scholarly journals Efficacy and Safety of Iranian Poly Herbal Formulation (Compound Honey Syrup) in Pediatric Patients with Mild to Moderate Asthma: A Randomized Clinical Trial

2017 ◽  
Vol 6 (4) ◽  
pp. 291-301
Author(s):  
Saeed Sadr ◽  
Shahpar Kaveh ◽  
Rasool Choopani ◽  
Houman Bayat ◽  
Mahmoud Mosaddegh
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Pediatric Asthma ◽  
Public Health Problem ◽  
Major Public Health Problem ◽  
Efficacy And Safety ◽  
Asthma Control Questionnaire ◽  
Moderate Asthma ◽  
Herbal Formulation ◽  
Significant Difference

Background: Asthma is a chronic relapsing airways disease that represents a major public health problem worldwide. With the high incidence of asthma, there has been a surge in the use of complementary therapies, such as compound honey syrup in Traditional Persian Medicine, in the treatment of asthma. The aim of this study was to evaluate the efficacy and safety of Iranian poly herbal formulation (compound honey syrup) in the treatment of mild to moder­ate pediatric asthma. Materials and Methods: The study was a randomized clinical trial that was conducted on 80 patients with mild to moderate asthma assigned to two groups (n=40 for each group) for eight weeks. Control and experimental groups received classical treatment of asthma with fluticasone spray; in case of worsening of symptoms, salbutamol spray was used for short term. The experimental group also received compound honey syrup (the combina­tion of honey and an extract of the following five medicinal plants: ginger, cinnamon, saf­fron, cardamom, and galangal). Asthma Control Questionnaire (ACQ) items and total scores of ACQ were evaluated before and after treatment. Results: To this end, 72 patients complet­ed this study. There was no significant difference between the experimental and the control groups in baseline data such as age, sex, body mass index, ACQ items, and ACQ scores. Total scores and all items of ACQ, with the exception of forced expiratory volume in one second (FEV1%), were significant between groups (P<0.05). No serious adverse effects were ob­served in the two groups. Conclusions: The results of this study reveal that compound honey syrup can be a safe and effective complementary drug for the treatment of pediatric asthma [GMJ.2017;6(4):291-301] DOI: 10.22086/gmj.v6i3.884

Comparison of Sertraline with Rifampin in the treatment of Cholestatic Pruritus: A Randomized Clinical Trial

2019 ◽  
Vol 14 (3) ◽  
pp. 217-223
Author(s):  
Sara Ataei ◽  
Leila Kord ◽  
Amir Larki ◽  
Fatemeh Yasrebifar ◽  
Maryam Mehrpooya ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Total Bilirubin ◽  
Total Bilirubin Level ◽  
Intervention Strategies ◽  
Primary Biliary Cholangitis ◽  
Efficacy And Safety ◽  
Analog Scale ◽  
Significant Difference

Background: Pruritus is one of the most common and disabling symptoms of liver disease such as Primary Sclerosing Cholangitis and Primary Biliary Cholangitis. Cholestyramine, rifampin, opioid antagonists, antihistaminic agents and SSRIs are used for the management of pruritus. Due to rifampin drug interactions as well as its serious side effects such as hepatotoxicity, clinicians are endeavoruing to find a safer and a more effective substitution. Objective: The purpose of this study was to compare the efficacy and safety of sertraline with rifampin in the management of cholestatic pruritus. Methods: In a single-blinded randomized clinical trial a total of 36 patients of PSC and PBC were divided into two equal groups, one group received 100 mg/day sertraline and the other group received rifampin 300 mg/day for 4 weeks. Visual analog scale was used to record pruritus severity at baseline and 4 weeks after drug intervention, also, ALT, AST, ALP and total bilirubin of all patients were measured at three different time points. Results: Over the follow-up period, pruritus had relieved in both groups, but there was no significant differences between sertraline and rifampin in pruritus management (pvalue=0.740), also there was no significant difference between the two intervention strategies (A versus B) in total bilirubin level (pvalue=0.106). Moreover, the ALT, AST and ALP levels were found to be significantly different between the two groups (Pvalue˂0.01). Conclusion: There is no difference between sertraline and rifampin in pruritus improvement, but sertraline has less adverse effects on hepatobiliary enzyme levels, so it seems to be safer than rifampin.

scholarly journals Efficacy and Safety of Subcutaneous Golimumab in Methotrexate-Naive Patients With Rheumatoid Arthritis: Five-Year Results of a Randomized Clinical Trial

2016 ◽  
Vol 68 (6) ◽  
pp. 744-752 ◽  
Author(s):  
Paul Emery ◽  
Roy M. Fleischmann ◽  
Ingrid Strusberg ◽  
Patrick Durez ◽  
Peter Nash ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Efficacy And Safety

scholarly journals Comparing the efficacy and side-effects of PDLASTA® (Pegfilgrastim) with PDGRASTIM® (Filgrastim) in breast cancer patients: a non-inferiority randomized clinical trial

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Safa Najafi ◽  
Maryam Ansari ◽  
Vahid Kaveh ◽  
Shahpar Haghighat
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Single Dose ◽  
Side Effects ◽  
Randomized Clinical Trial ◽  
Cancer Patients ◽  
Injection Site Reaction ◽  
Study Groups ◽  
Breast Cancer Patients ◽  
Significant Difference

Abstract Background The objective of this study was to compare the efficacy and side effects of a single dose (Pegfilgrastim or PDL) or repeated six daily injections (Filgrastim or PDG) during chemotherapy courses in breast cancer patients in a non-inferiority clinical trial. Methods In this randomized clinical trial, 80 patients were recruited and allocated randomly to two equal arms. In one group, a single subcutaneous dose of PDL was injected the day after receiving the chemotherapy regimen in each cycle. The second arm received a subcutaneous injection of PDG for six consecutive days in each cycle of treatment. The side effects of GCF treatment and its effect on blood parameters were compared in each cycle and during eight cycles of chemotherapy. Results Hematologic parameters showed no significant differences in any of the treatment courses between the two study groups. The comparison of WBC (p = 0.527), Hgb (p = 0.075), Platelet (p = 0.819), Neutrophil (p = 0.575), Lymphocyte (p = 705) and ANC (p = 0.675) changes during the eight courses of treatment also revealed no statistically significant difference between the two study groups. Side effects including headache, injection site reaction and muscle pain had a lower frequency in patients receiving PDL drugs. Conclusion It seems that PDL is non-inferior in efficacy and also less toxic than PDG. Since PDL can be administered in a single dose and is also less costly, it can be regarded as a cost-effective drug for the treatment of chemotherapy-induced neutropenia. Trial registration IRCT20190504043465N1, May 2019.

Complications and surgical results of stone-directed antegrade pyelography compared to the retrograde pyelographic access method in percutaneous nephrolithotomy using ‘bull’s eye’ technique: A randomized clinical trial

2021 ◽  
pp. 205141582199372
Author(s):  
Dariush Irani ◽  
Abdolreza Haghpanah ◽  
Mohammad Mehdi Hosseini ◽  
Leila Malekmakan ◽  
Mohammad Ali Ashraf ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Percutaneous Nephrolithotomy ◽  
Renal Stones ◽  
Surgical Results ◽  
Retrograde Pyelography ◽  
Antegrade Approach ◽  
Antegrade Pyelography ◽  
Significant Difference ◽  
Bull's Eye

Objectives: This study aimed to evaluate the differences in outcomes and complications in stone-directed antegrade pyelography using the ‘bull’s eye’ technique in patients with renal stones versus the conventional method of percutaneous nephrolithotomy (PCNL). Although conventional PCNL access using retrograde pyelography is useful, it is time-consuming and may cause postoperative discomfort. Herein, we report our experience in the application of this new technique. Methods: Between January 2017 and June 2018, 100 patients participated in this randomized clinical trial. Stone-directed antegrade pyelography using the ‘bull’s eye’ technique under fluoroscopic guidance was used for percutaneous access in the intervention group. The second group, consisting of those who had undergone conventional PCNL using retrograde pyelography and ‘bull’s eye’ technique in the same period, were considered as the controls. Pre- and postoperative laboratory examinations, surgical results and complications were recorded and compared between the two groups. Results: A single calyceal puncture in partial staghorn and staghorn stone patients was sufficient in 72.2% of the antegrade group and in 78.9% of the retrograde group ( p=0.69). The double-puncture technique was necessary for 71.9% of renal pelvis stones in the antegrade group and for 9.4% in the retrograde group ( p<0.001). The antegrade approach reduced the mean operative time and analgesic requirement significantly ( p<0.001). No statistically significant difference, however, was found between the two groups regarding stone migration to the ureter, radiation time and postoperative complications. Conclusions: The stone-directed antegrade approach using the ‘bull’s eye’ technique is a safe and accurate method in PCNL access in patients with radiopaque and semi-opaque renal stones.

scholarly journals A Randomized Clinical Trial to Evaluate the Efficacy and Safety of Co-Administration of Sitagliptin with Intensively Titrated Insulin Glargine

2015 ◽  
Vol 6 (2) ◽  
pp. 127-142 ◽  
Author(s):  
Chantal Mathieu ◽  
R. Ravi Shankar ◽  
Daniel Lorber ◽  
Guillermo Umpierrez ◽  
Fan Wu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Insulin Glargine ◽  
Randomized Clinical Trial ◽  
Efficacy And Safety

Dance Rhythms Improve Motor Symptoms in Individuals with Parkinson’s Disease: A Randomized Clinical Trial

2021 ◽  
Author(s):  
Jéssica A. Moratelli ◽  
Kettlyn H. Alexandre ◽  
Leonessa Boing ◽  
Alessandra Swarowsky ◽  
Clynton L. Corrêa ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Clinical Trial ◽  
Parkinson's Disease ◽  
Randomized Clinical Trial ◽  
Rating Scale ◽  
Freezing Of Gait ◽  
Motor Symptoms ◽  
Score Change ◽  
Significant Difference ◽  
Binary Group

Background: Evidence-based practices involving dance modalities found in binary (two-beat rhythm) or quaternary (four-beat rhythm) show that dance positively influences the motor aspects of disease.Aim: This randomized clinical trial aimed to analyze the effect of two dance rhythm (binary and quaternary) on the balance, gait, and mobility in individuals with Parkinson’s disease (PD). Methods: Thirty-one individuals with PD were randomized into the binary group (n = 18) and the quaternary group (n = 13). Both groups participated in different dance rhythms lasting 12 weeks, twice a week, for 45 minutes. Results: The binary group showed a significant difference in balance (p = 0.003), freezing of gait (p = 0.007), as well as in the motor aspects of MDS-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), with emphasis on the total values with a score change of 3.23. In the quaternary group, significant differences were found in balance (p = 0.021) with a score change of -2.54 and in the motor aspects of the MDS-UPDRS Part III where the total values stood out with a change of 3.54. Discussion: When comparing the possible effects of binary and quaternary rhythms on the motor symptoms of individuals with PD, it was demonstrated that binary rhythm improved balance, freezing gait, and UPDRSIII. As for the quaternary rhythm, the benefits were in balance and the UPDRSIII. Conclusion: The binary and the quaternary rhythm dance protocols positively influenced the motor symptoms of individuals with PD after 12 weeks of intervention.

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