scholarly journals Efficacy and Safety of Ningmitai Capsules in Patients with Chronic Epididymitis: A Prospective, Parallel Randomized Controlled Clinical Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-6
Author(s):  
Zhang Jing ◽  
Guan Liying ◽  
Wang Zhenqing ◽  
Zhang Hui ◽  
Liu Shuai ◽  
...  
Keyword(s):  
Clinical Efficacy ◽  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
Efficacy Rate ◽  
Efficacy And Safety ◽  
Symptom Index ◽  
Randomized Controlled ◽  
Significant Difference ◽  
The Mean ◽  
Hepatorenal Function

Objectives. To evaluate the efficacy and safety of Ningmitai (NMT) capsules in patients with chronic epididymitis. Methods. This prospective randomized controlled trial included 112 patients diagnosed with chronic epididymitis. The patients were randomized (1 : 1 : 1) to receive levofloxacin (LVX), NMT, or NMT combined with LVX for 4 weeks. The patients were followed up at 2 and 4 weeks after initiation of treatment and were evaluated in terms of Chronic Epididymitis Symptom Index (CESI) scores, epididymal nodules, and safety parameters. The primary endpoints were the CESI scores at the end of 2 and 4 weeks of treatment. The secondary endpoints included the mean epididymal nodule diameter and the clinical efficacy rate. Safety was evaluated by hepatorenal function tests and adverse event reports during the trial. Results. After 2 weeks of treatment, the CESI score of the NMT group was significantly lower than that of the LVX group ( P < 0.05 ). In addition, the clinical efficacy rate of the NMT group was significantly higher than that of the LVX group (55% vs. 8.33%, P < 0.0001 ), indicating that NMT has a rapid effect on chronic epididymitis. After 4 weeks of treatment, there was no significant difference in CESI scores or clinical efficacy rates between the two monotherapy regimens ( P > 0.05 ); however, the mean diameter of epididymal nodules was significantly smaller in the NMT group than in the LVX group ( P < 0.0001 ). Moreover, after 4 weeks of treatment, the patients in the LVX + NMT group, which had a clinical efficacy rate of 97.22%, had lower CESI scores (both P < 0.01 ) and a smaller epididymal nodule diameter (vs. LVX, P < 0.0001 ; vs. NMT, P < 0.05 ) than those in the other two groups. No adverse events or abnormal hepatorenal function were found during the study. Conclusion. NMT significantly improved CESI scores and epididymal nodule diameter in patients with chronic epididymitis. The combination of NMT and LVX provides a much better effect than monotherapy, and this treatment regimen was well tolerated.

scholarly journals Randomized Controlled Clinical Trial Comparing Transurethral Eneucleation and Resection of Prostate and Trans-urethral Resection of Prostate in the Management of Benign Prostatic Hyperplasia

2017 ◽  
Vol 7 (3) ◽  
pp. 216-220
Author(s):  
Md Mehedi Hasan ◽  
Samira Rahat Afroze ◽  
Muhammad Abdur Rahim ◽  
Muhammad Abdus Salam
Keyword(s):  
Controlled Trial ◽  
Ethical Review ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Transurethral Resection Of Prostate ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Group A ◽  
The Mean ◽  
Group B

Background: Transurethral resection of prostate (TURP) is the predominant surgical procedure for benign prostatic hypertension (BPH) but is not devoid of complications like capsular perforation, drop in Hb%, drop in Na+, residual adenoma; hence endeavors are evolving to combat such complications. A newer technique transurethral enucleation and resection of prostate (TUERP) has been devised to solve these problems. This study was designed to compare the safety and the efficacy of newer technique, TUERP with widely practiced TURP Methods: This randomized controlled trial was done at BSMMU, after getting ethical approval from the ethical review committee of the institute, from January to October, 2009. A total of 60 BPH patients were purposively enrolled in this study, after obtaining informed written consent and they were randomized as control, Group A (30 patients, underwent TURP) and experimental group, Group B (30 patients, underwent TEURP).Results: The mean preoperative Hb% level of Group A was 15.1 gm% (SD ± 0.5) and perioperative Hb% level was 13.04 gm% (SD ± 6.06). There was significant difference (P <0.05). The mean preoperative Hb% of Group B was 15.2 gm% (SD ± 0.5) and perioperative Hb% was 15.2 gm% (SD ± 0.48). There was no difference (P >0.05). The mean preoperative Na + of Group A was 140 mmol/l (SD ± 4.1) and perioperative Na+ was 126 mmol/l (SD ± 6.8). There was significant difference (P<0.01). The mean preoperative Na+ of Group B was 136 mmol/l (SD ± 4) and perioperative Na+ was 136 mmol/l (SD ± 2.70). There was no difference (P >0.05).Conclusion: TUERP eliminates drop in Hb% and Na+which are usual consequences following TURP. Thus TUERP can be advocated in the treatment of BPH as it also allows completeresection down to surgical capsule.Birdem Med J 2017; 7(3): 216-220

scholarly journals The effectiveness of the robotic game kit on anxiety among hospitalized preschool children: A non-randomized controlled trial

2021 ◽  
Author(s):  
Sima Pourteimour ◽  
Sahar Kazemi
Keyword(s):  
Separation Anxiety ◽  
Controlled Trial ◽  
Intervention Group ◽  
Analysis Of Covariance ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Psychological Burden ◽  
Randomized Controlled ◽  
Significant Difference ◽  
The Mean

Background & Aim: Hospitalization is a challenging experience all children go through in their lives, leading to their utmost anxiety. In this sense, interactive games and activities can help ease this psychological burden. Therefore, we endeavored to determine the effectiveness of a robotic game kit (RGK) on the anxiety of hospitalized preschoolers. Methods & Materials: This non-randomized controlled clinical trial was conducted in a pediatric hospital, Iran, between March and July 2019. 59 participants were assigned to intervention (n=30) or control (n=29) groups through available sampling. Inclusion criteria were Iranian native children aged 3-7 years with communication ability. The RGK was applied in eight sessions at least seven consecutive days of hospitalization. The collected data by using the demographic information form and the preschool anxiety scale (PAS) were analyzed in descriptive, chi-square, t-test, the one-way ANCOVA (analysis of covariance), and multivariate analysis of covariance (MANCOVA). Results: Two groups were homogenous in terms of demographic variables (p>0.05). There was no statistically significant difference between the mean score of PAS before the intervention in the intervention 46.33±15.81 and control groups 37.24±19.65 (p=0.055). However, the mean score of PAS in the intervention group was significantly lower than the control group (P=0.030). Also, using the RGK was effective in two subscales related to separation anxiety and physical injury fears (P=0.034). Conclusion: The modern RGKs could have a significant place in pediatric health care in hospitals. It is thus an undeniable fact that high-quality, comprehensive care can be boosted through RGK based interventions for children encountering stressful situations.

Effect of Delayed Cord Clamping Reduced Anemic Outcome in Preterm Neonate

2021 ◽  
Vol 104 (5) ◽  
pp. 695-700
Keyword(s):  
Intraventricular Hemorrhage ◽  
Preterm Neonate ◽  
Controlled Trial ◽  
Preterm Neonates ◽  
Maternal Outcomes ◽  
Delayed Cord Clamping ◽  
Randomized Controlled ◽  
Cord Clamping ◽  
Significant Difference ◽  
The Mean

Objective: To compare the effects of immediate versus delayed cord clamping on neonatal outcomes in preterm neonates of gestational age of 32 to 36⁺⁶ weeks, and maternal outcomes. Materials and Methods: A randomized controlled trial was conducted in the Obstetrics and Gynecology Department at Bhumibol Adulyadej Hospital, in Bangkok, Thailand. The study compared the effects of immediate to delayed cord clamping at 60 seconds among preterm neonates born between 32 weeks, 0 day and 36 weeks, 6 days of gestation between August and October 2018. Results: The mean age of the participants was 26 years old, and half of the cases were nulliparous. One hundred ten women were randomly separated into two equal groups (n=55). Delayed cord clamping at 60 seconds increased hematocrit levels (Hct) in both two (p=0.004) and 48 (p<0.001) hours after delivery compared to the immediate cord clamping group. There were no differences in exposing the neonate to hypothermia, hypoxemia, Apgar score at 1-minute, polycythemia, intraventricular hemorrhage, hyperbilirubinemia, length of stay in hospital, and affecting the process of resuscitation. There were no statistical differences between the two groups in maternal outcomes such as retained placenta and postpartum hemorrhage. Conclusion: Delayed cord clamping at 60 seconds increased Hct in the newborn at two to 48 hours after birth. There was no significant difference in adverse maternal and neonatal complications within both groups. Keywords: Delayed cord clamping, Hematocrit, Preterm

scholarly journals A randomized controlled trial comparing oxytocin administration before and after placental delivery in the prevention of postpartum haemorrhage in a tertiary care hospital in Bankura district of West Bengal, India

2020 ◽  
Vol 9 (5) ◽  
pp. 1976
Author(s):  
Rahul Kirtania ◽  
Jayita Pal ◽  
Sisir Biswas ◽  
Aditi Aich
Keyword(s):  
Randomized Controlled Trial ◽  
Blood Loss ◽  
Controlled Trial ◽  
Active Management ◽  
Control Group ◽  
Care Hospital ◽  
Normal Delivery ◽  
Randomized Controlled ◽  
Significant Difference ◽  
The Mean

Background: PPH is the prime cause of maternal mortality worldwide. The incidence of PPH can be drastically combatted by application of uterotonic in active management of third stage labour. Timing of its administration is a matter of concern. This study aimed to assess whether timing of administration of oxytocin would have any impact on incidence or mean blood loss of PPH.Methods: It was a single blinded randomized controlled trial conducted in the department of Obstetrics and Gynecology, Bankura Sammilani Medical College for 6 months where 100 antenatal mothers admitted for normal delivery in labour room were allocated randomly in study and control group considering inclusion and exclusion criteria. Incidence of PPH and mean blood loss had been identified clinically by following them for 24 hours.Results: Only 9% of study population had experienced PPH. There was no statistically significant difference in incidence of PPH with difference in timing of administration of oxytocin (p >0.05). But there was statistically significant decrease in mean blood loss if oxytocin was administered before the placental delivery. The mean blood loss with oxytocin administered before placental delivery was 296.8 ml (102.45) and after placental delivery was 452.0 (128.87) ml respectively.Conclusions: Policy makers should keep in mind not only the incidence of PPH, but the mean blood loss amount too in a setting where anaemia in pregnancy is quite prevalent.

scholarly journals Randomized controlled trial on the effectiveness of silver diamine fluoride in arresting caries in Lagos, Nigeria

2021 ◽  
Vol 21 ◽  
pp. e226341
Author(s):  
Moses Okechukwu Azouru ◽  
Modupe Olufunmilayo Ashiwaju ◽  
Augustine Edomwonyi ◽  
Afolabi Oyapero ◽  
Bola Obisesan ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Phase Iii ◽  
Treatment Modalities ◽  
Control Group ◽  
Chi Square ◽  
Silver Diamine Fluoride ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Chi Square Test ◽  
The Mean

Treatment of dental caries in children still remains challenging due to lack of cooperation with conventional treatment modalities. Recently, the use of Silver Diamine Fluoride (SDF) has proved useful in addressing this challenge. Aim: This clinical trial aimed to evaluate the effectiveness of Silver Diamine Fluoride (SDF) in arresting caries in children in Lagos, Nigeria. Methods: This was a phase III balanced randomized controlled school based interventional study on 240 children. The study group was treated with SDF while GIC was used in the control group. Follow up visits in 2 weeks, 1 month, and 3 months were carried out to assess the treatment outcome. Inferential statistics with the use of Pearson Chi-square test and Independent Student t-test were used at 5% level of significance. Results: There was significant relationship between SDF and caries arrest in 2 weeks, 1 month and 3 months’ assessment period (p = 0.001). The control group showed continuous decline (71.7%, 54.3% and 50.9%) in restorative success from 2 weeks to 3 months respectively. The mean ± SD and Confidence Interval (CI) of arrested caries in the SDF group were 113± 1.24 and 113.1 – 113.5 respectively. In the control group the mean ± SD and CI of restorative success were 69.3±11.8 and 67.2 – 71.4. The effect size was 5.24. Conclusion: The result of the study showed that SDF was effective in arresting caries in children without any harm and there was statistically significant difference in the use of 38% SDF in arresting caries in children.

scholarly journals Effect of Play Therapy on Social Development: A Randomized Controlled Trial

2019 ◽  
pp. 1-8
Author(s):  
Malihe Masoudifard ◽  
Zohreh Mahmoodi ◽  
Azam Bagheri ◽  
Mahrokh Dolatian ◽  
Kourosh Kabir
Keyword(s):  
Randomized Controlled Trial ◽  
Social Development ◽  
Play Therapy ◽  
Controlled Trial ◽  
Early Years ◽  
Randomized Controlled ◽  
The Social ◽  
Significant Difference ◽  
Comprehensive Health ◽  
The Mean

Background: The early years of life are vital and sensitive for the growth and development of a child. This aimed to examine the effect of play therapy on the social development and maturity of infants aged from 12 to 24 months. Methods: This study was a randomized controlled trial conducted on 76 eligible infants aged from 12 to 24 months referred to comprehensive health centers in Kashan city during 2017-2018. Infants who had inclusion criteria were included in the study and then randomly assigned to the two groups of intervention and control. Before the intervention and the end of the counseling sessions, Vineland Social Maturity Test Toolkit for Children in the both groups was completed and the data were analyzed using SPSS software. Results: There was no significant differences between the two groups regarding the social development score before the intervention (p >0.001). There was a significant difference between the mean score of social development in the two groups after the intervention, in which the mean of the total score and each area of social development increased significantly (P <0.001). Conclusion: Considering the importance of the early years of life in the development of infants and findings of the present study, it can be said that the advisory of play therapy for improving the development of a infants can be very helpful.

scholarly journals Baidu Jieduan granule, traditional Chinese medicine, in the treatment of moderate coronavirus disease-2019 (COVID-19): study protocol for an open-label randomized controlled clinical trial

2020 ◽  
Author(s):  
Wen Zhang ◽  
Qin Xie ◽  
Xiaoming Xu ◽  
Shuting Sun ◽  
Tian Fan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Controlled Trial ◽  
Theory And Practice ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Open Label ◽  
Randomized Controlled

Abstract Background: Currently, coronavirus disease-2019 (COVID-19) is continuously and rapidly circulating, resulting in serious and extensive impact on human health. Due to the absence of antiviral medicine for COVID-19 thus far, it is desperately need to develop the effective medicine. Traditional Chinese medicine (TCM) has been widely applied in the treatment of epidemic diseases in China, hoping to produce clinical efficacy and decrease the use of antibiotics and glucocorticoid. The aim of this study is to evaluate the efficacy and safety of Baidu Jieduan granule in curing COVID-19. Methods/design: This multicenter, open-label randomized controlled trial is conducted 300 cases with COVID-19. The patients will be randomly (1:1) divided into treatment group or control group. All cases will receive standard therapy at the same time. The experiment group will receive Baidu Jieduan granule treatment twice a day for 14 days. The outcomes are assessed at baseline and at 3, 5, 7, 14 days after treatment initiation. The primary outcome is the rate of symptom (fever, fatigue, and coughing) recovery. Adverse events (AEs) will be monitored throughout the trial.Discussion: The study will provide a high-quality clinical evidence to support the efficacy and safety of Baidu Jieduan granule in treatment of moderate COVID-19, and also enrich the theory and practice of TCM in treating COVID-19. Trial registration: Chinese Clinical Trial Registry, ChiCTR2000029869. Registered on 15 February 2020

scholarly journals Clinical Efficacy of Intra-Articular Injection With P-PRP Versus That of L-PRP in Treating Knee Cartilage Lesion: A Randomized Controlled Trial.

2021 ◽  
Author(s):  
Yiqin Zhou ◽  
Haobo Li ◽  
Shiqi Cao ◽  
Yaguang Han ◽  
Jiahua Shao ◽  
...  
Keyword(s):  
Adverse Events ◽  
Clinical Efficacy ◽  
Platelet Rich Plasma ◽  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
Womac Pain ◽  
Knee Cartilage ◽  
Cartilage Lesions ◽  
Randomized Controlled

Abstract Background: To evaluate the clinical efficacy and safety of intra-articular injection with pure platelet-rich plasma (P-PRP) versus those of leukocyte platelet-rich plasma (L-PRP) in treating knee cartilage lesions, we conducted a double-blind, randomized controlled clinical trial with a larger sample and longer follow-up period.Methods: From October 2019 to October 2020, 95 patients were invited to participate in our study, and 60 (63.2%) were randomized to P-PRP (n = 30) or L-PRP (n = 30) groups. Patients from the two groups were treated with knee intra-articular injections of P-PRP or L-PRP. Visual analog scale (VAS) and Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores were assessed preoperatively and at 6 weeks, 12 weeks, 6 months, and 12 months after intervention.Results: We followed up 27 cases in the P-PRP group and 26 cases in the L-PRP group. No significant differences in VAS and WOMAC scores were found between the two groups before the intervention (P>0.05). The WOMAC Pain and VAS-Motions scores of the P-PRP group were significantly lower than those of the L-PRP group at 6 weeks after the intervention (P<0.05). While the long-term clinical efficacy of both injections was similar and weakened after 12 months, more adverse events were found in the L-PRP group.Conclusions: The short-term results of our study are encouraging and demonstrate that both L-PRP and P-PRP intra-articular injections reduce pain and improve function in patients with knee cartilage lesions. Compared with the L-PRP injection, the P-PRP injection (which had a lower risk of early inflammation caused by leukocytes) showed better clinical efficacy in the early phase of postoperative rehabilitation and resulted in fewer adverse events. However, long-term clinical efficacy for both injections were similar and weakened after 12 months.Trial registration: ChiCTR1900026365. Registered on 3 October 2019, http://www.chictr.org.cn/showproj.aspx?proj=43911.

scholarly journals Effects of a novel dye containing toothpaste versus regular fluoridated toothpaste for supragingival biofilm reduction in patients with chronic gingivitis: A Randomized Controlled Trial

2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Avita Rath ◽  
Chong Junning ◽  
Priyadarshini HR ◽  
Brandon Nicholas Teo ◽  
Naik Hsian Zhen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Image Analysis ◽  
Controlled Trial ◽  
Control Group ◽  
Dental Biofilm ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Tooth Surfaces ◽  
The Mean

AIM:To compare the effects of a plaque disclosing toothpaste with a regular fluoridated toothpaste for supragingival biofilm reduction in patients with chronic gingivitis.MATERIALS AND METHODS:This study was a randomized controlled trial with a parallel design. Forty patients, both males and females aged 18-25 years with chronic generalized gingivitis (N=40) were randomly allocated to two groups of twenty each (n=20), using lottery method. Participants in the experimental group brushed with a plaque disclosing toothpaste, while participants in the control group brushed with regular fluoridated toothpaste. Clinically, biofilm was measured using Silness & Loe Plaque Index, both at baseline and at follow up visits by two assessors who were blinded to group allocation. Adjunctly, intraoral photographs were taken for Digital Plaque Image Analysis of the remaining dental biofilm in the upper and lower anterior labial tooth surfaces, and calculated based on the area of stained pixels. Data was analyzed using SPSS version 22. Mean plaque scores between the groups were compared using independent sample t-test and p<0.05 was considered significant.RESULTS:Data of all the 40 participants were analyzed as they were no drop outs. No significant differences were found in the mean plaque scores between the two groups (p=0.059) at the end of the study. Similarly, Digital Plaque Image Analysis showed no significant difference in the mean plaque scores between the groups (p= 0.93).CONCLUSION:This study showed that there are no additional benefits of using a plaque disclosing toothpaste, in enhancing the removal of the supragingival dental biofilm during routine oral hygiene maintenance.   

Comparative effects of suture and non-suture surgical techniques on platysma after Thyroid surgery

2021 ◽  
Vol 15 (7) ◽  
pp. 1661-1664
Author(s):  
Hafiz Ali Wasay ◽  
Muhammad Aamir Jameel ◽  
Muhammad Imran Anwar ◽  
HaroonJavaid Majid ◽  
Sameen Tahir
Keyword(s):  
Randomized Controlled Trial ◽  
Thyroid Surgery ◽  
Controlled Trial ◽  
Surgical Techniques ◽  
Platysma Muscle ◽  
Randomized Controlled ◽  
Post Operative Pain ◽  
Increased Risk ◽  
Significant Difference ◽  
The Mean

Background: Thyroidectomy is a routine general surgical procedure and pain after thyroidectomy is responsible for prolongation of hospital stay and increased risk of respiratory complications. Platysma is routinely sutured at the end of thyroidectomy before wound closure. This randomized controlled trial was conducted to compare the outcome of suturing platysma muscle versus not suturing in thyroid surgery patients. Aim: To compare the outcome of suturing platysma muscle versus not suturing in thyroid surgery patients. Place and duration of study: Dept. of Surgery at Sh. Zayed Hospital, Lahore from 26-12-2019 to 25-06-2020. Methodology: It is a randomized controlled trial study which consists of 92 patients, between 18 to 70 years of age in both gender and planned for thyroidectomy for nodular thyroid enlargement. Patients were randomly allocated into two treatment groups. After excision of thyroid, platysma was sutured as per conventional practice in one group while in the other group platysma was not sutured. For pain assessment Visual Analogue Scale (VAS) was used to 24 hours after surgery. Results: The mean age was 36.4±13.4 years. The mean VAS score for post-operative pain measured 24 hours after the surgery was significantly lower in patients undergoing thyroidectomy without platysmal suture as compared to those with conventional suturing of platysma during thyroidectomy (2.37±0.97 vs. 3.67±1.28; p <0.001). Similar significant difference was also noted between groups and subgroups which based on patient’s age, gender, BMI and educational status. Conclusion: Avoiding the suturing of platysma significantly reduced the post-operative pain which advocates a change in current practice and encourages non-suturing of platysma to decrease the morbidity of patients in post-operative period. Keywords: Thyroidectomy, Platysma, Suture, No Suture, Pain

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