scholarly journals The use of drug based on technologically processed antibodies to endocannabinoid receptor type 1 in the treatment of obesity in adults: results of a multicenter double blind placebo controlled randomized clinical trial

2021 ◽  
Vol 93 (8) ◽  
pp. 904-915
Author(s):  
Tatiana Y. Demidova ◽  
Elena I. Krasil’nikova ◽  
Sergey V. Vorob’ev ◽  
Tatiana V. Morugova ◽  
Tatiana V. Adasheva
Keyword(s):  
Clinical Trial ◽  
Body Weight ◽  
Waist Circumference ◽  
Clinical Efficacy ◽  
Double Blind ◽  
Average Decrease ◽  
Treatment Regimens ◽  
Class 1 ◽  
Treatment Of Obesity ◽  
Weight Decrease

Aim. To evaluate the clinical efficacy and safety of Dietressa at a dose of 6 tablets per day for 24 weeks in the treatment of patients with Class 1 obesity. To compare the clinical efficacy of two treatment regimens (1 tablet 6 times per day and 2 tablets 3 times per day) for 24 weeks in the treatment of patients with Class 1 obesity. Materials and methods. A clinical trial included 493 patients with Class 1 obesity from 18 to 65 years. The proportion of patients who lose greater than or equal to 5 percent of baseline body weight, an average decrease of body weight, a change in waist circumference, dynamics of the quality of life, and the safety of the therapy were assessed. Results. A weight decrease was established among patients without regard to the studied regimens of Dietressa (in a daily dose of 6 tablets with a six- or three-time intake). The goals were achieved by 49% [53%] of patients in the first treatment regimen (statistically significant compared to placebo therapy: p=0.04) [р=0.018]), 48% (51%) in the second (p=0.004 [р=0.0004]) and 48% [52%] of patients in the combined Dietressa group (p=0.0007 [р0.0001]). The average absolute weight loss was -4.44.2 [-4.84.2] kg in the Dietressa-1 group (p=0.0001 [р0.0001]) and -4.44.4 [-4.74.4] kg in the Dietressa-2 group (p0.0001) [р0.0001]). Against the background of the conducted therapy mental component was improved on week 4 (p0.0001) and 24 (p=0.006) as well as parameter of physical health on week 4 (p=0,003) and 12 (p=0,006). Waist circumference significantly decreased every 4 weeks in patients receiving Dietressa (p0.0001 for three comparisons between weeks). A 6-month course of Dietressa therapy demonstrated a favorable safety profile. The frequency of adverse events had no significant differences between Dietressa and Placebo groups. Conclusion. The monotherapy with Dietressa is safe, and it leads to at least 5 percent reduction in body weight during 24 weeks of therapy in patients with Class 1 obesity.

scholarly journals The effects of steamed ginger ethanolic extract on weight and body fat loss: a randomized, double-blind, placebo-controlled clinical trial

2019 ◽  
Vol 29 (2) ◽  
pp. 265-273 ◽  
Author(s):  
Soo-Hyun Park ◽  
Su-Jin Jung ◽  
Eun-Kyung Choi ◽  
Ki-Chan Ha ◽  
Hyang-Im Baek ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Body Mass Index ◽  
Body Weight ◽  
Body Mass ◽  
Body Fat ◽  
Ethanolic Extract ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Fat Loss

Abstract Steamed ginger ethanolic extract (SGE) is a product with a high 6-shogaol contents and is thought to be more potent than other ginger products. We conducted a 12-week, randomized, double-blind, placebo-controlled clinical trial to determine the effects of SGE on weight and body fat loss. Eighty healthy obese participants were recruited and randomly divided into the SGE and placebo groups. The outcome measures comprised indicators of efficacy (body weight, body mass index, body composition, and blood markers) and safety. Following the supplementation period, mean body weight, body mass index, and body fat level were significantly lower in the SGE group than in the placebo group. No clinically significant changes were observed for any safety parameter. These results suggest that SGE is a potent anti-obesity agent that does not cause significant side effects. Therefore, SGE supplementation combined with lifestyle modification could be effective in the management of body weight and fat mass.

scholarly journals Zinc supplementation improves body weight management, inflammatory biomarkers and insulin resistance in individuals with obesity: a randomized, placebo-controlled, double-blind trial

2019 ◽  
Vol 11 (1) ◽  
Author(s):  
Hoda Khorsandi ◽  
Omid Nikpayam ◽  
Reyhaneh Yousefi ◽  
Maryam Parandoosh ◽  
Nima Hosseinzadeh ◽  
...  
Keyword(s):  
Insulin Resistance ◽  
Clinical Trial ◽  
Body Weight ◽  
Placebo Group ◽  
Zinc Supplementation ◽  
Energy Requirement ◽  
Anthropometric Measurements ◽  
Model Assessment ◽  
Double Blind ◽  
Calorie Diet

Abstract Background The present study was designed to determine whether zinc supplementation would increase the effects of restricted calorie diet (RCD) on obesity. Methods and materials A randomized, double-blind clinical trial was performed on 40 obese subjects who were randomly assigned to receive zinc supplements (30 mg/day) or placebo for a period of 15-weeks. Both groups were under a restricted calorie diet (~ 300 kcal lower than the estimated energy requirement). Anthropometric measurements, biochemical markers, appetite, and dietary intakes were determined during the study period. Results The reductions of body weight, body mass index, waist circumference, and hip circumference were significantly higher in the zinc group compared to the placebo group (P = 0.032, 0.025, 0.003, and 0.0001, respectively). Lower levels of high sensitivity C-reactive protein, apelin, homeostatic model assessment of insulin resistance (HOMA-IR), and appetite score were observed in the zinc group in comparison with the placebo group (P = 0.0001, 0.001, 0.031 and 0.001 respectively). Conclusion This study indicates that Zn supplementation with a restricted calorie diet has favorable effects in reducing anthropometric measurements, inflammatory markers, insulin resistance and appetite in individuals with obesity, and may play an effective role in the treatment of obesity. Trial registration This clinical trial was registered at clinicaltrials.gov at the U.S. National Library of Medicine (NCT02516475).

Clinical efficacy of milbemycin oxime in the treatment of nasal mite infection in dogs

1999 ◽  
Vol 35 (1) ◽  
pp. 81-84 ◽  
Author(s):  
LK Gunnarsson ◽  
LC Moller ◽  
AM Einarsson ◽  
G Zakrisson ◽  
BG Hagman ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Body Weight ◽  
Clinical Efficacy ◽  
Clinical Signs ◽  
Caninum Infection ◽  
Milbemycin Oxime

A multicentric clinical trial was done to evaluate the clinical efficacy of milbemycin oxime in the treatment of nasal mite (Pneumonyssoides caninum) infection in dogs. Milbemycin oxime was given to 70 dogs of different breeds, genders, and ages, with clinical signs associated with nasal mite infection. Twenty-five dogs had a verified infection, and 45 dogs had signs suggestive of nasal mite infection. Milbemycin oxime was given at the dosage of 0.5 to 1.0 mg/kg body weight orally once a week for three consecutive weeks. One month after initiation of treatment, 68 of the dogs had no more clinical signs associated with nasal mite infection.

Maprotiline (Ludiomil) and Imipramine in Depressed In-Patients: A Controlled Study

1975 ◽  
Vol 3 (6) ◽  
pp. 413-416 ◽  
Author(s):  
W Rieger ◽  
K Rickels ◽  
N Norstad ◽  
J Johnson
Keyword(s):  
Clinical Trial ◽  
Side Effects ◽  
Clinical Efficacy ◽  
Hospitalized Patients ◽  
Strong Tendency ◽  
Controlled Study ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Double Blind ◽  
Randomized Controlled

In this double-blind, randomized, controlled clinical trial of maprotiline ( Ludiomil) against imipramine involving twenty-five newly admitted hospitalized patients, a strong tendency in favour of maprotiline over imipramine emerged. Improvement occurred faster and also at treatment end-point the trend in favour of maprotiline was still to be seen. The slight superiority in clinical efficacy of maprotiline over imipramine was present in both physician and patient measures. Incidences of side-effects were slightly lower for maprotiline than for imipramine.

scholarly journals Six-Month Treatment of Obesity with Sibutramine 15 mg; A Double-Blind, Placebo-Controlled Monocenter Clinical Trial in a Hispanic Population

2000 ◽  
Vol 8 (1) ◽  
pp. 71-82 ◽  
Author(s):  
Guillermina Elisa Martínez Cuellar ◽  
Alberto Martínez Ruiz ◽  
Maria Cristina Revilla Monsalve ◽  
Arturo Berber
Keyword(s):  
Clinical Trial ◽  
Hispanic Population ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Treatment Of Obesity

scholarly journals Comparison of the effect of polyethylene glycol and simultaneous administration of polyethylene glycol with probiotics in the treatment of chronic functional constipation: a clinical trial

2020 ◽  
Vol 22 (3) ◽  
pp. 135-140
Author(s):  
Karamali Kasiri ◽  
Morteza Sedehi ◽  
Sheida Mortazavi
Keyword(s):  
Clinical Trial ◽  
Body Weight ◽  
Polyethylene Glycol ◽  
Lactobacillus Rhamnosus ◽  
Functional Constipation ◽  
Water Soluble ◽  
Fecal Excretion ◽  
Simultaneous Administration ◽  
Double Blind ◽  
Significant Difference

Background and aims: Constipation is one of the most common issues in pediatrics. The aim of this study was to compare the effect of polyethylene glycol and the simultaneous administration of polyethylene glycol along with probiotics in the treatment of chronic functional constipation. Materials and Methods: In this randomized double-blind clinical trial, 150 children with chronic functional constipation referred to Imam Ali Clinic affiliated with Shahrekord University of Medical Sciences from 2017 to 2018 were included. The first group (A) consumed 1 g/ kg of body weight per day of water-soluble polyethylene glycol powder and the second group (B) consumed a probiotic powder and 1 g/kg of body weight of the water-soluble polyethylene glycol powder daily. In weeks 0, 1, and 2, questionnaires were filled out by the parents of the children and the data were analyzed. Results: The results showed that there was no significant difference in any of the variables between groups A and B (P=0.07) including the frequency of fecal excretion in week 1 (77% and 71%) and week 2 (4% and 5.4%) and stool consistency in week 1 (4% and 6.7%) and week 2 (86.7% and 92%). Moreover, there was no significant difference between groups A and B in any of the variables frequency of painful excretion in week 1 (74% and 73%, respectively) and week 2 (5.3% and 4%, respectively), frequency of abdominal pain in week 1 (61.3% and 49.3%, respectively) and week 2 (4% and 5.3%, respectively), and the frequency of fecal incontinence in week 1 (22.77% and 18.7%, respectively) and week 2 (6.7% and 1.3%) (P>0.05, respectively). Conclusion: Our results indicated that the administration of probiotic supplement (Lactobacillus Rhamnosus, Lactobacillus acidophilus, Lactobacillous Bulgaricus) has no effect on the improvement of symptoms in children with chronic constipation.

scholarly journals Study protocol for the use of photobiomodulation with red or infrared LED on waist circumference reduction: a randomised, double-blind clinical trial

BMJ Open ◽  
2020 ◽  
Vol 10 (8) ◽  
pp. e036684
Author(s):  
Marcelo Marreira ◽  
Lidiane Rocha Mota ◽  
Daniela Fátima Teixeira Silva ◽  
Christiane Pavani
Keyword(s):  
Clinical Trial ◽  
Adipose Tissue ◽  
Waist Circumference ◽  
Lipid Profile ◽  
Body Contouring ◽  
Double Blind ◽  
Related Field ◽  
Long Term Follow Up ◽  
Registration Number ◽  
Group B

IntroductionThe search for non-invasive procedures to reduce localised adiposity in aesthetics clinics has recently been increasing. In this context, procedures, such as cryolipolysis, ultracavitation, photobiomodulation (PBM) and other techniques have been proposed. Some studies have shown that PBM can be used in body contouring. However, there is no standardisation of the protocol. More than that, as in other techniques for reducing adipose tissue, the availability of triacylglycerol may affect the lipid profile in the blood, bringing consequences to the general health of an individual. This work will aim to compare the light wavelengths when using PBM as a technique for reducing the abdominal waist circumference, while also evaluating the efficacy of the method. Changes in the lipid profile in the blood, with a long-term follow-up, will also be appraised.Methods and analysisThis will be a controlled, randomised, double-blind, single-centred clinical trial. 174 patients will be recruited at the Nove de Julho University, Brazil, and then divided into three groups: Group A—RED PBM; Group B—INFRARED PBM; Group C—PLACEBO (Sham) treatment. The treatments will consist of eight sessions, two times a week, for 4 weeks. At each session, the participants will receive 30 minutes PBM (using a radiant exposure of 127 J/cm2), with an abdominal strap containing 4 LED clusters, with 72 devices each, following the indication of randomisation. All of the groups will receive 30 min of Aussie Current, at 4 kHz, modulated at 10 Hz, 40–60 mA. The main outcome of this study will be waist circumference reduction. The secondary variables will be anthropometric data, lipid profile, liver function and adipose tissue thickness, changes in the local microcirculation, and the quality of life and self-esteem. The analyses will be performed at four stages of the research, D0, end of the eighth session (D30), 15 days after the last session (FU15), 90 days after the last session (FU90) and 180 days after the last session (FU180).Ethics and disseminationThe Ethics Committee of the Nove de Julho University, Brazil, approved the modified version of this project under No. 3414146 on 26 June 2019. This study is not yet recruiting. The results obtained will be published in a peer-reviewed journal in the related field.Trial registration numberBrazilian Registry of Clinical Trials—ReBec (RBR-9bwxcx).

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