• Title/Summary/Keyword: Randomized clinical trial

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The anti-hypertensive effect of ginseng in patients with mild hypertension

  • Kim, Young-Suk;Jung, Woo-Sang;Park, Seong-Uk;Moon, Sang-Kwan;Park, Jung-Mi;Ko, Chang-Nam;Cho, Ki-Ho;Bae, Hyung-Sup
    • Advances in Traditional Medicine
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    • v.7 no.5
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    • pp.494-500
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    • 2008
  • Ginseng has been traditionally used to recover vital energy from Qi deficiency in oriental countries. Recent reports suggested that ginseng could regulate blood pressure (BP), but much controversy still remain. Therefore, we intended to assess the anti-hypertensive effect of some ginseng species on Koreans and Chinese. This is a randomized, double blinded controlled clinical trial. The study subjects were recruited from the mild hypertensive patients who belonged prehypertension(120/80 to 139/89 mmHg) and stage I hypertension (140/90 to 159/99 mmHg) in Korea and China. After assigning the subjects into a Korean, a Chinese, and an American ginseng group by randomization, we prescribed ginseng with the dose of 4.5 g per a day for 4 w. To assess the anti-hypertensive effect, we compared the mean of systolic and diastolic BP between before and after ginseng medication by 24 h Ambulatory Blood Pressure Monitor (24 h ABPM). We also monitored adverse effect and laboratory findings to secure the subjects' safety. There were 64 subjects treated with Korean ginseng, 58 treated with Chinese ginseng, and 64 treated with American ginseng. All of the ginseng species reduced subjects' BP. Especially, Korean and Chinese ginseng showed more excellent effects. The secondary analysis on the subjects' nationality revealed that all of the ginseng species showed more significant anti-hypertensive effect in Chinese than in Koreans. We suggest ginseng could be useful for mild hypertension regardless of its species. And it would be safe within the dosage of 4.5 g per a day.

The efficacy and safety of Montelukast sodium in the prevention of bronchopulmonary dysplasia

  • Kim, Sang Bum;Lee, Jang Hoon;Lee, Juyoung;Shin, Seung Han;Eun, Ho Sun;Lee, Soon Min;Sohn, Jin A;Kim, Han Suk;Choi, Byung Min;Park, Min Soo;Park, Kook In;Namgung, Ran;Park, Moon Sung
    • Clinical and Experimental Pediatrics
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    • v.58 no.9
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    • pp.347-353
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    • 2015
  • Purpose: The purpose of this study was to evaluate the efficacy and safety of Montelukast sodium in the prevention of bronchopulmonarydysplasia (BPD). Methods: The Interventional study was designed as a multicenter, prospective, and randomized trial, with open labeled and parallel-experimental groups, 66 infants were enrolled and allocated to either the case group (n=30) or the control group (n=36) based on gestational age (GA). Infants in the case group were given Montelukast sodium (Singulair) based on their body weight (BW). Zero week was defined as the start time of the study. Results: The incidence of moderate to severe BPD was not different between the groups (case group: 13 of 30 [43.3%] vs. control group: 19 of 36 [52.8%], P=0.912). Additionally, secondary outcomes such as ventilation index, mean airway pressure and resort to systemic steroids were not significantly different. There were no serious adverse drug reactions in either group, and furthermore the rate of occurrence of mild drug related-events were not significantly different (case group: 10 of 42 [23.8%] vs. control group: 6 of 48 (15.8%), P=0.414). Conclusion: Montelukast was not effective in reducing moderate or severe BPD. There were no significant adverse drug events associated with Montelukast treatment.

A Clinical Study of Acupuncture with Aromatherapy on Poststroke Depression Patients (중풍후우울증 환자에 대한 향기침요법의 임상적 연구)

  • Chung, Sae-Yun;Hwang, Jae-Woong;Kim, Seok-Min;Jung, Jae-Han;Choi, Chang-Min;Jung, Woo-Sang;Moon, Sang-Kwan;Cho, Ki-Ho;Kim, Young-Suk;Sun, Jong-Joo
    • The Journal of Internal Korean Medicine
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    • v.27 no.2
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    • pp.480-487
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    • 2006
  • Objectives : In this study we investigated BDI(Beck Depression Inventory) improvement of poststroke depression Patients who took the acupuncture with aromatherapy, in order to examine its capacity as a new treatment and to establish a primary data for further studies of developments of diverse Practical acupunctures. Methods : Physicians applied the acupuncture with aromatherapy every day for two weeks. We had evaluated baseline characteristics and BDI of all Patients, and revaluated BDI and examined the side effects two weeks later. The qualified Patients were classified into two groups, depression group (more than 10 points and 10 in BDI) and non-depression group (less than 10 points in BDI) according to the baseline BDI. Results : The study was completed with 27stroke patients. The acupuncture with aroma therapy was applied in 18 post-stroke depression patients and 9 non-depression patients for 2 weeks. And the result showed that the BDI scores in the depression group decreased to $16.5{\pm}11.1$ after the treatment (compared to $24.4{\pm}11.5$ before the treatment). so proved the significant effect on post-stroke depression of the acupuncture. On the other hand. the scores in the non-depression group increased to $9.2{\pm}9.5$ (compared to $3.3{\pm}3.0$). Conclusions : The acupuncture with aromatherapy applied on post-stroke depression patients showed the effect of BDI improvement. Further researches are needed to evaluate the distinct functional mechanism of acupuncture with aromatherapy, and to estimate its effectiveness by well-designed randomized controlled trial.

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Polydeoxyribonucleotide Improves Peripheral Tissue Oxygenation and Accelerates Angiogenesis in Diabetic Foot Ulcers

  • Kim, Seoyoung;Kim, Junhyung;Choi, Jaehoon;Jeong, Woonhyeok;Kwon, Sunyoung
    • Archives of Plastic Surgery
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    • v.44 no.6
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    • pp.482-489
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    • 2017
  • Background Polydeoxyribonucleotide (PDRN) is known to have anti-inflammatory and angiogenic effects and to accelerate wound healing. The aim of this study was to investigate whether PDRN could improve peripheral tissue oxygenation and angiogenesis in diabetic foot ulcers. Methods This was a prospective randomized controlled clinical trial. Twenty patients with a non-healing diabetic foot ulcer were randomly distributed into a control group (n=10) and a PDRN group (n=10). Initial surgical debridement and secondary surgical procedures such as a split-thickness skin graft, primary closure, or local flap were performed. Between the initial surgical debridement and secondary surgical procedures, 0.9% normal saline (3 mL) or PDRN was injected for 2 weeks by the intramuscular (1 ampule, 3 mL, 5.625 mg, 5 days per week) and perilesional routes (1 ampule, 3 mL, 5.625 mg, 2 days per week). Transcutaneous oxygen tension ($TcPO_2$) was evaluated using the Periflux System 5000 with $TcPO_2/CO_2$ unit 5040 before the injections and on days 1, 3, 7, 14, and 28 after the start of the injections. A pathologic review (hematoxylin and eosin stain) of the debrided specimens was conducted by a pathologist, and vessel density (average number of vessels per visual field) was calculated. Results Compared with the control group, the PDRN-treated group showed improvements in peripheral tissue oxygenation on day 7 (P<0.01), day 14 (P<0.001), and day 28 (P<0.001). The pathologic review of the specimens from the PDRN group showed increased angiogenesis and improved inflammation compared with the control group. No statistically significant difference was found between the control group and the PDRN group in terms of vessel density (P=0.094). Complete healing was achieved in every patient. Conclusions In this study, PDRN improved peripheral tissue oxygenation. Moreover, PDRN is thought to be effective in improving inflammation and angiogenesis in diabetic foot ulcers.

The Effects of distilled Rehmannia glutinosa Herbal Acupuncture on the Heart Rate Variability(HRV) (생지황 약침이 정상인의 심박변이도(HRV)에 미치는 영향)

  • Shin, Jin-Cheol;Kim, Lak-Hyung;Song, Beom-Yong;Yook, Tae-Han
    • Journal of Pharmacopuncture
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    • v.11 no.1
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    • pp.83-97
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    • 2008
  • Objectives : We investigated the effects of distilled Rehmannia glutinosa Herbal Acupuncture on autonomic nervous system with the Heart Rate Variability(HRV) in adult man. as well as we tried to observe how distilled Rehmannia glutinosa Herbal Acupuncture on the balance of the autonomic nervous system. Methods : We investigated on 58 healthy volunteers consisted of 28 subjects in experiment(distilled Rehmannia glutinosa Herbal Acupuncture) group and 30 subjects in control(Normal Saline) group. Study form was a randomized, placebo-controlled, double-blind clinical trial. 28 subjects in experiment group were injected distilled Rehmannia glutinosa Herbal Acupuncture at $GB_{21}$(Kyonjong) and 30 subjects in control group were injected Normal Saline at $G_{21}$(Kyonjong). except of 2 subjects(in control group) who can't be measured and 6 subjects(2 in experiment group and 4 in control group) who move or make unforceable error during measuring. Finally 26 subject in experiment group and 24 subject in control group are studied. We measured HRV by PolyG-I on 7 times : before and after injection per 5 minutes during 30 minutes. The SPSS 10.0 for windows was used to analyze the data and the paired t-test(in group) and Student t-test(between two groups) were used to verify the result. Results : 1. After distilled Rehmannia glutinosa Herbal Acupuncture injection, Mean HRV is significantly low only for first 5 minute, SDNN is significantly high after 5 minute, Complexity is significantly low only from 20 minute to 25 minute. HRV index is significantly high for first 5minute and from 10 minute to after 10 minute. 2. HRV index of distilled Rehmannia glutinosa Herbal Acupuncture Group significantly increased from 25 minute to 30 minute, and pNN50 of Rehmannia glutinosa Herbal Acupuncture Group significantly decreased from 20 minute to 30 minute compared with those of Normal Saline group. 3. After distilled Rehmannia glutinosa Herbal Acupuncture injection, Ln(TP) and Ln(VLF) are significantly high after injection. Normalized LF is significantly high from 5 minute to 20 minute and from 25 minute and 30 minute. Normalized HF is significantly low from 5minute to 20 minute and from 25 minute and 30 minute. 4. Ln(TP) and Ln(VLF) of distilled Rehmannia glutinosa Herbal Acupuncture Group significantly increased from 20 minute to 25 minute compared with those of Normal Saline group. Conclusions : The results suggest that Rehmannia glutinosa Herbal Acupuncture in healthy adult man tend to activate the autonomic nervous system and parasympathetic nervous system compared to Normal Saline within normal range.

Development of a standardized mucositis and osteoradionecrosis animal model using external radiation

  • Seo, Mi Hyun;Lee, Min Young;Eo, Mi Young;Lee, Suk Keun;Woo, Kyung Mi;Kim, Soung Min
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
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    • v.46 no.4
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    • pp.240-249
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    • 2020
  • Objectives: Although the side effects of radiation therapy vary from mucositis to osteomyelitis depending on the dose of radiation therapy, to date, an experimental animal model has not yet been proposed. The aim of this study was to develop an animal model for assessing complications of irradiated bone, especially to quantify the dose of radiation needed to develop a rat model. Materials and Methods: Sixteen Sprague-Dawley rats aged seven weeks with a mean weight of 267.59 g were used. Atraumatic extraction of a right mandibular first molar was performed. At one week after the extraction, the rats were randomized into four groups and received a single dose of external radiation administered to the right lower jaw at a level of 14, 16, 18, or 20 Gy, respectively. Clinical alopecia with body weight changes were compared and bony volumetric analysis with micro-computed tomography (CT), histologic analysis with H&E were performed. Results: The progression of the skin alopecia was different depending on the irradiation dose. Micro-CT parameters including bone volume, bone volume/tissue volume, bone mineral density, and trabecular spaces, showed no significant differences. The progression of osteoradionecrosis (ORN) along with that of inflammation, fibrosis, and bone resorption, was found with increased osteoclast or fibrosis in the radiated group. As the radiation dose increases, osteoclast numbers begin to decrease and osteoclast tends to increase. Osteoclasts respond more sensitively to the radiation dose, and osteoblasts are degraded at doses above 18 Gy. Conclusion: A standardized animal model clinically comparable to ORN of the jaw is a valuable tool that can be used to examine the pathophysiology of the disease and trial any potential treatment modalities. We present a methodology for the use of an experimental rat model that incorporates a guideline regarding radiation dose.

Effect of Ephedra Sinica and Evodia Rutaecarpa on Resting Metabolic Rate in Obese Premenopausal Women during Low-calorie Diet: A Randomized Controlled Clinical Trial (저열량 식이요법을 한 폐경 전 비만 여성의 휴식 대사량에 대한 마황과 오수유의 효과)

  • Kim, Su-Jin;Ko, Byung-Pyo;Kim, Hyung-Do;Kim, Jin-Ah;Park, Jeong-Mi;Choi, Seung-Ki;Jeon, Uoo-Hyun;Kim, Ho-Jun
    • Journal of Korean Medicine for Obesity Research
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    • v.4 no.1
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    • pp.45-54
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    • 2004
  • Objective: To evaluate the effect of Ephedra Sinica and Evodia Rutaecarpa on resting metabolic rate(RMR), weight and body composition in obese women during low-calorie diet. Methods: We recruited 90 healthy premenopausal women$(body\;mass\;index{\geq}25kg/m^2)$ and randomly assigned to three groups(ephedra group, evodia group and placebo group). Subjects were administered Ephedra Sinica(6g twice a day) or Evodia Rutaecarpa(6g twice a day) or placebo in a double-blind fashion and participated in low-calorie diet for 8 weeks. Resting metabolic rate and body composition were measured at baseline, 4 and 8 weeks. Results: RMR change for 4 weeks was significantly higher in the ephedra group compared with the placebo group(p<.05). But the change for 8 weeks was not significant and the Evodia group showed no significant RMR change. Weight and percent body fat changes for 4 weeks and 8 weeks were significantly higher than the placebo group in the ephedra group(p<.05), but the Evodia group didn't show significant level. Conclusions: This study supports and emphasizes the benefits of herbal medicine in maintaining or increasing RMR during low-calorie diet. Especially Ephedra treatment was effective on significant maintainment of RMR, loss of weight and percent body fat(P<.05).

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The effect of oral breast milk on pain response of the neonates during heel lancing (모유경구투여가 발뒤꿈치 천자 시 신생아의 통증반응에 미치는 효과)

  • Kim, Kyunghwa;Park, Youngim;Kim, Taeim
    • Journal of the Korean Data and Information Science Society
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    • v.27 no.1
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    • pp.203-215
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    • 2016
  • This study was performed in order to investigate the effect of breast milk on pain relief in newborn during heel lancing. Nonequivalent control group pretest-posttest design by double blinded experiment was used. 50 neonates were randomized to receive breast milk (experimental group, n=25) or no treatment (control group, n=25) before undergoing heel lancing. Informed consent was obtained from parents of 50 neonates. Neonatal infant pain scale (NIPS), respiration rate, heart rate, oxygen saturation, and crying duration were used to assess subjects' pain reaction. Data were analyzed using SPSS 18.0. The experimental and control group showed a statistically significant differences in NIPS score (F=28.89, p<.001), heart rate (F=14.03, p<.001), respiration rate (F=4.79, p=.001), oxygen saturation (F=2.69, p=.027), and crying duration (t=-8.78, p <.001) at each time points (during heel lancing, right after heel lancing, 1, 2, 3 minutes after heel lancing). The result suggest that oral administration of expressed breast milk is safe and natural agents for reducing procedural pain of neonates. Another clinical trial study with more samples is recommended.

The Effect of Sa-am Acupuncture Simjeongkyeok Treatment for Major Symptom of Hwa-byung (화병의 핵심증상에 대한 사암침 심정격 치료의 효과)

  • Jeong, In-Chul;Lee, Sang-Ryong;Park, Yang-Chun;Hong, Kwon-Eui;Lee, Young-Koo;Kang, Wee-Chang;Choi, Sun-Mi;Choi, Kang-Wook;Oh, Dal-Seok;Park, Ji-Eun
    • Journal of Oriental Neuropsychiatry
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    • v.19 no.1
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    • pp.1-18
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    • 2008
  • The purpose of this research is to examine the effect of Simjeongkyeok Sa-am acupuncture treatment for major symptoms of Hwa-byung. Method : In this randomized, single blind, placebo-controlled study, we compared Simjeongkyeok acupuncture with Sham acupuncture in the treatment for major symptoms of Hwa-byung. Likert scale for major symptom of Hwa-byung was measured as the 1st evaluative instrument, and STAXI-K, STAI-K, BDI-K and HRV were also measured as the 2nd evaluative instrument at the before treatment and after treatment. Results : In comparison of Likert scale for major symptoms, total score of after treatment decreased significantly at each point on both groups, but there was no significant difference between both groups. In comparison of STAXI-K, STAI-K, BDI-K, there was no significant difference in variation of score between both groups. But Simjeongkyeok group showed higher ratio variation of STAXI expression than that of Sham group, Also on subjects whose main complaint symptom were burning sensation and whose pattern identification were Qizhi, Simjeongkyeok group showed higher variation of Likert scale score and BDI-K than that of Sham group. The significance was border line around. Conclusion : We considered that Shimjeongkeok treatment will he likely to he recommended for treating Hwa-byung, especially on subjects in each group whose main complaint symptom were burning sensation or whose pattern identification were Qizhi. Also it may also be effective on the management of anger expression.

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The Effects of distilled Astragali Radix Herbal Acupuncture on the Heart Rate Variability(HRV) (황인 약침이 정산인의 심박변이도(HRV)에 미치는 영향)

  • Lim, Sung-Taek;Kim, Lak-Hyung;Song, Beom-Yong;Yook, Tae-Han
    • Journal of Oriental Neuropsychiatry
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    • v.19 no.1
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    • pp.107-124
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    • 2008
  • We investigated the effects of distilled Astragali Radix Herbal Acupuncture on autonomic nervous system with the Heart Rate Variability(HRV) in adult man. as well as we tried to observe how distilled Astragali Radix Herbal Acupuncture on the balance of the autonomic nervous system. Methods : We investigated on 61 healthy volunteers consisted of 31 subjects in experiment(distilled Astragali Radix Herbal Acupuncture) group and 30 subjects in control(Normal Saline) group. Study form was a randomized, placebo-controlled, double-blind clinical trial. 31 subjects in experiment group were injected distilled Astragali Radix Herbal Acupuncture at GB21(Kyonjong) and 30 subjects in control group were injected Normal Saline at GB21(Kyonjong). except of 2 subjects(in control group) who can't be measured and 10 subjects(6 in experiment group and 4 in control group) who move or make unforceable error during measuring. Finally 25 subject in experiment group and 24 subject in control group are studied. We measured HRV by PolyG-I on 7 times : before and after injection per 5 minutes during 30 minutes. The SPSS 10.0 for windows was used to analyze the data and the paired t test(in group) and Student t test(between two groups) were used to verify the result. Results : I. After distilled Astragali Radix Herbal Acupuncture injection, SDNN is significantly high from 5 minute to 10 minute and from 15 minute to 30 minute, Complexity is significantly low from 20 minute to 30minute. HRV index is significantly mgb for first 20 minute and from 25 minute to 30 minute, RMSSD is significantly high only from 15 minute to 20 minute. 2. HRV index of distilled Astragali Radix Herbal Acupuncture Group significantly increased from 25 minute to 30 minute, pNN50 of distilled Astragali Radix Herbal Acupuncture Group significantly decreased from 25 minute to 30 minute and RMSSD of distilled Astragali Radix Herbal Acupuncture Group significantly increased from 25 minute to 30 minute compared with those of Normal Saline group. 3. After distilled Astragali Radix Herbal Acupuncture injection, Ln(TP) is significantly high from 5 minute to 10 minute and from 15 minute to 30 minute. Ln(VLF) is significantly high after 5 minute, Ln(LF) is significantly high after 15 minute and Ln(HF) is significantly high from 5 minute to 10 minute and 25 minute to 30 minute, but significantly low for first 5 minute and from 10 minute to 20 minute. Normalized LF is significantly high after 20 minute and Normalized LF is significantly low after 20 minute. Conclusions : The results suggest that distilled Astragali Radix Herbal Acupuncture in healthy adult man tend to activate the autonomic nervous system within normal range. This result is derived from that parasympathetic nervous system was continuously activated and sympathetic nervous system was activated a little later.

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