Intramuscular injection safety without aspiration in the ventro-gluteal region during vaccination: randomized clinical trial

ABSTRACT Objectives: to compare adverse events after administrating hepatitis A vaccine intramuscularly in the ventro-gluteal region between techniques with and without aspiration. Methods: randomized double-blind clinical trial, using hepatitis A vaccine (inactivated) in the ventro-gluteal region, with a sample of 74 participants in the intervention group, vaccinated with the slow injection technique without aspiration, and 74 participants in the control group undergoing slow injection with aspiration. Daily assessment of participants was carried out in the 72 hours after vaccination, in order to ascertain local, systemic adverse events, local and contralateral temperatures. Results: the occurrence of local and systemic adverse events was homogeneous between the groups in the three days after vaccination (p>0.05). There was no influence of sex, race, pre-existing disease and use of medication. Conclusions: the intramuscular vaccination technique without aspiration in the ventro-gluteal region is safe for adverse events following immunization compared to the conventional technique with aspiration.

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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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Safety and efficacy of hydroxychloroquine for treatment of non-severe COVID-19 among adults in Uganda: a randomized open label phase II clinical trial

BMC Infectious Diseases ◽

10.1186/s12879-021-06897-9 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Pauline Byakika-Kibwika ◽

Christine Sekaggya-Wiltshire ◽

Jerome Roy Semakula ◽

Jane Nakibuuka ◽

Joseph Musaazi ◽

...

Keyword(s):

Clinical Trial ◽

Viral Load ◽

Adverse Events ◽

Phase Ii ◽

Intervention Group ◽

Viral Clearance ◽

Control Group ◽

Rt Pcr ◽

Open Label ◽

Open Label Phase

Abstract Background Several repurposed drugs such as hydroxychloroquine (HCQ) have been investigated for treatment of COVID-19, but none was confirmed to be efficacious. While in vitro studies have demonstrated antiviral properties of HCQ, data from clinical trials were conflicting regarding its benefit for COVID-19 treatment. Drugs that limit viral replication may be beneficial in the earlier course of the disease thus slowing progression to severe and critical illness. Design We conducted a randomized open label Phase II clinical trial from October–December 2020. Methods Patients diagnosed with COVID-19 using RT-PCR were included in the study if they were 18 years and above and had a diagnosis of COVID-19 made in the last 3 days. Patients were randomized in blocks, to receive either HCQ 400 mg twice a day for the first day followed by 200 mg twice daily for the next 4 days plus standard of care (SOC) treatment or SOC treatment alone. SARS COV-2 viral load (CT values) from RT-PCR testing of samples collected using nasal/orapharyngeal swabs was performed at baseline, day 2, 4, 6, 8 and 10. The primary outcome was median time from randomization to SARS COV-2 viral clearance by day 6. Results Of the 105 participants enrolled, 55 were assigned to the intervention group (HCQ plus SOC) and 50 to the control group (SOC only). Baseline characteristics were similar across treatment arms. Viral clearance did not differ by treatment arm, 20 and 19 participants respectively had SARS COV-2 viral load clearance by day 6 with no significant difference, median (IQR) number of days to viral load clearance between the two groups was 4(3–4) vs 4(2–4): p = 0.457. There were no significant differences in secondary outcomes (symptom resolution and adverse events) between the intervention group and the control group. There were no significant differences in specific adverse events such as elevated alkaline phosphatase, prolonged QTc interval on ECG, among patients in the intervention group as compared to the control group. Conclusion Our results show that HCQ 400 mg twice a day for the first day followed by 200 mg twice daily for the next 4 days was safe but not associated with reduction in viral clearance or symptom resolution among adults with COVID-19 in Uganda. Trial registration: NCT04860284.

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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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Efficacy of a Low Dose of Melatonin as an Adjunctive Therapy in Hospitalized Patients with COVID-19: A Randomized, Double-blind Clinical Trial

10.22541/au.160734344.45295921/v1 ◽

2020 ◽

Author(s):

Gholamreza Farnoosh ◽

Mostafa Akbariqomi ◽

Taleb Badri ◽

Mahdi Bagheri ◽

Morteza Izadi ◽

...

Keyword(s):

Clinical Trial ◽

Adjunctive Therapy ◽

Clinical Symptoms ◽

Intervention Group ◽

Standard Of Care ◽

Hospitalized Patients ◽

Control Group ◽

Post Intervention ◽

Double Blind ◽

Baseline Health

Abstract Aim: To evaluate the clinical efficacy of adjuvant use of melatonin in patients with coronavirus disease 2019 (COVID-19). Methods: This single-center, double-blind, randomized clinical trial included 74 hospitalized patients with confirmed mild to moderate COVID-19 at Baqiyatallah Hospital in Tehran, Iran, from April 25, 2020 to June 5, 2020. Patients were randomly assigned in a 1:1 ratio to receive standard of care and standard of care plus melatonin at a dose of 3 mg three times daily for 14 days. Clinical characteristics, laboratory, and radiological findings were assessed and compared between two study groups at baseline and post-intervention. Safety and clinical outcomes were followed up for four weeks. Results: A total of 24 patients in the intervention group and 20 patients in the control group completed the treatment. Compared with the control group, the clinical symptoms such as cough, dyspnea, and fatigue, as well as the level of CRP and the pulmonary involvement in the intervention group had significantly improved (P < 0.05). The mean time of hospital discharge of patients and return to baseline health was significantly shorter in the intervention group compared to the control group (P < 0.05). No deaths and adverse events were observed in both groups during this study. Conclusions: Adjuvant use of melatonin has a potential to improve clinical symptoms of COVID-19 patients and contribute to a faster return of patients to baseline health. Keywords: COVID-19, Melatonin, Clinical trial, Adjunctive therapy Trial Registration: ClinicalTrials.gov Identifier: NCT04409522

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The Effect of Intravenous Magnesium Sulphate as an Adjuvant in the Treatment of Acute Exacerbations of COPD in the Emergency Department: A Double-Blind Randomized Clinical Trial

Ethiopian Journal of Health Sciences ◽

10.4314/ejhs.v31i2.9 ◽

2021 ◽

Vol 31 (2) ◽

Author(s):

Fatemeh Jahanian ◽

Iraj Goli Khatir ◽

Hamed Amini Ahidashti ◽

Sepideh Amirifard

Keyword(s):

Clinical Trial ◽

Emergency Department ◽

Magnesium Sulfate ◽

Magnesium Sulphate ◽

Intervention Group ◽

Control Group ◽

Double Blind ◽

Intravenous Magnesium ◽

Acute Exacerbations ◽

And Control

BACKGROUND፡ Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are serious complications that often require immediate intervention in an emergency department (ED). The aim of this study was to investigate the effect of intravenous magnesium sulphate as an adjuvant in the treatment of AECOPD in the ED.METHODS: In a double-blind, randomized clinical trial, a total of 60 patients with AECOPD presenting to the ED of Imam Khomeini Hospital in Sari, Iran, were included. The study was conducted between September 2016 and February 2018. Eligible patients were randomly allocated into two groups of intervention and control. Patients in the intervention and control groups received intravenous infusion of magnesium sulfate (2 gr) or normal saline over 30 minutes, respectively. For all patients, Borgdyspnea score, forced expiratory volume in one second (FEV1) result and clinical variables of interest were evaluated before the beginning of the intervention, and also 45 minutes and 6 hours after the commencement of intervention.RESULTS: Regardless of time of evaluation, pulse rate (PR), respiratory rate (RR) and Borg score in intervention group was lower than control group. Also, FEV1 and SPO2 were greater in intervention group compared to control group. However, these differences were not statistically significant (between-subject differences or group effect) (p<0.001). The trends of FEV1, SPO2, PR, RR and Borg score were similar between two groups of study (no interaction effect; P>0.05).CONCLUSION: According to the results of this study, it seems that using intravenous magnesium sulfate has no significant effect on SPO2, FEV1, RR, and PR of patients with AECOPD who presented to ED.

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Effect of probiotic supplement (kidilact) on prevention of acute diarrhea in children: a double-blind randomized clinical trial

International Journal of Research in Medical Sciences ◽

10.18203/2320-6012.ijrms20172595 ◽

2017 ◽

Vol 5 (7) ◽

pp. 2861

Author(s):

Mehran Hesaraki

Keyword(s):

Clinical Trial ◽

Heart Rate ◽

Body Temperature ◽

Randomized Clinical Trial ◽

Intervention Group ◽

Vital Signs ◽

Control Group ◽

Early Recovery ◽

Double Blind ◽

Viral Diarrhea

Background: Acute viral diarrhea is one of the most common diseases in children, which is associated with high risk of mortality. The present study aimed to determine the effect of Kidilact on the treatment of children with acute diarrhea.Methods: This double-blind randomized clinical trial was conducted on 84 children aged 6-60 months with diarrhea, hospitalized in pediatric ward of Amir al-Mu'minin hospital of Zabol, Iran. The patients who met the inclusion criteria were included and assigned to the control and treatment groups (42 patients in each group). Data collection instruments included clinical examination of participants in terms of gender, medication, diet, stool test, weight, average heart rate, average respiratory rate, average body temperature, and average frequency of defecation Data was analyzed with descriptive and analytical tests (chi-square, Fisher's exact test, t-test, etc.) in SPSS-21.Results: Body temperature, heart rate, and frequency of defecation significantly reduced in the intervention group after three days (p<0.05). In addition, weight gain presented an improving trend in the intervention group, but not significantly different from the control group (p<0.05).Conclusions: Findings indicated that the use of Kidilact may be helpful in the treatment of acute viral diarrhea in children and play a key role in early recovery, reduction of disease severity, and improvement of vital signs in these patients.

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