XP-828L in the Treatment of Mild to Moderate Psoriasis: Randomized, Double-Blind, Placebo-Controlled Study

2006 ◽  
Vol 10 (5) ◽  
pp. 241-248 ◽  
Author(s):  
Yves Poulin ◽  
Robert Bissonnette ◽  
Christina Juneau ◽  
Kim Cantin ◽  
Rejean Drouin ◽  
...  
Keyword(s):  
Severity Index ◽  
Controlled Study ◽  
Open Label ◽  
Double Blind ◽  
Open Label Study ◽  
Double Blind Placebo ◽  
Sweet Whey ◽  
Severity Index Score ◽  
Group A ◽  
Group B

Background: XP-828L, a protein extract obtained from sweet whey, has demonstrated potential benefit for the treatment of mild to moderate psoriasis in an open-label study. Objective: To study in a randomized, double-blind, placebo-controlled study the safety and efficacy of XP-828L in the treatment of mild to moderate psoriasis. Design: XP-828L 5 g/d (group A, n = 42) or placebo (group B, n = 42) was given orally for 56 days followed by XP-828L 5 g/d in group A and by XP-828L 10 g/d in group B for an additional 56 days. Results: Patients receiving XP-828L 5 g/d for 56 days had an improved Physician's Global Assessment (PGA) score compared with patients under placebo ( p < .05). Considering the data of group A only, the PGA score improved from day 1 to day 56 ( p < .01); the Psoriasis Area and Severity Index score improved as well, but to a lesser extent ( p < .05). Conclusion: Oral administration of 5 g/d XP-828L compared with a placebo significantly improved the PGA score of patients with mild to moderate psoriasis.

scholarly journals Efficacy of green jackfruit flour as a medical nutrition therapy replacing rice or wheat in patients with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled study

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
A. Gopal Rao ◽  
K. Sunil Naik ◽  
A. G. Unnikrishnan ◽  
James Joseph
Keyword(s):  
Diabetes Mellitus ◽  
Nutrition Therapy ◽  
Controlled Study ◽  
Medical Nutrition Therapy ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Group A ◽  
Group B ◽  
Medical Nutrition

Abstract Background/Objectives Medical nutrition therapy along with pharmacological interventions as a multidisciplinary approach is required to treat type 2 diabetes mellitus (T2DM). This study evaluated the efficacy of Jackfruit365™ green jackfruit flour as an integral part of daily meal in patients with T2DM. Subjects/Methods This was a randomized, double-blind, placebo-controlled study conducted between May 2019 and February 2020. Patients of either sex aged ≥18 to ≤60 years with a diagnosis of T2DM for >1 year receiving oral antihyperglycemic agents were randomized (1:1) to receive either jackfruit flour 30 g/day (Group A) or placebo flour (Group B) (breakfast and dinner) daily for 12 weeks replacing an equal volume of rice or wheat flour. The primary endpoint was a mean change in glycosylated hemoglobin (HbA1c). Other endpoints were mean changes in fasting plasma glucose (FPG), postprandial plasma glucose (PPG), lipid profile, and body weight. The independent t-test was used to compare changes between the groups. Results A total of 40 patients were enrolled (n = 20 each). A significantly higher reduction in HbA1c was observed in Group A compared to Group B from baseline to week 12 [−2.73 mmol/mol (−0.25%) vs. 0.22 mmol/mol (0.02%), p = 0.006]. The mean change in FPG and PPG was significantly higher in Group A than that of Group B (p = 0.043 and p = 0.001). The continuous glucose monitoring showed decreasing mean blood glucose in 7 days of administration of jackfruit flour meal. Conclusion Patients from Group A had a significantly higher reduction in HbA1c, FPG, and PPG than Group B demonstrating the efficacy of jackfruit flour in glycemic control as medical nutrition therapy replacing an equal volume of rice or wheat flour in daily meal. Clinical trial registry CTRI/2019/05/019417.

scholarly journals Design of the Tocilizumab in Giant Cell Arteritis Trial

2013 ◽  
Vol 2013 ◽  
pp. 1-10 ◽  
Author(s):  
Sebastian H. Unizony ◽  
Bhaskar Dasgupta ◽  
Elena Fisheleva ◽  
Lucy Rowell ◽  
Georg Schett ◽  
...  
Keyword(s):  
Giant Cell Arteritis ◽  
Giant Cell ◽  
Treatment Phase ◽  
Controlled Study ◽  
Sustained Remission ◽  
Open Label ◽  
Double Blind ◽  
Open Label Extension ◽  
Group A ◽  
Group B

Overview. The GiACTA trial is a multicenter, randomized, double-blind, and placebo-controlled study designed to test the ability of tocilizumab (TCZ), an interleukin (IL)-6 receptor antagonist, to maintain disease remission in patients with giant cell arteritis (GCA).Design. Approximately 100 centers will enroll 250 patients with active disease. The trial consists of a 52-week blinded treatment phase followed by 104 weeks of open-label extension. Patients will be randomized into one of four groups. Group A (TCZ 162 mg weekly plus a 6-month prednisone-taper); group B (TCZ 162 mg every other week plus a 6-month prednisone-taper); group C (placebo plus a 6-month prednisone-taper); and group D (placebo plus a 12-month prednisone taper). We hypothesize that patients assigned to TCZ in addition to a 6-month prednisone course are more likely to achieve the primary efficacy endpoint of sustained remission (SR) at 52 weeks compared with those assigned to a 6-month prednisone course alone, thus potentially minimizing the long-term adverse effects of corticosteroids.Conclusion. GiACTA will test the hypothesis that interference with IL-6 signaling exerts a beneficial effect on patients with GCA. The objective of this paper is to describe the design of the trial and address major issues related to its development.

Effect of human chorionic gonadotrophin (hCG)/follicle-stimulating hormone treatment versus hCG treatment alone on testicular descent: a double-blind placebo-controlled study

1994 ◽  
Vol 130 (1) ◽  
pp. 60-64 ◽  
Author(s):  
Jantine JG Hoorweg-Nijman ◽  
Hester M Havers ◽  
Henriette A Delemarre-van de Waal
Keyword(s):  
Follicle Stimulating Hormone ◽  
Chorionic Gonadotrophin ◽  
Human Chorionic Gonadotrophin ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Retentio Testis ◽  
Group A ◽  
Group B ◽  
Stimulating Hormone

Hoorweg-Nijman JJG, Havers HM, Delemarre-van de Waal HA. Effect of human chorionic gonadotrophin (hCG)/follicle-stimulating hormone treatment versus hCG treatment alone on testicular descent: a double-blind placebo-controlled study. Eur J Endocrinol 1994;1 30:60–4. ISSN 0804–4643 The medical treatment of retentio testis remains controversial because of ineffectiveness and/or adverse events. Follicle-stimulating hormone (FSH) seems to influence the spontaneous descent of the testis; furthermore, it induces luteinizing hormone (LH) receptors. Therefore, we performed a double-blind placebo-controlled study to investigate the effect of FSH with human chorionic gonadotrophin (hCG) versus hCG alone in retentio testis patients. Twenty-two boys with retentio testis were investigated, excluding retractile testis. Group A (N= 14: four with bilateral and 10 with unilateral retentio testis; mean age 3.1 5 years) was treated with 150 IU of FSH twice a week for 2 weeks followed by 1 50 IU of FSH and 250 IU of hCG (half the recommended World Health Organization dose) twice a week for another 4 weeks. Group B (N = 8: two with bilateral and six with unilateral retentio testis: mean age 3.3 years) was treated with 250 IU of hCG twice a week for 6 weeks. Testicular position, volume and consistency as well as the appearance of the scrotum and the penile length were determined at the start of the treatment as well as at weeks 2.4.6 and 12 by two independent investigators. Blood investigation consisted of measurements of LH, FSH, testosterone and sex hormone-binding globulin. Successful descent was considered when the testis reached a mid- or low scrotal position. In group A, 6/18 testes descended successfully. In group B, 6/10 testes descended. Of the unsuccessfully treated patients, six of group A and three of group B underwent surgery. Of these patients, 6/8 testes of group A and all testes of group B showed anatomical abnormalities, which could explain the lack of hormonal response. There were no significant differences in hormonal parameters between the two groups. In both groups no serious adverse events were mentioned or observed. In conclusion, half the recommended WHO dose of hCG is sufficient to reach successful descent in 43% of treated patients, with no serious adverse events; this response rate is in agreement with the literature. Follicle-stimulating hormone does not seem to have an additional effect on the success rate, and most of the unsuccessfully treated patients showed anatomical abnormalities at operation. JJG Hoorweg-Nijman, Department of Paediatrics, Free University Hospital. PO Box 7057, 1007 MB Amsterdam, The Netherlands

scholarly journals Combined Use of Tranexamic Acid and Rivaroxaban in Posterior/Transforaminal Lumbar Interbody Fusion Surgeries Safely Reduces Blood Loss and Incidence of Thrombosis: Evidence From a Prospective, Randomized, Double-Blind, Placebo-Controlled Study

2021 ◽  
pp. 219256822110245
Author(s):  
Xiang Li ◽  
Guangjun Jiao ◽  
Jingyi Li ◽  
Weibin Ji ◽  
Zhiwei Hao ◽  
...  
Keyword(s):  
Blood Loss ◽  
Tranexamic Acid ◽  
Interbody Fusion ◽  
Transforaminal Lumbar Interbody Fusion ◽  
Controlled Study ◽  
Lumbar Interbody Fusion ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Group A ◽  
Group B

Study Design: A prospective, randomized, double-blind, placebo-controlled study. Objectives: There are few studies examining the balance between preventing venous thrombus embolism (VTE) and reducing blood loss in posterior/transforaminal lumbar interbody fusion (PLIF/TLIF) surgeries. This study aimed to evaluate the efficacy and safety of the combine application of TXA and rivaroxaban in patients undergoing PLIF/TLIF and explore relevant factors related to blood loss and VTE. Methods: Patients in group A which was the control group received 0.9% NaCl solution intravenously. Group B was treated by an intravenous injection of 2 g tranexamic acid (TXA) and the local use of 1 g intraoperatively. Group C was treated the same as group B intraoperatively, and they received 10 mg rivaroxaban qd treatment postoperatively. Eligible patients with an Autar score ≤ 10 were randomly assigned to group A or group B. Patients with an Autar score >10 were allocated into group C. Results: The intraoperative blood loss and postoperative drainage were lower in groups B and C than in group A ( P < .001). The blood transfusion rate in group B was lower than that in group A ( P < .001), while the incidence of VTE in group C was lower ( P < .001). Four factors were found to be positively correlated with obvious total blood loss ( P < .05). The data showed that 5 factors were correlated with the development of a thrombus ( P < .1). Conclusions: The combination of TXA and rivaroxaban in PLIF/TLIF patients is safe and effective in reducing D-dimer levels associated with VTE and reducing blood loss.

Pregabalin As A Premedicant To Attenuate Pressor Response In Patients Undergoing Laparoscopic Cholecystectomy: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study

2020 ◽  
Vol 11 (3) ◽  
pp. 3418-3423
Author(s):  
Sweety Agrawal ◽  
Shubdha Bhagat ◽  
Pratibha Deshmukh ◽  
Amol Singham
Keyword(s):  
Laparoscopic Cholecystectomy ◽  
Pressor Response ◽  
Controlled Study ◽  
Double Blind ◽  
Co2 Insufflation ◽  
Ramsay Sedation Scale ◽  
Minute Interval ◽  
Group A ◽  
Group B ◽  
Induction Of Anaesthesia

The present study was done to evaluate the ability of oral pregabalin to attenuate the pressor response to airway instrumentation in patients undergoing laparoscopic cholecystectomy under general anesthesia. Sixty-four adult patients aged between 25-55 year of either gender belonging to ASA-1 or ASA2 physical status weighing 50-70 kg were enrolled in this study. Thirty-two patients each were randomized to group A, or group B. Patients in group A received tablet Pregabalin (150mg) and those in group B received placebo orally one hour before induction of anaesthesia. Heart rate, blood pressure, and sedation were assessed preoperatively before giving the tablets and after 30 minutes, and just before induction of anaesthesia. Intraoperative, pulse rate, mean arterial pressure, ECG in the lead II, SPO2 and ETCO2 were monitored. All the above parameters were noted during laryngoscopy and intubation, 3 minutes after CO2 insufflation, and then at every 10-minute interval till the end of surgery. These parameters were also recorded after extubating the patient. The Ramsay sedation scale was used to assess the sedation at the baseline, one hour after drug intake , one hour after extubation and 4 hour after surgery. Any adverse effects in the postoperative period were recorded. The result of our study shows that pre-emptive administration of oral pregabalin 150 mg significantly reduced the pressor response at the time of laryngoscopy and intubation, after CO2 insufflation and just after extubation. We conclude that oral pregabalin premedication is effective in successful attenuation of hemodynamic pressor response to laryngoscopy, intubation and pneumoperitoneum in patients undergoing laparoscopic cholecystectomy

scholarly journals A179 CANADIAN INVOLVEMENT IN THE EVALUATION OF NOVEL THERAPY FOR DIABETIC GASTROPARESIS: OVERVIEW OF PLEDGE TRIALS

2020 ◽  
Vol 3 (Supplement_1) ◽  
pp. 45-47
Author(s):  
L W Liu ◽  
M Syrzycka ◽  
P Janiszewski ◽  
L Kemps ◽  
B Degeronimo
Keyword(s):  
Diabetic Gastroparesis ◽  
Extension Study ◽  
Open Label ◽  
Double Blind ◽  
Open Label Study ◽  
Label Study ◽  
Safety And Efficacy ◽  
Double Blind Placebo ◽  
The Third ◽  
Parallel Group

Abstract Background Diabetic gastroparesis(DG) is a serious, chronic complication of type 1 or 2 diabetes mellitus(DM) presenting with a delay in gastric emptying(GE). An estimated 3 million Canadians have been diagnosed with DM; up to 5% of these patients may develop DG. DG can result in poor glycemic control, recurrent nausea and vomiting, often resulting in hospitalization. To date, no effective treatments are available. A phase 2 study showed that relamorelin (RLM), a synthetic ghrelin agonist, was safe and effective in treating DG. Investigators across Canada are participating in a set of phase 3 international trials of RLM in the treatment of DG. Aims To report the Canadian involvement in the international effort to evaluate the safety and efficacy of RLM in the treatment of DG. PLEDGE is a set of 5 trials: two identical 12-week studies, a 46-week extension study, a 52-week exposure study, and an open-label extension study. Collectively, the data from these studies will help to evaluate the safety and efficacy of RLM, a novel treatment for Canadian patients living with DG. Methods Four global, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies compare the efficacy of RLM with placebo in participants with DG using composite endpoints of nausea, abdominal pain, postprandial fullness, bloating. Participants are randomized to RLM 10μg or placebo subcutaneously (SC) twice daily groups. The open-label continuation of treatment will follow participants until RLM becomes commercially available to provide long-term safety information to support the safe use of RLM as a chronic treatment of DG. As seen in Figure 1, participants from the two 12-week studies will rollover into the third study that will continue for 46 weeks. The fourth study will enroll participants that were not randomized in the first two studies because their symptoms were less severe and will also accept new participants. Participants will be randomized 2:1 to RLM 10μg or placebo SC twice daily groups. Participants from the third and fourth studies have the option to enroll in the open-label study. Results Target enrollment is approx. 1800 participants for the 4 global, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies and 1000 participants for the open label study. 700 sites are expected to participate globally; 15 Canadian sites in 6 provinces are participating. Conclusions Canadian centers are actively involved in the PLEDGE trials to help determine the efficacy and safety of RLM, a potential new treatment for DG. This publication increases awareness of the Canadian gastroenterology community, providing an option to refer interested patients to PLEDGE study centers. PLEDGE Studies (NCT03285308, NCT03426345, NCT03420781, NCT03383146, NCT03786380): Placebo-controlled, randomized RLM-MD-01/02/03/04 and open-label study 3071-305-020 to study the safety and efficacy of relamorelin for the treatment of diabetic gastroparesis Funding Agencies None

Studies of Carbamazepine Extended-Release Capsules in Bipolar Disorder

CNS Spectrums ◽  
2005 ◽  
Vol 10 (6) ◽  
pp. 3-5
Author(s):  
Richard H. Weisler
Keyword(s):  
Extended Release ◽  
Rating Scale ◽  
Controlled Trial ◽  
Controlled Study ◽  
Mixed States ◽  
Open Label ◽  
Young Mania ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Bipolar Patients

This discussion reviews data from two 3-week, double-blind, placebo-controlled pivotal trials of carbamazepine extended release capsules (CBZ ERC; SPD417.301 and SPD417.304); pooled results from these trials; data from a 3-week, double-blind, placebo-controlled trial in lithium non-responders or non-tolerators (SPD417.302); and additional supportive data from a 6-month, open-label, extension trial (SPD417.303). In addition, information on a retrospective chart review of 600 adolescent and adult bipolar patients on CBZ ERC is presented.In the first large double-blind, placebo-controlled study assessing CBZ ERC in acute mania, manic and mixed bipolar patients from multiple centers were hospitalized and all medications were discontinued. After reaching a stable baseline 2–5 days later, the patients were randomized to CBZ ERC (n=101; 59% with mixed states) or placebo (n=103; 47% with mixed states) for 3 weeks. An aggressive initial titration schedule was implemented, beginning with 200 mg BID and increased by 200 mg/day until good clinical response was achieved or the patient could not tolerate the dosage. Many patients were taking 1,200–1,600 mg/day by the end of week 1. Efficacy was assessed using the Young Mania Rating Scale (YMRS). The Clinical Global Impressions (CGI) scale and the Hamilton Rating Scale for Depression (HAM-D) were also followed.

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