scholarly journals Efficacy and Safety of Maxing Xianchang Su in the Treatment of Functional Constipation: A Randomized Controlled Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-9
Author(s):  
Mi Li ◽  
Lijuan Zhao ◽  
Li Ma ◽  
Wen Zhang ◽  
Hua Huang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Treatment Group ◽  
Controlled Trial ◽  
Functional Constipation ◽  
Oral Solution ◽  
Controlled Study ◽  
Symptom Improvement ◽  
Control Group ◽  
Efficacy And Safety ◽  
Randomized Controlled

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.

scholarly journals Efficacy and safety of duloxetine for postoperative pain after total knee arthroplasty in centrally sensitized patients: study protocol for a randomized controlled trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Shicheng Wang ◽  
Wensheng Wang ◽  
Long Shao ◽  
Jing Ling
Keyword(s):  
Clinical Trial ◽  
Total Knee Arthroplasty ◽  
Randomized Controlled Trial ◽  
Pain Control ◽  
Controlled Trial ◽  
Control Group ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Total Knee ◽  
Postoperative Residual

Abstract Background Postoperative residual knee pain after total knee arthroplasty (TKA) is a significant factor that contributes to patient dissatisfaction. Patients with preoperative central sensitization (CS) may be more susceptible to unexplained chronic pain after TKA, and duloxetine has been reported to be effective in post-TKA pain control in patients with CS. However, there remains limited evidence to support this off-label use in routine clinical practice. Hence, we designed this randomized, placebo-controlled, triple-blind clinical trial to evaluate the effects of preoperative screening and targeted duloxetine treatment of CS on postoperative residual pain compared with the care-as-usual control group. Methods This randomized controlled trial includes patients with knee osteoarthritis on a waiting list for primary unilateral TKA. Patients with preoperative CS will be randomly allocated to the perioperative duloxetine treatment group (duloxetine group) or the care-as-usual control group (placebo group). Patients in the duloxetine group will receive a half-dose of preemptive duloxetine (30 mg/day) for a week before surgery and a full-dose of duloxetine (60 mg/day) for six weeks after surgery. The primary outcome is the intensity of residual pain at six months after TKA, including the visual analogue scale, 11-point numeric rating scale, the sensory dimension of the brief pain inventory, and the pain subscale of the Knee injury and Osteoarthritis Outcome Score. The secondary outcome measures will include the pain and function related outcomes. All of the patients will be followed up at one, three, and six months after surgery. All adverse events will be recorded and immediately reported to the primary investigator and ethics committee to decide if the patient needs to drop out from the trial. Discussion This clinical trial will convey the latest evidence of the efficacy and safety of the application of duloxetine in postoperative pain control in CS patients who are scheduled for TKA. The study results will be disseminated at national and international conferences and published in peer-reviewed journals. Trial registration Chinese Clinical Trial Registry (http://www.chictr.org.cn) registration number: ChiCTR2000031674. Registered 07 April 2020.

scholarly journals Evaluating the Efficacy of Internet-Delivered Cognitive Behavioral Therapy Blended With Synchronous Chat Sessions to Treat Adolescent Depression: Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Naira Topooco ◽  
Sandra Byléhn ◽  
Ellen Dahlström Nysäter ◽  
Jenny Holmlund ◽  
Johanna Lindegaard ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Adolescent Depression ◽  
Controlled Trial ◽  
National Level ◽  
Cognitive Behavioral ◽  
Controlled Study ◽  
Control Group ◽  
Depression Symptoms ◽  
Group Effect ◽  
Randomized Controlled

BACKGROUND Depression is a common and serious problem among adolescents, but few seek or have access to therapy. Internet-delivered cognitive behavioral therapies (ICBTs), developed to increase treatment access, show promise in reducing depression. The inclusion of coach support in treatment is desired and may be needed. OBJECTIVE The aim of this study was to determine the efficacy of an ICBT protocol blended with weekly real-time therapist sessions via chat; blended treatment, for adolescent depression, including major depressive episode (MDE). The protocol has previously been evaluated in a controlled study. METHODS In a two-arm randomized controlled trial, adolescents 15 to 19 years of age were recruited through a community setting at the national level in Sweden (n=70) and allocated to either 8 weeks of treatment or to minimal attention control. Depression was assessed at baseline, at posttreatment, and at 12 months following treatment (in the intervention group). The primary outcome was self-reported depression level as measured with the Beck Depression Inventory II at posttreatment. The intervention was offered without the need for parental consent. RESULTS Over two weeks, 162 adolescents registered and completed the baseline screening. Eligible participants (n=70) were on average 17.5 years of age (SD 1.15), female (96%, 67/70), suffered from MDE (76%, 53/70), had no previous treatment experience (64%, 45/70), and reported guardian(s) to be aware about their depression state (71%, 50/70). The average intervention completion was 74% (11.8 of 16 modules and sessions). Following the treatment, ICBT participants demonstrated a significant decrease in depression symptoms compared with controls (<italic>P</italic>&lt;.001), corresponding to a large between-group effect (intention-to-treat analysis: <italic>d</italic>=0.86, 95% CI 0.37-1.35; of completer analysis: <italic>d</italic>=0.99, 95% CI 0.48-1.51). A significant between-group effect was observed in the secondary depression outcome (<italic>P</italic>=.003); clinically significant improvement was found in 46% (16/35) of ICBT participants compared with 11% (4/35) in the control group (<italic>P</italic>=.001). CONCLUSIONS The results are in line with our previous study, further demonstrating that adolescents with depression can successfully be engaged in and experience significant improvement following ICBT blended with therapist chat sessions. Findings on participants’ age and baseline depression severity are of interest in relation to used study methods. CLINICALTRIAL ClinicalTrials.gov NCT02363205; https://clinicaltrials.gov/ct2/show/NCT02363205

scholarly journals Efficacy of Guizhi Fuling Wan for primary dysmenorrhea: protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Yun Du ◽  
Yatong Li ◽  
Xianyun Fu ◽  
Chenjie Li ◽  
Lou Yanan
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Blood Stasis ◽  
The Self ◽  
Blood Stasis Syndrome ◽  
Control Group ◽  
Primary Dysmenorrhea ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Self Rating

Abstract Background Primary dysmenorrhea (PD) is one of the main gynecological complaints in women of child-bearing age, but limited effective treatments are available. Guizhi Fuling Wan (GFW), one of the most widely known traditional Chinese medicine (TCM) formulations, has been commonly used in clinical practice to treat gynecological disorders in China. In recent years, a growing number of studies have shown that GFW is beneficial for patients with PD. However, the quality of evidence is limited, and there are few studies on specific TCM syndromes of GFW for PD. Therefore, we plan to conduct a randomized controlled trial to explore the efficacy and safety of GFW for PD patients with heat-burning blood-stasis syndrome. Methods and analysis The clinical study is a randomized, double-blinded, placebo-controlled trial. Eligible patients will be randomly assigned to the GFW group (treated with GFW) and the control group (treated with a matching placebo) in a 1:1 ratio for three menstrual cycles with a 3-month follow-up. The primary outcome will be the mean change of pain intensity measured by the visual analog scale (VAS). The secondary outcomes will include the Cox Menstrual Symptom Scale (CMSS), the Self-rating Depression Scale (SDS), the Self-rating Anxiety Scale (SAS), and the TCM syndrome scale. Adverse events will also be reported. Discussion This randomized trial will be the first rigorous study designed to assess the efficacy and safety of GFW in treating PD with heat-burning blood-stasis syndrome. The finding of this study will provide an objective clinical basis for the use of GFW for PD in the future. Trial registration Chinese Clinical Trial Registry ChiCTR2000034118. Registered on 24 June 2020

Early outcomes of primary total hip arthroplasty with use of a smartphone-based care platform: a prospective randomized controlled trial

2021 ◽  
Vol 103-B (7 Supple B) ◽  
pp. 91-97 ◽  
Author(s):  
David A. Crawford ◽  
Adolph V. Lombardi ◽  
Keith R. Berend ◽  
James I. Huddleston ◽  
Christopher L. Peters ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Treatment Group ◽  
Total Hip Arthroplasty ◽  
Hip Arthroplasty ◽  
Care Management ◽  
Controlled Trial ◽  
Urgent Care ◽  
Control Group ◽  
Randomized Controlled ◽  
Prospective Randomized Controlled Trial

Aims The purpose of this study is to evaluate early outcomes with the use of a smartphone-based exercise and educational care management system after total hip arthroplasty (THA) and demonstrate decreased use of in-person physiotherapy (PT). Methods A multicentre, prospective randomized controlled trial was conducted to evaluate a smartphone-based care platform for primary THA. Patients randomized to the control group (198) received the institution’s standard of care. Those randomized to the treatment group (167) were provided with a smartwatch and smartphone application. PT use, THA complications, readmissions, emergency department/urgent care visits, and physician office visits were evaluated. Outcome scores include the Hip disability and Osteoarthritis Outcome Score (HOOS, JR), health-related quality-of-life EuroQol five-dimension five-level score (EQ-5D-5L), single leg stance (SLS) test, and the Timed Up and Go (TUG) test. Results The control group was significantly younger by a mean 3.0 years (SD 9.8 for control, 10.4 for treatment group; p = 0.007), but there were no significant differences between groups in BMI, sex, or preoperative diagnosis. Postoperative PT use was significantly lower in the treatment group (34%) than in the control group (55.4%; p = 0.001). There were no statistically significant differences in complications, readmissions, or outpatient visits. The 90-day outcomes showed no significant differences in mean hip flexion between controls (101° (SD 10.8)) and treatment (100° (SD 11.3); p = 0.507) groups. The HOOS, JR scores were not significantly different between control group (73 points (SD 13.8)) and treatment group (73.6 points (SD 13); p = 0.660). Mean 30-day SLS time was 22.9 seconds (SD 19.8) in the control group and 20.7 seconds (SD 19.5) in the treatment group (p = 0.342). Mean TUG time was 11.8 seconds (SD 5.1) for the control group and 11.9 (SD 5) seconds for the treatment group (p = 0.859). Conclusion The use of the smartphone care management system demonstrated similar early outcomes to those achieved using traditional care models, along with a significant decrease in PT use. Noninferiority was demonstrated with regard to complications, readmissions, and ED and urgent care visits. This technology allows patients to rehabilitate on a more flexible schedule and avoid unnecessary healthcare visits, as well as potentially reducing overall healthcare costs. Cite this article: Bone Joint J 2021;103-B(7 Supple B):91–97.

scholarly journals Total Glucosides of Paeony Capsule Plus Compound Glycyrrhizin Tablets for the Treatment of Severe Alopecia Areata in Children: A Randomized Controlled Trial

2013 ◽  
Vol 2013 ◽  
pp. 1-5 ◽  
Author(s):  
Dingquan Yang ◽  
Jingwen Zheng ◽  
Yuming Zhang ◽  
Yueli Jin ◽  
Chaonan Gan ◽  
...  
Keyword(s):  
Treatment Group ◽  
Adverse Events ◽  
Alopecia Areata ◽  
Statistical Difference ◽  
Controlled Trial ◽  
Effective Rate ◽  
Control Group ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Total Glucosides Of Paeony

Total glucosides of paeony capsule (TGPC) and compound glycyrrhizin tablets (CGT) are plant extracts of glycosides. We conducted this study to examine the efficacy and safety of TGPC plus CGT for severe alopecia areata in children. 117 subjects were randomly allocated into TGPC plus CGT group or CGT group. For consecutive 12 months, subjects were given oral TGPC and CGT or oral CGT alone. The outcome measures included score of alopecia areata severity, effective rate, and adverse events observed in the 3rd, 6th, and 12th month. We found that the scores of alopecia areata severity of both groups were significantly reduced, and the scores of treatment group were lower than those of control group; for effective rate, there was no statistical difference between the two groups in the 3rd month, while in the 6th and 12th months the treatment group was superior compared with control group; the incidence rate of adverse events between the two groups was not statistically different, and no severe adverse events were observed. In conclusion, TGPC plus CGT appears effective and safe for severe alopecia areata in children.

scholarly journals EXPRESS: Bufei Huoxue Capsules in the management of convalescent COVID-19 infection: study protocol for a multicentre, double-blind, and randomized controlled trial

2021 ◽  
pp. 204589402110321
Author(s):  
Yuqin Chen ◽  
Wenjun He ◽  
Wenju Lu ◽  
Yue Xing ◽  
Jianling Bai ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Blood Stasis ◽  
Blood Stasis Syndrome ◽  
Small Scale ◽  
Control Group ◽  
Cumulative Number ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Number Of Patients

Up to the 30th May, 2021, the cumulative number of patients diagnosed with Corona Virus Disease-19 (COVID-19) globally has exceeded 170 million, with more than 152 million patients recovered from COVID-19. However, the long-term effect of the virus infection on the human body’s function is unknown for convalescent patients. It was reported that about 63% of COVID-19 patients had observable lung damage on CT scans after being released from the hospital. Bufei Huoxue Capsules (BFHX), including three active ingredients of traditional Chinese herbal medicine, has been used clinically to prevent and treat pulmonary heart diseases with Qi deficiency and blood stasis syndrome. Some small-scale clinical trials have found that BFHX can improve lung ventilation function, reduce blood viscosity, and improve cardiopulmonary function. However, the efficacy and safety of BFHX in the treatment of the recovery phase of COVID-19 are unknown. This study is a multicentre, double-blinded, randomized, controlled trial. Subjects with convalescent COVID-19 were randomized (1:1) into either a BFHX or control group and observed for 3months concomitant with receiving routine treatment. The primary efficacy indicators are the evaluation results and changes of the St. George’s Respiratory Questionnaire (SGRQ) score, Fatigue Assessment Inventory (FAI), and 6-minute walk distance (6MWD). Based on the intention-to-treat (ITT) principle, all randomly assigned participants will be included in the statistical analysis. The last visit’s outcomes will be used as the final outcomes for participants who prematurely withdraw from the trial. Per protocol set will pick up from the full analysis set for analysis. Efficacy analysis will be performed on the ITT datasets and per-protocol datasets. Prior to participation, all subjects provided written informed consent. Results will be disseminated at medical conferences and in journal publications. We aimed to determine the efficacy and safety of BFHX for the treatment of the convalescent COVID-19 patients.

scholarly journals Yiqi Fumai Injection for patients with Septic Shock: study protocol for a randomized controlled trial

2021 ◽  
Author(s):  
Bo-jun Chen ◽  
Zeng Jing ◽  
Cai Xingui ◽  
Cai Hairong ◽  
Luo Sicong ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Septic Shock ◽  
Randomized Controlled Trial ◽  
Conventional Treatment ◽  
Controlled Trial ◽  
Small Sample ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Randomized Controlled

Abstract Background: Septic shock is an important problem in critical care medicine and one of the leading causes of death in intensive care units (ICU). In China, Traditional Chinese medicine (TCM) has been widely used as the adjuvant treatment to improve the symptoms and prognosis in patients with septic shock. Yiqi Fumai Injection (YFI) is one of the most important proprietary TCM for septic shock, previous studies have demonstrated its efficacy and safety. However, these conclusions were limited due to the small sample size and low quality of methodologies of these studies. Therefore, we designed this study to evaluate the efficacy and safety of using YFI as an adjunct treatment for septic shock.Methods/design: This is a double-blind, randomized, parallel, placebo-controlled clinical trial. A total of 800 participants will be randomly assigned to receive either treatment or placebo in a 1:1 ratio. The treatment group will receive YFI combined with conventional treatment, and the control group will receive 0.9% sodium chloride injection combined with conventional treatment for 2 weeks. The primary outcome is the 28-days mortality. Secondary outcomes are blood lactate levels, hemodynamics, blood gas analysis, immune function indicators, inflammatory indicators, acute physiology improvement and chronic health assessment (APACHE) II scores, and sepsis-related organ failure score (SOFA). Adverse events will be observed and recorded at the same time for safety assessment.Discussion: This randomized controlled trial will help evaluate the efficacy and safety of YFI for the treatment of septic shock. The results of this trial will provide recommendations for the management of septic shock.Trial registration {2a and 2b}：China Clinical Trial Registry, ChiCTR-1900026424.Registered on 15 June 2019.

Psychodynamic therapy for adolescents suffering from co-morbid disorders of conduct and emotions in an in-patient setting: a randomized controlled trial

2013 ◽  
Vol 44 (10) ◽  
pp. 2213-2222 ◽  
Author(s):  
S. Salzer ◽  
C. Cropp ◽  
U. Jaeger ◽  
O. Masuhr ◽  
A. Streeck-Fischer
Keyword(s):  
Randomized Controlled Trial ◽  
Treatment Group ◽  
Controlled Trial ◽  
Academic Failure ◽  
Psychodynamic Therapy ◽  
Post Treatment ◽  
Control Group ◽  
Global Severity Index ◽  
Randomized Controlled

BackgroundCo-morbid disorders of conduct and emotions can be regarded as childhood antecedents of further negative developments (e.g. manifestation of personality disorders in adulthood). We evaluated a manualized psychodynamic therapy (PDT) for adolescents with these co-morbid disorders.MethodIn a randomized controlled trial (RCT), 66 adolescents diagnosed with mixed disorders of conduct and emotions (F92 in ICD-10) were randomly assigned to a manualized in-patient PDT group or a waiting list/treatment-as-usual (WL/TAU) control condition. Diagnoses according to DSM-IV were also documented. Patients were compared using rates of remission as the primary outcome. The Global Severity Index (GSI) and the Strengths and Difficulties Questionnaire (SDQ) were used as secondary measures. Assessments were performed at baseline, post-treatment and at the 6-month follow-up.ResultsThe sample consisted of severely impaired adolescents with high rates of further co-morbid disorders and academic failure. Patients in the treatment group had a significantly higher rate of remission [odds ratio (OR) 26.41, 95% confidence interval (CI) 6.42–108.55, p < 0.001]. Compared with the control group, the PDT group resulted in significantly better outcomes on the SDQ (p = 0.04) but not the GSI (p = 0.18), with small between-group effect sizes (SDQ: d = 0.38, GSI: d = 0.18). However, the scores of patients treated with PDT were post-treatment no longer significantly different from normative data on the GSI and within the normal range on the SDQ. The effects in the treatment group were stable at follow-up. Furthermore, most patients were reintegrated into educational processes.ConclusionPDT led to remarkable improvement and furthered necessary preconditions for long-term stabilization. In future, PDT should be compared to other strong active treatments.

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