Corticocortical paired associative stimulation for treating motor dysfunction after stroke: study protocol for a randomised sham-controlled double-blind clinical trial

IntroductionStroke survivors can have a high disability rate with low quality of daily life, resulting in a heavy burden on family and society. Transcranial magnetic stimulation has been widely applied to brain injury repair, neurological disease treatment, cognition and emotion regulation and so on. However, there is still much to be desired in the theories of using these neuromodulation techniques to treat stroke-caused hemiplegia. It is generally recognised that synaptic plasticity is an important basis for functional repair after brain injury. This study protocol aims to examine the corticocortical paired associative stimulation (ccPAS) for inducing synaptic plasticity to rescue the paralysed after stroke.Methods and analysisThe current study is designed as a 14-week double-blind randomised sham-controlled clinical trial, composed of 2-week intervention and 12-week follow-up. For the study, 42 patients who had a stroke aged 40–70 will be recruited, who are randomly assigned either to the ccPAS intervention group, or to the control group at a 1:1 ratio, hence an equal number each. In the intervention group, ccPAS is practised in conjunction with the conventional rehabilitation treatment, and in the control group, the conventional rehabilitation treatment is administered with sham stimulation. A total of 10 interventions will be made, 5 times a week for 2 weeks. The same assessors are supposed to evaluate the participants’ motor function at four time points of the baseline (before 10 interventions), treatment ending (after 10 interventions), and two intervals of follow-up (1 and 3 months later, respectively). The Fugl-Meyer Assessment Upper Extremity is used for the primary outcomes. The secondary outcomes include changes in the assessment of Action Research Arm Test (ARAT), Modified Barthel Index (MBI), electroencephalogram (EEG) and functional MRI data. The adverse events are to be recorded throughout the study.Ethics and disseminationThis study was approved by the Medical Ethics Committee of Yueyang Hospital. All ethical work was performed in accordance with the Helsinki declaration. Written informed consent was obtained from all individual participants included in the study. Study findings will be disseminated in the printed media.Trial registration numberChinese Clinical Trial Registry: ChiCTR2000036685.

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Efficacy of Aloe vera/ Plantago Major Gel in Diabetic Foot Ulcer: A Randomized Double-Blind Clinical Trial

Current Drug Discovery Technologies ◽

10.2174/1570163815666180115093007 ◽

2019 ◽

Vol 16 (2) ◽

pp. 223-231 ◽

Cited By ~ 2

Author(s):

Younes Najafian ◽

Zahra M. Khorasani ◽

Mona N. Najafi ◽

Shokouh S. Hamedi ◽

Marjan Mahjour ◽

...

Keyword(s):

Clinical Trial ◽

Diabetic Foot ◽

Intervention Group ◽

Aloe Vera ◽

Foot Ulcer ◽

Diabetic Foot Ulcer ◽

Control Group ◽

Plantago Major ◽

Double Blind ◽

Significant Difference

Background:Diabetic foot ulcer (DFU) is one of the most common complications of diabetic patients. Mostly, non-healing DFU leads to infection, gangrene, amputation and even death. High costs and poor healing of the wounds need a new treatment such as alternative medicine. So, the aim of this study was to evaluate the efficacy of Aloe vera/ Plantago major gel (Plantavera gel) in healing of DFUMethods:Forty patients with DFU enrolled in a double-blind randomized clinical trial. The patients who were randomly assigned into the intervention group (n = 20), received topical Plantavera gel in addition to the routine cares, whereas the patients in the control group (n = 20), received topical Placebo gel in addition to the routine cares. Intervention was done twice a day for 4 weeks in the both groups. Photography and an evaluation of DFU healing were conducted by a checklist and then were scored at baseline and at the end of each week. The collected data was analyzed by SPSS software.Results:At the end of the study, there was a significant difference between the two groups in terms of total ulcer score (P<0.001) and Plantavera gel significantly reduced the ulcer surface comparing with the control group (P=0.039). However, there was not a significant difference between the two groups (P=0.263) in terms of the ulcer depth. During this study, no side effect was observed for Plantavera gel in the intervention group.Conclusion:Topical Plantavera gel seems to be an effective, cheap and safe treatment. Of course, further studies are required to confirm the properties of the wound healing of this gel.

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Efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia: a protocol for randomised double-blind controlled clinical trial

BMJ Open ◽

10.1136/bmjopen-2020-041958 ◽

2020 ◽

Vol 10 (10) ◽

pp. e041958

Author(s):

Nirmani Yasara ◽

Nethmi Wickramarathne ◽

Chamila Mettananda ◽

Aresha Manamperi ◽

Anuja Premawardhena ◽

...

Keyword(s):

Clinical Trial ◽

Sri Lanka ◽

Intervention Group ◽

Primary Outcome Measure ◽

Control Group ◽

Controlled Clinical Trial ◽

Efficacy And Safety ◽

Scientific Publications ◽

Double Blind ◽

Fetal Haemoglobin

IntroductionDespite being one of the first diseases to be genetically characterised, β-thalassaemia remains a disorder without a cure in a majority of patients. Most patients with β-thalassaemia receive only supportive treatment and therefore have a poor quality of life and shorter life spans. Hydroxyurea, which has shown to induce fetal haemoglobin synthesis in human erythroid cells, is currently recommended for the treatment of sickle cell disease. However, its clinical usefulness in transfusion-dependent β-thalassaemia is unclear. Here, we present a protocol for a randomised double-blind controlled clinical trial to evaluate the efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia.Methods and analysisThis single-centre randomised double-blind placebo-controlled clinical trial is conducted at the Thalassaemia Centre of Colombo North Teaching Hospital, Ragama, Sri Lanka. Adult and adolescent patients with haematologically and genetically confirmed transfusion-dependent β-thalassaemia are enrolled and randomised into the intervention or control group. The intervention group receives oral hydroxyurea 10–20 mg/kg daily for 6 months, while the control group receives a placebo which is identical in size, shape and colour to hydroxyurea without its active ingredient. Transfused blood volume, pretransfusion haemoglobin level, fetal haemoglobin percentage and adverse effects of treatment are monitored during treatment and 6 months post-treatment. Cessation or reduction of blood transfusions during the treatment period will be the primary outcome measure. The statistical analysis will be based on intention to treat.Ethics and disseminationEthical approval has been obtained from the Ethics Committee of Faculty of Medicine, University of Kelaniya (P/116/05/2018) and the trial is approved by the National Medicinal Regulatory Authority of Sri Lanka. Results of the trial will be disseminated in scientific publications in reputed journals.Trial registration numberSLCTR/2018/024; Pre-results.

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Effectiveness of a home care teaching program for prostatectomized patients: a randomized controlled clinical trial

Revista da Escola de Enfermagem da USP ◽

10.1590/s1980-220x2018012503421 ◽

2019 ◽

Vol 53 ◽

Author(s):

Luciana Regina Ferreira da Mata ◽

Cissa Azevedo ◽

Mariana Ferreira Vaz Gontijo Bernardes ◽

Tânia Couto Machado Chianca ◽

Maria da Graça Pereira ◽

...

Keyword(s):

Clinical Trial ◽

Home Care ◽

Self Efficacy ◽

Intervention Group ◽

Control Group ◽

Controlled Clinical Trial ◽

Teaching Program ◽

Significant Difference ◽

The Times

ABSTRACT Objective: To evaluate the effectiveness of a teaching program for hospital discharge of patients submitted to radical prostatectomy based on the self-efficacy construct of the Cognitive Social Theory. Method: A controlled clinical trial carried out on a 2-month follow-up of 68 prostatectomized men randomized into intervention group (n = 34) and control (n = 34). The intervention group received routine guidance from the service plus the teaching program. The control group only received routine guidance from the service. The data collection instruments were: sociodemographic and clinical questionnaire, self-efficacy scale, hospital depression and anxiety scale, household care knowledge questionnaire, and an item on satisfaction with a score of 1 to 5. Results: There was a significant difference between the intragroups for satisfaction (p<0.001) and knowledge (p<0.001) of the pre-test to the post-test. In the intervention group, there were significant changes between the times for anxiety (p=0.011) and knowledge (p<0.001). Conclusion: The teaching program with a combination of oral guidance, written instruction and telephone follow-up was effective in improving knowledge about home care and personal satisfaction. Brazilian Registry of Clinical Trials: RBR-5n95rm.

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Acupuncture for Olfactory Dysfunction in Infected COVID-19 Patients: Study Protocol for a Single Blind, Randomized, Sham-Controlled Clinical Trial

10.21203/rs.3.rs-823921/v1 ◽

2021 ◽

Author(s):

Linda LD Zhong ◽

Chi-Fung CHOY ◽

Hung-Wai CHO ◽

Yi-Ping WONG ◽

Alan Yat-Lun WONG ◽

...

Keyword(s):

Clinical Trial ◽

Intervention Group ◽

Sham Acupuncture ◽

Olfactory Dysfunction ◽

Secondary Outcome ◽

Control Group ◽

Common Symptom ◽

Real Acupuncture ◽

Single Blind

Abstract Background: Olfactory dysfunction (OD) was recognized as one of common symptom of COVID-19. OD, defined as the reduced or distorted ability to smell during sniffing (orthonasal olfaction) and may represent one of early symptoms in the clinical course of COVID-19 infection. A large online questionnaire-based survey found that some of post COVID-19 patients showed no improvement at one month after they were discharged from hospital. Therefore, this clinical trial is designed to explore the efficacy of acupuncture for OD in infected COVID-19 patients and to determine whether acupuncture could have benefits than sham acupuncture for OD in post- COVID-19 patients.Methods: This is a single blind, randomized controlled, cross over trial. We plan to recruit forty post-COVID-19 patients who are presenting with smell loss or smell distortions more than one month. Qualified patients will be randomly allocated into the intervention group (real acupuncture) or the control group (sham acupuncture) in a 1:1 ratio. Each patient will receive 8 sessions of treatment over 4 week (Cycle 1), and 2-week follow-up. After the follow-up, the control group will be conducted with real acupuncture for another 4 weeks (Cycle 2), and the real acupuncture group will be conducted with the 4-week sham acupuncture. The primary outcomes are the scores change on the questionnaire of olfactory functioning and olfaction related quality of life at weeks 6, 8, 12 and 14 from the baseline. Secondary outcome is the change on the Olfactory Test score at the week 6 and 12 from the baseline measured by using the Traditional Chinese version of the University of Pennsylvania Smell Identification Test (UPSIT-TC).Discussion: The results of this trial will help to determine the effectiveness of acupuncture for OD in post-COVID-19 Patients. This may provide a new treatment option for patients.Trial registration: ClinicalTrials.gov, NCT04959747, Registered on July 13, 2021.

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Impact of Epley manoeuvre on self-perceived disability: A randomised controlled trial in primary care

10.21203/rs.3.rs-36678/v1 ◽

2020 ◽

Author(s):

Ricard Carrillo Muñoz ◽

Jose Luis Ballve Moreno ◽

Ivan Villar Balboa ◽

Yolanda Rando Matos ◽

Oriol Cunillera Puertolas ◽

...

Keyword(s):

Primary Care ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Controlled Clinical Trial ◽

Double Blind ◽

Perceived Disability ◽

Randomised Controlled ◽

The Impact

Abstract Background: Posterior canal benign paroxysmal positional vertigo (pc-BPPV) causes physical, functional, and emotional impairment. The treatment of choice is the Epley manoeuvre (EM). The purpose of the study was to compare the impact of the EM and a sham manoeuvre in primary care on self-perceived disability.Method: Randomised, double-blind, sham-controlled clinical trial conducted in primary care with a follow-up of 1 year. Patients aged ≥18 years old diagnosed with pc-BPPV according to the Dix-Hallpike test (DHT) were randomised to an intervention (EM) group or a control (sham manoeuvre) group. The main study covariables were age, sex, history of depression and anxiety, presence of nystagmus in the DHT, patient-perceived disability assessed with the Dizziness Handicap Inventory-screening version (DHI-S). Data were analyzed using bivariate and multivariate mixed Tobit analyses. Results: Overall, 134 patients were studied: 66 in the intervention group and 68 in the control group. Median age was 52 years (interquartile range [IQR], 38.25–68.00 years) and 76.12% of the patients were women. The DHT triggered nystagmus in 40.30% of patients. The median total DHI-S score for the overall sample at baseline was 16 (IQR, 8.00–22.00); 16 [IQR, 10.5–24.0] vs 10 [6.0–14.0] for women vs men (P<0.001) and 16 [IQR, 10.0-24.0] vs 12 [IQR, 8.0–18.0] for patients without nystagmus vs those with nystagmus (P=0.033).Patients treated with the EM experienced a mean reduction of 2.03 points in DHI-S score over the follow-up period compared with patients in the sham group. Conclusion: Pc-BPPV affects the quality of life of primary care patients. A single EM can improve self-perceptions of disability by around 2 points on the DHI-S scale, Trial registration: ClinicalTrials.gov Identifier: NCT01969513. Retrospectively registered. First Posted: October 25, 2013. https://clinicaltrials.gov/ct2/show/NCT01969513

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Evaluation of the Effect of Atorvastatin Administration on the Outcomes of Patients with Traumatic Brain Injury: A Double-Blinded Randomized Clinical Trial

Anesthesiology and Pain Medicine ◽

10.5812/aapm.117140 ◽

2021 ◽

Vol 11 (4) ◽

Author(s):

Farhad Soltani ◽

Farahzad Janatmakan ◽

Sara Jorairahmadi ◽

Fatemeh Javaherforooshzadeh ◽

Pooyan Alizadeh ◽

...

Keyword(s):

Clinical Trial ◽

Traumatic Brain Injury ◽

Brain Injury ◽

Randomized Clinical Trial ◽

Rating Scale ◽

Intervention Group ◽

Control Group ◽

Post Intervention ◽

Disability Rating Scale ◽

Double Blinded

Background: Traumatic brain injury (TBI) is one of the common causes of long-term disabilities and mortality. This study aimed to evaluate the effect of atorvastatin administration on the Glasgow Coma Scale (GCS), Glasgow Outcome Scale (GOS), and Disability Rating Scale (DRS) in patients with TBI. Methods: This double-blinded randomized clinical trial included 60 patients with TBI in Golestan Hospital of Ahvaz, Iran. After obtaining an informed consent from all patients, the patients were randomly assigned into two groups. For the intervention group, atorvastatin with a daily dose of 20 mg was used. The control group was administered the same amount of placebo for 10 days. Changes in the level of consciousness were measured using the GCS, and functional recovery rate in patients was measured by GOS and DRS in the third follow-up month. Results: According to the obtained results, compared with the control group, the atorvastatin administration significantly increased the level of GCS and DRS within 2 - 3 months post-intervention and improved GOS since the tenth day after the study (P < 0.05). Conclusions: The results revealed the positive effect of atorvastatin on the improvement of outcomes measurements such as GCS, DRS, and GOS in patients after moderate and severe TBI.

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The effect of propolis supplementation on clinical symptoms in patients with coronavirus (COVID-19): A structured summary of a study protocol for a randomised controlled trial

Trials ◽

10.1186/s13063-020-04934-7 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Mahsa Miryan ◽

Davood Soleimani ◽

Leila Dehghani ◽

Karim Sohrabi ◽

Farzin Khorvash ◽

...

Keyword(s):

Clinical Trial ◽

Sample Size ◽

Clinical Symptoms ◽

Intervention Group ◽

Trial Registration ◽

Control Group ◽

Double Blind ◽

Double Blind Placebo ◽

Placebo Tablet ◽

Full Protocol

Abstract Objectives This study aims to assess the effect of propolis supplementation on clinical symptoms in patients with coronavirus (COVID-19). Trial design This is a Double-Blind, Placebo-Controlled, Parallel Arm, Randomized Phase ΙΙ Clinical Trial. Participants Patients with the confirmed COVID-19 based on the PCR test are eligible to participate in the trial if they are 18 to 75 years of age and have no history of the current use of warfarin or propolis supplement and presence of sensitivity to bee products. Patients will be recruited from the Al-Zahra hospital in Isfahan city, Isfahan, Iran. Intervention and comparator Participants (N=40) in the intervention group will receive an identical propolis tablet (containing 300 mg Iranian green propolis extract) three times a day for a period of 2 weeks. Participants (N=40) in the control group will receive an identical placebo tablet (containing 300 mg microcrystalline cellulose) three times a day for 2 weeks. All tablets are prepared by the Reyhan Naghsh Jahan Pharmaceutical Co., Isfahan, Iran. Main outcomes The main outcomes are changes in the coronavirus disease’s clinical symptoms including duration and severity from baseline to the end of 2 weeks. Randomization Eligible patients will be randomly allocated in a 1:1 ratio to the intervention or control group. Randomization will be performed on the basis of permuted block sizes of 4 and will be stratified according to sex categories. Randomization sequences will be prepared by the trial’s pharmacist with the use of random-number tables. Blinding (masking) The trial-group assignment will be concealed from all participants, clinicians, and investigators throughout the trial. To ensure blinding, randomization sequences will be kept in identical, opaque, sealed, sequentially numbered envelopes. Only the trial's pharmacist has access to the randomization list. Also, the placebo tablet will be similar to the propolis tablet in terms of texture, taste, color, odor, and weight. Both tablets will be provided in containers that are completely identical in weight, shape, labelling, and packaging. Numbers to be randomized (sample size) The calculated total sample size is 80 patients, with 40 patients in each group. Trial status The protocol is Version 1.0, October 10, 2020. Recruitment began August 22, 2020, and is anticipated to be completed by March 21, 2021. Trial registration The name of the trial register: The effect of propolis supplementation on clinical symptoms in patients with coronavirus (COVID-19): A randomized, double-blind, placebo-controlled clinical trial. IRCT registration number: IRCT20200802048267N1. Date of trial registration: 20 October 2020, retrospectively registered. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting the dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

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The Effect of Artichoke Leaf Extract on Alanine Aminotransferase and Aspartate Aminotransferase in the Patients with Nonalcoholic Steatohepatitis

International Journal of Hepatology ◽

10.1155/2016/4030476 ◽

2016 ◽

Vol 2016 ◽

pp. 1-6 ◽

Cited By ~ 23

Author(s):

Vajiheh Rangboo ◽

Mostafa Noroozi ◽

Roza Zavoshy ◽

Seyed Amirmansoor Rezadoost ◽

Asghar Mohammadpoorasl

Keyword(s):

Clinical Trial ◽

Nonalcoholic Steatohepatitis ◽

Liver Enzymes ◽

Intervention Group ◽

Control Group ◽

Therapeutic Effects ◽

Hypolipidemic Effect ◽

Linear Regression Models ◽

Double Blind ◽

Cynara Scolymus

Background. Based on recent basic and clinical investigations, the extract of artichoke (Cynara scolymus) leaf has been revealed to be used for hepatoprotective and cholesterol reducing purposes. We aimed to assess the therapeutic effects of artichoke on biochemical and liver biomarkers in patients with nonalcoholic steatohepatitis (NASH).Methods. In a randomized double blind clinical trial, 60 consecutive patients suffering NASH were randomly assigned to receiveCynara scolymusextract (as 6 tablets per day consisting of 2700 mg extract of the herb) as the intervention group or placebo as the control group for two months.Results. Comparing changes in study markers following interventions showed improvement in liver enzymes. The levels of triglycerides and cholesterol were significantly reduced in the group treated withCynara scolymuswhen compared to placebo group. To compare the role ofCynara scolymususe with placebo in changes in study parameters, multivariate linear regression models were employed indicating higher improvement in liver enzymes and also lipid profile particularly triglycerides and total cholesterol following administration ofCynara scolymusin comparison with placebo use.Conclusion. This study sheds light on the potential hepatoprotective activity and hypolipidemic effect ofCynara scolymusin management of NASH. This clinical trial is registered in the IRCT, Iranian Registry of Clinical Trials, by numberIRCT2014070218321N1.

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Effect of Nebulized Eucalyptus for Preventing Ventilator-Associated Pneumonia in Patients under Mechanical Ventilation: A Randomized Double Blind Clinical Trial

10.21203/rs.1.15/v1 ◽

2018 ◽

Author(s):

HasanAli Karimpour ◽

Behzad Hematpour ◽

Saeed Mohammadi ◽

Javad Aminisaman ◽

Maryam Mirzaei ◽

...

Keyword(s):

Clinical Trial ◽

Intensive Care Unit ◽

Intensive Care ◽

Intervention Group ◽

Control Group ◽

Pulmonary Infections ◽

Double Blind ◽

Double Blind Clinical Trial ◽

And Control ◽

And Staphylococcus Aureus

Abstract Background: Pneumonia caused by the ventilator is the most common acquired infection in the intensive care unit, which increases the morbidity and mortality of the patients. Eucalyptus plant has antiseptic properties. Therefore, the present study investigates the effect of eucalyptus incense on prevention of pneumonia in patients with endotracheal tube in the intensive care unit. Methods: This clinical trial study was performed on 100 patients under ventilation in two intervention and control groups in Imam Reza Hospital, Kermanshah, Iran in 2018. The patients in the intervention group, Eucalyptus solution 2% and in the control group received 10 cc distilled water as an inhaler three times a day. The results of the two groups were compared to the incidence of pulmonary infections based on CPIS criteria and compared with SPSS version 19 software. Results: The incidence of late pneumonia was significantly lower in the intervention group (P=0.02). The onset of pneumonia significantly later in the intervention group than the control group (P=0.01). The prevalence of Klebsiella, Candida albicans, and Staphylococcus aureus was significantly decreased in the intervention group (P=0.02) (P=0.04) (P=0.01). Conclusion: The results of this study showed that eucalyptus inhalation is effective in reducing the incidence of pulmonary infection in patients under ventilation. It is recommended that these products be used to prevent pulmonary infections in these patients.

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The effect of Melissa officinalis syrup on patients with mild to moderate psoriasis: a randomized, double-blind placebo-controlled clinical trial

BMC Research Notes ◽

10.1186/s13104-021-05667-9 ◽

2021 ◽

Vol 14 (1) ◽

Author(s):

Alireza Yargholi ◽

Leila Shirbeigi ◽

Roja Rahimi ◽

Parvin Mansouri ◽

Mohammad Hossein Ayati

Keyword(s):

Clinical Trial ◽

Intervention Group ◽

Herbal Medicines ◽

Control Group ◽

Controlled Clinical Trial ◽

Skin Area ◽

Melissa Officinalis ◽

Double Blind ◽

Significant Difference ◽

Pre Treatment

Abstract Objective Psoriasis is an immune-mediated inflammatory skin disease. It can involve any body skin area, particularly the scalp, lower back, elbows, and knees. There are several topical and systemic therapies for the treatment. Nowadays, herbal medicines are popular treatments for dermatologic conditions. This two-arm parallel, randomized placebo-controlled clinical trial was conducted to examine the hypothesis of the efficacy of Melissa officinalis syrup on patients with mild-to-moderate Plaque psoriasis. Result Among 100 patients, 95 participants completed the trial and five of them withdrew. The mean pruritus intensity and PASI scores decreased significantly in the intervention group compared to the placebo group (P < 0.001). The DLQI score in the intervention group increased post-treatment compared to pre-treatment (P = 0.029); however, there was no significant difference between the intervention and control group at the end of the study (0.065). Trial registration: The trial was registered in the Iranian registry of clinical trials on November 9th, 2019 (https://www.irct.ir/trial/43434; registration number: IRCT20191104045326N1).

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