scholarly journals Efficacy of INtensive Treatment Versus Standard Treatment of COmpound DanshEn Dripping Pills in Refractory Angina Patients With Incomplete Revascularization (INCODER Study): Study Protocol for a Multicenter, Double-blind, Randomized Controlled, Superiority Trial

2021 ◽  
Author(s):  
Zexuan Wu ◽  
Danping Xu ◽  
Zhen Wu ◽  
Ailan Chen ◽  
Lin Xu ◽  
...  
Keyword(s):  
Cardiopulmonary Exercise Testing ◽  
Intensive Treatment ◽  
Control Group ◽  
Refractory Angina ◽  
Double Blind ◽  
Randomized Controlled ◽  
Total Exercise Time ◽  
Incomplete Revascularization ◽  
Registration Number ◽  
Superiority Trial

Abstract Introduction: Patients with incomplete revascularization (ICR) tend to develop refractory angina despite optimal medical therapy. Compound Danshen Dripping Pills (CDDP) is a widely used antianginal drug in China and is showed to significantly alleviate myocardial ischemia. Previous studies showed dose-efficacy tendency when increasing doses of CDDP. The study is aim to investigate the efficacy and safety of intensive doses of CDDP in patients with refractory angina with ICR.Methods and Analysis: The INCODER study is a multicenter, double-blind, randomized controlled, superiority trial. We plan to recruit 250 patients aged 18 to 85 years with a diagnosis of refractory angina with ICR. Patients will be randomized (1:1) to intensive treatment group (CDDP 20 pills three times per day) or control group (10 pills CDDP and 10 pills placebo three times per day). Patients will have a 6-week medication period and be followed up every two weeks. The primary end point is the change of total exercise time from baseline to week 6 as assessed by cardiopulmonary exercise testing (CPET). Secondary end points include changes in frequency of angina, Canadian Cardiovascular Society angina class, nitroglycerin use, Seattle Angina Questionnaire scores, O2 uptake kinetics and other parameters as measured by CPET, and levels of plasma C-reactive protein, homocysteine and N-terminal pro-B-type natriuretic peptide. Safety events related to CDDP use will be monitored.Ethics and dissemination: The research had been approved by the Clinical research and laboratory animal ethics committee of the First Affiliated Hospital, Sun Yat-sen University ([2019]65). The results will be reported through peer-reviewed journals, seminars and conference presentations.Trial registration number: www.chictr.org.cn (ChiCTR2000032384). Registered on 27 April 2020.

scholarly journals Randomized, controlled trial of lasmiditan over four migraine attacks: Findings from the CENTURION study

Cephalalgia ◽  
2021 ◽  
Vol 41 (3) ◽  
pp. 294-304 ◽  
Author(s):  
Messoud Ashina ◽  
Uwe Reuter ◽  
Timothy Smith ◽  
Judith Krikke-Workel ◽  
Suzanne R Klise ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Study Drug ◽  
Statistical Testing ◽  
Control Group ◽  
Double Blind ◽  
Treatment Groups ◽  
Primary Endpoints ◽  
Registration Number ◽  
Secondary Endpoints ◽  
Common Teaes

Background We present findings from the multicenter, double-blind Phase 3 study, CENTURION. This study was designed to assess the efficacy of and consistency of response to lasmiditan in the acute treatment of migraine across four attacks. Methods Patients were randomized 1:1:1 to one of three treatment groups – lasmiditan 200 mg; lasmiditan 100 mg; or a control group that received placebo for three attacks and lasmiditan 50 mg for either the third or fourth attack. The primary endpoints were pain freedom at 2 h (first attack) and pain freedom at 2 h in ≥2/3 attacks. Secondary endpoints included pain relief, sustained pain freedom and disability freedom. Statistical testing used a logistic regression model and graphical methodology to control for multiplicity. Results Overall, 1471 patients treated ≥1 migraine attack with the study drug. Both primary endpoints were met for lasmiditan 100 mg and 200 mg ( p < 0.001). All gated secondary endpoints were met. The incidence of treatment-emergent adverse events (TEAEs) was highest during the first attack. The most common TEAEs with lasmiditan were dizziness, paresthesia, fatigue, and nausea; these were generally mild or moderate in severity. Conclusions These results confirm the early and sustained efficacy of lasmiditan 100 mg and 200 mg and demonstrate consistency of response across multiple attacks. Trial Registration Number: NCT03670810

scholarly journals Neurofeedback for tinnitus: Study protocol for a double-blind randomized controlled trial assessing the specificity of an alpha/delta neurofeedback training protocol in alleviating both the sound perception and the psychological distress, in a cohort of chronic tinnitus sufferers

2019 ◽  
Author(s):  
Martin Jensen ◽  
Eva Hüttenrauch ◽  
Jennifer Schmidt ◽  
Gerhard Andersson ◽  
Mira-Lynn Chavanon ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Control Group ◽  
Neurofeedback Training ◽  
Double Blind ◽  
Sound Perception ◽  
Active Comparator ◽  
Randomized Controlled ◽  
Tinnitus Distress ◽  
Training Protocol

Abstract Background Tinnitus is a very common condition, which for some can have debilitating psychological consequences. Although some interventions are helpful in learning how to cope better with the tinnitus, at present there is no cure. Neurofeedback is an emerging treatment modality in tinnitus. Previous studies, utilizing an alpha/delta training protocol have shown promise. However, they were characterized by small sample sizes and lack of neurofeedback control conditions. Therefore, the aim of this study is to investigate, if an alpha/delta neurofeedback training protocol, compared to beta/theta neurofeedback or a diary control group, is effective in reducing, not only the tinnitus sound perception, but also the psychological symptoms associated with the condition. Methods The study is designed as a three-armed, single-blinded randomized controlled trial. Participants are randomly assigned to either an established neurofeedback protocol for tinnitus (alpha/delta training), another neurofeedback protocol as active comparator (beta/theta training) or diary control group. In the four-week intervention period, participants in both neurofeedback groups undergo ten sessions, whereas participants in the diary control group complete a diary bi-weekly. The primary outcomes are between group differences in tinnitus sound percept change, as measured with the Tinnitus Magnitude Index (TMI) and changes in tinnitus distress, measured with the Tinnitus Handicap Inventory (THI), four weeks post baseline. Secondary outcome measures include changes in tinnitus distress, sleep quality, depressive symptoms and whether neurofeedback leads to specific power changes in the trained frequency bands. Discussion This is the first double-blind, randomized controlled trial examining the efficacy of an alpha/delta neurofeedback training protocol in reducing the tinnitus sound percept and the distress associated with the condition. Compared to former studies, the present study is designed to assess both the specificity of an alpha/delta neurofeedback training protocol by including an active comparator, beta/theta neurofeedback training, and in addition to control for placebo effects by inclusion of a diary control group. We hope this study contributes not only to our understanding of the neurological underpinnings of tinnitus, but also to the potentiality of neurofeedback as a therapeutic agent.

Urokinase-Containing Locking Solution in the Prevention of Dialysis Catheter Dysfunction: A Double Blind Randomized Controlled Trial

2017 ◽  
Vol 18 (5) ◽  
pp. 436-442 ◽  
Author(s):  
Florence Bonkain ◽  
Freya Van Hulle ◽  
Peter Janssens ◽  
Concetta Catalano ◽  
Mandelina Allamani ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Incidence Rate ◽  
Controlled Trial ◽  
Recombinant Tissue Plasminogen Activator ◽  
Hemodialysis Patients ◽  
Control Group ◽  
Double Blind ◽  
Systemic Thrombolysis ◽  
Randomized Controlled ◽  
History Of

Introduction The prophylactic use of recombinant tissue plasminogen activator once weekly reduces the incidence rate of tunneled cuffed catheter (TCC) malfunction and bacteremia as compared to the exclusive use of heparin as locking solution. Restricting the use of prophylactic thrombolytic agents to patients with a history of thrombotic TCC malfunction could be more cost effective. We conduct a multicenter, double-blind, randomized controlled trial and test the hypothesis that weekly use of urokinase lock will reduce the incidence of thrombotic malfunction by 50% in prevalent hemodialysis patients with a history of thrombotic malfunction. Methods Patients with a history of at least two separate TCC thrombotic dysfunctions treated with urokinase lock during the 6 months preceding inclusion are recruited in eight Belgian dialysis units. Patients are randomized in two groups: the control group receiving Taurolock™-HEP500 (heparin 500 IU/mL, taurolidine, citrate 4%) after each hemodialysis session and the treatment group receiving Taurolock-U 25,000 (urokinase 25,000, taurolidine, citrate 4%) once a week and the standard Taurolock-HEP500 at the end of the two others sessions. The primary outcome is the incidence rate of TCC thrombotic dysfunction defined by the use of urokinase. The secondary outcomes are the incidence rate of TCC removal and systemic thrombolysis. For the study, both patients and healthcare staff are blinded to treatment allocation. Conclusions The present trial is the first to investigate the effect of Taurolock-U 25,000 catheter lock once a week as secondary prevention in hemodialysis patients with the highest risk of TCC-related thrombotic dysfunction. Trial Registration ClinicalTrials.gov Identifier: NCT02036255

scholarly journals Effects of Bupropion on Cognitive Function in Schizophrenia: A Double Blind Randomized Controlled Trial

2016 ◽  
Vol 9 (5) ◽  
pp. 67
Author(s):  
Mansoureh Mirzadeh ◽  
Najmeh Shahini ◽  
Masoud Kashani Lotf Abadi ◽  
Maryam Tavakoli ◽  
Arash Javanbakht ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Function ◽  
Rating Scale ◽  
Controlled Trial ◽  
Control Group ◽  
P Value ◽  
Double Blind ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Schizophrenic Patients

<p>Smoking habits are common in schizophrenic patients. Nicotine can suppress negative symptoms and cognitive impairments. The aim of this study was to determine the efficacy of bupropion on cognitive function in schizophrenic patients.<strong> </strong>This study is a double blind randomized controlled trial in a large referral psychiatric university hospital in Iran. Ninety smoker schizophrenic patients were randomly allocated (based on DSM -IV TR criteria) in two groups (46 patients for case group and 44 patients in control group). They get risperidone up to 6 mg/d and bupropion up to 400 mg/d .clinical assessment (Positive and Negative Syndrome Scale (PANSS), Brief psychiatric rating scale (BPRS) were taken in beginning of study, 14<sup>th</sup> and 28<sup>th</sup> days of study. Cognitive assessment (Stroop, Digit Span, and Wechsler, Wisconsin) were taken in begging of study, the days 2<sup>nd</sup>, 7<sup>th</sup>, 14<sup>th</sup>, 28<sup>th</sup>. All data were analyzed by SPSS Ver. 17 with analytic and descriptive tests. Mean age of patients was 37.66±1.01. Mean duration of disorder was 11.63±.98 years. The scores were significantly lower at the day 28<sup>th</sup> compared to the beginning of the study in both groups in Wechsler, Stroop color word , Stroop word , Stroop color , BPRS, PANSS p value ≤0.05 .The difference between the two treatments was not significant as indicated by the effect of group, the between-subjects factor<strong> </strong><strong>p </strong>value ≥0.05. In this study, the side effects were examined and there was no significant difference between the two groups p value ≥0.05.<strong> </strong>Augmentation of bupropion to routine treatment improves cognitive symptoms of schizophrenia in abstinence of tobacco.</p>

scholarly journals Tranexamic Acid has no Effect on Post-Operative Hemarthrosis or Pain Control Following ACL Reconstruction Using Bone Patella Tendon Bone Autograft: A Double-Blind Randomized Controlled Double-Blind Trial (169)

2021 ◽  
Vol 9 (10_suppl5) ◽  
pp. 2325967121S0029
Author(s):  
Jordan Fried ◽  
David Bloom ◽  
Samuel Baron ◽  
Eoghan Hurley ◽  
Jovan Popovic ◽  
...  
Keyword(s):  
Blood Loss ◽  
Tranexamic Acid ◽  
Acl Reconstruction ◽  
Control Group ◽  
Patella Tendon ◽  
Double Blind ◽  
Randomized Controlled ◽  
Perioperative Blood Loss ◽  
Significant Difference ◽  
Experimental Group

Objectives: Tranexamic acid (TXA) is a commonly used medication in orthopaedic procedures, reducing perioperative bleeding and need for transfusion. The purpose of this double-blind randomized controlled study was to evaluate if IV TXA for primary anterior cruciate ligament (ACL) reconstruction with bone-patella tendon-bone (BTB) could reduce perioperative blood loss or postoperative intra-articular hemarthrosis without postoperative drains. Methods: A controlled, randomized, double-blinded trial was conducted in 110 patients who underwent ACLR with BTB autograft. Patients were equally randomized to the control and experimental groups. The experimental group received two 1-gram boluses of IV TXA, one prior to tourniquet inflation and one prior to wound closure; the control group did not receive TXA. If a clinically significant hemarthrosis was evident, the knee was aspirated, and the volume of blood (ml) was recorded. Additionally, perioperative blood loss (ml); Visual Analog Scale (VAS) on postoperative days (POD) 1-7 and post-operative weeks (POW) 1, 6 and 12; postoperative opioid consumption POD 1-7; range of motion (ROM) and ability to straight leg raise (SLR) at POW 1, 6, 12; and pre and postoperative thigh circumference ratio (TCR). Results: There was no significant difference in perioperative blood loss between the experimental and control groups (32.5ml v. 35.6ml, p=0.47). The experimental group had 23 knees aspirated; control group had 26 knees aspirated (p=0.56). No significant difference seen in postoperative hemarthrosis volume with IV TXA (26.7ml v. 37.3ml, p=0.12). There was no significant difference in VAS score between the two groups (p=0.15), additionally, there was no difference in postoperative opioid consumption (p=0.33). There was no significant difference in ROM or ability to SLR, or pre- nor post-operative TCR (p > 0.05 for all). Conclusions: IV TXA in patients who undergo ACLR with BTB autograft does not significantly impact perioperative blood loss, postoperative hemarthrosis, or postoperative pain levels. Additionally, no significant differences were seen in early post-operative recovery regarding ROM or quadriceps reactivation.

scholarly journals A Double-Blind, Randomized Controlled 12-Week Follow-Up Trial to Evaluate the Efficacy and Safety of Polycan in Combination with Glucosamine for the Treatment of Knee Osteoarthritis

2019 ◽  
Vol 2019 ◽  
pp. 1-8 ◽  
Author(s):  
Thi Thanh Thuy Truong ◽  
Jong Min Lim ◽  
Hyung-Rae Cho ◽  
Young Suk Kim ◽  
Duc Giang Dao ◽  
...  
Keyword(s):  
Knee Osteoarthritis ◽  
Rescue Medication ◽  
Secondary Outcome ◽  
Control Group ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Randomized Controlled ◽  
Patient Reported ◽  
Group A ◽  
Group B

Aim. The aim of the present study was to examine the efficacy and safety of Polycan, a β-glucan produced from the black yeast Aureobasidium pullulans SM-2001, in combination with glucosamine in reducing knee osteoarthritis-associated symptoms. Methods. This was a double-blind, randomized controlled trial of a formulated product composed of 16.7 mg of Polycan and 250 mg of glucosamine (Group A), 16.7 mg of Polycan and 500 mg of glucosamine (Group B), or 500 mg of glucosamine (control group) per capsule, administered as three capsules once per day over a period of 12 weeks, conducted with 100 osteoarthritis patients, aged 35–80 years. The primary outcome measure was osteoarthritis symptoms assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire. The secondary outcome measures included rescue medication use (according to data from a patient-reported diary) and other safety indices (body weight, blood pressure, hematological, and biochemistry markers). Results. Compared with the control group, Group B demonstrated a statistically significant reduction in the total WOMAC score after 12 weeks of treatment (p < 0.05). There was a significant reduction in the frequency of rescue medication used in Groups A and B compared with the control group (p < 0.05). There were no significant changes in hematology and biochemistry parameters or health indices between the active and the control group. Conclusion. Among patients with mild or moderate osteoarthritis, a daily oral dose of Polycan (50 mg) in combination with glucosamine (750 mg or 1500 mg; Group A or B, respectively) resulted in a better treatment outcome than treatment with glucosamine (1500 mg) alone.

scholarly journals Randomized Controlled Clinical Trial of Nanostructured Carbonated Hydroxyapatite for Alveolar Bone Repair

Materials ◽  
2019 ◽  
Vol 12 (22) ◽  
pp. 3645 ◽  
Author(s):  
Rodrigo F. B. Resende ◽  
Suelen C. Sartoretto ◽  
Marcelo J. Uzeda ◽  
Adriana T. N. N. Alves ◽  
José A. Calasans-Maia ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Bone Repair ◽  
Alveolar Bone ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Double Blind ◽  
Socket Preservation ◽  
Carbonated Hydroxyapatite ◽  
Randomized Controlled

The properties of the biodegradation of bone substitutes in the dental socket after extraction is one of the goals of regenerative medicine. This double-blind, randomized, controlled clinical trial aimed to compare the effects of a new bioabsorbable nanostructured carbonated hydroxyapatite (CHA) with a commercially available bovine xenograft (Bio-Oss®) and clot (control group) in alveolar preservation. Thirty participants who required tooth extraction and implant placement were enrolled in this study. After 90 days, a sample of the grafted area was obtained for histological and histomorphometric evaluation and an implant was installed at the site. All surgical procedures were successfully carried out without complications and none of the patients were excluded. The samples revealed a statistically significant increase of new bone formation (NFB) in the CHA group compared with Bio-Oss® after 90 days from surgery (p < 0.05). However, the clot group presented no differences of NFB compared to CHA and Bio-Oss®. The CHA group presented less amount of reminiscent biomaterial compared to Bio-Oss®. Both biomaterials were considered osteoconductors, easy to handle, biocompatible, and suitable for alveolar filling. Nanostructured carbonated hydroxyapatite spheres promoted a higher biodegradation rate and is a promising biomaterial for alveolar socket preservation before implant treatment.

A Perioperative Course of Gabapentin Does Not Produce a Clinically Meaningful Improvement in Analgesia after Cesarean Delivery

2015 ◽  
Vol 123 (2) ◽  
pp. 320-326 ◽  
Author(s):  
David T. Monks ◽  
David W. Hoppe ◽  
Kristi Downey ◽  
Vibhuti Shah ◽  
Paul Bernstein ◽  
...  
Keyword(s):  
Cesarean Delivery ◽  
Analgesic Efficacy ◽  
Control Group ◽  
Double Blind ◽  
Meaningful Improvement ◽  
Analgesic Regimen ◽  
Parallel Group ◽  
Superiority Trial ◽  
Perioperative Course ◽  
To Receive

Abstract Background: Studies examining the efficacy of a single preoperative dose of gabapentin for analgesia after cesarean delivery (CD) have been inconclusive. The authors hypothesized that a perioperative course of gabapentin would improve analgesia after CD. Methods: This single-center, randomized, double-blind, placebo-controlled, parallel-group, superiority trial was designed to determine the analgesic efficacy of a perioperative course of gabapentin when added to a multimodal analgesic regimen. Women scheduled for elective CD during spinal anesthesia were randomized to receive a perioperative oral course of either gabapentin (600 mg preoperatively followed by 200 mg every 8 h for 2 days) or placebo. Postoperative pain was measured at 24 and 48 h, at rest and on movement, on a visual analogue scale (VAS, 0 to 100 mm). The primary outcome was pain on movement at 24 h. Neonatal outcomes, opiate consumption, VAS satisfaction (0 to 100 mm), adverse effects, and persistent pain were also assessed. Results: Baseline characteristics were similar between groups. There was a statistically significant but small reduction in VAS pain score (mean [95% CI]) on “movement” (40 mm [36 to 45] vs. 47 mm [42 to 51]; difference, −7 mm [−13 to 0]; P = 0.047) at 24 h in the gabapentin (n = 100) compared with control group (n = 97). There was more sedation in the gabapentin group at 24 h (55 vs. 39%, P = 0.026) but greater patient VAS satisfaction (87 vs. 77 mm, P = 0.003). Conclusions: A perioperative course of gabapentin produces a clinically insignificant improvement in analgesia after CD and is associated with a higher incidence of sedation.

scholarly journals A double-blind randomized controlled trial of the local application of vancomycin versus ampicillin powder into the operative field for thoracic and/or lumbar fusions

2018 ◽  
Vol 29 (5) ◽  
pp. 553-559 ◽  
Author(s):  
Mikinobu Takeuchi ◽  
Norimitsu Wakao ◽  
Mitsuhiro Kamiya ◽  
Atsuhiko Hirasawa ◽  
Kenta Murotani ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Lumbar Fusion ◽  
Controlled Trial ◽  
Deep Infection ◽  
Local Application ◽  
Control Group ◽  
Operative Field ◽  
Double Blind ◽  
Randomized Controlled ◽  
Group 1

OBJECTIVERetrospective studies have reported that the local application of vancomycin (VCM) powder into the operative field decreases the incidence of surgical site infection (SSI) in thoracic and/or lumbar fusion. Authors of the present study prospectively evaluated the effects of VCM in patients undergoing thoracic and/or lumbar fusion.METHODSIn this randomized double-blind trial, 230 patients undergoing thoracic and/or lumbar fusion were randomly assigned to the local administration of VCM (interventional group, 1 g) or ampicillin (AMP; control group, 1 g) into the surgical field. The primary outcome was SSI results within 1 year of surgery.RESULTSThe trial was prematurely stopped according to predetermined rules. The results showed one superficial infection (0.9%, Staphylococcus aureus) and one deep infection (0.9%, S. aureus) in the VCM group and two superficial infections (1.8%, Staphylococcus epidermidis and culture negative) and one deep infection (0.9%, methicillin-resistant S. aureus) in the AMP group. No significant differences in infection rates were observed between the groups (p = 0.8).CONCLUSIONSThis double-blind randomized controlled trial demonstrated that the local application of VCM or AMP powder into the operative field in short thoracic and/or lumbar fusion procedures resulted in a similar incidence of SSI.■ CLASSIFICATION OF EVIDENCE Type of question: therapeutic; study design: randomized controlled trial; evidence: class III.Clinical trial registration no.: UMIN000009377 (umin.ac.jp/ctr)

scholarly journals Contributions of auriculotherapy in smoking cessation: a pilot study

2014 ◽  
Vol 48 (5) ◽  
pp. 883-890
Author(s):  
Roberta de Paiva Silva ◽  
Erika de Cássia Lopes Chaves ◽  
Sandra Cristina Pillon ◽  
Andréia Maria Silva ◽  
Denis da Silva Moreira ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Smoking Cessation ◽  
Pilot Study ◽  
Controlled Trial ◽  
Control Group ◽  
Double Blind ◽  
Future Studies ◽  
Randomized Controlled ◽  
And Control ◽  
Experimental Group

Objective To evaluate the contribution of auriculotherapy in smoking cessation. Method Double-blind randomized controlled trial, conducted with 30 smokers allocated into two groups: Experimental Group (21 participants received 10 sessions of auriculotherapy at specific points for smoking) and Control Group (nine participants received auriculotherapy in points that have no effect on the focus of research). Results Auriculotherapy contributed in reducing the number of cigarettes smoked in 61.9% of participants (p=0.002), in reducing the difficult to abstain from smoking in places where it is forbidden by 38% (p=0.050) and in not smoking when ill 23.8% (p=0.025). Conclusion Given the efficacy only in terms of reducing the number of cigarettes smoked and other parameters, we suggest that future studies consider the use of auriculotherapy combined with other treatment methods, in order to achieve better results in cessation/abstinence.

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