• Title/Summary/Keyword: double-blind

Search Result 544, Processing Time 0.025 seconds

Effectiveness of dexamethasone or adrenaline with lignocaine 2% for prolonging inferior alveolar nerve block: a randomized controlled trial

  • Deo, Saroj Prasad;Ahmad, Md Shakeel;Singh, Abanish
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
    • /
    • v.48 no.1
    • /
    • pp.21-32
    • /
    • 2022
  • Objectives: Inferior alveolar nerve block (IANB) is commonly used for mandibular dentoalveolar surgery. The objective of this study was to evaluate and compare the effectiveness of coadministration of dexamethasone (4 mg/mL) or adrenaline (0.01 mg/mL) as an adjuvant with lignocaine 2% in IANB during third molar surgery (TMS). Patients and Methods: This double-blind, randomized controlled trial was conducted between March and August 2020. The investigators screened patients needing elective TMS under local anesthesia. Based on strict inclusion and exclusion criteria, patients were enrolled in this study. These patients were assigned randomly into two study groups: dexamethasone group (DXN) or adrenaline group (ADN). Outcome variables were postoperative edema, trismus, visual analogue scale (VAS), perioperative analgesia, onset time, and duration of IANB. Results: Eighty-three patients were enrolled in this study, of whom 23 (27.7%) were eliminated or excluded during follow-up. This study thus included data from 60 samples. Mean age was 32.28±11.74 years, including 28 females (46.7%) in the ADN (16 patients, 57.1%) and DXN (12 patients, 42.9%) groups. The duration of action for DXN (mean±standard deviation [SD], 4:02:07±0:34:01 hours; standard error [SE], 0:06:00 hours; log-rank P=0.001) and for ADN (mean±SD, 1:58:34±0:24:52 hours; SE, 0:04:42 hours; log-rank P=0.001) were found. Similarly, time at which 1st analgesic consume and total number of nonsteroidal antiinflammatory drugs need to rescue postoperative analgesia was found statistically significant between study groups (t (58)=-11.95; confidence interval, -2:25:41 to -1:43:53; P=0.001). Early-hours VAS was also significantly different between the study groups. Conclusion: A single injection of dexamethasone prolongs the duration of action of lignocaine 2% IANB. Additionally, it can be used in cases where adrenaline is contraindicated.

A Pilot Clinical Study of the Efficacy and Safety of Phellinus Linteus (Sanghuang) Extract Treatment for Knee Osteoarthritis

  • Ryu, Hwa yeon;Lee, Hyun;Kang, Jae Hui
    • Journal of Acupuncture Research
    • /
    • v.39 no.2
    • /
    • pp.115-121
    • /
    • 2022
  • Background: To evaluate the efficacy and safety of Phellinus linteus (PL) extract for the treatment of knee osteoarthritis (KOA) a pilot clinical study was performed. Methods: There were 24 patients with KOA who enrolled in this double-blind, randomized, controlled, clinical trial. There were 3 groups: PL 1,000 mg/day (PL 1,000), PL 1,500 mg/day (PL 1,500), and dextrin 3,000 mg/day (placebo). Patients took capsules twice a day, 3 capsules at a time, over 8 weeks. Patients were monitored prior to treatment (Visit 1: Week 0), and followed up every 4 weeks (Visit 2: Week 4 and Visit 3: Week 8) where outcome measurements were taken. The primary outcome measure was the score from the Korean version of the Western Ontario and McMasters Universities from baseline to Week 8. The secondary outcomes were measurements from the visual analog scale, quality of life scale, erythrocyte sedimentation, and c-reactive protein. Adverse events were recorded at every visit. Results: The Korean version of the Western Ontario and McMasters Universities score showed the greatest improvement in symptoms of KOA in the PL 1,500 group compared with the placebo group. The erythrocyte sedimentation tended to decrease in the PL 1,500 group compared with the placebo group (which was within the normal range). The visual analog scale score decreased in all groups, with no significant differences between groups. No adverse events related to PL were reported. There were no abnormal hematological or physical findings. Conclusion: This pilot clinical trial was the first step to assess the efficacy and safety of PL used in the treatment of patients with KOA.

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
    • /
    • v.23 no.1
    • /
    • pp.68-72
    • /
    • 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.

Effects of 3 mg·kg-1 Caffeine Ingestion during Exercise on Fluid-Electrolyte Balance and Tympanic temperature changes in the Heat (고온 환경에서 3 mg·kg-1의 카페인 섭취가 운동 시 체액, 전해질 균형 및 외이온의 변화에 미치는 영향)

  • Kim, Tae-Wook;Park, Bong-Sup
    • Korean Journal of Exercise Nutrition
    • /
    • v.13 no.1
    • /
    • pp.75-81
    • /
    • 2009
  • This study aims to find out the effect of ingestion of 3 mg·kg-1 caffeine on fluid-electrolyte balance and Tty change during exercise under heat environment of 30~32℃ (40-50% humidity). Five trained males who routinely trained for approximately 60 min·d-1, 3-6 d·wk-1 (age; 28.20±3.56yrs, height; 174.56±5.46 cm, body mass; 76.13±9.02 kg, body fat(%); 14.24±3.99, VO2max; 54.00±4.30 mL·kg-1·min-1, exercise career; 4.20±1.95yrs) performed 40min of treadmill running in heat chamber. The study was a double-blind, randomized, crossover design. Body mass change following exercise was higher for the PLAC (Placebo) and CAFF (Caffeine) in comparison to the CON (Control), there was no significant difference between the CAFF, PLAC, CON (p= .997). The Usg not significant differences (p= .731) and Osmurine not significant differences between the CAFF, PLAC, CON (p= .901). There also were not significant between the CAFF, PLAC, CON for [Na+]urine and [K+]urine (p= .928, p= .469). In the case of Tty, although the increase rate of Tty was the highest for the CAFF on exercise early, exercise the second half in comparison to the CON and PLAC, there was not significant interaction effect between the CAFF, PLAC, and CON of Tty (p= .067), In conclusion, it was confirmed that the 3 mg·kg-1 caffeine ingestion prior to exercising in heat environment does not impart negative effect on body fluid, electrolyte balance and changes in Tty.

Effects of whey protein supplementation prior to, and following, resistance exercise on body composition and training responses: A randomized double-blind placebo-controlled study

  • Park, Yeram;Park, Hun-Young;Kim, Jisu;Hwang, Hyejung;Jung, Yanghoon;Kreider, Richard;Lim, Kiwon
    • Korean Journal of Exercise Nutrition
    • /
    • v.23 no.2
    • /
    • pp.34-44
    • /
    • 2019
  • [Purpose] The composition of protein supplements, the consumption timing immediately before and after resistance exercise training (RET), and the quantity of protein supplementation may be important factors for the im-provement of muscle mass and function. Although these factors should be considered comprehensively for effective improvement of muscular function in protein supplementation, relatively few studies have focused on this area. Therefore, this study was designed to investigate whether a protein blend supplement before and after resistance exercise for 12 weeks would be effective in increasing muscular function. [Methods] In total, 18 participants were randomly assigned to a placebo (PLA) or protein blend supplement (PRO) group. All subjects followed the same training routine 3 times per week for 12 weeks, taking placebo or protein supplements immediately before and after each exercise session. The protein supplement consisted of 40 g of blend protein, including hydrolyzed whey protein. The RET consisted of lower body (barbell squat, dead lift, seated leg extension, and lying leg curl) and upper body (bench press, barbell rowing, preacher bench biceps curl, and dumbbell shoulder press) exercises. A repetition was defined as three sets of 10-12 times with 80% of one repetition maximum (1RM). [Results] Although the PRO group had a lower protein intake in terms of total food intake than the PLA group, the mean changes in muscle circumference, strength, and exercise volume increased, especially at week 12, compared to the PLA group. [Conclusion] These results suggest that the composition and timing of protein intake are more important than the total amount.

The effects of Korean Red Ginseng on stress-related neurotransmitters and gene expression: A randomized, double-blind, placebo-controlled trial

  • Jihyun Yoon;Byoungjin Park;Kyung-Won Hong;Dong-Hyuk Jung
    • Journal of Ginseng Research
    • /
    • v.47 no.6
    • /
    • pp.766-772
    • /
    • 2023
  • Background: Korean Red Ginseng (KRG) is an effective anti-stress treatment. In this study, we investigated the therapeutic potential effects of KRG on relieving stress in a general population using transcriptome analysis. Methods: We conducted an 8-week clinical pilot study on 90 healthy men who reported stress. The study was completed by 43 participants in the KRG group and 44 participants in the placebo group. Participants were randomized 1:1 to the KRG and placebo groups. We evaluated the stress by stress response inventory (SRI) at baseline and 8 weeks. The main outcomes were changes in the levels of neurotransmitters (NTs) and NT-related gene expression. NTs were analyzed using automated (GC) content, and levels of gene expression were measured by reads per kilobase of transcript per million mapped reads (RPKM). Results: The KRG group showed significantly preserved epinephrine decrease compared with placebo group at 8 weeks (changes in epinephrine, KRG vs. placebo; -1623.2 ± 46101.5 vs. -35116.3 ± 86288.2, p = 0012). Among subjects who higher SRI score, meaning stress increased compared to baseline, the KRG group showed a smaller decrease in serotonin than the placebo group (changes in serotonin, KRG vs. placebo; -2627.5 ± 5859.1 vs, -8087.4 ± 7162.4, p = 0.005) and a smaller increase in cortisol than the placebo group (changes in cortisol, KRG vs. placebo; 1912.7 ± 10097.75 vs. 8046.2 ± 8050.6 , p = 0.019) in subgroup analysis. Transcriptome findings indicated that KRG intake affects gene expression related with metabolism of choline, adrenalin, and monoamine. Conclusion: These findings suggest that KRG has beneficial effects on the amelioration of stress response in NTs, and this effect is more prominent in stressful situations. Further clinical studies are required to confirm the anti-stress effect of KRG.

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
    • /
    • v.27 no.2
    • /
    • pp.82-90
    • /
    • 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.

Effects of Soy Bread on Cardiovascular Risk Factor, Inflammation and Oxidative Stress in Women With Active Rheumatoid Arthritis: A Randomized Double-Blind Controlled Trial

  • Afsaneh Sayyaf;Ehsan Ghaedi;Fatemeh Haidari;Elham Rajaei;Kambiz Ahmadi-engali;Bijan Helli
    • Clinical Nutrition Research
    • /
    • v.13 no.1
    • /
    • pp.22-32
    • /
    • 2024
  • Rheumatoid arthritis (RA) is a systemic inflammatory autoimmune disorder with widespread synovitis. Isoflavones, the main active component of soy, have been reported to have potent anti-inflammatory effects; the previous RA animal models showed the promising effect of soy supplementation. We aimed to evaluate the effect of soy bread on inflammatory markers and lipid profiles in RA patients. The present study was designed as a randomized controlled trial. RA patients were randomly allocated to obtain soy bread (n = 22) or placebo bread (n = 22) for 8 weeks. Fasting serum levels of lipid profile, total antioxidant capacity (TAC), tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), and DAS28 were checked. Findings showed that there were no significant differences between the two groups in physical activity and dietary intake at the beginning of the study and the end of the study. There were no significant differences between the two groups in measured lipid profile markers, including high-density lipoprotein, low-density lipoprotein, total cholesterol, triglyceride, and very low-density lipoprotein, at the end of the trial. In addition, TAC and CRP also were not significant at the end of the trial between the 2 groups (0.66 and 0.12, respectively). However, the serum levels of TNF-α reduced significantly in the soy bread group at the end of the intervention (p < 0.000) and compared with the control group (p < 0.019). Soy bread consumption only decreased circulating TNF-α serum concentration. Other outcome measures were not changed following supplementation. Future long-term, well-designed studies are needed to confirm these findings.

Clinical effect of Vitamin C, Vitamin E, lysozyme, carbazochrome complex medicine($IGATAN^{(R)}$) in periodontal disease : Double blind, randomized control study (중등도 치주질환에 대한 Vitamin C, Vitamin E, lysozyme, carbazochrome (이가탄$^{(R)}$) 복합제제의 임상 효과)

  • Chang, Yun-Young;Jang, Yong-Ju;Jung, Im-Hee;Um, Yoo-Jung;Jung, Ui-Won;Kim, Chang-Sung;Kim, Baek-Il;Choi, Seong-Ho
    • The Journal of the Korean dental association
    • /
    • v.47 no.12
    • /
    • pp.830-837
    • /
    • 2009
  • Purpose : The purpose of this study was to evaluate the clinical effect of Vitamin C, Vitamin E, lysozyme, carbazochrome complex medicine($IGATAN^{(R)}$) for periodontal disease. Material and Methods : The study was performed by double blinded, ramdomized method. Forty two subjects diagnosed as chronic incipient or moderate periodontitis at department of periodontology, Yonsei Dental Hospital were included in the study. This study was approved by Institutional Review Board, Yonsei University Hospital. All subjects received scaling at their first examination and second examination was scheduled after 2 weeks. At second examination, periodontal parameters such as plaque index(PI), gingival index(GI), probing depth(PD), bleeding on probing(BOP), gingival recession(GR) and clinical attachment level(CAL) were recorded(Baseline) with prescription of Vitamin C, Vitamin E, lysozyme, carbazochrome complex($IGATAN^{(R)}$) (Experimental group 23 subjects) or placebo medicine(Control group; 19 subjects). The subjects were recalled after 4 weeks for periodontal parameters measurement. Results : In the experimental groups, PI, GI, CAL and BOP scores were significantly reduced at 4 weeks compared to baseline. A statistically significant decrease in or and BOP scores were observed in the experimental group compared to the control group. Conclusion : It can be concluded that Vitamin C, Vitamin E, lysozyme, carbazochrome complex medicine($IGATAN^{(R)}$) have an effect in reducing gingival bleeding and improving periodontal inflammatory condition inchronic incipient- moderate periodontitis.

  • PDF

Dose-related Effect of Extracorporeal Shock Wave Therapy for Lateral Epicondylitis - Prospective Randomized Double Blind Comparative Study - (주관절 외상과염의 체외 충격파 시술에서 에너지량에 따른 치료 효과 - 전향적 무작위적 이중 맹검 대조군 연구 -)

  • Oh, Joo-Han;Yoon, Jong-Pil;Oh, Chung-Hee;Jo, Ki-Hyun;Gong, Hyun-Sik
    • Clinics in Shoulder and Elbow
    • /
    • v.12 no.1
    • /
    • pp.21-26
    • /
    • 2009
  • Purpose: The aim of this study was to examine the dose-related effect of extracorporeal shock wave therapy (ESWT) for lateral epicondylitis. Materials and methods: Thirty patients with refractory lateral epicondylitis despite conservative treatment for 6 months were enrolled in this study. The patients were divided randomly into a low- and high-energy group. All patients were treated 3 times with ESWT with an interval of 1 week in a double blinded manner. The mean energy level in the low- and high-energy group was $0.12 mJ/mm^2$ and $0.24 mJ/mm^2$, respectively. The upper extremity functional scales and Mayo elbow scores were measured prospectively at the baseline, 1, 3 and 6 months after ESWT. Results: Significant clinical improvement was observed in both groups after ESWT. The high-energy group showed better pain improvement at 6 months after ESWT (p=0.019). The effect of ESWT was dominant between 1 and 6 months after ESWT than within 1 month. Conclusion: ESWT for lateral epicondylitis demonstrated showed good results regardless of the energy dose. However, a high-energy level was more effective in pain improvement after 6 months of treatment.