scholarly journals Shenmayizhi Formula Combined with Ginkgo Extract Tablets for the Treatment of Vascular Dementia: A Randomized, Double-Blind, Controlled Trial

2020 ◽  
Vol 2020 ◽  
pp. 1-11
Author(s):  
Huiqin Zhang ◽  
Yu Cao ◽  
Hui Pei ◽  
Huichan Wang ◽  
Lina Ma ◽  
...  
Keyword(s):  
Chinese Medicine ◽  
Vascular Dementia ◽  
Controlled Trial ◽  
Neuron Specific Enolase ◽  
Serum Levels ◽  
Controlled Study ◽  
Vascular Endothelial ◽  
Symptom Scale ◽  
Double Blind ◽  
Ginkgo Extract

Shenmayizhi formula (SMYZF) has been shown to have an effect on vascular dementia (VaD) in previous studies. The aim of this study was to evaluate whether a combination of SMYZF with Ginkgo extract tablets improves mild-to-moderate VaD. In this 12-week, randomized, double-blind, controlled study, we randomly assigned 196 patients with VaD (aged 50–85 years) to either the SMYZF group (n = 98) or the Ginkgo group (n = 98). All patients received Ginkgo extract tablets as a basic treatment, while the SMYZF group also received SMYZF treatment. We evaluated the participants at baseline and after 12 weeks of the intervention for the following: the Mini-Mental State Examination (MMSE), National Institutes of Health Stroke Scale (NIHSS), activities of daily living (ADL), Chinese Medicine Symptom Scale (CM-SS) scores, serum endothelin-1 (ET-1), nitric oxide (NO), vascular endothelial growth factor (VEGF), von Willebrand factor (vWF), neuron-specific enolase (NSE), brain-derived neurotrophic factor (BDNF), and homocysteine (Hcy) serum levels. Both interventions significantly increased MMSE scores and decreased NIHSS, ADL, and CM-SS scores. The SMYZF group showed greater improvement in MMSE, NIHSS, and CM-SS scores. Both groups showed a significant decrease in serum ET-1 and an increase in serum VEGF. Furthermore, serum NO increased, and vWF decreased significantly in the SMYZF group. Changes in serum ET-1 and NO were greater in the SMYZF group. Both groups showed a significant increase in serum BDNF and a decrease in serum NSE and Hcy. Improvement in serum NSE and BDNF was greater in the SMYZF group. SMYZF combined with Ginkgo extract tablets improved vascular endothelial and cognitive functions, as well as the syndromes diagnosed based on the traditional Chinese medicine in patients with VaD.

scholarly journals Targeting Mitochondrial and Brain Injury Markers in Acquired Brain Injuries: A Randomized, Double-Blind, Placebo-Controlled Study with Melatonin

2021 ◽  
Author(s):  
Bahareh Hakiminia ◽  
Babak Alikiaii ◽  
Fariborz Khorvash ◽  
Sarah Mousavi
Keyword(s):  
Brain Injury ◽  
Clinical Outcomes ◽  
Brain Injuries ◽  
Controlled Trial ◽  
Serum Levels ◽  
Controlled Study ◽  
Double Blind ◽  
Reactive Protein ◽  
Secondary Endpoints ◽  
Hospital Stays

Purpose: Oxidative stress-induced mitochondrial damage is the main event in acquired brain injuries (ABI). This study aimed to evaluate the effects of melatonin, a mitochondria-targeted antioxidant, on mitochondrial and brain injury markers, and the clinical outcomes of patients with ABI. Methods: In this randomized controlled trial, intensive care unit (ICU) or neurology patients with ABI (n=60) received melatonin (21 mg/day) or placebo tablets, within the first 72 hours of injury onset for five days. As a primary endpoint, serum levels of malondialdehyde (MDA), S100B and C-reactive protein (CRP) were compared at baseline, and after five days’ intervention. Secondary endpoints included assessment of Glasgow Coma Scale and Sequential Organ Failure Assessment (at the end of day 5), Rancho Los Amigos Revised Scale and modified Rankin Scale (at the end of month 3), the duration of mechanical ventilation, the lengths of ICU and hospital stays, and in-hospital and three-month mortality. Results: There were no significant effects of melatonin on the primary and secondary outcomes. However, the subgroup analysis showed a significant reduction in S100B in patients with non-traumatic brain injuries, receiving melatonin versus placebo (p: 0.016). Conclusion: This study showed that melatonin supplementation in the early phase of brain injury had no significant effects on the injury markers and clinical outcomes of patients with ABI. However, it reduced the level of S100B in the non-traumatic subgroup. Further larger-scale studies are needed to determine the effects of melatonin on the ABI and its subgroups.

Continuous bilateral thoracic paravertebral blockade for analgesia after cardiac surgery: a randomised, controlled trial

Perfusion ◽  
2017 ◽  
Vol 32 (7) ◽  
pp. 591-597 ◽  
Author(s):  
Geoff G. Lockwood ◽  
Leilani Cabreros ◽  
Dorota Banach ◽  
Prakash P. Punjabi
Keyword(s):  
Cardiac Surgery ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Morphine Consumption ◽  
Controlled Study ◽  
Double Blind ◽  
Clinical Trial Registration ◽  
Subcutaneous Infusion ◽  
Randomised Controlled Study ◽  
Randomised Controlled

Background: Continuous bilateral thoracic paravertebral blockade has been used for analgesia after cardiac surgery, but its efficacy has never been formally tested. Method: Fifty adult patients were enrolled in a double-blind, randomised, controlled study of continuous bilateral thoracic paravertebral infusion of 0.5% lidocaine (1 mg.kg-1.hr-1) for analgesia after coronary surgery. Control patients received a subcutaneous infusion of lidocaine at the same rate through catheters inserted at the same locations as the study group. The primary outcome was morphine consumption at 48 hours using patient-controlled analgesia (PCA). Secondary outcomes included pain, respiratory function, nausea and vomiting. Serum lidocaine concentrations were measured on the first two post-operative days. Results: There was no difference in morphine consumption or in any other outcome measure between the groups. Serum lidocaine concentrations increased during the study, with a maximum of 5.9 mg.l-1. There were no adverse events as a consequence of the study. Conclusion: Bilateral paravertebral infusion of lidocaine confers no advantage over systemic lidocaine infusion after cardiac surgery. Clinical trial registration: ISRCTN13424423 ( https://www.isrctn.com )

Controlled Study of the Use of Local Steroid Injection in the Treatment of Trigger Finger and Thumb

1992 ◽  
Vol 17 (1) ◽  
pp. 69-70 ◽  
Author(s):  
M. A. LAMBERT ◽  
R. J. MORTON ◽  
J. P. SLOAN
Keyword(s):  
Local Anaesthetic ◽  
Steroid Injection ◽  
Controlled Trial ◽  
Trigger Finger ◽  
Controlled Study ◽  
Control Group ◽  
Methylprednisolone Acetate ◽  
Double Blind ◽  
Local Steroid Injection ◽  
Control Injection

A controlled double-blind prospective study of injection of methylprednisolone acetate plus local anaesthetic against a control injection of a local anaesthetic in the treatment of trigger finger and thumb has shown a 60% success rate for the steroid injection against 16% for the control group (p < 0.05). This is the first controlled trial of local steroid therapy in this condition.

Effects of dehydroepiandrosterone on fatigue and well-being in women with quiescent systemic lupus erythematosus: a randomised controlled trial

2009 ◽  
Vol 69 (6) ◽  
pp. 1144-1147 ◽  
Author(s):  
A Hartkamp ◽  
R Geenen ◽  
G L R Godaert ◽  
M Bijl ◽  
J W J Bijlsma ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Lupus Erythematosus ◽  
Controlled Trial ◽  
Well Being ◽  
Controlled Study ◽  
Systemic Lupus ◽  
Double Blind ◽  
Female Patients ◽  
General Fatigue ◽  
Mental Well Being

ObjectiveDehydroepiandrosterone (DHEA) has been reported to improve fatigue and reduced well-being. Both are major problems in patients with systemic lupus erythematosus (SLE), even with quiescent disease. Low serum DHEA levels are common in SLE. The present work investigates the effects of DHEA administration on fatigue, well-being and functioning in women with inactive SLE.MethodsIn a double-blind, randomised, placebo-controlled study, 60 female patients with inactive SLE received 200 mg oral DHEA or placebo. Primary outcome measures were general fatigue, depressive mood, mental well-being and physical functioning. Assessments were made before treatment, after 3, 6 and 12 months on medication, and 6 months after cessation of treatment.ResultsPatients from the DHEA and placebo group improved on general fatigue (p<0.001) and mental well-being (p=0.04). There was no differential effect of DHEA. The belief that DHEA had been used was a stronger predictor for improvement of general fatigue than the actual use of DHEA (p=0.04).ConclusionsThe trial does not indicate an effect of daily 200 mg oral DHEA on fatigue and well-being, and therefore DHEA treatment is not recommended in unselected female patients with quiescent SLE.Clinical Trials Registration Number NCT00391924

scholarly journals The effect of Sang-qi Granules on blood pressure and endothelial dysfunction in stageI or II hypertension: study protocol for a randomized double-blind double-simulation controlled trial

2019 ◽  
Author(s):  
Haoyue Shi ◽  
Deshuang Yang ◽  
Jiajun Qiao ◽  
Rui Sun ◽  
Ruihan Li ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Endothelial Dysfunction ◽  
Vascular Function ◽  
Short Form ◽  
Controlled Trial ◽  
Ankle Brachial Index ◽  
Vascular Endothelial ◽  
Double Blind ◽  
Endothelial Cell Function ◽  
Self Rating

Abstract Background Hypertension is an important worldwide public health challenge because of its high prevalence and concomitant risks of cardiovascular disease. It induces half of the coronary heart disease and approximately two-thirds of the cerebrovascular disease burdens. Vascular endothelial dysfunction plays important roles in the pathophysiology of essential hypertension. Sang-qi Granules (SQG), a Chinese herbal formula, is used to treat I or II hypertension. Several animal experimental studies have shown that SQG can lower blood pressure and myocardial fibrosis by suppressing inflammatory responses. However, there is no standard clinical trial to confirm this and whether SQG can improve endothelial cell function is unknown.Methods In this randomized, double-blind, double-simulation controlled trial, 300 patients with stage I or II hypertension will be recruited and randomly allocated in a 1:1:1 ratio to group A(treatment with SQG and placebo of Cozaar), group B (treatment with Cozaar and placebo of SQG), and group C (treatment with SQG and Cozaar). SQG (or its placebo) will be administrated twice a day at the doze of 10g each time, and 50mg Cozaar(or its placebo) will be administrated once in the morning. The primary endpoint is the drug efficiency of the each three groups. The secondary endpoints are the change of average systolic and diastolic blood pressure during the day and the night, the change of blood pressure drop rate at night, target organ damage assessment (heart rate variability, ankle-brachial index and pulse wave velocity), symptoms improvement assessment (hypertension symptom scale, TCM syndrome integral scale, Pittsburgh sleep quality index scale, Self-Rating Anxiety Scale, Self-Rating Depression Scale and the Short Form-36 Health Survey), blood lipids, serum indicators of vascular function (changes in serum ET-1, TXA2, NO, PGI2 values) and safety indicators.Discussion This study will provide clinical evidence for the efficacy and safety of SQG in the treatment of hypertension. Meanwhile, the possible mechanism of SQG for lowering blood pressure will be further explored by observing the protective effect of SQG on vascular endothelial function, as well as its effect on related clinical symptoms, risk factors and target organs of hypertension.

scholarly journals Reliable and rapid smooth extubation after Ketofol for induction of general anesthesia in Laparoscopic Drilling of polycystic ovary: A randomized controlled trial

2020 ◽  
Author(s):  
Atef Mohamed Sayed Mahmoud ◽  
Joseph Makram Botros ◽  
Safaa Gaber Ragab
Keyword(s):  
General Anesthesia ◽  
Polycystic Ovary ◽  
Controlled Trial ◽  
Controlled Study ◽  
Double Blind ◽  
Randomized Controlled ◽  
Airway Response ◽  
American Society ◽  
American Society Of Anesthesiologists ◽  
Better Than

Abstract Background the outcome of ketofol on the hemodynamics and the airway response during induction of general anesthesia has been studied before. Its effect on smoothness of extubation has not been studied before. So, we aimed to assess the effect of ketofol on the smoothness of extubation and compare it with propofol only for induction of general anesthesia. Methods This double-blind, randomized, and controlled study was conducted on one hundred and six American Society of Anesthesiologists Physical status ''ASA PS'' class I and II female patients aged 18–40 years old and scheduled for laparoscopic drilling for polycystic ovary disease under general anesthesia. The patients were assigned into one of two groups (53) patients each; group KP = ketofol and group P = propofol. Results There was good sedation score during suction and extubation in the ketofol group. Airway response and smoothness of extubation were better in the ketofol group better than the propofol group. Conclusion Ketofol as an induction anesthetic agent was effective in attenuating the airway response during extubation more than profofol only. Trial registration: This trial was retrospectively registered at the Clinical Trial.gov with the Identification Number: NCT04365686.

scholarly journals Evaluation of the effectiveness of transcranial electrostimulation in treatment of neuropsychiatric disorders

2021 ◽  
Vol 5 (2) ◽  
pp. 019-026
Author(s):  
Hakobyan Gagik ◽  
Sekoyan Eduard ◽  
Shoman Karyna ◽  
Ekaterina Krasnopeeva
Keyword(s):  
Side Effects ◽  
Vascular Dementia ◽  
Flexible Substrate ◽  
Age Groups ◽  
Adhesive Layer ◽  
Neuropsychiatric Disorders ◽  
Controlled Study ◽  
Double Blind ◽  
Transcranial Electrostimulation ◽  
Clinical Diagnoses

Objectives: Evaluation of the effectiveness the method of transcranial electrostimulation in treatment of neuropsychiatric disorders with the use of a patches by the company “Aganyan”. Materials and methods: The study was a double-blind, randomized, placebo-controlled study, participated 106 patients with neuropsychiatric disorders. All participants in were divided into tables according to gender, age and diagnosis. Each subject was given the “Aganyan” patches and a special brochure, in which the method of application was indicated in detail. The wearable patch includes a flexible substrate, a binder an adhesive layer, with an electrode foil attached to it. Patients applied one patch behind each ear. The patches were applied for eight hours every third day for three months. To assess the effectiveness of therapy in patients the following tests were used: The Montreal Cognitive Assessment Scale; MMSE Scale: Concise Mental Status Scale; diaries of observation of the patient’s condition to identify side effects; special brochures in which the subjects independently indicated the effects of the “Aganyan” patches. Tests were performed before and after the use of the “Aganyan” patches. Results: When using the patches of the “Aganyan” company, none of the participants in the study had any side effects; According to the results of the Montreal test according to the criterion of memory and the MMSE test, the effectiveness of the patch was noted in patients with all clinical diagnoses. The greatest positive dynamics was revealed according to the results of the Montreal test according to the criterion of memory in patients with migraine (30%), insomnia (31%), vascular dementia (32%), and according to the results of the MMSE test in patients with diagnoses: cerebrovascular disease: consequences of a cerebral infarction brain (31%), vascular dementia (56%). Conclusion: The patches of “Aganyan” company have proven its effectiveness through electrical stimulation with low-intensity current in patients in different age groups with different clinical diagnoses.

scholarly journals A Randomised Controlled Trial on the Efficacy and Safety of Oral Ketamine in Neonatal Circumcision

2021 ◽  
Author(s):  
Victor Ifeanyichukwu Modekwe ◽  
Jideofor Okechukwu Ugwu ◽  
Okechukwu Hyginus Ekwunife ◽  
Andrew Nwankwo Osuigwe ◽  
Jideofor Chukwuma Orakwe ◽  
...  
Keyword(s):  
Placebo Group ◽  
Controlled Trial ◽  
Controlled Study ◽  
Categorical Variables ◽  
Paediatric Surgery ◽  
Peripheral Oxygen Saturation ◽  
Double Blind ◽  
Oral Ketamine ◽  
The Mean ◽  
Neonatal Circumcision

Introduction: Procedural analgesia use in neonatal circumcision is not widespread in the developing world. An easy-to-administer, adequate and safe analgesia will encourage usage in neonatal circumcision. Orally administered ketamine may prove effective and safe, and may encourage procedural analgesia use in neonatal circumcision. Aim: To determine the analgesic efficacy of oral ketamine in Plastibell® neonatal circumcision. Materials and Methods: A hospital based randomised double blind controlled study was conducted at the paediatric surgery unit of the hospital, from March 2015 to December 2015. Total 121 neonates were sequentially recruited, and randomised into two groups. Group A received oral ketamine, and Group B received plain syrup (placebo) as procedural analgesia. Continuous pulse oximeter monitoring was done before, during and immediately after the procedure. The pre-procedural and intra-procedural peripheral oxygen saturation (SpO2) and Pulse Rate (PR) were determined at the various stages. Also, the Neonatal Infant Pain Scale (NIPS) scores were assessed during the stages of the procedure. Differences in mean scores were analysed. Mann-Whitney U test and Independent t-test were used to compare means of continuous variable, while Fisher’s exact test was used to compare categorical variables. Significance was set at p<0.05. Results: Sixty-one neonates received oral ketamine, while 60 received placebo. The intraoperative mean SpO2 were lower in the placebo group and significant at the tying stage with p=0.022. The mean intraoperative PR was higher in the placebo group and significant at dorsal-slit, tying and excision stages (p<0.05). The mean intraoperative NIPS scores were significantly higher in the placebo group. Conclusion: Oral ketamine provides effective and safe analgesia for neonatal Plastibell® circumcision in comparison to placebo.

scholarly journals Faecal microbiota transplantation alters gut microbiota in patients with irritable bowel syndrome: results from a randomised, double-blind placebo-controlled study

Gut ◽  
2018 ◽  
Vol 67 (12) ◽  
pp. 2107-2115 ◽  
Author(s):  
Sofie Ingdam Halkjær ◽  
Alice Højer Christensen ◽  
Bobby Zhao Sheng Lo ◽  
Patrick Denis Browne ◽  
Stig Günther ◽  
...  
Keyword(s):  
Gut Microbiota ◽  
Controlled Trial ◽  
Symptom Relief ◽  
Controlled Study ◽  
Faecal Microbiota ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Faecal Microbiota Transplantation ◽  
Faecal Samples ◽  
Significant Difference

ObjectiveIBS is associated with an intestinal dysbiosis and faecal microbiota transplantation (FMT) has been hypothesised to have a positive effect in patients with IBS. We performed a randomised, double-blind placebo-controlled trial to investigate if FMT resulted in an altered gut microbiota and improvement in clinical outcome in patients with IBS.DesignWe performed this study in 52 adult patients with moderate-to-severe IBS. At the screening visit, clinical history and symptoms were assessed and faecal samples were collected. Patients were randomised to FMT or placebo capsules for 12 days and followed for 6 months. Study visits were performed at baseline, 1, 3 and 6 months, where patients were asked to register their symptoms using the IBS-severity scoring system (IBS-SSS) and IBS-specific quality of life (IBS-QoL). Prior to each visit, faecal samples were collected.ResultsA significant difference in improvement in IBS-SSS score was observed 3 months after treatment (p=0.012) favouring placebo. This was similar for IBS-QoL data after 3 months (p=0.003) favouring placebo. Patients receiving FMT capsules had an increase in faecal microbial biodiversity while placebos did not.ConclusionIn this randomised double-blinded placebo-controlled study, we found that FMT changed gut microbiota in patients with IBS. But patients in the placebo group experienced greater symptom relief compared with the FMT group after 3 months. Altering the gut microbiota is not enough to obtain clinical improvement in IBS. However, different study designs and larger studies are required to examine the role of FMT in IBS.Trial registration numberNCT02788071.

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