• Title/Summary/Keyword: randomized controlled double blind study

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Comparing the effect of a desensitizing material and a self-etch adhesive on dentin sensitivity after periodontal surgery: a randomized clinical trial

  • Hajizadeh, Hila;Nemati-Karimooy, Atefeh;Majidinia, Sara;Moeintaghavi, Amir;Ghavamnasiri, Marjaneh
    • Restorative Dentistry and Endodontics
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    • v.42 no.3
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    • pp.168-175
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    • 2017
  • Objectives: This double-blind randomized placebo-controlled clinical trial evaluated the ability of a desensitizing agent and a self-etch adhesive on cervical dentin sensitivity (CDS) after periodontal surgery. Materials and Methods: Ninety hypersensitive teeth of 13 subjects were included in the study. After periodontal surgery, the teeth of each posterior sextant treated with one of the following materials: G1: Clearfil $S^3$ Bond (Kuraray Dental), G2: Gluma Desensitizer (Heraeus Kulzer), and G3: placebo (water). The sensitivity was assessed using evaporative stimuli before treatment (baseline, T0), 1 day after treatment (T1), after 1 week (T2), and 1 month (T3) according to visual analog scale (VAS). Results: Following the treatment, all the 3 groups showed significant reduction of CDS in T1 compared to T0. Reduction of CDS between T1 and T2 was observed only in G1 but there was no significant difference between T2 and T3 in this group. Although we observed a significant difference in T3 compared to T1 and T2 in G2 and G3, comparison of treatment groups in each assessment time showed a significant difference only in T3. According to paired comparison, this was due to the difference between G2 and G3. Conclusions: Dentin sensitivity following periodontal surgery will decrease spontaneously over time, but treating the sensitive teeth with Gluma Desensitizer and Clearfil $S^3$ Bond can have some benefits.

Impact of GNB3, ADRB3, UCP2, and PPAR${\gamma}$-Pro12Ala polymorphisms on Boiogito response in obese subjects : A randomized, double-blind, placebo-controlled trial (방기황기탕의 유전자 다형성에 따른 비만 치료 효과 : 무작위 배정, 이중 맹검, 위약-대조군 임상시험)

  • Park, Jung-Hyun;Bose, Shambhunath;Lim, Chi-Yeon;Kim, Ho-Jun
    • Journal of Korean Medicine for Obesity Research
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    • v.12 no.2
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    • pp.28-43
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    • 2012
  • Objectives: The aim of the study was to investigate the efficacy of Boiogito for obesity. We examined the efficacy of Boiogito for obese patients and we expected the reaction of Boiogito would vary according to the single nucleotide polymorphism(SNPs). Methods: 111 subjects(body mass index${\geq}25m/kg^2$) were recruited and randomized to receive Boiogito(n=55) or Placebo(n=56) for 8weeks. Anthropometric factors, serum lipid profile, glucose, blood pressure(BP), pulse rate, resting metabolic rate and Korean version of obesity-related quality of life(KOQOL) scale measured at baseline and 8weeks. SNPs(${\beta}3$-adrenergic receptor(ADRB3), G protein ${\beta}3$(GNB3), peroxisome proliferator activated receptor gamma 2 gene(PPAR-${\gamma}2$), uncoupling protein(UCP2)) were conducted at baseline. Adverse reactions and safety outcome variables were also checked during trials. Results: Both groups showed significant improvement on obesity after treatment. Boiogito group decreased triglyceride than did control group and improved KOQOL. Boiogito showed a significant higher efficacy in C/T and T/T genotype of GNB3 gene / in Trp64 and Arg64 genotype of ADRB3 gene / in D/D genotype of UCP2 gene / in Pro/Pro genotype of PPAR-${\gamma}$ gene. Conclusions: Boiogito promoted obesity indexes without severe adverse reactions and proved its safety. Pharmacogenetical studies of Boiogito on obesity could be a effective method for the individualized treatment and prevention of obesity.

Influence of Ketamine and Midazolam on the Analgesic Effect of Epidural Bupivacaine and Fentanyl after Low Abdominal Surgery (하복부수술 후 경막외 부피바케인과 펜타닐에 첨가한 케타민과 미다졸람의 제통효과)

  • Jung, Jai Yun;Park, Sun Young;Kim, Yong Ik
    • The Korean Journal of Pain
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    • v.19 no.1
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    • pp.87-90
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    • 2006
  • Background: There are many ways to provide superior analgesia for postoperative pain after abdominal surgery of which epidural analgesics with opioids and local analgesics are the most useful. In an effort to maximize the level of analgesia and to minimize the side effects, ketamine, midazolam, clonidine, and adrenalin can be co-administrated as an adjuvant. This study examined the analgesic effect and side effects of midazolam compared with those given an epidural injection of bupivacaine, fentanyl and ketamine. Methods: In a double blind randomized controlled trial, 50 patients received either fentanyl $0.3{\mu}g/kg/h$ and ketamine 0.1 mg/kg/h (Group FK) or fentanyl $0.3{\mu}g/kg/h$, ketamine 0.1 mg/kg/h and midazolam 0.4 mg/h (Group FKM), added to 0.125% of bupivacaine at a rate of as much as 2 ml/h, for patient controlled epidural analgesia (PCEA) after low abdominal surgery. Ten minutes before surgery, the patients received either 10 ml of 0.125% bupivacaine with 0.5 mg/kg of ketamine or 10 ml of 0.125% bupivacaine with the same amount of normal saline, added to fentanyl $50{\mu}g$. The pain score and the side effects were recorded at 1, 3, 6, and 24 hours after surgery. Results: There was no difference in the pain score except for the VAS on coughing 1 hour after surgery. FKM group had fewer side effects. Conclusions: There was a better analgesic effect and fewer side effects with the addition of epidural midazolam to bupivacaine and fentanyl with ketamine formula. However, more study on the dose and route of administration will be needed.

Randomized Double-Blind Placebo-Controlled Trial of Propolis for Oral Mucositis in Patients Receiving Chemotherapy for Head and Neck Cancer

  • Akhavan-Karbassi, Mohammad Hasan;Yazdi, Mohammad Forat;Ahadian, Hakimeh;Sadr-Abad, Maryam Jalili
    • Asian Pacific Journal of Cancer Prevention
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    • v.17 no.7
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    • pp.3611-3614
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    • 2016
  • Background: Propolis based preparations have a wide range of applications in various specialties of dentistry. The aim of this clinical trial was to test the efficacy of propolis as a mouthwash in the reduction of chemotherapy induced oral mucositis (OM) in a single center. Materials and Methods: In this randomised, controlled study patients undergoing chemotherapy were included consecutively and randomised to an experimental group receiving propolis mouthwash (n = 20) and a control group receiving diluted water (n=20). Oral mucositis, erythema and eating and drink ability were assessed at baseline and after 3 and 7 days using the World Health Organization (WHO) scale and the oral mucositis assessment scale (OMAS). Results: There were significant differences in OM, wound and erythema in propolis group compared to placebo, but no significant difference in eating and drink ability. However, it was interesting that 65% of the patients in the propolis group were completely healed at day 7 of the trial. No significant adverse events were reported by the patients. Conclusions: This study found that oral care with propolis as mouthwash for patients undergoing chemotherapy is an effective intervention to improve oral health. Our findings shouldlencourage health practitioners to apply propolis mouth rinse for the oral care of patients under chemotherapy.

A Randomized, Double-blind, Placebo-controlled Study to the efficacy and Safety of NMED-01 and NMED-02 in Mild Alcoholic Liver Subjects (NMED-01과 NMED-02의 간기능 개선에 대한 인체 효능 평가)

  • Park, Sangwoug;Kwon, Yongbeom;Kim, Ki Tae;Shin, Seon Mi;Leem, Kang-Hyun;Ko, Heung;Song, MiKyung;Jung, Yoon Chul;Kim, Hocheol;Park, Juyeon
    • The Korea Journal of Herbology
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    • v.28 no.6
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    • pp.31-38
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    • 2013
  • Objectives : The purpose of this study was to determine whether NMED-01 or NMED-02 improves laboratory test results in participants with liver function disorder. Methods : This is a randomized, placebo-controlled trial in which participants, treating physicians and data management staff were blinded to treatment group. The study was conducted at Semyung university oriental medicine hospital in Jecheon where participants with high level of serum ${\gamma}$-GTP (60-350 U/L) were enrolled. The intervention consisted of three times daily ingestion of either two capsules of placebo, NMED-01 (NeuMed. co. ltd., Seoul), or NMED-02 (NeuMed. co. ltd., Seoul) for twelve weeks. To evaluate the efficacy and safety of NMED-01 and NMED-02, we primarily evaluated the degree of decrement of serum ${\gamma}$-GPT level among three groups. Secondarily the decrement of serum ALT, AST, and triglyceride level in each group were also evaluated. Adverse effects were monitored during the twelve weeks treatment. Results : The change of ${\gamma}$-GTP level of NMED-01 group was lower than that of placebo group at the end of 12-week administration ($28.1{\pm}38.7U/L$ vs. $9.3{\pm}27.0U/L$, p=0.046). Other variables including AST, ALT, and triglyceride level were not significantly reduced. The decrement of ${\gamma}$-GPT, AST, ALT, and triglyceride level of NMED-02 group was not significant. There were no significant adverse effects or toxicities during treatment period. Conclusions : Participants receiving NMED-01 had improvement in laboratory test results. Despite a modest sample size, our results suggest that NMED-01 are safe and may be potentially effective in improving liver function. However, NMED-02 have lack of a detectable effect in this study.

A Study on Thermal Effect and Medication Compliance of Red Ginseng Extract (홍삼의 온열 효과와 복약 순응도에 관한 연구)

  • Choi, Min-Sun;Jeong, Jae-Cheol;Park, Jang-Kyung;Ahn, Hong-Yeop;Kim, Dong-Il
    • Journal of Oriental Medical Thermology
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    • v.7 no.1
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    • pp.44-54
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    • 2009
  • Purpose: To evaluate thermal effect and medication compliance of red ginseng extract. Methods: Randomized, double-blind, placebo-controlled, cross-over clinical study was performed. Twenty four healthy, married women aged 30-45 years with FSFI score below 25 were randomly divided into two groups; red ginseng group(N=12) and placebo group(N=12). During the first 6-week period (Study1), each group was dosed with red ginseng or placebo twice a day. Before starting the second 6-week period(Study2), a crossover design was chosen with a 2-week break(Washout period). Interchanging two groups after Washout period, red ginseng and placebo were dosed to each group. The efficacy of thermal effect was measured with subjective warm sensation scale and lower abdomen temperature by Digital Infrared Thermographic imaging(DITI) before and after each 6-week period. A medication compliance was assessed after each 6-week period and the correlation medication compliance between Sasang Constitution and subjective warm sensation was analyzed. Results: Overall 23 participants completed the study. In subjective warm sensation scale, after taking placebo, all participants exhibited an improving trend, but there was no significant difference. In lower abdomen temperature by DITI, statistically significant objective thermal effect of red ginseng was also not shown. A medication compliance was higher in Yin constitution(Taeumin, Soeumin), and showed an upward trend with decreasing subjective warm sensation. But no statistically significant difference was exhibited. Conclusion: Statistically significant thermal effect of red ginseng was not shown in this study. We anticipate if a long-term clinical trial is practiced, significant thermal effect of red ginseng will be shown.

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A Study on Thermal Effect and Medication Compliance of Red Ginseng Extract (홍삼의 온열 효과와 복약 순응도에 관한 연구)

  • Choi, Min-Sun;Jeong, Jae-Cheol;Park, Jang-Kyung;Ahn, Hong-Yeop;Kim, Dong-Il
    • The Journal of Korean Obstetrics and Gynecology
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    • v.22 no.3
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    • pp.223-235
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    • 2009
  • Purpose: To evaluate thermal effect and medication compliance of red ginseng extract. Methods: Randomized, double-blind, placebo-controlled, cross-over clinical study was performed. Twenty four healthy, married women aged 30-45 years with FSFI score below 25 were randomly divided into two groups; red ginseng group(N=12) and placebo group(N=12). During the first 6-week period (Study1), each group was dosed with red ginseng or placebo twice a day. Before starting the second 6-week period(Study2), a crossover design was chosen with a 2-week break(Washout period). Interchanging two groups after Washout period, red ginseng and placebo were dosed to each group. The efficacy of thermal effect was measured with subjective warm sensation scale and lower abdomen temperature by Digital Infrared Thermographic imaging(DITI) before and after each 6-week period. A medication compliance was assessed after each 6-week period and the correlation medication compliance between Sasang Constitution and subjective warm sensation was analyzed. Results: Overall 23 participants completed the study. In subjective warm sensation scale, after taking placebo, all participants exhibited an improving trend, but there was no significant difference. In lower abdomen temperature by DITI, statistically significant objective thermal effect of red ginseng was also not shown. A medication compliance was higher in Yin constitution(Taeumin, Soeumin), and showed an upward trend with decreasing subjective warm sensation. But no statistically significant difference was exhibited. Conclusion: Statistically significant thermal effect of red ginseng was not shown in this study. We anticipate if a long-term clinical trial is practiced, significant thermal effect of red ginseng will be shown.

Effects of AIF on Knee Osteoarthritis Patients: Double-blind, Randomized Placebo-controlled Study

  • Park, Sung-Hoon;Kim, Seong-Kyu;Shin, Im-Hee;Kim, Hyung-Gun;Choe, Jung-Yoon
    • The Korean Journal of Physiology and Pharmacology
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    • v.13 no.1
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    • pp.33-37
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    • 2009
  • Anti-inflammatory factor(AIF) is a water soluble extract of three herbs, Panax notoginseng(Burk.) F. H. Chen, Rehmannia glutinosa Libosch and Eleutherococcus senticosus. The present study aimed to investigate the safety and efficacy of herb extracts, AIF, on Korean knee osteoarthritis patients for six weeks. Fifty seven patients with knee osteoarthritis, ranging from 43 to 73 years of age, who fulfilled the "American College of Rheumatology"(ACR) classification of idiopathic osteoarthritis of knee and radiographic criteria were randomly selected and enrolled for the study. After initial screening and resting period, two capsules each of AIF(Each capsule contains; 400 mg) and similar identical placebo were administered twice a day to both groups. Pain intensity at second, fourth, and sixth weeks of study as well as one week after discontinuation of drugs was assessed by using 100 mm visual analogue scale(VAS). Changes in the Korean version of the Western Ontario and McMaster Universities(K-WOMAC) index score were compared at the initiation and completion of the study. VAS assessed by patients were significantly reduced(at visit 2; $54.64{\pm}14.72$, at visit 4, $37.32{\pm}16.58$, p<0.001) after AIF administration. Results showed an improvement in the physical function of K-WOMAC scale which was significantly higher(p=0.013) in AIF than placebo group, and decreases of total K-WOMAC score were also significantly higher(p=0.030) in AIF groups than placebo group. No serious adverse effect was observed, and there was no difference in incidence of adverse effect between AIF and placebo groups. In this population of Korean patients with knee osteoarthritis, AIF was found to be safe, tolerable and effective for symptomatic improvement of pain and physical function.

Effects of Extracts from the Mushroom Keumsa Sangwhang (Phellinus linteus) on Fasting Blood Glucose and Cholesterol Levels in Human (금사상황버섯 추출물 복용이 공복혈당 및 혈중지질농도에 미치는 효과)

  • Kim, Yong-Dae;Kim, Nam-Sik;Eom, Sang-Yong;Kim, Sung-Hoon;Kang, Jong-Won;Lee, Sang-Won;Park, Soon-Young;Kim, Jeong-Su;Kim, Heon;Hong, Jang-Soo
    • Journal of the Korean Society of Food Culture
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    • v.23 no.1
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    • pp.68-72
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    • 2008
  • This study demonstrated the effects of extracts from the mushroom Keumsa sangwhang(Phellinus linteus) (KPLE) on fasting glucose and cholesterol levels in human blood. In this double-blind, placebo-controlled human intervention study, healthy volunteers were randomized to receive 3.3 g of KPLE (n=31) or placebo (n=31) per day by oral administration for 8 weeks. The cholesterol and fasting serum glucose levels were evaluated before and after treatment. The fasting serum glucose level was significantly decreased by KPLE administration (p<0.01), but the total cholesterol, triglyceride, HDLcholesterol and LDL-cholesterol concentrations did not change. This study suggests a possibility that KPLE may be useful as a functional food for the prevention of diabetes mellitus.

Adverse Event Study on Ojeok-san Extract Powders RCT in Low Back Pain Patients (요통환자 대상 오적산 엑스산 투여 임상시험 이상반응 연구)

  • Yoon, Eun-Hye;Jang, Min-Gee;Hwang, Ji-Hoo;Lee, Seung-Hoon;Jeong, Won-Je;Lee, Jae-Dong;Lee, Seung-Deok;Kim, Kyung-Ho;Kim, Kap-Sung;Kim, Eun-Jung
    • Journal of Acupuncture Research
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    • v.27 no.4
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    • pp.195-202
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    • 2010
  • Objectives : This study was performed to report adverse events in Ojeok-san extract powders RCT. Methods : 180 patients with LBP were randomized into groups for a double blind, placebo-controlled clinical study. They received Ojeok-san simple Extract, Ojeok-san complex Extract or placebo in powders, orally dissolved 3times a day for 4weeks. During 4weeks, we researched the symptoms and duration of adverse events and Digest ability, Milk hypersensitivity, Starch hypersensitivity, Caramel hypersensitivity, West-med hypersensitivity, Herb-med hypersensitivity in patients who had adverse events. Results : 52patients(28.9%) had adverse events and of them 44patients(28.9%) had lost adverse events naturally. But 5patients(2.8%) were withdrawn from the research because of the adverse events. Most of the symptoms of adverse event was Gastrointestinal symptom(88.3%) and adverse events frequency was not different from Ojeok-san simple Extract, Ojeok-san complex Extract and placebo. Conclusions : Ojeok-san extract powders had adverse events no different from the placebo, which shows that it is a safe drug.