• 제목/요약/키워드: randomized controlled double blind study

검색결과 209건 처리시간 0.025초

Preventive Effect of Sugar-free Chewing Gum Containing Maltitol on Dental Caries in situ

  • Lee, Eun-Jung;Jin, Bo-Hyoung;Paik, Dai-Il;Hwang, In-Kyeong
    • Food Science and Biotechnology
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    • 제18권2호
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    • pp.432-435
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    • 2009
  • The preventive effect of chewing gum containing maltitol, xylitol, gum base, and sugar on remineralization were investigated. The clinical study consisted of 8 weeks' randomized, double blind, controlled, cross-over clinical trials including 24 healthy adults had chew gum. After each test week, remineralization effect was evaluated by measuring microhardness and scanning electron microscopy (SEM). Microhardness of experimental chewing gum containing maltitol or xylitol was significantly higher than that of sugar gum (p<0.005). Images of SEM showed the remineralization effect of gum containing gum base, maltitol, or xylitol compared with sugar gum. Maltitol and xylitol gums were more effective in remineralization than sugar gum. It was concluded that maltitol and xylitol can be used as sugar substitute to prevent dental caries.

부인과적 수술 후 오심 및 구토에 대한 경혈자극 임상 연구 고찰 (Review of the Studies on Acustimulation for Gynecological Surgery induced Nausea and Vomiting)

  • 박장경;정재철;최민선;김동일
    • 대한한방부인과학회지
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    • 제22권3호
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    • pp.185-196
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    • 2009
  • Purpose: This study aims to estimate the effects of on acustimulation for Gynecological surgery induced nausea and vomiting through reviewing the tendency of the studies. Methods: Literature searches were made through Pubmed, Koreanstudies Information Service System(KISS) and Korean Oriental medical Society database. Data were extracted according to pre-defined criteria. The methodological quality was assessed using Modified Jadad scale. Results: 8 studies were met the condition among the 43 searched studies. They were designed as double blind or observer blind and randomized controlled trial, and were analyzed statistically. 6 studies out of the 8 reported that acupuncture could prevent PONV effectively. Conclusion: The hypothesis that acustimulation may be effective for the prevention of Gynecological surgery induced PONV is supported by the data in recent literatures.

중풍으로 유발된 연하 장애 환자에 대한 전침 치료의 임상 효과 (Efficacy of Electroacupuncture with Dysphagia Caused by Stroke - Double-blind, Randomized Controlled Trial -)

  • 김민경;여서원;조승연;정우상;문상관;박정미;고창남;조기호;박성욱
    • 대한한의학회지
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    • 제35권1호
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    • pp.26-40
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    • 2014
  • Objectives: This study investigated the effect of electroacupuncture on swallow function in stroke patients with dysphagia. The purpose was to determine whether electroacupuncture could improve swallow function and quality of life for patients with dysphagia caused by stroke. A pilot double-blind, randomized controlled trial design was used Methods: A total of 17 stroke patients with dysphagia were recruited to this study, 8 assigned to the swallowing electroacupuncture (SE) group and 9 to the control group. Swallowing electroacupuncture was assessed for 5 Hz electrical or sham stimulation for 20 min duration 3 times a week. Outcome measurements were DOSS, 14-item questionnaire from the SWAL-QOL, NIHSS and MBI. Assessment was carried out for baseline, 2 weeks and 4 weeks Results: In the 2 weeks follow up data, the study group showed significant difference in DOSS and SWAL-QOL compared with the baseline. The study group also showed significant difference in DOSS and SWAL-QOL compared with the control group. Similarly in the 4 weeks follow up data, the study group showed improvement tendency in DOSS and SWAL-QOL compared with baseline and also with the control. The NIHSS and MBI scores returned no significant differences. The swallowing electroacupuncture was well tolerated in all cases with no serious adverse effects. Conclusions: The findings from the pilot study indicated that electroacupuncture has significant effects on improvement in swallowing function and quality of life. With both inpatients and outpatients, further larger and longer-term follow-up study is needed to confirm this suggestion.

Efficacy of extracorporeal shock wave therapy for pillar pain after open carpal tunnel release: a double-blind, randomized, sham-controlled study

  • Turgut, Mehmet Cenk;Saglam, Gonca;Toy, Serdar
    • The Korean Journal of Pain
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    • 제34권3호
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    • pp.315-321
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    • 2021
  • Background: Pillar pain may develop after carpal tunnel release surgery (CTRS). This prospective double-blinded randomized trial investigated the effectiveness of extracorporeal shock wave therapy (ESWT) in pillar pain relief and hand function improvement. Methods: The sample consisted of 60 patients with post-CTRS pillar pain, randomized into two groups. The ESWT group (experimental) received three sessions of ESWT, while the control group received three sessions of sham ESWT, one session per week. Participants were evaluated before treatment, and three weeks, three months, and six months after treatment. The pain was assessed using the visual analogue scale (VAS). Hand functions were assessed using the Michigan hand outcomes questionnaire (MHQ). Results: The ESWT group showed significant improvement in VAS and MHQ scores after treatment at all time points compared to the control group (P < 0.001). Before treatment, the ESWT and control groups had a VAS score of 6.8 ± 1.3 and 6.7 ± 1.0, respectively. Three weeks after treatment, they had a VAS score of 2.8 ± 1.1 and 6.1 ± 1.0, respectively. Six months after treatment, the VAS score was reduced to 1.9 ± 0.9 and 5.1 ± 1.0, respectively. The ESWT group had a MHQ score of 54.4 ± 7.7 before treatment and 73.3 ± 6.8 six months after. The control group had a MHQ score of 54.2 ± 7.1 before treatment and 57.8 ± 4.4 six months after. Conclusions: ESWT is an effective and a safe non-invasive treatment option for pain management and hand functionality in pillar pain.

기질성 뇌증후군에서 Oxiracetam의 임상적 효과에 대한 이중맹검 대조연구 (The Clinical Effect of Oxiracetam in Patients with Organic Brain Syndrome-Double Blind, Placebo-Controlled Study)

  • 이병철;권기한;권기한;송홍기;김성민;유경호;이현미;강경수;윤여훈
    • 약학회지
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    • 제37권5호
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    • pp.442-452
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    • 1993
  • Previous experimental and clinical investigations suggest a possible role of new nootropic drug, oxiracetam, in improving cognitive performances in patients affected by organic brain syndrome. In this study, the cognitive and behavioral effects of oxiracetam treatment in patients with clinical symptoms of organic brain syndrome were evaluated. Sixty-six patients were enrolled and assigned to either oxiracetam or placebo, according to a randomized, double-blind design between two patient-groups. Either oxiracetam or placebo was orally given bid for 8 weeks ; daily dose of oxiracetam was 1600mg. All the patients, enrolled in this study, were diagnosed as having mild to moderate cognitive dysfunction as defined by a baseline Mini Mental State ExaminationKorean version (MMSE-K) score between 14 and 25. The patients under-went, at baseline, 4 weeks and 8 weeks after, routine laboratory study (CBC, SMA12, U/A, EKG) and the following neuropsychological tests ; MMSE-K, modified Korean Wechsler Intelligence Scale(MKWIS), Nurses' Observation Scale for Geriatric patients(NOSGER). Fifteen patients of whom were dropped out or excluded from the analysis because of poor compliance or violation of the protocol. Fiftyone patients (aged 54~78 years, male 25, female 26) were analyzed (vascular dementia, 30 ; senile dementia of Alzheimer type, 9 ; mixed type, 5 ; other cause, 7). Statistical analysis of the data demonstrated that the two groups were comparable at baseline. At the end of each study period the oxiracetam group scored significantly better on the majority of the tests evaluating cognitive function, psychometricity and the improvement rating scale of subjective symptoms than placebo group, in which worsening trends or no changes were seen on the whole. No side effects were noted during oxiracetam treatment. The present study, showing positive clinical findings after oxiracetam therapy, confirmed that this drug can be useful pharmacological treatment in organic brain syndrome.

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Conjugated Linoleic Acid (CLA) Supplementation for 8 Weeks Reduces Body Weight in Healthy Overweight/Obese Korean Subjects

  • Park, Eun-Ju;Kim, Jung-Mi;Kim, Kee-Tae;Paik, Hyun-Dong
    • Food Science and Biotechnology
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    • 제17권6호
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    • pp.1261-1264
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    • 2008
  • In the present study, a randomized, double-blind, placebo-controlled trial to determine the effect of conjugated linoleic acid (CLA) supplementation (50:50 ratio of cis-9, trans-11 and trans-10, cis-12 isomers) for 8 weeks on body composition and biochemical parameters in healthy overweight/obese (body mass index, BMI${\geq}23\;kg/m^2$) Korean subjects was performed, Thirty participants (3 males and 27 females) were randomized to receive placebo (2.4 g olive oil/day) or 2.4g/day CLA (mixture containing 36.9% of cis-9, trans-11 and 37.9% of trans-10, cis-12). Eight weeks of CLA supplementation significantly decreased body weight by -0.75kg, BMI by $-0.27\;kg/m^2$, and hip circumference by -1.11 cm. The reduction of body weight was ascribed to the reduction of body fat mass (-0.59 kg) and lean body mass (-0.18 kg), although these changes were not significant. No significant differences in serum lipid profiles, liver function enzyme activities, and protein concentration were observed in either the CLA or placebo groups. These results indicate that short tenn supplementation (8 weeks) with CLA (2.4 g/day) may decrease body weight in Korean overweight/obese subjects.

Pre-emptive analgesia efficacy of piroxicam versus tramadol in oral surgery

  • Tejdeep, Muthuluri;Siddardha Gowtam, Chandrupatla;Ritesh, Rajan;Viveka V., Reddy;Dinesh K., Jhawar;Abhinand, Potturi
    • Journal of Dental Anesthesia and Pain Medicine
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    • 제22권6호
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    • pp.443-450
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    • 2022
  • Background: This double-blind randomized controlled trial (RCT) was conducted to evaluate the pre-emptive analgesia and anti-inflammatory efficacy of piroxicam compared with tramadol in patients undergoing oral surgery. Methods: Seventy-eight patients who required extraction of impacted mandibular third molars were randomized into three treatment groups of 26 patients each: group I received 100 mg of tramadol, group II received 20 mg of piroxicam, and group III received a placebo. Drugs were administered intramuscularly 30 min prior to the extraction procedure. Results: Pain intensity, time to first analgesic administration, total analgesic consumption, facial edema, and trismus were the outcomes of interest. The group receiving 20 mg of piroxicam showed significantly lower pain intensity, increased time to first analgesic, and reduced edema from preoperative to postoperative day seven than those in the tramadol and placebo groups. Conclusion: The findings of this study showed that piroxicam had significant pain relief efficacy after third molar surgery compared with that in tramadol.

마황용량에 따른 이상반응에 관한 예비연구: 무작위배정이중맹검시험 (Adverse Effects of Ma-huang according to Dose : A Randomized Double-Blind Placebo-Controlled Pilot Study)

  • 형례창;이태호;손동혁;여진주;양창섭;서의석;장인수
    • 대한한방내과학회지
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    • 제27권1호
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    • pp.188-196
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    • 2006
  • Background: Ma-huang (Ephedra sinica) has been widely used to treat respiratory disease in oriental medicine for over a hundred years. Ma-huang preparations contain approximately 1.25% ephedrine alkaloids. Recently, the ephedra alkaloids have received much press lately due to adverse effects in those using whole extracts as 'dietary supplements' for weight loss or athletic performance enhancement, and these reports are troubling given the increasing use of Ma-huang by the general public. The purpose of this report is to determine the proper dosage to minimize adverse effects and maximize the potential curative value. Objectives : The object of this study was to find an effective yet low risk dosage of Ma-huang. Methods : The study was designed as a double-blind randomized placebo-controlled trial. The subjects of this study were 26 adults between 20 to 40 of age who agreed to participate in this study. They were allocated through randomization into three groups. Each group took three opaque capsules three times a day. A group (N=9) took one Ma-huang capsule and two placebo capsules, B group (N=8) took two Ma-huang capsules and one placebo capsule, C group (N=9) took three Ma-huang capsules. The total trial periods was two days. To compare the adverse effects of Ma-huang according to dosage, blood pressure and pulse were checked, and other adverse effects were assessed using a morning questionnaire, patient's global assessment scale and Wong-Baker faces pain rating. Results : The following result were obtained: 1. After taking 18 g of Ma-huang per day, pulse rate had a significant increase. 2. After taking more than 6 g of Ma-huang per day, palpitation would be increased significantly. 3. After taking more than 18 g of Ma-huang per day, tiredness would be increased significantly. Conclusion: According to the results, 12 g of Ma-huang per day will minimize adverse effects and maximize the potential curative value.

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여성의 주요우울증에 대한 노에스액(육울탕)의 안전성, 유효성 평가 : 무작위배정, 양측눈가림, 위약대조, 평행설계 임상시험 프로토콜 (A Research to Evaluate the Safety and Efficacy of Yukwool-tang (Liuyu-tang) for Major Depression in Women: A Study Protocol for a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Clinical Trial)

  • 서영경;이은희;김환;이지윤;박채린;최선영;장은수;권오진;김형준;정인철
    • 동의신경정신과학회지
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    • 제29권1호
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    • pp.35-46
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    • 2018
  • Objectives: The aim of this trial is to evaluate the efficacy and safety of Yukwool-tang (Liuyu-tang) for the treatment of major depression in women by comparing the Yukwool-tang (Liuyu-tang)-treated group with the placebo-treated group and assessing the association of various biological factors related to depression through various outcome measures. Methods: This study is a single-center, randomized, double-blind, placebo-controlled, parallel-design clinical trial. The subjects to be selected are women between the ages of 19 and 65, and the registered subjects are to be randomly assigned to treatment with Yukwool-tang or the placebo control. The Yukwool-tang group will take 1 bottle of Yukwool-tang (30 mg) for 8 weeks, 3 times a day, before meals. The control group will take the placebo in the same way. The primary outcome to be examined will be the change between the total score after 8 weeks and the total score before the start of the study of the K-HDRS score. Secondary outcomes are assessed by the change in total score after 12 weeks of K-HDRS, K-HDRS remission rate, K-HDRS improvement rate, BDI-K, PITD, KSCL-95, ISI, STAI-K, EQ-5D, VAS, Emotional Stimulation Test, BDNF test, inflammatory cytokine and tumor necrosis factor test, intestinal microbiome test, dietary report and Beck's hopelessness scale. Results: This protocol has been approved by the IRB of Dunsan Korean Medicine Hospital of Daejeon University and is registered in the CRIS, and it is made public in advance to ensure transparency of the research process and conduct ethical clinical trials. Conclusions: Based on this protocol, when the trial is completed, its data can be used to access the validity and safety of Yukwool-tang for major depression in women, and it is also expected to be helpful in the study of the correlation between future treatment of Korean medicine for depression and related biological factors, and quality of life.

The Effect of Adding Kami-guibi-tang to Acetylcholinesterase Inhibitor Treatment on the Cognitive Function of Mild Alzheimer's Disease Patients: Study Protocol of a Randomized, Placebo-Controlled, Double-Blind Pilot Trial

  • Yang, Seung-bo;Kim, Ha-ri;Shin, Hee-yeon;Kim, Jeong-hwa;Lee, Chang-woo;Jahng, Geon-ho;Park, Seong-uk;Ko, Chang-nam;Park, Jung-mi
    • 대한한방내과학회지
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    • 제41권3호
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    • pp.326-338
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    • 2020
  • Background: Alzheimer's disease (AD) is a chronic neurodegenerative disease that causes disorientation, mood swings, problems with language, and difficulty remembering recent events. Acetylcholinesterase inhibitors (AchEIs) and memantine have been used to slow the course of the disease, but they can neither modify its progression nor prevent disease onset. Previous studies have suggested that Kami-guibi-tang (KGT) could be beneficial for supporting cognitive function in AD patients, but few clinical trials have been published. This pilot study aimed to evaluate the effect of KGT in improving cognitive function in AD patients. Methods: The study will be a randomized, placebo-controlled, double-blind, single-center trial conducted using subjects diagnosed with mild AD by neurologists. Study subjects will be randomly assigned to either a treatment or control group. The treatment group will receive KGT granules for 24 weeks, while the control group will receive placebo granules. AchEI administration will be maintained in both groups during the entirety of the study. Subjects will be assessed using the following exams: the Seoul Neuropsychologic Screening Battery (SNSB) for cognitive function; brain magnetic resonance imaging (MRI) for brain metabolite, neurotransmitter, and cerebral blood flow (CBF) measurements; the Korean version of Quality of Life-Alzheimer's Disease (KQol-AD) for quality of life; the Caregiver-Administered Neuropsychiatric Inventory (CGA-NPI) for neurobehavioral symptoms; blood tests for amyloid and tau proteins and general blood parameters; and electrocardiography (ECG) before and after taking the medication. Discussion: Our findings will provide insight into the feasibility of large-scale trials to consolidate evidence for the efficacy of KGT for dementia treatment. Registration ID in CRIS: KCT0002904 (Clinical Research Information Service of the Republic of Korea).