A controlled study of the efficacy and safety of tandospirone citrate combined with escitalopram in the treatment of vascular depression: A pilot randomized controlled trial at a single-center in China

Background. Functional constipation (FC) is one of the prevalent gastrointestinal disorders that affect people of all ages. Long-term FC has significant effects on the quality of life of patients. Although commonly used drugs have reliable short-term effects, they are easily addictive and have side effects. Therefore, pursuing a convenient drug-food homogenous program is critical for FC patients. Maxing Xianchang Su is a functional food based on traditional Chinese medicine. To investigate the efficacy and safety of Maxing Xianchang Su in FC treatment, we conducted a randomized controlled trial. Methods. We carried out a prospective multicenter randomized parallel controlled study in three hospitals in Jiangsu Province, China, from January 2020 to March 2021, which included 206 FC patients. All patients were arbitrarily assigned into a treatment group and a control group at a ratio of 1 : 1; 103 cases in each group. The treatment group was given oral Maxing Xianchang Su, whereas the control group was treated with lactulose oral solution. The course of treatment was two weeks. The two groups of patients were evaluated after six weeks for symptom improvement before and after taking the drug. Furthermore, the safety of Maxing Xianchang Su was assessed. Results. Both groups of patients successfully completed the study without shedding cases. The effective rates of the treatment group and control group after two weeks were 90.6% and 67.0%, respectively. The treatment group had a better curative effect than the control group ( P < 0.05 ). The symptom score of the two groups improved compared with that before the treatment. The difference between the two groups was statistically significant ( P < 0.05 ). During the treatment process, neither group experienced abnormal changes in blood lipid, blood glucose, routine hematuria, or liver and kidney functions. There were no adverse reactions in both groups. Conclusion. Maxing Xianchang Su has a positive effect on FC treatment with reliable mid-term effect and a high level of safety.

Download Full-text

Acupuncture for persistent atrial fibrillation after catheter ablation: study protocol for a pilot randomized controlled trial

Trials ◽

10.1186/s13063-020-04967-y ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Ying Lin ◽

Xian Wang ◽

Xue-Bin Li ◽

Bang-Qi Wu ◽

Zhao-Hui Zhang ◽

...

Keyword(s):

Atrial Fibrillation ◽

Randomized Controlled Trial ◽

Catheter Ablation ◽

Controlled Trial ◽

Pilot Trial ◽

Sample Size Calculation ◽

Efficacy And Safety ◽

Randomized Controlled ◽

Cardiovascular Morbidity And Mortality ◽

Pilot Randomized Controlled Trial

Abstract Background Atrial fibrillation (AF) is a common arrhythmia, which is closely related to cardiovascular morbidity and mortality. Although acupuncture is used in the treatment of AF, the evidence is insufficient. The objective of this pilot trial is to evaluate the feasibility, preliminary efficacy, and safety of acupuncture in reducing AF burden for persistent AF after catheter ablation (CA). Methods and design This will be a multi-center, 3-arm, pilot randomized controlled trial in China. Sixty patients in total will be randomly assigned to the specific acupoints group, the non-specific acupoints group, or the non-acupoints group in a 1:1:1 ratio. The whole study period is 6 months, including a 3-month treatment period and a 3-month follow-up period. All patients will receive 18 sessions of acupuncture over 12 weeks after CA and appropriate post-ablation routine treatment. The primary outcome is AF burden at 6 months after CA measured by electrocardiography patch that can carry out a 7-day continuous ambulatory electrocardiographic monitoring. The secondary outcomes include AF burden at 3 months after CA, recurrence of AF, quality of life, etc. The adverse events will also be recorded. Discussion This pilot study will contribute to evaluating the feasibility, preliminary efficacy, and safety of acupuncture in reducing AF burden for persistent AF after CA. The results will be used for the sample size calculation of a subsequent large-scale trial. Trial registration Chinese Clinical Trial Registry ChiCTR2000030576. Registered on 7 March 2020.

Download Full-text

The Application of Augmented Reality in Craniofacial Bone Fracture Reduction: Study Protocol For a Randomized Controlled Trial.

10.21203/rs.3.rs-864609/v1 ◽

2021 ◽

Author(s):

Li Lin ◽

Xiangqi Liu ◽

Yuan Gao ◽

Zin Mar Aung ◽

Haisong Xu ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Augmented Reality ◽

Navigation System ◽

Controlled Trial ◽

Fracture Reduction ◽

Efficacy And Safety ◽

Single Center ◽

Randomized Controlled ◽

Key Points ◽

Zygomaticomaxillary Complex

Abstract Background: Augmented reality (AR) is a new technology that increases users’ perception of the real world. The purpose of this study is to evaluate the efficacy and safety of augmented reality navigation system in treatment with craniofacial fracture reduction.Methods: This will be a single-center prospective randomized controlled trial. Twenty-two patients will be assigned to two groups of 11 and those with zygomaticomaxillary complex fractures will undergo preoperative three-dimensional CT modeling and have operational plans designed. The control team will use traditional optical navigation to perform the surgery and the experimental team will use an AR navigation system. The primary outcome measures will be the accuracy of the key points of surgical area between the preoperational surgical plan and post-operation. The secondary outcome measures will be the blood loss, operation time, bone reduction time, hospital time and complication rate. The findings obtained through this study are expected to evaluate efficacy and safety of the augmented reality navigation system in the treatment of zygomaticomaxillary complex fractures.Discussion: This controlled trial of augmented reality navigation system in treatment with zygomaticomaxillary complex fracture reduction is expected to clarify the efficacy and safety of this technology by measuring the accuracy of the key points of surgical area and blood loss, operation and bone reduction times, hospital stay duration and complication rates. This is a single-center study, and the results are expected to promote the application of augmented reality in craniofacial fracture reduction to improve surgery accuracy and efficacy.Trial registration: Trial registration: Chinese Clinical Trial Registry: No. ChiCTR1900022626. Registered on April 19, 2019.

Download Full-text

Efficacy and safety of using premedication with simethicone/Pronase during upper gastrointestinal endoscopy examination with sedation: A single center, prospective, single blinded, randomized controlled trial

Digestive Endoscopy ◽

10.1111/den.12952 ◽

2017 ◽

Vol 30 (1) ◽

pp. 57-64 ◽

Cited By ~ 2

Author(s):

Ling‐Ye Zhang ◽

Wen‐Yan Li ◽

Ming Ji ◽

Fu‐Kun Liu ◽

Guang‐Yong Chen ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Gastrointestinal Endoscopy ◽

Controlled Trial ◽

Upper Gastrointestinal Endoscopy ◽

Efficacy And Safety ◽

Single Center ◽

Randomized Controlled ◽

Upper Gastrointestinal

Download Full-text

Efficacy and Safety of Triazavirin Therapy for Coronavirus Disease 2019: A Pilot Randomized Controlled Trial

Engineering ◽

10.1016/j.eng.2020.08.011 ◽

2020 ◽

Vol 6 (10) ◽

pp. 1185-1191 ◽

Cited By ~ 6

Author(s):

Xiaoke Wu ◽

Kaijiang Yu ◽

Yongchen Wang ◽

Wanhai Xu ◽

Hongli Ma ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Efficacy And Safety ◽

Randomized Controlled ◽

Pilot Randomized Controlled Trial

Download Full-text

The Efficacy and Safety of Two Low-Dose Peri-Operative Dexamethasone in Total Hip Arthroplasty: A Single-Center Randomized Controlled Trial

10.21203/rs.3.rs-257598/v1 ◽

2021 ◽

Author(s):

fulin Li ◽

dong yin ◽

yu Huang ◽

Xiao Huang ◽

Wenwen Huang

Keyword(s):

Randomized Controlled Trial ◽

Total Hip Arthroplasty ◽

Low Dose ◽

Controlled Trial ◽

Perioperative Period ◽

Efficacy And Safety ◽

Single Center ◽

Blank Group ◽

Randomized Controlled ◽

Vas Score

Abstract Objective To evaluate the efficacy and safety of two low-dose dexamethasone in the perioperative period of total hip arthroplasty (THA) with a single-center randomized controlled trial.Method 98 patients who underwent THA received two low-dose (10 mg) IV-dexamethasone (group dexa) or IV- isotonic saline group (The placebo).The post-operative day 24 h,48 h,72 h c reactive protein (CRP) and interleukin-6(IL-6), the pain VAS scores at rest and mobilization, the incidence of postoperative nausea and vomiting (PONV), nausea VAS score, postoperative fatigue rating and analgesia and antiemetic, the postoperative lengh of stay (PLOS), wound problems and complications were recorded and compared.Results The inflammatory markers (CRP, IL - 6) level postoperative 24,48,72 hours in dexa group of was lower than the placebo group (P<0.05).The 24 hours of rest and dynamic pain VAS score in dexa group was lower than those in blank group (P<0.05).The incidence of PONV, nausea VAS score, fatigue ICFS score in dexa group was lower than the blank group (P<0.05) and the dosage of analgesic and antiemetic were decreased significantly (P<0.05).In addition, the PLOS of dexa group was shorter than the blank group (P< 0.05).There was no significant difference in perioperative complications between the two groups (P> 0.05).Conclusion The application of two low-dose dexamethasone in the perioperative period of THA can effectively reduce the postoperative CRP and IL-6 levels, reduce pain, nausea, postoperative fatigue and the use of opioid analgesics, shorten the PLOS, without increasing the risk of incision infection or gastrointestinal hemorrhage.

Download Full-text