake on Human Antioxidant Activity and Blood Alcohol Concentration

  • Nam, Hae-Seon;Lee, Kyong-Ae;Lee, Yong-Jin;Kim, Yong-Bae;Kim, Sung-Ho;Lee, Sang-Han;Lee, Sun-Hwa;Lee, Yoon-Jin;Kim, Ho-Young;Ahn, Young-Tae;Lim, Kwang-Sei;Huh, Chul-Sung
    • Food Science and Biotechnology
    • /
    • v.15 no.1
    • /
    • pp.82-85
    • /
    • 2006
  • Randomized, double-blinded, placebo-controlled, cross-over clinical trial was performed to assess effects of fermented milk intake on antioxidant activities and blood alcohol levels of 26 healthy volunteers. All subjects received fermented milk ($Kupffer's^{(R)}$, n=13) or placebo (n=13) twice daily for 2 weeks. After 3 weeks resting period, subjects under same test but in reverse role. In both tests, fermented milk intake significantly increased total antioxidant status (p<0.05) and decreased thiobarbituric acid reactive substance (p<0.05) levels compared to before fermented milk intake. Blood alcohol levels of fermented milk intake group were significantly lower than those of placebo group (p<0.05).

Effects of Cordyceps militaris supplementation on the immune response and upper respiratory infection in healthy adults: a randomized, double-blind, placebo-controlled study (건강한 성인을 대상으로 면역증강 및 상기도 감염 예방에 대한 동충하초주정추출물의 유효성 평가 : 이중맹검 플라세보 대조 연구)

  • Jung, Su Jin;Hwang, Ji Hyun;Oh, Mi Ra;Chae, Soo Wan
    • Journal of Nutrition and Health
    • /
    • v.52 no.3
    • /
    • pp.258-267
    • /
    • 2019
  • Purpose: Upper respiratory tract infections are major causes of the common cold throughout the world. Cordyceps militaris (C. militaris) is a well-known functional food for its anti-fatigue and immunomodulating activities. On the other hand, there are no reports on the protective effect against upper respiratory tract infections (URI). This study was a 12 week randomized, double-blind, and placebo-controlled trial in healthy volunteers. Methods: A total of 100 subjects 20 ~ 70 years of age with a history of at least two colds in the year were enrolled in the study. The participants were required to record any adverse events and rate any cold-related incidents in a diary during the investigation period. The efficacy end point was the symptoms and incidence of URI, and changes in cytokines, IgA and natural killer (NK) cell activity. Results: The Cordyceps militaris group over 12 weeks showed no significant impact on the incidence and symptomatology of URI compared to the placebo group. On the other hand, the experimental group showed significantly higher NK cell activity (p = 0.047) and IgA level (p = 0.035) compared to the placebo group. The NK-cell activity and IgA level were increased significantly by Cordyceps militaris over 12 weeks. Conclusion: The results suggest the possible beneficial immunomodulating effects, but the protective effects on URI could not be demonstrated under these conditions. Additional research will be needed to determine the efficacy and mechanisms of Cordyceps militaris function.

Present Status of the Proton Therapy Project at the Wakasa Wan Energy Research Center

  • Kyo Kume;Shigekazu Fukuda;Sadayoshi.Fukumoto;Hisakazu Hamachi;Ha, Takashi.segawa;Satoshi Hatori;Yutaka Hayashi;Go Kagiya;Shuji Kakiuchi
    • Proceedings of the Korean Society of Medical Physics Conference
    • /
    • 2002.09a
    • /
    • pp.171-173
    • /
    • 2002
  • Present status of the proton therapy project at the Wakasa Wan Energy Research Center, Japan, is reported. Construction of the accelerator system was finished in 2001, followed by some trials of the production of the flat clinical irradiation field for the clinical usage. After the patient positioning system with X-ray CT was verified, the first clinical trial was started for two patients with prostate cancer.

  • PDF

An Analysis of the Existing Guidelines and Clinical Trials for the Development of the Guidelines of Clinical Trials with Herbal Medicinal Products for Gastroesophageal Reflux Disease (GERD) (위식도역류질환 한약제제 임상시험 가이드라인 개발을 위한 관련 국내 가이드라인 분석 및 기존 한약임상시험과의 비교)

  • Han, Ga-jin;Leem, Jung-tae;Kim, Jin-sung;Lee, Jun-hee
    • The Journal of Internal Korean Medicine
    • /
    • v.37 no.1
    • /
    • pp.90-108
    • /
    • 2016
  • Objectives: This study aimed to learn what should be considered in the Guidelines of Clinical Trials with Herbal Medicinal Products for Gastroesophageal Reflux Disease (GERD) by analyzing the existing guidelines and clinical trials.Methods: The development committee searched the existing guidelines for herbal medicinal products or GERD. Then, clinical trials related to GERD using herbal medicine were selected. The chosen trials were analyzed in terms of their inclusion and exclusion of participants, intervention, comparators, outcome, and trial design. Then, we compared the results of the analysis according to the regulations and guidelines of the Ministry of Food and Drug Safety to suggest the issues that we will have to consider when developing the Guidelines of Clinical Trials with Herbal Medicinal Products for Gastroesophageal Reflux Disease (GERD).Results: As a result, few guidelines for GERD and clinical trials with herbal medicinal products were located in the national institution homepage. In addition, 8 articles were found using the following combination of search terms: “Gastroesophageal reflux disease”, “GERD”, “herbal medicine”, “herbal therapy”, “Korean Medicine”, “Traditional Chinese Medicine”, and “TCM”. Even though all trials had their own unique research questions, all studies were performed using a randomization method. Most trials included participants with reflux esophagitis, but two trials targeted proton pump inhibitor-refractory GERD. The type of intervention varied, such as decoction, granules, and capsules. Additionally, individualized herbal medicines were used in two studies. Comparators were diverse, such as placebo, Western medicine, and electro-acupuncture. The most frequently used outcome for efficacy was the effectiveness rate. In addition, the outcome for evaluating quality of life, esophageal mucosa and pressure, esophageal acid reflux, and recurrence rates were used. Safety was investigated by recording adverse events and carrying out laboratory tests.Conclusions: We identified some issues by reviewing the existing guidelines and comparing them with clinical trials for GERD and herbal medicinal products. These results will be utilized for developing the Guidelines of Clinical Trials with Herbal Medicinal Products for Gastroesophageal Reflux Disease (GERD).

Prospective Multicenter Feasibility Study of Laparoscopic Sentinel Basin Dissection after Endoscopic Submucosal Dissection for Early Gastric Cancer: SENORITA 2 Trial Protocol

  • Eom, Bang Wool;Yoon, Hong Man;Min, Jae Seok;Cho, In;Park, Ji-Ho;Jung, Mi Ran;Hur, Hoon;Kim, Young-Woo;Park, Young Kyu;Nam, Byung-Ho;Ryu, Keun Won;Sentinel Node Oriented Tailored Approach (SENORITA) Study Group
    • Journal of Gastric Cancer
    • /
    • v.19 no.2
    • /
    • pp.157-164
    • /
    • 2019
  • Purpose: Although standard radical gastrectomy is recommended after noncurative resection of endoscopic submucosal dissection (ESD) for early gastric cancer in most cases, residual tumor and lymph node metastasis have not been identified after surgery. The aim of this study is to evaluate the feasibility of sentinel node navigation surgery after noncurative ESD. Materials and Methods: This trial is an investigator-initiated, multicenter prospective phase II trial. Patients who underwent ESD for clinical stage T1N0M0 gastric cancer with noncurative resections were eligible. Qualified investigators who completed the prior phase III trial (SENORITA 1) are exclusively allowed to participate. In this study, 2 detection methods will be used: 1) intraoperative endoscopic submucosal injection of dual tracer, including radioisotope and indocyanine green (ICG) with sentinel basins detected using gamma-probe; 2) endoscopic injection of ICG, with sentinel basins detected using a fluorescence imaging system. Standard laparoscopic gastrectomy with lymphadenectomy will be performed. Sample size is calculated based on the inferior confidence interval of the detection rate of 95%, and the calculated accrual is 237 patients. The primary endpoint is detection rate, and the secondary endpoints are sensitivity and postoperative complications. Conclusions: This study is expected to clarify the feasibility of laparoscopic sentinel basin dissection after noncurative ESD. If the feasibility is demonstrated, a multicenter phase III trial will be initiated to compare laparoscopic sentinel node navigation surgery versus laparoscopic standard gastrectomy in early gastric cancer after endoscopic resection.

An overview of acupuncture for cancer related pain (암성통증에 대한 침치료의 고찰)

  • Kim, June-Lae;Yoo, Hwa-Seung;Lee, Nam-Heon;Yoon, Dam-Hee;Cho, Jung-Hyo;Lee, Yeon-Weol;Son, Chang-Gue;Cho, Chong-Kwan
    • Journal of Haehwa Medicine
    • /
    • v.15 no.1
    • /
    • pp.41-45
    • /
    • 2006
  • Aims: This overview summarizes the existing evidence on acupuncture for cancer-related pain. Methods: Literature searches were conducted in 7 databases. All clinical studies of acupuncture, electroacupuncture, ear acupuncture and transcutaneous electrical nerve stimulation (TENS) in cancer patients with the main outcome measure of pain were included. Results: Of the 8 studies included, one high quality randomized clinical trial (RCT) of ear acupuncture showed statistically significant pain relief in comparison with placebo ear acupuncture. All the other studies were either non-blinded (n = 2) or uncontrolled clinical trials (n = 5). Most investigations suffered from methodological flaws such as inadequate study design, poor reporting of results, small sample size and overestimation of the results. Conclusions: The current evidence does not support the use of acupuncture as an adjunctive analgesic method for cancer patients. Only one high quality RCT showed promising results thus warranting further investigation into this under-researched area.

  • PDF

Effects of Acupuncture Stimulation on the Radial artery's Pressure Pulse Wave in Healthy Young Participants: Protocol for a prospective, single-Arm, Exploratory, Clinical Study

  • Shin, Jae-Young;Ku, Boncho;Kim, Tae-Hun;Bae, Jang Han;Jun, Min-Ho;Lee, Jun-Hwan;Kim, Jaeuk U.
    • Journal of Pharmacopuncture
    • /
    • v.19 no.3
    • /
    • pp.197-206
    • /
    • 2016
  • Introduction: This study aims to investigate the effects of acupuncture stimulation on the radial artery's pressure pulse wave, along with various hemodynamic parameters, and to explore the possible underlying mechanism of pulse diagnosis in healthy participants in their twenties. Methods and analysis: This study is a prospective, single-arm, exploratory clinical study. A total of 25 healthy participants, without regard to gender, in their twenties will be recruited by physicians. Written informed consent will be obtained from all participants. The participants will receive acupuncture once at ST36 on both sides. The radial arterial pulse waves will be measured on the left arm of the subjects by using an applicable pulse tonometric device (KIOM-PAS). On the right arm (appearing twice), electrocardiogram (ECG), photoplethysmogram (PPG), respiration and cardiac output (CO) signals, will be measured using a physiological data acquisition system (Biopac module), while the velocity of blood flow, and the diameter and the depth of the blood vessel will be measured using an ultrasonogram machine on the right arm (appearing twice). All measurements will be conducted before, during, and after acupuncture. The primary outcome will be the spectral energy at high frequencies above 10 Hz ($SE_{10-30Hz}$) calculated from the KIOM-PAS device signal. Secondary outcomes will be various variables obtained from the KIOM-PAS device, ECG, PPG, impedance cardiography modules, and an ultrasonogram machine. Discussion: The results of this trial will provide information regarding the physiological and the hemodynamic mechanisms underlying acupuncture stimulation and clinical evidence for the influence of acupuncture on the pressure pulse wave in the radial artery. Ethics and dissemination: This study was approved by the Institutional Review Board (IRB) of Kyung Hee University's Oriental Medical Center, Seoul, Korea (KOMCIRB-150818-HR-030). The study findings will be published in peer-reviewed journals and presented at national and international conferences. Trial registration number: This trial was registered with the Clinical Research Information Service (CRIS) at the Korea National Institute of Health (NIH), Republic of Korea (KCT0001663), which is a registry in the World Health Organization's (WHO's) Registry Network.