scholarly journals Efficacy and Safety of Taeeumjowi-tang in Obese Korean Adults: A Double-Blind, Randomized, and Placebo-Controlled Pilot Trial

2013 ◽  
Vol 2013 ◽  
pp. 1-10 ◽  
Author(s):  
Sunju Park ◽  
Won Nahmkoong ◽  
ChunHoo Cheon ◽  
Jeong-Su Park ◽  
Bo-Hyoung Jang ◽  
...  
Keyword(s):  
Body Fat ◽  
Statistical Significance ◽  
Pilot Trial ◽  
Efficacy And Safety ◽  
Initial Weight ◽  
Anthropometric Parameters ◽  
Related Factors ◽  
Double Blind ◽  
Significant Difference ◽  
Fat Composition

Objective. The purpose of this study was to assess the efficacy and safety of Taeeumjowi-tang (TJ001) as well as to estimate obesity-related factors.Methods. This was a 12-week trial with 5 visits. A total of 102 participants of both genders were randomized to either TJ001 (n=57) group or the placebo group (n=55). Subjects were administered 7 g of either TJ001 or placebo 3 times a day. The primary outcome was a rate of subjects who lost 5% or more of initial weight. Secondary outcomes included anthropometric parameters, lipid profiles, and body fat composition.Results. The subject response rate of ≥5% weight loss compared to baseline was similar in both groups, and no statistically significant difference was observed (P=0.87). Changes in anthropometric parameters were greater during the first 4 weeks in the treatment group (P<0.0001). There were no significant changes in both within groups and between groups for lipid profile and body fat composition. No adverse event was reported in either group.Conclusion. Although the difference between the groups regarding a rate of subjects who lost 5% or more of initial weight did not show statistical significance, TJ001 appears to be beneficial in safely controlling weight.

scholarly journals EXPRESS: Efficacy and Safety of Tadalafil in a Pediatric Population with Pulmonary Arterial Hypertension: Phase 3 randomized, Double Blind Placebo-Controlled Study

2021 ◽  
pp. 204589402110249
Author(s):  
David D Ivy ◽  
Damien Bonnet ◽  
Rolf MF Berger ◽  
Gisela Meyer ◽  
Simin Baygani ◽  
...  
Keyword(s):  
Pediatric Patients ◽  
Statistical Significance ◽  
Significance Testing ◽  
Efficacy And Safety ◽  
Phase 3 ◽  
Statistical Significance Testing ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Treatment Groups ◽  
Pulmonary Arterial

Objective: This study evaluated the efficacy and safety of tadalafil in pediatric patients with pulmonary arterial hypertension (PAH). Methods: This phase-3, international, randomized, multicenter (24 weeks double-blind placebo controlled period; 2-year, open-labelled extension period), add-on (patient’s current endothelin receptor antagonist therapy) study included pediatric patients aged <18 years with PAH. Patients received tadalafil 20 mg or 40 mg based on their weight (Heavy-weight: ≥40 kg; Middle-weight: ≥25—<40 kg) or placebo orally QD for 24 weeks. Primary endpoint was change from baseline in 6-minute walk (6MW) distance in patients aged ≥6 years at Week 24. Sample size was amended from 134 to ≥34 patients, due to serious recruitment challenges. Therefore, statistical significance testing was not performed between treatment groups. Results: Patient demographics and baseline characteristics (N=35; tadalafil=17; placebo=18) were comparable between treatment groups; median age was 14.2 years (6.2 to 17.9 years) and majority (71.4%, n=25) of patients were in HW cohort. Least square mean (SE) changes from baseline in 6MW distance at Week 24 was numerically greater with tadalafil versus placebo (60.48 [20.41] vs 36.60 [20.78] meters; placebo-adjusted mean difference [SD] 23.88 [29.11]). Safety of tadalafil treatment was as expected without any new safety concerns. During study period 1, two patients (1 in each group) discontinued due to investigator’s reported clinical worsening, and no deaths were reported. Conclusions: The statistical significance testing was not performed between the treatment groups due to low sample size, however, the study results show positive trend in improvement in non invasive measurements, commonly utilized by clinicians to evaluate the disease status for children with PAH. Safety of tadalafil treatment was as expected without any new safety signals.

Rehydration with a Caffeinated Beverage during the Nonexercise Periods of 3 Consecutive Days of 2-a-Day Practices

2004 ◽  
Vol 14 (4) ◽  
pp. 419-429 ◽  
Author(s):  
Kelly A. Fiala ◽  
Douglas J. Casa ◽  
Melissa W. Roti
Keyword(s):  
Body Fat ◽  
Hydration Status ◽  
Double Blind ◽  
Psychological Measures ◽  
Mild Heat ◽  
Urine Color ◽  
Significant Difference ◽  
Before And After ◽  
Time Point

The purpose of this study was to assess the influence of rehydration with a caffeinated beverage during non exercise periods on hydration status throughout consecutive practices in the heat. Ten (7 women, 3 men) partially heat-acclimated athletes (age 24 ± ly, body fat 19.2 ± 2%, weight 68.4 ± 4.0 kg, height 170 ± 3 cm) completed 3 successive days of 2-a-day practices (2 h/ practice, 4 h/d) in mild heat (WBGT = 23 °C). The 2 trials (double-blind, random, cross-over design) included; 1) caffeine (CAF) rehydrated with Coca-Cola® and 2) caffeine-free (CF) rehydrated with Caffeine-Free Coca-Cola®. Urine and psychological measures were determined before and after each 2-h practice. A significant difference was found for urine color for the post-AM time point, F = 5.526, P = 0.031. No differences were found among other variables (P > 0.05). In summary, there is little evidence to suggest that the use of beverages containing caffeine during non exercise might hinder hydration status.

scholarly journals Evaluation of the efficacy of an appeasing pheromone diffuser product vs placebo for management of feline aggression in multi-cat households: a pilot study

2018 ◽  
Vol 21 (4) ◽  
pp. 293-305 ◽  
Author(s):  
Theresa L DePorter ◽  
David L Bledsoe ◽  
Alexandra Beck ◽  
Elodie Ollivier
Keyword(s):  
Treatment Group ◽  
Positive Reinforcement ◽  
Pilot Trial ◽  
Time Factor ◽  
Educational Training ◽  
Double Blind ◽  
Aggression Score ◽  
Significant Difference ◽  
Full Analysis ◽  
Promising Treatment

Objectives Aggression and social tension among housemate cats is common and puts cats at risk of injury or relinquishment. The aim of this study was to evaluate the effectiveness of a new pheromone product in reducing aggression between housemate cats. Methods A new pheromone product (Feliway Friends) containing a proprietary cat-appeasing pheromone was evaluated for efficacy in reducing aggression between housemate cats via a randomized, double-blind, placebo-controlled pilot trial of 45 multi-cat households (pheromone [n = 20], placebo [n = 25]) reporting aggression for at least 2 weeks. Each household had 2–5 cats. Participants attended an educational training meeting on day (D) –7 and the veterinary behaviorist described behaviors to be monitored for 7 weeks using the Oakland Feline Social Interaction Scale (OFSIS), which assessed the frequency and intensity of 12 representative aggressive interactions. Participants were also provided with instructions for handling aggressive events, including classical conditioning, redirection by positive reinforcement and not punishing or startling the cat for aggressive displays. Punishment techniques were strongly discouraged. Plug-in diffusers with the pheromone product or placebo were utilized from D0–D28. Participants completed a daily diary of aggressive events and weekly OFSIS assessments through to D42. Results Evolution of the OFSIS–Aggression score according to treatment group in the full analysis set population revealed a significant effect on time and treatment group. The OFSIS–Aggression score decreased over time from D0–D28 in both groups (time factor P = 0.0001) with a significant difference in favor of the verum P = 0.06); similar results were found considering the D0–D42 period (time factor P = 0.0001 [D0] and P = 0.04 [D42]). Conclusions and relevance The OFSIS provided a quantifiable measure of the frequency and intensity of 12 intercat interactions reflecting conflict between cats. The cat-appeasing pheromone is a promising treatment for the management of aggression between housemate cats in multi-cat households.

scholarly journals Randomized, placebo-controlled, double-blind, pilot trial to investigate safety and efficacy of Cerebrolysin in patients with aneurysmal subarachnoid hemorrhage

BMC Neurology ◽  
2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Peter Y. M. Woo ◽  
Joanna W. K. Ho ◽  
Natalie M. W. Ko ◽  
Ronald P. T. Li ◽  
Leo Jian ◽  
...  
Keyword(s):  
Subarachnoid Hemorrhage ◽  
Adverse Effects ◽  
Aneurysmal Subarachnoid Hemorrhage ◽  
Pilot Trial ◽  
Delayed Cerebral Ischemia ◽  
Trial Registration ◽  
Study Group ◽  
Double Blind ◽  
Link Type ◽  
Significant Difference

Asbtract Background There are limited neuroprotective treatment options for patients with aneurysmal subarachnoid hemorrhage (SAH). Cerebrolysin, a brain-specific proposed pleiotropic neuroprotective agent, has been suggested to improve global functional outcomes in ischemic stroke. We investigated the efficacy, safety and feasibility of administering Cerebrolysin for SAH patients. Methods This was a prospective, randomized, double-blind, placebo-controlled, single-center, parallel-group pilot study. Fifty patients received either daily Cerebrolysin (30 ml/day) or a placebo (saline) for 14 days (25 patients per study group). The primary endpoint was a favorable Extended Glasgow Outcome Scale (GOSE) of 5 to 8 (moderate disability to good recovery) at six-months. Secondary endpoints included the modified Ranking Scale (mRS), the Montreal Cognitive Assessment (MOCA) score, occurrence of adverse effects and the occurrence of delayed cerebral ischemia (DCI). Results No severe adverse effects or mortality attributable to Cerebrolysin were observed. No significant difference was detected in the proportion of patients with favorable six-month GOSE in either study group (odds ratio (OR): 1.49; 95% confidence interval (CI): 0.43–5.17). Secondary functional outcome measures for favorable six-month recovery i.e. a mRS of 0 to 3 (OR: 3.45; 95% CI 0.79–15.01) were comparable for both groups. Similarly, there was no difference in MOCA neurocognitive performance (p-value: 0.75) and in the incidence of DCI (OR: 0.85 95% CI: 0.28–2.59). Conclusions Use of Cerebrolysin in addition to standard-of-care management of aneurysmal SAH is safe, well tolerated and feasible. However, the neutral results of this trial suggest that it does not improve the six-month global functional performance of patients. Clinical trial registration Name of Registry: ClinicalTrials.gov Trial Registration Number: NCT01787123. Date of Registration: 8th February 2013.

scholarly journals A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for Evaluation of the Efficacy and Safety of DKB114 on Reduction of Uric Acid in Serum

Nutrients ◽  
2020 ◽  
Vol 12 (12) ◽  
pp. 3794
Author(s):  
Yu Hwa Park ◽  
Do Hoon Kim ◽  
Jung Suk Lee ◽  
Hyun Il Jeong ◽  
Kye Wan Lee ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Uric Acid ◽  
Placebo Group ◽  
Serum Uric Acid ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Food Ingredient ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Significant Difference

This study sought to investigate the antihyperuricemia efficacy and safety of DKB114 (a mixture of Chrysanthemum indicum Linn flower extract and Cinnamomum cassia extract) to evaluate its potential as a dietary supplement ingredient. This clinical trial was a randomized, 12-week, double-blind, placebo-controlled study. A total of 80 subjects (40 subjects with an intake of DKB114 and 40 subjects with that of placebo) who had asymptomatic hyperuricemia (7.0–9.0 mg/dL with serum uric acid) was randomly assigned. No significant difference between the DKB114 and placebo groups was observed in the amount of uric acid in serum after six weeks of intake. However, after 12 weeks of intake, the uric acid level in serum of subjects in the DKB114 group decreased by 0.58 ± 0.86 mg/dL and was 7.37 ± 0.92 mg/dL, whereas that in the placebo group decreased by 0.02 ± 0.93 mg/dL and was 7.67 ± 0.89 mg/dL, a significant difference (p = 0.0229). In the analysis of C-reactive protein (CRP) change, after 12 weeks of administration, the DKB114 group showed an increase of 0.05 ± 0.27 mg/dL (p = 0.3187), while the placebo group showed an increase of 0.10 ± 0.21 mg/dL (p = 0.0324), a statistically significant difference (p = 0.0443). In the analysis of amount of change in apoprotein B, after 12 weeks of administration, the DKB114 group decreased by 4.75 ± 16.69 mg/dL (p = 0.1175), and the placebo group increased by 3.13 ± 12.64 mg/dL (p = 0.2187), a statistically significant difference between the administration groups (p = 0.0189). In the clinical pathology test, vital signs and weight measurement, and electrocardiogram test conducted for safety evaluation, no clinically significant difference was found between the ingestion groups, confirming the safety of DKB114. Therefore, it may have potential as a treatment for hyperuricemia and gout. We suggest that DKB114 as a beneficial and safe food ingredient for individuals with high serum uric acid. Trial registration (CRIS.NIH. go. Kr): KCT0002840.

scholarly journals Comparing Therapeutic Efficacy and Safety of Epoetin Beta and Epoetin Alfa in the Treatment of Anemia in End-Stage Renal Disease Hemodialysis Patients

2018 ◽  
Vol 48 (4) ◽  
pp. 251-259 ◽  
Author(s):  
Jalal Azmandian ◽  
Mohammad Reza Abbasi ◽  
Vahid Pourfarziani ◽  
Amir Ahmad Nasiri ◽  
Shahrzad Ossareh ◽  
...  
Keyword(s):  
Body Weight ◽  
Hemodialysis Patients ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Epoetin Alfa ◽  
Double Blind ◽  
Epoetin Beta ◽  
Significant Difference ◽  
The Mean ◽  
Stage Renal Disease

Background: Anemia is one of the most prevalent complications in patients with chronic kidney disease, which is believed to be caused by the insufficient synthesis of erythropoietin by the kidney. This phase III study aimed to compare the efficacy and safety of CinnaPoietin® (epoetin beta, CinnaGen) with Eprex® (epoetin alfa, Janssen Cilag) in the treatment of anemia in ESRD hemodialysis patients. Methods: In this randomized, active-controlled, double-blind, parallel, and non-inferiority trial, patients were randomized to receive either CinnaPoietin® or Eprex® for a 26-week period. The primary endpoints of this study were to assess the mean hemoglobin (Hb) change during the last 4 weeks of treatment from baseline along with the evaluation of the mean weekly epoetin dosage per kilogram of body weight that was necessary to maintain the Hb level within 10–12 g/dL during the last 4 weeks of treatment. As the secondary objective, safety was assessed along with other efficacy endpoints. Results: A total of 156 patients were included in this clinical trial. There was no statistically significant difference between treatment groups regarding the mean Hb change (p = 0.21). In addition, the mean weekly epoetin dosage per kg of body weight for maintaining the Hb level within 10–12 g/dL showed no statistically significant difference between treatment arms (p = 0.63). Moreover, both products had comparable safety profiles. However, the incidence of Hb levels above 13 g/dL was significantly lower in the CinnaPoietin® group. Conclusion: CinnaPoietin® was proved to be non-inferior to Eprex® in the treatment of anemia in ESRD hemodialysis patients. The trial was registered in Clinicaltrials.gov (NCT03408639).

scholarly journals Interesterified Palm Olein (IEPalm) and Interesterified Stearic Acid-Rich Fat Blend (IEStear) Have No Adverse Effects on Insulin Resistance: A Randomized Control Trial

Nutrients ◽  
2018 ◽  
Vol 10 (8) ◽  
pp. 1112 ◽  
Author(s):  
Yen Ng ◽  
Phooi Voon ◽  
Tony Ng ◽  
Verna Lee ◽  
Miskandar Mat Sahri ◽  
...  
Keyword(s):  
Insulin Resistance ◽  
Body Fat ◽  
Palm Olein ◽  
Saturated Fatty Acids ◽  
Metabolic Effects ◽  
Fat Percentage ◽  
Double Blind ◽  
Significant Difference ◽  
Hydrogenated Oils ◽  
Overweight Adult

Chemically-interesterified (CIE) fats are trans-fat free and are increasingly being used as an alternative to hydrogenated oils for food manufacturing industries to optimize their products’ characteristics and nutrient compositions. The metabolic effects of CIE fats on insulin activity, lipids, and adiposity in humans are not well established. We investigated the effects of CIE fats rich in palmitic (C16:0, IEPalm) and stearic (C18:0, IEStear) acids on insulin resistance, serum lipids, apolipoprotein concentrations, and adiposity, using C16:0-rich natural palm olein (NatPO) as the control. We designed a parallel, double-blind clinical trial. Three test fats were used to prepare daily snacks for consumption with a standard background diet over a period of 8 weeks by three groups of a total of 85 healthy, overweight adult volunteers. We measured the outcome variables at weeks 0, 6, and at the endpoint of 8. After 8 weeks, there was no significant difference in surrogate biomarkers of insulin resistance in any of the IE fat diets (IEPalm and IEStear) compared to the NatPO diet. The change in serum triacylglycerol concentrations was significantly lower with the IEStear diet, and the changes in serum leptin and body fat percentages were significantly lower in the NatPO-diet compared to the IEPalm diet. We conclude that diets containing C16:0 and C18:0-rich CIE fats do not affect markers of insulin resistance compared to a natural C16:0-rich fat (NatPO) diet. Higher amounts of saturated fatty acids (SFAs) and longer chain SFAs situated at the sn-1,3 position of the triacylglycerol (TAG) backbones resulted in less weight gain and lower changes in body fat percentage and leptin concentration to those observed in NatPO and IEStear.

Double-Blind Comparison of Maternal Analgesia and Neonatal Neurobehaviour following Intravenous Butorphanol and Meperidine

1979 ◽  
Vol 7 (3) ◽  
pp. 224-230 ◽  
Author(s):  
Robert Hodgkinson ◽  
Robert W Huff ◽  
Robert H Hayashi ◽  
Farkhanda J Husain
Keyword(s):  
Side Effects ◽  
Severe Pain ◽  
Randomized Study ◽  
Analgesic Efficacy ◽  
Foetal Heart Rate ◽  
Efficacy And Safety ◽  
Cervical Dilation ◽  
Double Blind ◽  
Significant Difference ◽  
Blind Comparison

Butorphanol (1 mg and 2 mg) and meperidine (40 mg and 80 mg), given intravenously, were evaluated for analgesic efficacy and safety in a double-blind randomized study employing 200 consenting pre-partum patients in moderate to severe pain during the late first stage of labour. Both drugs provided adequate relief of pain to the mothers. There was no significant difference in the rate of cervical dilation, the foetal heart rate, the Apgar score, pain relief or neonatal neurobehavioural scores between those receiving butorphanol and those receiving meperidine. Twenty-two mothers who received butorphanol and eleven who received meperidine nursed their infants with no adverse effects observed. Side-effects were generally infrequent in this study; however, more side-effects were reported by the patients and observed by the investigator in the meperidine-treated cases (13%) than in the cases treated with butorphanol (2%).

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