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   Table of Contents - Current issue
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January-March 2019
Volume 4 | Issue 1
Page Nos. 1-29

Online since Monday, March 25, 2019

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RESEARCH ARTICLES  

Effects of flash glucose-sensing technology-based continuous glucose monitoring on compliance of patients with type 2 diabetes mellitus: Study protocol for a randomized controlled trial Highly accessed article p. 1
Jing Chen, Na Luo, Li Wang, Zhen-Wen Zhang, Yan Liu
DOI:10.4103/2542-3975.254105  
Background and objectives: Multiple insulin injection therapy has been widely used in the intensive treatment of diabetes mellitus and enabled more patients to obtain good glycemic control. Intensive insulin treatment such as multiple insulin injection every day had been proven to have effects on the protection of islet and delay the onset of diabetic complications. However, during the insulin intensive therapy, severe hypoglycemia must be avoided by intensive glucose monitoring because it can increase the risks of stroke and cardiovascular disease. Conventional invasive intensive blood glucose monitoring is limited in clinical practice because it can cause patient pain and inconveniences. Patient's poor compliance in blood glucose monitoring would restrict the application of insulin intensive therapy in patients outside the hospital. The latest method of flash glucose-sensing technology-based continuous glucose monitoring (CGM) made insulin intensive therapy safer and less painful for a patient with diabetes mellitus. However, little is reported on the effects of flash glucose-sensing technology based CGM in patients receiving multiple daily injections of insulin. This study will provide evidence to validate whether flash glucose-sensing technology-based CGM can increase the behavioral self-monitoring and compliance with self-management of a Chinese patient with diabetes mellitus receiving multiple daily injections of insulin compared with conventional invasive blood glucose monitoring. Subjects and methods: This is a prospective, single-center, open-label, randomized controlled trial. Forty patients with type 2 diabetes mellitus who receive multiple daily injections of insulin at the Department of Endocrinology, Northern Jiangsu People's Hospital, Yangzhou University, China between August 2018 and December 2019 are included in this study. These patients are randomly divided to undergo conventional blood glucose monitoring (n = 20) or a flash glucose-sensing technology-based CGM group (n = 20). Patient recruitment began in August 2018 and will end in June 2019. Analysis of primary outcome measure will be completed in June 2019. The study will end in December 2019. Study protocol: 1.0. The protocol was approved by the Medical Ethics Committee of Northern Jiangsu People's Hospital (approval No. 2018045) and is performed in strict accordance with the Declaration of Helsinki formulated by the World Medical Association. All participants provide written informed consent. Outcome measures: The primary outcome measure is the compliance of glycemic monitoring. The secondary outcome measures include the time taken for reaching the goal of glycemic control, HbA1c, self-management scores, the number of hypoglycemia attacks, and Hamilton Anxiety Scale score. Discussion: This study will provide evidence to validate whether flash glucose-sensing technology can increase patient's compliance of intensive insulin treatments, control blood glucose, and improve quality of life. Trial registration: This study was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR1800017456) on July 31, 2018.
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Efficacy and safety of Mamajjaka Ghanavati in the treatment of type 2 diabetes mellitus: A prospective open label multi-center clinical study p. 7
Malalur Nagesh Shubhashree, Bikartan Das, Gopal Chandra Nanda, Gaddam Kumara Swamy, Sarada Ota, Shashidhar Doddamani, Meda Mruthyumjaya Rao, Vimal Tewari, Baghwan Sahai Sharma, Shruti Khanduri, Rakesh Rana, Richa Singhal, Adarsh Kumar, Narayanam Srikanth
DOI:10.4103/2542-3975.254106  
Background and objectives: The purpose of this study is to investigate the efficacy and safety of Mamajjaka Ghanavati on blood glucose level, symptoms, and quality of life in patients with type 2 diabetes mellitus. Subjects and methods: This prospective, multi-center, open-label, single-arm clinical study was performed at three peripheral institutes of the Central Council for Research in Ayurvedic Sciences, New Delhi during April 2016 to May 2017. A total of 177 eligible patients with type 2 diabetes mellitus were included and administered Mamajjaka Ghanavati two tablets (500 mg each) twice daily after food for 84 days. At the end of the treatment period (84th day), the changes in Diabetes Symptom Questionnaire (i.e., glycosylated hemoglobin and fasting and postprandial blood sugar levels) were analyzed. Quality of life was evaluated using 36-Item Short Form Health Survey (SF-36). Clinical safety of Mamajjaka Ghanavati was assessed by liver and renal function tests. This study was approved by the Medical Ethics Committee of Central Council for Research in Ayurvedic Sciences, New Delhi (approval number: CTRI Reg No Ref/2016/06/011468) on March 14, 2016. Results: Compared to baseline data, after 84 days of treatment with Mamajjaka Ghanavati, Diabetes Symptom Questionnaire score was significantly decreased, and SF-36 score was significantly increased (both P < 0.01). However, compared to baseline data, no significant differences in glycated hemoglobin, fasting and postprandial blood sugar levels as well as hepatic and renal parameters were observed after 84 days of treatment with Mamajjaka Ghanavati. Conclusion: Mamajjaka Ghanavati can greatly improve the quality of life and is safe in the treatment of type 2 diabetes mellitus. Actually, Mamajjaka Ghanavati does not change blood sugar level greatly. Trial registration: This study was registered in the Clinical Trial Registry of India (CTRI/2017/09/009887) on September 22, 2017.
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Effect of beraprost sodium on pulmonary hypertension due to left ventricular systolic dysfunction: Protocol for a randomized controlled clinical trial p. 14
Li Wang, Yu-Qi Chen, Liang-Ping Zhao, Xian-Song Chang, Xiang Liu, Wen-Jing Wang, Jian-Chang Chen, Wei-Ting Xu
DOI:10.4103/2542-3975.254107  
Background and objectives: Beraprost sodium is mainly adapted to peripheral chronic arterial occlusive disease. However, the efficacy and safety of beraprost sodium in patients with pulmonary hypertension (PH) due to left ventricular systolic dysfunction (PH-HFrEF) remain unknown. The main objective of this study is to ascertain the efficacy and safety of beraprost sodium in the treatment of PH-HFrEF. Subjects and methods: In this prospective, multi-center, randomized, controlled clinical trial, 462 consecutively recruited patients with PH-HFrEF are randomly assigned to receive routine treatment only or routine treatment in combination with oral administration of beraprost sodium 1 μg/kg for 1 year. All patients are followed up at 3, 6, 9 and 12 months after treatment. Systolic pulmonary artery pressure and left ventricular ejection fraction are assessed by echocardiography, and exercise tolerance is assessed by a 6-minute walk test. Cardiac events are also recorded. This trial was approved by the Medical Ethics Committee of the Second Affiliated Hospital of Soochow University (approval number: JD-LK-2017-021-02). Patient recruitment began in February 2018. Analysis of primary outcome measure will be completed in September 2021, and the study will be finished in September 2021. Outcome measures: Outcome measures are assessed at baseline and at 3, 6, 9 and 12 months after treatment. The primary outcome measure is the reduction rate of systolic pulmonary artery pressure. The secondary outcome measures are the incidence of major adverse cardiac events, left ventricular ejection fraction, and 6-minute walking distance. Discussion: Results of this study will provide evidence to validate whether application of beraprost sodium based on routine treatment can further reduce pulmonary artery pressure, improve cardiac function, reduce the incidence of heart events, and finally determine whether beraprost sodium is suitable for the treatment of PH-HFrEF. Trial registration: This trial was registered in the Chinese Clinical Trial Registry (registration number: ChiCTR-IPR-17012961) on October 12, 2017.
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Effects of exergames on motor coordination and balance in convalescent drug addicts: A feasibility study p. 19
Adriele Nunes Sales, Jane Terezinha Finckler Botelho, Arislander Jonathan Lopes Dumont, Ana Francisca Rozin Kleiner, Gileno Edu Lameira de Melo
DOI:10.4103/2542-3975.254108  
Background and objectives: Drugs are public health problem in terms of mental and physical impairments. As respect to the physical commitments, addicted people present severe motor coordination and balance disturbances. The aim of this study was to evaluate the effect of exergames on the rehabilitation of motor coordination and balance in recovering drug addicts. Participants and methods: This is a prospective non-randomized, self-controlled study. Nine male addicts aged 25.78 ± 6.76 years were recruited from the Rescuing Lives Center for Recovery from Alcohol and Drugs, Altamira, Brazil. The intervention consisted of sixteen 45-minute sessions involving the use of virtual reality games (Xbox 360 Kinect console). Evaluations were performed before and after the intervention. The static and dynamic balance was accessed by the Berg Balance Scale, Timed Up and Go test and 6-minute walk test. The motor coordination was assessed by the Senior Motor Scale. Gait was also analyzed using an inertial sensor (G-Walk). This study was conducted at the Rescuing Lives Center for Recovery from Alcohol and Drugs, Altamira, Brazil and received approval from the Human Research Ethics Committee of the Universidade do Estado do Pará - XII Campus (certificate number: 2.129.360) on April 7, 2017. Written informed consent was obtained from each participant. Results: Significant improvements were found in the Berg Balance Scale, Senior Motor Scale and Timed Up and Go test (sitting and standing) after intervention (P < 0.05 or P < 0.01), whereas no significant change occurred on the six-minute walk test (P > 0.05). Conclusion: Virtual reality is a promising technology for improving motor coordination and balance in recovering drug addicts.
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INSTRUCTION Top

Information for Authors - Clinical Trials in Degenerative Diseases (CTDD) p. 24
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