New therapy for chemotherapy-induced hepatic failure in leukemia; a randomized double-blind clinical trial study

Introduction: Hepatotoxicity is usual toxicity after chemotherapy in acute lymphoblastic leukemia (ALL) patients. Conventional treatment methods such as supportive care did not have an effective role in the improvement of hepatotoxicity. Objectives: In this study clinical efficacy of milk thistle in contrast with placebo was compared in leukemia patients with chemotherapy-induced hepatotoxicity. Patients and Methods: In this double-blind study, 93 ALL patients with chemotherapy-induced hepatotoxicity were randomized to a clinical trial with milk thistle or placebo. Liver enzymes level evaluated during 70 days. We divided patients randomly into two groups. Milk thistle at dosage of 7 mg/kg daily was prescribed in the intervention group while in the control group, placebo pills similar to milk thistle in shape and color were prescribed daily. Results: At day 35 and day 70 of the study, in the milk thistle arm ALT and AST mean serum levels were lower than the placebo group (P<0.001). In the milk thistle group there was a significant reduction in mean of AST and ALT during the first 35 days in patients who were taking livergol in comparison to next 35 days that patients stopped taking it. Children’s age was between 3-15 years. Conclusion: Based on our results, milk thistle improves liver function in chemotherapy-induced hepatotoxicity and there was no need for dose reduction or discontinuation of chemotherapy. Future clinical trials should be conducted to explore longtime effect of livergol in leukemia patients and to determine if there is any need for prophylactic administration of antioxidants. Trial Registration: This clinical trial has been approved by the Iranian Registry of Clinical Trials at 2018-02-14 (identifier: IRCT20170821035831N2; http://en.irct.ir/trial/26957).

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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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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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Probiotic Supplementation and Systemic Inflammation in Relapsing-Remitting Multiple Sclerosis: A Randomized, Double-Blind, Placebo-Controlled Trial

10.21203/rs.3.rs-501036/v1 ◽

2021 ◽

Author(s):

Seyed Ahmad Hosseini ◽

Shima Nematollahi ◽

Durdana Husain ◽

Nasrin Banaei-Jahromi ◽

Nastaran Majdinasab ◽

...

Keyword(s):

Multiple Sclerosis ◽

Systemic Inflammation ◽

Intervention Group ◽

Serum Levels ◽

Intestinal Microbiome ◽

Control Group ◽

Probiotic Supplementation ◽

Double Blind ◽

Factors Associated ◽

Significant Difference

Abstract Background: Multiple sclerosis (MS) is a complex inflammatory disease in which demyelination occurs in the central nervous system affecting approximately 2.5 million people worldwide. Intestinal microbiome changes play an important role in the etiology of chronic diseases. This study aimed to investigate the effect of probiotic supplementation on systemic inflammation in patients with MS.Methods: A twenty-four-week double-blind clinical trial study was designed and seventy patients with MS were randomly divided into two groups receiving probiotics and placebo. Patients in the intervention group received two capsules containing multi-strain probiotics daily and patients in the control group received the same amount of placebo. Factors associated with systemic inflammation were assessed at the beginning and end of the study.Results: Sixty-five patients were included in the final analysis. There was no significant difference between the two groups in terms of baseline variables except for the duration of the disease (P>0.05). At the end of the study, probiotic supplementation compared to the placebo caused a significant reduction in the serum levels of CRP (-0.93± 1.62 vs. 0.05 ± 1.74, P=0.03), TNF-a ( -2.09 ± 1.88 vs. 0.48 ± 2.53, P=0.015) and IFN-γ (-13.18± 7.33 vs. -1.93± 5.99, P<0.001). Also, we found a significant increase in the FOXP3 and TGF-β levels in the intervention group (P<0.05).Conclusion: The results of our study showed that supplementation with probiotics can have beneficial effects on serum levels of some factors associated with systemic inflammation.Trial registration: Approved by the Ethics Committee of the Ahwaz Jundishapur University of Medical Sciences, Ahvaz, Iran. This study was registered within Iranian Registry of Clinical Trials (IRCT) ( http://www.irct.ir) under the number IRCT20181210041918N2.

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Clinical effect of a herbal dentifrice on the control of plaque and gingivitis: a double-blind study

Pesquisa Odontológica Brasileira ◽

10.1590/s1517-74912003000400004 ◽

2003 ◽

Vol 17 (4) ◽

pp. 314-318 ◽

Cited By ~ 25

Author(s):

Claudio Mendes Pannuti ◽

Joyce Pereira de Mattos ◽

Paula Nini Ranoya ◽

Alberto Martins de Jesus ◽

Roberto Fraga Moreira Lotufo ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Effect ◽

Test Group ◽

Control Group ◽

Double Blind Study ◽

Gingival Index ◽

Control Groups ◽

Double Blind ◽

Double Blind Clinical Trial ◽

Significant Difference

The aim of this randomized, double-blind clinical trial was to evaluate the effect of the Paradontax dentifrice on the reduction of plaque and gingivitis. Subjects were randomly allocated into either the test group (n = 15, Paradontax) or the control group (n = 15, standard dentifrice with fluoride). Plaque levels were measured using the Turesky modification of the Quigley & Hein Plaque Index (PI), and gingivitis was evaluated with the Gingival Index (GI). Subjects were asked to brush their teeth with the allocated dentifrice, three times a day, for 21 days. There was no significant difference between groups in relation to the PI and GI medians, at baseline and at the end of the 21-day period. There was no significant reduction in PI in either the test or control groups. There was a significant decrease in GI in the test group. The authors concluded that there was no difference between the dentifrices in the reduction of plaque and gingivitis.

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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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