• Title/Summary/Keyword: Clinical trial,

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The Effect of the Combination of Ginseng, Tribulus Terrestris, and L-arginine on the Sexual Performance of Men with Erectile Dysfunction: a randomized, double-blind, parallel, and placebo-controlled clinical trial

  • Reza Tahvilian;Mohammad Amin Golesorkhi;Farajollah Parhoudeh;Fatemeh Heydarpour;Hossein Hosseini;Hojjat Baghshahi;Hossein Akbari;Mohammad Reza Memarzadeh;Mehdi Mehran;Hosna Bagheri
    • Journal of Pharmacopuncture
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    • v.27 no.2
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    • pp.82-90
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    • 2024
  • Objectives: Nitric oxide is the most important mediator of penile erection after the onset of sexual excitement. It activates cyclic guanosine monophosphate (cGMP), increasing penile blood flow. Most pharmaceutical medications prevent enzyme phosphodiesterase type 5 (PDE-5) from breaking down cGMP, thus keeping its level high. However, due to the adverse effects of pharmacological therapies, herbal drugs that improve sexual function have gained attention recently. This study aimed to investigate the combined effects of ginseng, Tribulus terrestris, and L-arginine amino acid on the sexual performance of individuals with erectile dysfunction (ED) using the 5-item version of the International Index of Erectile Function (IIEF-5) questionnaire. Methods: Over three months, 98 men with erectile dysfunction were randomly assigned to receive either 500 mg of herbal supplements or placebo pills. Each herbal tablet contained 100 mg of protodioscin, 35 mg of ginsenosides, and 250 mg of L-arginine. Results: The results showed that the changes in the average scores of ILEF-5 within each group before and after the intervention indicated that all parameters related to the improvement of sexual function in patients with erectile dysfunction improved in the herbal treatment group (p < 0.001). The herbal group significantly improved IIEF-5 scores in nondiabetics (p < 0.05). However, there was no significant difference in the changes of IIEF-5 scores between the two intervention and control groups in diabetic patients. Conclusion: In conclusion, ginseng, Tribulus terrestris, and L-arginine have properties that increase energy and strengthen sexual function, making them suitable for patients with sexual disorders.

A Study on the Skin Improvement Effect of Microneedle Therapy Treatment and Application of Placenta Extract on the Treatment Area (미세다륜침 자극과 자극부위에 시행된 자하거추출물 도포에 의한 피부개선 효과연구)

  • Jin Suk Koo
    • The Korea Journal of Herbology
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    • v.39 no.3
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    • pp.1-9
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    • 2024
  • Objectives : The purpose of this study was to find out the efficacy of placenta on the skin by comparing the difference effect between only MTS (microneedle therapy system) and the placenta extract application after MTS treatment. Methods : The present author performed once a week and total 4 times of MTS treatment. The treatment time took about 5~10 minutes and the depth of the needle was adjusted according to the participant's skin condition. One week after each treatment, the change of skin condition was measured. Two weeks after the end of the clinical trial, the skin condition was checked again. Results : In the case of moisture and elasticity, significant increases were observed in both the experimental and control groups. In the experimental group, skin temperature significantly decreased one week after the second treatment, and pore size significantly increased one week after the third treatment. In the case of skin tone, there was a significant temporary decrease after the first treatment in the control group, and in the experimental group, the skin tone showed a total decrease. Conclusion : When placenta extract was applied after MTS, skin temperature decreased and pores enlarged in the second and third treatments, and side effects such as rash and itchiness appeared. The final result showed a significant increase in skin moisture and elasticity. When animal-based ingredients containing high fat content are applied to the skin, the effect on the skin is good, but hypersensitivity reactions may occur, so use them with caution.

Efficacy of kaleidoscope, virtual reality, and video games to alleviate dental anxiety during local anesthesia in children: a randomized clinical trial

  • Karthik Anchala;Voppathotty Tirumala;Kanamarlapudi Venkata Saikiran;Niharika Reddy Elicherla;Shaik Rahul;Sivakumar Nuvvula
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.24 no.3
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    • pp.195-204
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    • 2024
  • Background: Distraction is a technique used to divert a patient's attention from unpleasant procedures. This study aimed to evaluate the effectiveness of kaleidoscopy, virtual reality, and video games in reducing anxiety and pain during invasive dental procedures in children. Methods: Sixty-six children aged 6 to 9 years were randomly assigned to three groups during local anesthesia administration: Group 1 (kaleidoscope), Group 2 (virtual reality), and Group 3 (mobile video games). The anxiety of the children was evaluated using physiological measures (heart rate) at three different time points: before, during, and after the procedure. The Raghavendra, Madhuri, and Sujata pictorial scale was used as a subjective measure before and after the procedure. Subjective measures of pain were assessed using the Wong-Baker Faces Pain Scale. The data were statistically analyzed using the Kruskal-Wallis and Wilcoxon signed-rank tests. Results: In the intergroup comparison, there were no statistically significant differences in the physiological measures of anxiety scores between the three groups before, during, and after distraction. Raghavendra, Madhuri, and Sujata pictorial scale scores were assessed before and after distraction, but no statistically significant differences were observed. Among the three groups, the children in Group 2 showed a significant reduction in pain scores. Conclusion: Compared with kaleidoscopes and video games, virtual reality is a promising distraction technique for reducing dental fear, anxiety, and pain during local anesthesia administration in children.

A comparative evaluation of peppermint oil and lignocaine spray as topical anesthetic agents prior to local anesthesia in children: a randomized clinical trial

  • Harika Petluru;SVSG Nirmala;Sivakumar Nuvvula
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.24 no.2
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    • pp.119-128
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    • 2024
  • Background: In pediatric dentistry, fear and anxiety are common among children. Local anesthetics (LA) are widely used to control pain and reduce discomfort in children during dental treatment. Topical anesthetics play a vital role in reducing pain and the unpleasant sensation of a needle puncture in children. Peppermint oil has been extensively used for various diseases. However, its anesthetic properties remain unknown. Peppermint oil, used in mouthwashes, toothpastes, and other topical preparations has analgesic, anesthetic, and antiseptic properties. This study aimed to compare and evaluate pain perception following the topical application of peppermint oil versus lignocaine spray before an intraoral injection in children, aged 8-13 years. Method: Fifty-two children, aged between 8-13 years, who required local anesthesia for dental treatment were divided into two groups of 26 each by simple random sampling (Group 1: 0.2% peppermint oil and Group 2: lignocaine spray). In both groups, physiological measurements (e.g., heart rate) were recorded using pulse oximetry before, during, and after the procedure. Objective pain measurement (Sound Eye Motor (SEM) scale) during administration and subjective measuremeant (Wong-Baker Faces Pain Rating Scale (WBFPRS)) after LA administration were recorded. This was followed by the required treatment of the child. Physiological parameters were compared between the two groups using an independent t-test for intergroup assessment and a paired t-test and repeated-measures ANOVA for intragroup comparisons. The Mann-Whitney U test was used to analyze the pain scores. Results: Intragroup mean heart rates, before, during, and after treatment were statistically significantly different (P < 0.05). However, the intergroup mean pulse rates did not differ significantly between the two groups. The mean WBFPS score in the lignocaine spray group was 4.133 ± 2.06 was statistically different from that of the peppermint oil group (0.933 ± 1.03; P < 0.001*). The mean SEM score was significantly lower in the peppermint oil group than that in the lignocaine spray group (P = 0.006). No negative effects were observed in this study. Conclusion: 0.2% peppermint oil was effective in reducing pain perception.

Music and Art Therapy for Parkinson's Disease Patients: A Demand Survey (파킨슨병 환자 대상 음악 및 미술 치료 수요 설문조사)

  • Shin Young Park;Miso S. Park;Wang Jung Hur;Jaeson Pyeon;Horyong Yoo
    • Journal of TMJ Balancing Medicine
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    • v.13 no.sup
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    • pp.9-14
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    • 2023
  • Objectives: The purpose of this study was to investigate patients' demand for music and art therapy in the treatment of Parkinson's disease and to understand how patients view the use of music and art therapy as a complementary form of treatment that can improve their quality of life and increase their self-efficacy in addition to medication. Methods: To this end, 60 Parkinson's patients visiting Daejeon Korean Medicine Hospital at Daejeon University were surveyed about music and art therapy. Results: The survey demonstrated a highly positive response to the music program, with strong belief in its efficacy for Parkinson's disease and significant interest in participation. Group music therapy was perceived as effective for enhancing mental health, respiratory function, language disorders, and overall quality of life. Although the art program was also deemed effective, patients showed slightly lower interest and willingness to participate compared to music therapy. The patients preferred 60-minute sessions once a week for about 8 weeks. Conclusions: We propose the following directions for a Parkinson's music and art therapy program. First, develop a once-a-week, 8-week music and art program for Parkinson's patients. Second, design the music program to focus on improving respiratory function and quality of life. Third, the art program focuses on creating a sense of security and comfort through emotional exchange among patients and improving self-efficacy.

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Integrated Effect of Non-Invasive Neuromodulation on Bladder Capacity in Traumatic Spinal Cord Injury Patient: Single Case Report

  • Priyanka Dangi;Narkeesh Arumugam;Dinesh Suman
    • Physical Therapy Rehabilitation Science
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    • v.13 no.1
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    • pp.86-94
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    • 2024
  • Objective: To evaluate the changes in bladder capacity and storage through non-invasive neuromodulation by application of repetitive Trans magnetic stimulation (rTMS) and genital nerve stimulation (GNS) in traumatic spinal cord survivors. Design: A Single Case Study. Method: The Patient was registered in trail with the clinical trial registry of India (CTRI/2022/05/042431). The Patient was interposed with rTMS on lumbar area, from T11-L4 vertebrae with 1 Hz and the intensity was 20% below that elicited local paraspinal muscular contraction for 13 minutes. GNS was placed over dorsum of the penis with the cathode at the base and anode 2 cm distally at 20 Hz, 200 microseconds, Continuous and biphasic current was delivered and amplitude of stimulation necessary to elicit the genito-anal reflex. For assessment, Neurological examination was done for peri-anal sensation (PAS), voluntary anal contraction (VAC) and bulbocavernous reflex (BCR), deep anal pressure (DAP), and American Spinal Injury Association Impairment Scale (ASIA scale). Outcome assessment was done using Urodynamics, Spinal Cord Independence Measure Scale Version-III (SCIM-III), American Spinal Injury Association Impairment Score (ASIA Score), Beck's Depression Inventory Scale (BDI). The baseline evaluation was taken on Day 0 and on Day 30. Results: The pre-and post-data were collected through ASIA score, SCIM-III, BDI and Urodynamics test which showed significant improvement in bladder capacity and storage outcomes in the urodynamics study across the span of 4 weeks. Conclusion: rTMS along with GNS showed improvement in bladder capacity & storage, on sensory-motor score, in functional independence of individual after SCI.

The Current Status of Utilization of Palliative Care Units in Korea: 6 Month Results of 2009 Korean Terminal Cancer Patient Information System (말기암환자 정보시스템을 이용한 우리나라 암환자 완화의료기관의 이용현황)

  • Shin, Dong-Wook;Choi, Jin-Young;Nam, Byung-Ho;Seo, Won-Seok;Kim, Hyo-Young;Hwang, Eun-Joo;Kang, Jina;Kim, So-Hee;Kim, Yang-Hyuck;Park, Eun-Cheol
    • Journal of Hospice and Palliative Care
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    • v.13 no.3
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    • pp.181-189
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    • 2010
  • Purpose: Recently, health policy making is increasingly based on evidence. Therefore, Korean Terminal Cancer Patient Information System (KTCPIS) was developed to meet such need. We aimed to report its developmental process and statistics from 6 months data. Methods: Items for KTCPIS were developed through the consultation with practitioners. E-Velos web-based clinical trial management system was used as a technical platform. Data were collected for patients who were registered to 34 inpatient palliative care services, designated by Ministry of Health, Welfare, and Family Affairs, from $1^{st}$ of January to $30^{th}$ of June in 2009. Descriptive statistics were used for the analysis. Results: From the nationally representative set of 2,940 patients, we obtained the following results. Mean age was $64.8{\pm}12.9$ years, and 56.6% were male. Lung cancer (18.0%) was most common diagnosis. Only 50.3% of patients received the confirmation of terminal diagnosis by two or more physicians, and 69.7% had an insight of terminal diagnosis at the time of admission. About half of patients were admitted to the units on their own without any formal referral. Average and worst pain scores were significantly reduced after 1 week when compared to those at the time of admission. 73.4% faced death in the units, and home-discharge comprised only 13.3%. Mean length of stay per admission was $20.2{\pm}21.2$ days, with median value of 13. Conclusion: Nationally representative data on the characteristics of patients and their caregiver, and current practice of service delivery in palliative care units were obtained through the operation of KTCPIS.

The Clinical and Cost Effectiveness of Medical Nutrition Therapy for Patients with Type 2 Diabetes Mellitus (제2형 당뇨병환자에서 임상영앙치료의 임상적 효과와 비용효과 연구)

  • Cho, Youn-Yun;Lee, Moon-Kyu;Jang, Hak-Chul;Rha, Mi-Yong;Kim, Ji-Young;Park, Young-Mi;Sohn, Cheong-Min
    • Journal of Nutrition and Health
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    • v.41 no.2
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    • pp.147-155
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    • 2008
  • Medical nutrition therapy (MNT) is considered a keystone of medical treatment of chronic diseases. However, only few studies have evaluated medical and economical outcome of MNT. The study was performed on the patient with type 2 diabetes mellitus to evaluate the effect of clinical and cost-effective outcomes of MNT. Subjects from two general hospitals were randomly assigned to two different groups; One receiving basic nutritional education (BE) (n = 35), and the other receiving intensive nutritional education (IE) (n = 32) for a 6-month clinical trial. The group which received BE had a single visit with a dietitian, while the other group which received IE had an initial visit with a dietitian addition to two visits during the first 4 weeks of the study periods. Anthropometric parameters, blood components, and dietary intake were measures at the beginning of study period and after 6 month. Cost-effective analysis included direct labor costs, educational materials and medication cost difference during 6 months. After 6 month, subjects from IE group showed significant reduction of body weight (p <0.05) and systolic blood pressure (p <0.05), whereas BE group did not show any significant changes. Result from biochemical indices showed glycated hemoglobin concentration was significantly reduced by 0.7% (p <0.05) only in the IE group. The ratio of energy intake to prescribed energy intake decreased significantly in both groups (p <0.05). Mean time taken for a dietitian to educate the subject was 67.9 ${\pm}$ 9.3 min/person for BE group, while 96.4 ${\pm}$ 12.2 min/person for IE group. Mean number of educational materials was 1.9 ${\pm}$ 0.7/person for BE group and 2.5 ${\pm}$ 0.7/person for IE group. Change in glycated hemoglobin level along the 6 month period of study can be achieved with an investment of \88,510/% by implementing BE and \53,691/% by implementing IE. Considering the net cost-effect of blood glucose control and HbA Ic, IE which provides MNT by dietitian had a cost efficiency advantage than that of BE. According to this study, MNT provided by dietitian had a significant improvements in medical and clinical outcomes compared to that of BE intervention. Therefore, MNT protocol should be performed by systemic intensive nutrition care by dietitian in clinical setting to achieve good therapeutic results of DM with lower cost.

Optimal Scheme of Postoperative Chemoradiotherapy in Rectal Cancer : Phase III Prospective Randomized Trial (직장암의 근치적 수술 후 화학요법과 방사선치료의 순서)

  • Kim Young Seok;Kim Jong Hoon;Choi Eun Kyung;Ahn Seung Do;Lee Sang-Wook;Kim Kyoung-Ju;Lee Je Hwan;Kim Jin Cheon;You Chang Sik;Kim Hee Cheol
    • Radiation Oncology Journal
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    • v.20 no.1
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    • pp.53-61
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    • 2002
  • Purpose : To determine the optimal scheme of postoperative chemoradiotherapy in rectal cancer by comparing survival, Patterns of failure, toxicities in early and late radiotherapy groups using a Phase III randomized prospective clinical trial. Materials and Methods : From January 1996 to March 1999, 307 patients with curatively resected AJCC stage II and III rectal cancer were assigned randomly to an 'early (151 patients, arm 1)' or a 'late (156 patients, arm II)' and were administered combined chemotherapy (5-FU $375\;mg/m^2/day$, leucovorin $20\;mg/m^2$, IV bolus daily, for 3 days with RT, 5 days without RT, 8 cycles with 4 weeks interval) and radiation therapy (whole pelvis with 45 Gy/25 fractions/5 weeks). Patients of arm I received radiation therapy from day 1 of the first cycle of chemotherapy and those of arm II from day 57 with a third cycle of chemotherapy. The median follow-up period of living patients was 40 months. Results : Of the 307 patients enrolled, fifty patients did not receive scheduled radiation therapy or chemotherapy. The overall survival rate and disease free survival rate at 5 years were $78.3\%\;and\;68.7\%$ in arm I, and $78.4\%\;and\;67.5\%$ in arm II. The local recurrence rate was $6.6\%\;and\;6.4\%$ (p=0.46) in arms I and II, respectively, no significant difference was observed between the distant metastasis rates of the two arms ($23.8\%\;and\;29.5\%$, p=0.16). During radiation therapy, grade 3 diarrhea or more, by the NCI common toxicity criteria, was observed in $63.0\%\;and\;58.2\%$ of the respective arms (p=N.S.), but most were controlled with supportive care. Hematologic toxicity (leukopenia) greater than RTOG grade 2 was found in only $1.3\%\;and\;2.6\%$ of patients in each respective arm. Conclusion : There was no significant difference in survival, patterns of failure or toxicities between the early and late radiation therapy arms. Postoperative adjuvant chemoradiation was found to be a relatively safe treatment but higher compliance is needed.

The Ability of Anti-tumor Necrosis Factor Alpha(TNF-${\alpha}$) Antibodies Produced in Sheep Colostrums

  • Yun, Sung-Seob
    • 한국유가공학회:학술대회논문집
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    • 2007.09a
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    • pp.49-58
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    • 2007
  • Inflammatory process leads to the well-known mucosal damage and therefore a further disturbance of the epithelial barrier function, resulting abnormal intestinal wall function, even further accelerating the inflammatory process[1]. Despite of the records, etiology and pathogenesis of IBD remain rather unclear. There are many studies over the past couple of years have led to great advanced in understanding the inflammatory bowel disease(IBD) and their underlying pathophysiologic mechanisms. From the current understanding, it is likely that chronic inflammation in IBD is due to aggressive cellular immune responses including increased serum concentrations of different cytokines. Therefore, targeted molecules can be specifically eliminated in their expression directly on the transcriptional level. Interesting therapeutic trials are expected against adhesion molecules and pro-inflammatory cytokines such as TNF-${\alpha}$. The future development of immune therapies in IBD therefore holds great promises for better treatment modalities of IBD but will also open important new insights into a further understanding of inflammation pathophysiology. Treatment of cytokine inhibitors such as Immunex(Enbrel) and J&J/Centocor(Remicade) which are mouse-derived monoclonal antibodies have been shown in several studies to modulate the symptoms of patients, however, theses TNF inhibitors also have an adverse effect immune-related problems and also are costly and must be administered by injection. Because of the eventual development of unwanted side effects, these two products are used in only a select patient population. The present study was performed to elucidate the ability of TNF-${\alpha}$ antibodies produced in sheep colostrums to neutralize TNF-${\alpha}$ action in a cell-based bioassay and in a small animal model of intestinal inflammation. In vitro study, inhibitory effect of anti-TNF-${\alpha}$ antibody from the sheep was determined by cell bioassay. The antibody from the sheep at 1 in 10,000 dilution was able to completely inhibit TNF-${\alpha}$ activity in the cell bioassay. The antibodies from the same sheep, but different milkings, exhibited some variability in inhibition of TNF-${\alpha}$ activity, but were all greater than the control sample. In vivo study, the degree of inflammation was severe to experiment, despite of the initial pilot trial, main trial 1 was unable to figure out of any effect of antibody to reduce the impact of PAF and LPS. Main rat trial 2 resulted no significant symptoms like characteristic acute diarrhea and weight loss of colitis. This study suggested that colostrums from sheep immunized against TNF-${\alpha}$ significantly inhibited TNF-${\alpha}$ bioactivity in the cell based assay. And the higher than anticipated variability in the two animal models precluded assessment of the ability of antibody to prevent TNF-${\alpha}$ induced intestinal damage in the intact animal. Further study will require to find out an alternative animal model, which is more acceptable to test anti-TNF-${\alpha}$ IgA therapy for reducing the impact of inflammation on gut dysfunction. And subsequent pre-clinical and clinical testing also need generation of more antibody as current supplies are low.

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