جستجوی مقالات مرتبط با کلیدواژه « Randomized clinical trial » در نشریات گروه « پزشکی »

It is hypothesized that fenugreek seeds are a rich source of fiber with anti-diabetic effects, which can help to lower blood glucose in patients with polycystic ovary syndrome (PCOS). In this study, the clinical and metabolic effects of fenugreek were compared to those of metformin in women with PCOS aged 16-40 years.

In a randomized, triple-blind, parallel clinical trial, the efficacy of fenugreek 333 mg (n=55) was compared with metformin 500 mg (n=55), both administered three times a day in women with PCOS of reproductive age. Changes in some clinical outcomes and metabolic laboratory profile outcomes were evaluated at baseline and two months after the study.

By the end of the intervention period, all investigated factors improved significantly in patients of both groups (p<0.05). Reduction in biometric indices (body mass index and waist–hip ratio), fasting blood sugar (FBS), and insulin resistance was significantly higher after metformin consumption (p<0.001). Metformin also significantly improved irregular menstruation (p=0.02). In contrast, fenugreek significantly improved patients' lipid profiles, including low-density lipoprotein (LDL), high-density lipoprotein (HDL), and triglyceride (TG) compared to metformin (p<0.001). Both interventions improved the patient's hair loss and hirsutism.

Fenugreek cannot substitute metformin in PCOS treatment. However, regarding its lipid-lowering ability and low frequency of adverse effects, it can be used as an adjuvant treatment in PCOS, especially in PCOS patients with hyperlipidemia and severe hair loss.

Low back pain (LBP) is a common problem with a significant impact on individuals and society, leading to activity limitation and chronic pain. Quadratus lumborum (QL) muscle tightness can trigger symptoms of significant LBP. Muscle energy technique (MET), a gentle manual therapy for restricted motion in the spine and limbs, aims to induce muscle relaxation, reduce pain, and improve range of motion (ROM). The aim of this study was to investigate the effects of MET on pain reduction and ROM improvement in chronic LBP subjects with lateral flexion restriction.

This study was a randomized single-blind clinical trial. One hundred and two participants diagnosed with chronic LBP and lateral flexion restriction were randomly divided into two groups: Control (n=51) and intervention (n=51). The control group received conventional physiotherapy, while the intervention group was provided with a combination of conventional physiotherapy and MET (post-isometric relaxation). Pain and ROM were measured using the visual analogue scale (VAS) and a goniometer, respectively. Both groups were evaluated before and immediately after the treatment.

The results revealed a significant reduction in pain and improvement in ROM in both groups after the treatment. No significant differences were found in the mean pain scores between the two groups (P=0.77). However, the mean scores of ROM in the intervention group showed a significant difference compared to the control group (P≤0.001).

MET combination with conventional physiotherapy significantly improves LBP and ROM of lateral flexion in chronic LBP subjects with lateral flexion restriction.

Nutrition Clinical Trials (NCTs) are pivotal in establishing causal links between nutritional interventions and chronic diseases. This review comprehensively examines prevalent clinical trial designs, emphasizing their strengths and limitations. The goal is to provide insights into the selection and optimization of these designs for dietary intervention studies.

Various study designs in NCTs are explored, including quasi-experimental designs, double-blind randomized placebo-controlled trials for nutrient/functional foods supplementation, community-based lifestyle interventions, pragmatic nutrition interventions, and field trial projects. The characteristics, advantages, and challenges of each design are discussed. Real examples are presented to illustrate how these designs can be tailored and optimized for dietary intervention studies.

Parallel randomized clinical trials are acknowledged as the gold standard, despite requiring substantial sample sizes and having inherent limitations. Cross-over NCTs emerge as valuable for assessing temporary treatment effects while mitigating potential confounders and interpatient variability. However, they may not be suitable for acute diseases and progressive disorders, and attrition rates can be higher. Multi-arm randomized designs offer increased study power with a lower sample size but necessitate more intricate design, analysis, and result reporting.

In conclusion, each study design in NCTs comes with its set of strengths and limitations. The selection of an appropriate design should consider determinants and common considerations to provide robust evidence for establishing cause-and-effect associations or assessing the safety and efficacy of food products in nutrition research. This comprehensive understanding aids researchers in making informed choices when planning and conducting nutrition clinical trials.

Dysphagia can be a life-threatening issue for post-stroke patients, with aspiration pneumonia (AP) being a common risk. However, there is hope through the potential combination of transcranial direct current stimulation (tDCS) and classical behavior therapy. Our study aims to investigate the effectiveness of this combination in diminishing the risk of AP in patients with dysphagia who suffered from stroke.

In this randomized, parallel-group, blinded clinical trial, 48 patients were allocated into the sham group (speech therapy + 30 seconds of tDCS) and the real group (speech therapy + 20 minutes of tDCS). We used the Mann Assessment of Swallowing Ability (MASA) as an assessment tool. We assessed patients at baseline, one day after treatment, and at a one-month follow-up.

Groups showed no significant difference at baseline. After treatment, the real group showed a significant difference in the severity risk of AP (P = 0.02); the same was for the follow-up (P = 0.04). The number of patients showing severe risk of AP was higher in the sham group after treatment (n = 13, 54.20%) and at follow-up (n = 4, 18.20%) than the real group (n = 4, 16.70%; n = 1, 4.50%, respectively). None of the patients reported the history of AP at any stage of assessment.

Although the results were more promising in the real group than the sham group in reducing the risk of AP, both techniques can prevent AP. Therefore, we recommend early dysphagia management to prevent AP regardless of the treatment protocol.

Colistin is a drug of choice against multidrug-resistance (MDR) bacteria. The most important side effect of colistin is nephrotoxicity, observed in 20 - 54% of patients. According to the studies that examined its antioxidant effect, it can reduce the kidney toxicity of various drugs, including colistin.

This study aimed to investigate melatonin’s effect on reducing colistin-induced kidney toxicity to use this drug with fewer complications.

This double-blind, randomized clinical trials with two groups involved 56 critically ill adults infected by MDR bacteria. The intervention group received 3 mg of oral melatonin simultaneously with intravenous colistin, which continued until the end of the treatment. The control group received placebo orally with IV colistin. We measured urine volume, blood creatinine, and BUN daily and determined the patients with renal failure using the KDIGO guideline. STATA software analyzed data with a P-value of less than 0.05 as the significance level.

Data obtained from recipients were analyzed for age (P-value = 0.357), gender (P-value = 0.945), weight (P-value = 0.438), APACHE score (P-value = 0.162). We did not observe significant difference in AKI criteria between the two groups. Compared to the control group, melatonin did not decrease blood creatinine (P-value = 0.110) and BUN (P-value = 0.567) and, made no change of urinary volume (P-value = 0.913). There was no decrease in kidney failure in the intervention group compared to the control group. As a result, we did not find a significant difference in outcome of the two groups.

We did not reveal any significant difference in the AKI criteria including blood creatinine,BUN,anddaily urinevolume with the addition of melatonin in participants receiving colistin; However, no complication was observed in the intervention group who received melatonin.

Many clinical reasoning teaching techniques have been reported in the literature. The authors focused on 2 teaching techniques of clinical reasoning, the technique Summarize, Narrow, Analyze, Probe the preceptor, Plan, Self-selected topic (SNAPPS) and the Clinical Reasoning Technique (CRT), and compared their efficiency to improve the clinical reasoning competencies of third-year undergraduate medical students.

The authors performed a prospective randomized, controlled, non-blinded crossover trial including year-3 undergraduate medical students. Judgment criteria consisted of the scores attributed to a test assessing the cognitive competencies of the participants which was a structured summary performed by the students after each session. Besides, a satisfaction Likert-scale questionnaire was fulfilled by the students. Statistical analysis was performed using SPSS software (version 20.0).

Seventy-two students were included with a mean age of 21.03 (SD:2,30) years. The mean scores of the students allocated to the CRT arm reached 4.62 (SD:2.93)versus 4.99 (SD:2.93) for the SNAPPS arm. No significant statistical difference was observed between the mean scores according to the method used. The analysis of the satisfaction questionnaire revealed that 75% of the students preferred CRT because of the collaborative work performed.

This study highlights the need for varying techniques to improve the critical reasoning skills of medical students. Besides, it pointed out students' preference for collaborative approaches illustrating socio-constructivist theories of learning.

Chronic kidney disease is a progressive and irreversible disorder in which the kidneys are unable to excrete metabolic wastes and uremia occurs . Chronic kidney disease is an important cause of mortality and morbidity in the world .

which, in addition to physical health, also threatens other dimensions of health . Despite the widespread use of hemodialysis, this method has many problems and complications. Various approaches have been proposed to improve the quality of life of hemodialysis patients admitted in hospitals , the most important of which is the use of health-promoting behaviors and lifestyle modification. Several studies have highlighted the need of developing and executing appropriate training programs to improve hemodialysis patients' lifestyles and consequently their quality of life. An educational program that is designed based on a planned behavior pattern, can be applied as an effective method to improve all aspects of lifestyle in hemodialysis patients.

The findings of these studies show that researchers have employed a variety of behavioral interventions to enhance the lifestyle of hemodialysis patients, demonstrating the impact of educational behavioral patterns on improving patients' lifestyle and quality of life.

In hemodialysis patients, an educational program based on a Theory of planned behavior can be used as an effective technique to enhance all aspects of their lives.

Osteoarthritis (OA) is a degenerative joint disease that globally affects the elderly, leading to pain and disability. Herbal medications and alternative therapies have demonstrated positive effects on arthritis management. Pistacia vera has traditionally been used for inflammatory conditions and has also shown antinociceptive effects.

Given the limited available scientific evidence, our randomized controlled trial aimed to assess the potential protective role of topical P. vera seed oil preparation in patients with knee OA.

A total of 89 patients with kneeOA(n = 89) were randomly allocated into three groups: Placebo, piroxicam, and P. vera. The topical formulations were administered twice daily over a period of three months. Pain level, patient health status, andperformance were evaluated using the visual analog scale (VAS) andWestern Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Statistical analysis was performed using SPSS software.

The application of P. vera ointment demonstrated pain reduction in patients, as indicated by VAS andWOMACassessments. Additionally, WOMAC scores showed that P. vera ointment alleviated motion stiffness and improved activity difficulties in patients (P < 0.001). In certain parameters, the topical application of P. vera showed greater effectiveness in treating knee OA than piroxicam (P < 0.05).

Pistacia vera ointment shows promise as a potential therapeutic option for osteoarthritis, effectively addressing the detrimental effects of the disease. Further experimental and clinical studies are warranted to elucidate its efficacy and safety profile.

We set out to explore the effect of intrauterine human chorionic gonadotropin (hCG) instillation by intrauterine insemination (IUI) catheter before embryo transfer (ET) on assisted reproductive technologies (ART) outcomes of infertile women. 

One hundred women with infertility who were scheduled for in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) cycles were included in the study. They were randomly devoted to two groups: experimental (n= 50) and control (n= 50). In the experimental group, 500 IU hCG passed into the internal cervical orifice via IUI catheter within 15 minutes before the transfer of fresh or vitrified cleavage-stage embryos. The control group underwent the same ET procedure without prior injection of hCG.

None of the outcomes showed a statistically significant difference between the two groups. In the intervention and control groups, respectively, biochemical pregnancies rates were 26% and 18%, implantation rates were 13.5% and 8.6%, clinical pregnancies rates were 22% and 14%, ongoing pregnancies rates were 18% and 14%, and live birth rates were 14% and 12%.

Intrauterine injection of hCG via IUI catheter is not recommended in a clinical routine setting at this stage. Future efforts are warranted to further refine the applicability of this modality.

Due to the critical condition of COVID-19, it is necessary to evaluate the efficacy of administrating convalescent plasma to COVID-19 patients. Therefore, we decided to design a clinical trial to investigate the effect of convalescent plasma of patients recovered from COVID-19 on the treatment outcome of COVID-19-infected patients.
In this parallel randomized controlled clinical trial, patients in the intervention group received standard treatment plus convalescent plasma of patients recovered from COVID-19. We allocated 60 patients to each treatment group through balanced block randomization. Then, COVID-19 outcomes, vital signs, and biochemical parameters were compared between the two treatment groups by the independent t test and ANCOVA.
The mean age (SD) of the patients in the intervention and standard treatment groups was 52.84 (15.77) and 55.15 (14.34) years, respectively. Although patients in the intervention group reported more hospitalization days (11.45±5.86 vs. 10.42±6.79), death rates (26.67% vs. 18.13%), ICU admission (45 vs. 41.67%), and ARDS (11.67% vs. 3.33%), these differences were not statistically significant (P>0.05). Moreover, the two groups were homogenous in vital signs and biochemical parameters before and after treatment (P>0.05).
The present study indicated that convalescent plasma therapy has no significant effect on the survival, hospitalization, and ICU admission of COVID-19 patients.

The aim of this blind randomized clinical study was to prospectively compare the clinical and radiographic success outcomes of calcium-enriched mixture (CEM) pulpotomy versus white mineral trioxide aggregate (WMTA) pulpotomy in permanent molars diagnosed with irreversible pulpitis. 

 Forty patients met the inclusion criteria and agreed to join. The patients were randomly assigned into two groups: CEM pulpotomy (n=20) and WMTA pulpotomy (n=20). Clinical success was reviewed at 7 days and 3, 6 and 12 months after treatment. We organized radiographic assessment at 6 and 12 months. The data was analyzed using Chi-square, Independent t-test, and Mann-Whitney for the baseline and post-operative characteristics of the patients. 

None of the patients were lost during recalls. Twenty-one females and 19 males participated in the study ranging between 7-14 years of age. The follow up period was extended in some of the cases for more than 1 year (12-23 month). Regarding the baseline and post-operative characteristics of the patients, there was no significant difference between the groups (P>0.05). All the cases showed clinical and radiographic success outcomes for both groups at/after12-month recall periods. There was no significant difference between the two groups clinically and radiographically (P=1). 

 Based on this randomized clinical trial study, CEM and WMTA as pulpotomy agents expressed excellent clinical and radiographic outcomes with no significant difference in the treatment of permanent molars with irreversible pulpitis over a 12-month period.

While several antivirals have been considered among the candidate repurposed drugs against SARS-CoV-2 infection, limited evidence exists on Atazanavir/Ritonavir.

This trial was designed to assess the efficacy of Atazanavir/Ritonavir compared to Lopinavir/Ritonavir, another antiretroviral drug investigated in the previous studies.

This randomized, double-blind clinical trial was conducted on hospitalized patients with laboratory or confirmed SARS CoV-2 infection. Patients were randomly assigned (1:1) to receive either Lopinavir/Ritonavir (200mg Lopinavir+50mg Ritonavir, twice a day) or Atazanavir/Ritonavir (300mg Atazanavir+100 mg Ritonavir, once a day) for up to 14 days during their admission along with the standard care. The primary endpoint was total all-cause death in all patients during the hospitalization period. Secondary outcomes included length of hospitalization.  

Out of 103 adults included in the analysis 54 and 49 were assigned to Atazanavir/Ritonavir and Lopinavir/Ritonavir groups, respectively. The occurrence of adverse effects, defined as symptoms attributed to the drugs which no longer appear upon the cessation of the drug, was higher for cardiac side effects in Atazanavir/Ritonavir group. No statistically significant difference was observed between the two groups in terms of the length of hospitalization. After adjustment for other covariates in the study, treatment with Atazanavir/ritonavir did not result in a significant reduction in mortality compared to treatment with Lopinavir/Ritonavir.

The efficacy of Atazanavir/Ritonavir in this preliminary study was not superior to Lopinavir/Ritonavir in reducing mortality and length of hospitalization in COVID-19 patients. However, the limited efficacy of both compounds does not support their use in primary care for COVID-19 patients.

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), the super-spreading virus, has claimed hundreds of thousands of lives worldwide.

This study aimed to evaluate the effectiveness of the novel suggested herbal compound, formulated as compressed tablets, in reducing the length of hospital stay (LoS), intensive care unit (ICU) admission, and mortality in confirmed COVID-19 cases.

Following an open-label, single-blind randomized clinical trial design, a total of 200 patients aged 18-65 admitted to Imam Reza hospital in Tabriz, northwest of Iran, were randomized to intervention and control groups in a 1:1 ratio, i.e., 100 subjects in each group. The former received standard treatment along with the compressed herbal tablets, and the latter only received the standard treatment. Adverse reactions incidence within 180 days after the beginning of the intervention was set as the primary safety endpoint. The most important and active ingredients of the tablets were Terminalia chebula, Glycyrrhiza glabra, Anacyclus pyrethrum, Senna alexandrina, Ferrula asafoetida, Pistacia lentiscus, Zizyphus jujuba, Crocus sativus, Echinacea angustifolia, and Hyssopus officinalis. This trial is registered at the Iranian Registry of Clinical Trials (code: IRCT20200522047545N1).

Those in the intervention arm had significantly lower rates of LoS (7.38 vs. 9.45, P = 0.030), ICU admission (6 out of 100 vs. 32 out of 100, P = 0.000), and mortality (1 vs. 19 out of 100, P = 0.000).

Our observations suggest that adequate improvement is provided by the prepared herbal compound along with substantial savings in hospitalization hoteling costs. While further multi-center studies with a larger sample size are needed to extend our knowledge regarding the effect of this new option, these novel clinical data may well provide a new alternative for the management of COVID-19 disease.

Myocardial protection during cardiopulmonary bypass requires essential techniques to preserve myocardial function and protect the myocardium from cellular damage.

This study aimed to investigate the efficacy of del Nido cardioplegia in mitral valve surgery compared to Buckberg solution.

All patients who underwent mitral valve surgery from April 2018 to December 2018 were recruited in the present trial. The patients were assigned randomly into del Nido and Buckberg groups. Trans-thoracic and trans-esophageal echocardiography were performed before and after the procedure to evaluate left ventricular ejection fraction, as the primary outcome.

A total of 152 patients (77 in the del Nido group and 75 in the Buckberg group) were included in the final analysis. The mean age of the participants was 51.3 ± 13.4 years, and 55.3% of the patients were female. The two groups were comparable in terms of all baseline characteristics. The results also showed no significant difference between the two groups regarding pre-operative ejection fractions (P = 0.063). However, ventilation time and the mean length of ICU stay were higher in the Buckberg group (0.018 and 0.001, respectively). Moreover, the results indicated a more prominent reduction in left ventricular ejection fraction measured via trans-thoracic and trans-esophageal echocardiography in the Buckberg group compared to the del Nido group (13.7% versus 4.7%, P < 0.001 for trans-thoracic echocardiography).

Del Nido cardioplegia solution exerted beneficial effects on myocardial protection evaluated by echocardiography compared to Buckberg in adult patients with preserved ejection fraction undergoing mitral valve surgery

This study compares a new technique for teeth alignment to the conventional method. The teeth were aligned using an open-coil spring, i.e. simultaneous space opening and alignment, on round nickel-titanium (NiTi) archwires. The purpose of this 2-arm parallel trial (1:1 allocation ratio) was to evaluate the alignment efficiency of conventional and open-coil spring techniques in anterior crowding treatment.

In this clinical trial study, sixty-two non-extraction patients (70 dental arches: 24 upper arches and 46 lower arches) with ≥3mm of Little’s Irregularity Index (LII) were recruited in two groups based on the minimization method. Blinding was applicable for outcome assessment only. In one group, the teeth were aligned using an open-coil spring, whereas the alignment in the other group was done conventionally, (space opening on steel wires followed by alignment with an auxiliary NiTi wire). The alignment duration was the primary outcome that was investigated for survival analysis and alignment rate ratios, and levels of crowding were calculated with Cox proportional hazard regression. The pre- and post-treatment intercanine widths were also recorded as the secondary outcome. The chi-square and t-test were used to compare other variables between the groups. The level of statistical significance was set at P<0.05.

There was no significant difference in the alignment duration between the conventional (185.48±74.82 days) and open-coil (179.19±64.15 days) groups (P=0.725). No harm was detected using the mentioned methods.

The use of open-coil spring over brackets on NiTi or steel wires does not seem to affect anterior crowding treatment time.

Multiple sclerosis (MS) is an inflammatory disease of the central nervous system (CNS) with the most common complaint of fatigue. A high number of patients with MS are interested in taking dietary supplements as a complementary therapy. We propose a specially formulated supplement for patients with MS and aim to evaluate its effects on fatigue.

This study was a triple-blind, randomized, placebo-controlled trial using a stratified randomization method according to sex. 46 eligible patients participated in the study, 23 in the placebo group and 23 in the intervention group. The intervention group received two capsules of multivitamin-mineral (MVM) daily for 3 months.  Measurements of fatigue and cytokines were performed in all patients at the baseline and after the 3-month intervention

Finally, information of 41 participants was used for data analysis. However, fatigue was decreased after supplementation than before, in the intervention group (P = 0.005). There was no significant difference (P = 0.090) between the change of fatigue score in the MVM group (-3.00 ± 4.42) and the control group (-0.40 ± 5.14). Among cytokines, Interleukin 4 (IL-4) significantly increased in the intervention group compared to the placebo (P = 0.030).

Our study showed that the present MVM probably could improve the inflammatory state and fatigue in patients with MS.

Etomidate is an efficient general anesthetic associated with injection pain. Etomidate-Lipurois its lipid emulsion, suggested to have less adverse effects. We aim to compare the injection pain of etomidate vs. etomidate-lipuro.

This double-blind randomized clinical trial investigated 46 hands (23 patients) undergoing elective orthopedic surgery referring to our hospital from May to September 2017. For each patient, intravenous (IV) access was put on both hands, on oneof which 2 ml of etomidate (drug A) and on the other one, 2 ml of etomidate-lipuro (drug B) were infused simultaneously. Pain scores were compared between drug types by the Wilcoxon signed-rank test using the SPSS software.

Among 23 patients included in the study, 8 (34.8%) were female. Mean ± standard deviation (SD) of the patients’ age was 40.52 ± 13.07 years (range: 22-60 years). The type of drug injected to the right hand was drug A in 14 hands (60.9%) and drug B in 9 hands (39.1%). Mean ± SD of pain scores was 3.57 ± 3.30 for drug A (P < 0.001). The hand side (left/right) showed no significant effect on the pain scores (P = 0.535).

This randomized clinical trial used each person as his/her own control (left/right hands). Given the results, etomidate-lipuro showed significant superiority over etomidate regarding injection pain. In fact, most patients felt no pain, which suggests etomidate-Lipuro as an appropriate sedative.