• Title/Summary/Keyword: preliminary clinical trial

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Safety and Efficacy of Bone Cement (Spinofill®) for Verte-broplasty in Patients with Osteoporotic Compression Fracture : A Preliminary Prospective Study

  • Park, Han Byeol;Son, Seong;Jung, Jong Myung;Lee, Sang Gu;Yoo, Byung Rhae
    • Journal of Korean Neurosurgical Society
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    • v.65 no.5
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    • pp.730-740
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    • 2022
  • Objective : Although several commercialized bone cements are used during percutaneous vertebroplasty (PVP) for patients with osteoporotic vertebral compression fracture (OVCF), there are no reports using domestic products from South Korea. In this study, we investigated the safety and efficacy of Spinofill® (Injecta Inc., Gunpo, Korea), a new polymethyl methacrylate product. Methods : A prospective, single-center, and single-arm clinical trial of 30 participants who underwent PVP using Spinofill® for painful thoracolumbar OVCF was performed with 6-months follow-up. Clinical and surgical outcomes included the Visual analog scale (VAS), Korean-Oswestry disability index (K-ODI), and Odom's criteria, complication rate, and recurrence rate. Radiological outcomes were evaluated by measuring the findings of postoperative computed tomography and simple radiograph. Results : The pain of VAS (from 8.95±1.05 to 4.65±2.06, p<0.001) and the life quality based on K-ODI (from 33.95±5.84 to 25.65±4.79, p<0.001) improved significantly, and successful patient satisfaction were achieved in 20 patients (66.7%) 1 day after surgery. These immediate improvements were maintained or more improved during the follow-up. There was no surgery- or product-related complications, but OVCF recurred in two patients (6.7%). Favorable cement interdigitation was reported in 24 patients (80.0%), and extra-vertebral cement leakage was reported in 13 patients (43.0%). The mean vertebral height ratio (from 60.49%±21.97% to 80.07%±13.16%, p<0.001) and segmental kyphotic angle (from 11.46°±8.50° to 7.79°±6.08°, p=0.002) improved one day after surgery. However, these short-term radiological findings somewhat regressed at the end. Conclusion : The overall outcomes of PVP using Spinofill® were as favorable as those of other conventionally used products.

Clinical Evidence of Effects of Lactobacillus plantarum HY7714 on Skin Aging: A Randomized, Double Blind, Placebo-Controlled Study

  • Lee, Dong Eun;Huh, Chul-Sung;Ra, Jehyeon;Choi, Il-Dong;Jeong, Ji-Woong;Kim, Sung-Hwan;Ryu, Ja Hyun;Seo, Young Kyoung;Koh, Jae Sook;Lee, Jung-Hee;Sim, Jae-Hun;Ahn, Young-Tae
    • Journal of Microbiology and Biotechnology
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    • v.25 no.12
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    • pp.2160-2168
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    • 2015
  • The beneficial effects of probiotics are now widely reported, although there are only a few studies on their anti-aging effects. We have found that Lactobacillus plantarum HY7714 (HY7714) improves skin hydration and has anti-photoaging effects, and in the present study, we have further evaluated the anti-aging effect of HY7714 via a randomized, double blind, placebo-controlled clinical trial. The trial included 110 volunteers aged 41 and 59 years who have dry skin and wrinkles. Participants took 1 × 1010 CFU/day of HY7714 (probiotic group) or a placebo (placebo group) for 12 weeks. Skin hydration, wrinkles, skin gloss, and skin elasticity were measured every 4 weeks during the study period. There were significant increases in the skin water content in the face (p < 0.01) and hands (p < 0.05) at week 12 in the probiotic group. Transepidermal water loss decreased significantly in both groups at weeks 4, 8, and 12 (p < 0.001 compared with baseline), and was suppressed to a greater extent in the face and forearm in the probiotic group at week 12. Volunteers in the probiotic group had a significant reduction in wrinkle depth at week 12, and skin gloss was also significantly improved by week 12. Finally, skin elasticity in the probiotic group improved by 13.17% (p < 0.05 vs. controls) after 4 weeks and by 21.73% (p < 0.01 vs. controls) after 12 weeks. These findings are preliminary confirmation of the anti-aging benefit to the skin of L. plantarum HY7714 as a nutricosmetic agent.

Exploring the Effective Herbal Prescription for Cognitive Disorder Treatment among Licensed Herbal Medicines in Korea - A Preliminary Study for Clinical Trial of Cognitive Disorders (기허가 한약제제를 대상으로 한 인지장애 치료 유효 약물 탐색 - 인지장애 임상연구를 위한 예비연구)

  • Seo, Young Kyung;Lee, Ji yoon;Oh, You Chang;Lee, Jung Jin;Li, Wei;Jeong, Yun Hee;Lee, Sun Joo;Go, Young Hoon;Jung, In Chul
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.33 no.4
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    • pp.207-218
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    • 2019
  • It is necessary to investigate the efficacy of commercial Korean herbal medicine for cognitive disorder. The purpose of this study is to select candidates among licensed herbal medicines that are expected to be effective in the treatment of cognitive disorders and can be used in future clinical trial. From laboratory experiments, we first found individual single herbal drugs that could be effective for cognitive disorder, and then through experts recommendation, selected five priorities of single herbal drug and obtained the information of the best herb as a combination of each herbal drug. To derive the final herbal prescriptions, we searched the KFDA drug information system for licensed herbal medicines containing each drug and its combination. As a result of laboratory experiments and experts recommendation, we found that the five effective single herbal drugs for cognitive disorders. They are Ginseng Radix, Acori Graminei Rhizoma, Cyperi Rhizoma, Coptidis Rhizoma, Pinelliae Rhizoma, Hoelen cum Pini Radix, and Rehmanniae Radix Preparata(Pinelliae Rhizoma, Hoelen cum Pini Radix, and Rehmanniae Radix Preparata were tied for $5^{th}$). And licensed herbal prescriptions derived from the planned search are Palbohoichoon-tang, Taehwa-hwan, Bosim-hwan, and so on. Among these, in consideration of the feasibility of research and possibility of success in development, Yukgunja-tang, Samhwangjichul-hwan can be selected as future study subjects. Through experimental studies and expert recommendations, we have derived herbal prescriptions that can be effective in treating cognitive disorders from licensed herbal medicines.

Review of Recent Clinical Trials for Depression in Traditional Chinese Medicine-Based on Randomized Controlled Trials and Systematic Reviews- (우울증 치료의 중의학 최신 임상연구 동향-무작위 대조군 임상연구와 체계적 문헌 고찰을 중심으로-)

  • Woo, Jeong A;Nam, Yu Jin;Park, Yoon Jin;Kwon, Young Kyu
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.29 no.6
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    • pp.458-466
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    • 2015
  • The purpose of this study was to review the research on treating depression in Traditional Chinese Medicine(TCM) over the last 5 years to set the foundation for further studies. We searched for and analyzed articles about depression in CNKI(China National Knowledge Infrastructure) from January 2010 to December 2014. The results were as follows : The most frequently used diagnostic criteria was CCMD-3(The Chinese Classification of Mental Disorders-3), and the most used evaluation criteria was HAMD(Hamilton Depression Rating Scale). Prescription of decoction of medical herbs was most frequently used as a therapeutic method. Acupuncture, traditional Chinese psychotherapy, and music therapy were also used for some studies. The most frequent TCM Syndrome Differentiation Type was stagnation of liver-QI. For decoction of Chinese herbs, Soyo-san(Xiaoyao-san) and Sihosogan-san(Chaihushugan-san) were most often prescribed, and Bupleuri Radix, Paeoniae Radix Alba, Curcumae Radix, Poria cocos wolf, Angelicae Gigantis Radix, Atractylodis Rhizoma Alba were mainly used for medical herbs. BaekHoi(GV20) and Yindang(Ex-HN3) were often used as acupuncture sites. Post-Stroke Depression was the most common case of intercurrent or secondary depression. According to the Jadad Quality Assessment Scale, the quality of the reports was not high as most of the reports had a score of 3 or below. Most systematic reviews on depression were conducted by Chinese researchers. The problem with Clinical research on depression, according to those reviews, was that there were no standardized criteria for the diagnosis and treatment and the trials were usually not randomized nor controlled. We found out there are various clinical methods for treating depression in TCM, and hope that this research could provide the preliminary data for designing and conducting clinical trials for depression.

Early gonadotropin-releasing hormone antagonist protocol in women with polycystic ovary syndrome: A preliminary randomized trial

  • Shin, Jae Jun;Park, Kyung Eui;Choi, Young Min;Kim, Hye-Ok;Choi, Dong-Hee;Lee, Woo Sik;Cho, Jung-Hyun
    • Clinical and Experimental Reproductive Medicine
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    • v.45 no.3
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    • pp.135-142
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    • 2018
  • Objective: To prospectively evaluate the efficacy and safety of a fixed early gonadotropin-releasing hormone (GnRH) antagonist protocol compared to a conventional midfollicular GnRH antagonist protocol and a long GnRH agonist protocol for in vitro fertilization (IVF) in patients with polycystic ovary syndrome (PCOS). Methods: Randomized patients in all three groups (early antagonist, n = 14; conventional antagonist, n = 11; long agonist, n = 11) received 21 days of oral contraceptive pill treatment prior to stimulation. The GnRH antagonist was initiated on the 1st day of stimulation in the early antagonist group and on the 6th day in the conventional antagonist group. The GnRH agonist was initiated on the 18th day of the preceding cycle. The primary endpoint was the number of oocytes retrieved, and the secondary endpoints included the rate of moderate-to-severe ovarian hyperstimulation syndrome (OHSS) and the clinical pregnancy rate. Results: The median total number of oocytes was similar among the three groups (early, 16; conventional, 12; agonist, 19; p= 0.111). The early GnRH antagonist protocol showed statistically non-significant associations with a higher clinical pregnancy rate (early, 50.0%; conventional, 11.1%; agonist, 22.2%; p= 0.180) and lower incidence of moderate-to-severe OHSS (early, 7.7%; conventional, 18.2%; agonist, 27.3%; p= 0.463), especially among subjects at high risk for OHSS (early, 12.5%; conventional, 40.0%; agonist, 50.0%; p= 0.324). Conclusion: In PCOS patients undergoing IVF, early administration of a GnRH antagonist may possibly lead to benefits due to a reduced incidence of moderate-to-severe OHSS in high-risk subjects with a better clinical pregnancy rate per embryo transfer. Further studies with more subjects are required.

A Preliminary Study of the Effects of Monitor-Based Virtual Reality Games on the Cognition & Activities of Daily Living for Acute Stroke : A Double-blind Randomized Controled Trial (모니터기반 가상현실게임을 이용한 중재가 급성기 뇌졸중 환자의 인지 기능과 일상생활활동에 미치는 영향에 대한 사전연구: 이중 맹검 무작위 대조 시험 연구)

  • Choi, Bong-Geun;Kwon, Jae-Sung
    • The Journal of the Korea Contents Association
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    • v.20 no.9
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    • pp.531-540
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    • 2020
  • Objectives: This study aimed to investigate the effects of a 4-weeks intervention using a monitor-based virtual reality game intervention(VRI) on the cognitive function and activities of daily living of individuals with acute stroke. Methods: For this study, 19 individuals with acute stroke were recruited. To compare the effectiveness of the VRI and the computer based cognitive intervention(CBCI), Each of the two groups were provided different interventions a 30 minutes a day, 5 times per week for 4 weeks, and to measure the effects of the intervention, the TMT A&B, DST, RKMT and K-MBI were performed before and after interventions. Results: Both the VRI and the CBCI were found to have significantly improved the cognitive function and activities of daily living, and the difference in change compared between groups showed that the effectiveness of the VRI was significantly higher. Conclusion: Based on the findings of this study, the monitor-based VRI is anticipated to prove useful as an effective intervention for the cognitive function and activities of daily living of stroke patients. Furthermore, the utility of monitor-based VRI is likely to be high in clinical occupational therapy.

Preliminary Study to Develop the Instrument of Pattern Identification for Jing Ji and Zheng Chong (경계정충(驚悸怔忡) 변증도구 개발을 위한 기초 연구)

  • Park, Dae-Myung;Lee, Sang-Ryong;Kang, Wee-Chang;Jung, In-Chul
    • Journal of Oriental Neuropsychiatry
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    • v.21 no.2
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    • pp.1-15
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    • 2010
  • Objectives : This study was performed to develop a standard instrument of Pattern Identification for jing ji and zheng chong. Methods : The advisor committee on this study was organized by 15 neuropsychiatry professors of oriental medical colleges. The items and structure of the instrument were based on review of published literature. We took consultation 2 times from the advisor committee and we also took additional advices by e-mail. Results : 1. We divided the symptoms and signs of jing ji and zheng chong into 9 pattern identification. - heart deficiency with timidity(心膽虛怯), heart qi deficiency(心氣虛), heart blood deficiency(心血虛), heart yang inactivity(心陽不振), heart blood stasis(心血瘀阻), phlegm turbidity obstructing(痰濁阻滯), yin deficiency with effulgent fire(陰虛火旺), water qi intimidating the heart(水氣凌心), dual deficiency of the heart and spleen(心脾兩虛). 2. We got the mean weights that reflect standard deviation to each symptom of 9 pattern identification which had been scored on a 100-point scale. 3. We made out the Korean instrument of the pattern identification for jing ji and zheng chong. It was composed of 17 questions in question-and-answer form. Conclusions : Instrument of Pattern Identification for jing ji and zheng chong was developed through experts' disscussion. If the validity and reliability of this instrument is confirmed through additional clinical trial, the instrument of pattern identification for jing ji and zheng chong is expected to be applied to the subsequent research.

The Effects of Gabapentin in Treatment of Burning Mouth Syndrome: Retrospective Pilot Study

  • Heo, Jun-Young;Ok, Soo-Min;Jeong, Sung-Hee;Kim, Kyung-Hee;Ahn, Yong-Woo
    • Journal of Oral Medicine and Pain
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    • v.39 no.3
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    • pp.96-99
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    • 2014
  • Purpose: The objective of this retrospective pilot study was to evaluate the effectiveness of Gabapentin in patients with primary burning mouth syndrome (BMS). Methods: Ten subjects were diagnosed with primary BMS (8 women and 2 men). The mean age was 60.1 years. They had clinical examination to exclude local factors such as the presence of Candida species, xerostomia, lichen planus, etc. They also underwent hematological examination to exclude secondary BMS due to systemic disorders. Pain was assessed by patients on an 11-point numerical rating score system (0 to 10). Gabapentin was administered at a starting dose of 300 mg/day, slowly titrated up to maximum of 1,800 mg/day. All patients were treated for 4 weeks. Results: One half of the patients (n=5) obtained reduction in pain over the treatment period. Four patients reported no reduction in pain symptoms. One patient reported that symptoms were worsening. The average pain score before the treatment was 6.3 and after the treatment was 5.25. No significant relationship was detected between pretreatment and posttreatment pain score. Only one patient noted mild side effect (dizziness). Conclusions: This retrospective pilot study provides no preliminary evidence that Gabapentin has effect in the management of BMS. However, further research (well-designed, randomized, and controlled trial with large sample) would be needed to investigate the efficacy of Gabapentin in treatment of BMS.

Preliminary Study to Develop the Instrument of Oriental Medical Evaluation for dementia (치매 한의 평가도구 개발을 위한 기초 연구)

  • Ryu, Chang-Hee;Jung, In-Chul;Cho, Seung-Hun;Hwang, Wei-Wan;Kang, Wee-Chang;Lee, Sang-Ryong
    • Journal of Oriental Neuropsychiatry
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    • v.21 no.4
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    • pp.123-135
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    • 2010
  • Objectives : This study was performed to develop a standard instrument of oriental medical evaluation for dementia. Methods: The advisor committee on this study was organized by 17 neuropsychiatry professors of oriental medical colleges. The items and structure of the instrument were based on review of published literature. We took consultation twice from the advisor committee and we also took additional advices bye-mail. Results: We discriminated between bian-zheng and su-zheng from the answers of the advisor committee. We got the mean weight of each symptom and sign from the answers of the advisor committee. We got the final weight from the combination of the ratio of bian-zheng to the number of all answers of the advisor committee and mean weight. Conclusions : The instrument of oriental medical evaluation for dementia was developed through experts' discussion. If the validity and reliability of this instrument is confirmed through additional clinical trial. the instrument of oriental medical evaluation for dementia is expected to be applied to the subsequent research.

Preliminary Study to Develop the Instrument of Oriental Medical Evaluation for Jing Ji and Zheng Chong (경계정충 한의 평가도구 개발 기초 연구)

  • Seol, Seon-Hui;Jung, In-Chul;Lim, Jung-Hwa;Kang, Wee-Chang;Lee, Sang-Ryong
    • Journal of Oriental Neuropsychiatry
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    • v.21 no.3
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    • pp.1-18
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    • 2010
  • Objectives : This study was performed to develop a standard instrument of oriental medical evaluation for jing ji and zheng chong. Methods : The advisor committee on this study was organized by 17 neuropsychiatry professors of oriental medical colleges. The items and structure of the instrument were quoted from the instrument of pattern identification for jing ji and zheng chong. We took consultation twice from the advisor committee and we also took additional advices by e-mail. Results : We discriminated between bian-zheng and su-zheng from the answers of the advisor committee. We got the mean weight of each symptom and sign from the answers of the advisor committee. We got the final weight from the combination of the ratio of bian-zheng to the number of all answers of the advisor committee and mean weight. Conclusions : The instrument of oriental medical evaluation for jing ji and zheng chong was developed through experts' discussion. If the validity and reliability of this instrument is confirmed through additional clinical trial, the instrument of oriental medical evaluation for jing ji and zheng chong is expected to be applied to the subsequent research.