A Non-Amphetamine Anorectic Agent: Preclinical Background and a Double-Blind Clinical Trial

1975 ◽  
Vol 3 (5) ◽  
pp. 328-332 ◽  
Author(s):  
Louis N Schwartz
Keyword(s):  
Clinical Trial ◽  
Weight Loss ◽  
Adverse Effects ◽  
Clinical Evaluation ◽  
Comparative Trial ◽  
Obese Patients ◽  
Double Blind ◽  
Once Daily ◽  
Double Blind Clinical Trial ◽  
Anorectic Agent

Preclinical data suggesting potential advantages for mazindol prompted the design of a double-blind comparative trial with 60 obese patients. In it, mazindol, 2 mg once a day, was compared for 12 weeks to placebo. Weight loss was significantly greater with mazindol than placebo throughout the trial. After the 12 weeks, the mazindol patients had lost an average of 18.5 lbs compared to 2.4 lbs with placebo. Constant efficacy at the fixed once-daily dosage was obtained with no signs of tolerance. No significant adverse effects or other signs of toxicity to mazindol were encountered. Extensive clinical evaluation of this drug in relation to the established anorectics is strongly recommended.

scholarly journals Effectiveness and Adverse Effects of Tranexamic Acid in Bleeding during Adenotonsillectomy: A Randomized, Controlled, Double-blind Clinical Trial

2021 ◽  
Author(s):  
Marco Aurélio Fornazieri ◽  
Henrique Kazuo Lima Kubo ◽  
Lisandra Coneglian de Farias ◽  
Adriano Morita Fernandes da Silva ◽  
Ellen Cristine Duarte Garcia ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Effects ◽  
Tranexamic Acid ◽  
Postoperative Bleeding ◽  
Group Versus ◽  
Double Blind ◽  
Randomized Controlled ◽  
Bleeding Volume ◽  
Double Blind Clinical Trial ◽  
To Receive

Abstract Introduction Intra and postoperative bleeding are the most frequent and feared complications in adenotonsillectomy (AT). Tranexamic acid (TXA), which is known for its antifibrinolytic effects, has a proven benefit in reducing bleeding in hemorrhagic trauma and cardiac surgery; however, the effectiveness and timing of its application in AT have not yet been established. Objectives We aimed to evaluate the efficacy of TXA in controlling bleeding during and after AT and assess its possible adverse effects in children. Methods The present randomized, controlled, double-blind clinical trial included 63 children aged 2 to 12 years. They were randomly assigned to receive either intravenous TXA (10 mg/kg) or placebo 10 minutes before surgery. The volume of intraoperative bleeding, presence of postoperative bleeding, and adverse effects during and 8 hours after the surgery were assessed. Results No difference in bleeding volume was noted between the 2 groups (mean, 122.7 ml in the TXA group versus 115.5 ml in the placebo group, p = 0.36). No intraoperative or postoperative adverse effects were noted because of TXA use. Furthermore, no primary or secondary postoperative bleeding was observed in any of the participants. Conclusion In our pediatric sample, TXA (10 mg/kg) administration before AT was safely used, without any adverse effects. It did not reduce the bleeding volume in children during this type of surgery. Future studies should assess the use of higher doses of TXA and its administration at other time points before or during surgery.

Effect of Fenticonazole Spray in Cutaneous Mycosis: A Double-Blind Clinical Trial versus Cyclopyroxolamine Spray

1990 ◽  
Vol 18 (1) ◽  
pp. 61-67 ◽  
Author(s):  
P. Altmeyer ◽  
S. Nolting ◽  
A. Kuhlwein ◽  
E. Colli ◽  
M. Scatigna
Keyword(s):  
Clinical Trial ◽  
Side Effects ◽  
Clinical Improvement ◽  
Double Blind ◽  
Once Daily ◽  
Treatment Groups ◽  
Double Blind Clinical Trial ◽  
Cutaneous Mycosis ◽  
Drug Free ◽  
Microscopic Findings

A double-blind clinical trial was performed to evaluate efficacy and tolerance of once-daily 2% fenticonazole compared with 1% cyclopyroxolamine spray applied for 2–4 weeks in 100 patients with cutaneous mycotic lesions. After treatment lasting 21.9 ± 6.7 or 22.5 ± 6.2 days, respectively, patients receiving fenticonazole or cyclopyroxolamine had negative microscopic findings and cultures were sterile. Comparable clinical improvement was observed in both treatment groups, with 91.8% and 89.8% of patients, respectively, receiving fenticonazole or cyclopyroxolamine being evaluated as cured or greatly improved. Following a drug-free period, the clinical evaluation of nine (20.9%) patients treated with fenticonazole and 14 (30.4%) treated with cyclopyroxolamine worsened. The incidence of side-effects was low; only one patient withdrew from treatment because of a slight itch. It is suggested that fenticonazole and cyclopyroxolamine are equally effective in eradicating cutaneous mycoses and that their efficacy and tolerance are comparable.

scholarly journals Comparing the Efficacy of Dermolina-Henna Cream with Mometasone Cream in Improving Radiodermatitis Amongst Patients with Breast Cancer: A Randomized Active-control Double-blind Clinical Trial

2021 ◽  
Author(s):  
Mehdi Pasalar ◽  
Bahareh Ahadi ◽  
Hamid Reza Mirzaei ◽  
Judith Buentzel ◽  
Mojgan Mehri Ardestani ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Active Control ◽  
Radiation Therapy Oncology Group ◽  
Burning Sensation ◽  
Breast Cancer Patients ◽  
Double Blind ◽  
Once Daily ◽  
Double Blind Clinical Trial ◽  
High Prevalence

Abstract Purpose: Acute radiodermatitis is one of radiotherapy most common complications. Despite the high prevalence of radiodermatitis, few studies investigated how to prevent or treat this complication. Hence, any standard treatment has not been introduced so far. We sought to evaluate the efficacy of Dermolina-Henna cream, a new polyherbal formulation, compared to Mometasone cream for alleviating radiodermatitis amongst breast cancer patients. Methods: Women over 18 years of age with breast cancer undergoing radiotherapy were included in this double-blind active-control randomized clinical trial. A total of 93 eligible patients was randomly divided into the Dermolina-Henna and Mometasone groups. Patients were instructed to apply a thin layer of each cream once daily on their lesions at least 3 hours after radiotherapy for 4 weeks, and if grade I or II radiodermatitis developed, also afterward. Patients were visited weekly until end of study at after 4 weeks. RTOG (Radiation Therapy Oncology Group) standard questionnaires were evaluated and recorded every week as the primary outcome.Results: The trends on decrease in number of lesions, erythema, radiodermatitis grade, burning sensation, pain, and itchiness were statistically significant for each treatment, separately (P<0.001), except for radiodermatitis grade in Mometasone group (P=0.4). Dermolina-Henna was significantly better than Mometasone in alleviating burning sensation (P<0.001) and itchiness (P=0.041).Conclusion: In summary, we showed that Dermolina-Henna cream and Mometasone cream were significantly effective in decreasing severity of radiodermatitis symptoms amongst patients with breast cancer. Dermolina-Henna cream was significantly superior to Mometasone cream in alleviating burning and itchiness. IRCT20200115046144N1, 2020-03-04, retrospectively registered.

Effects of Dose Titration on Dipyridamole-Induced Headache: A Randomized, Double-Blind Clinical Trial

2022 ◽  
pp. 1-6
Author(s):  
Min Kyoung Kang ◽  
Jae-Kwan Cha ◽  
Dae-il Chang ◽  
Hyun Young Kim ◽  
Jong-Won Chung ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Ischemic Stroke ◽  
Primary Endpoint ◽  
Dose Titration ◽  
Control Group ◽  
Standard Group ◽  
Double Blind ◽  
Once Daily ◽  
Double Blind Clinical Trial ◽  
Ischemic Attack

<b><i>Purpose:</i></b> The aim of this study is to investigate the effect of gradual dipyridamole titration and the incidence of dipyridamole-induced headache in patients with ischemic stroke or transient ischemic attack (TIA). <b><i>Methods:</i></b> A randomized, double-blind, double-placebo, parallel group, phase 4 clinical trial (KCT0005457) was conducted between July 1, 2019, and February 25, 2020, at 15 medical centers in South Korea. The study included patients aged &#x3e;19 years diagnosed with a noncardioembolic ischemic stroke or TIA within the previous 3 weeks. The participants were randomized 1:1:1 to receive Adinox® (aspirin 25 mg/dipyridamole 200 mg) and aspirin (100 mg) once daily for the first 2 weeks followed by Adinox® twice daily for 2 weeks (titration group), Adinox® twice daily for 4 weeks (standard group), and aspirin 100 mg once daily for 4 weeks (control group). The primary endpoint was incidence of headache over 4 weeks. The key secondary endpoint was mean cumulative headache. <b><i>Results:</i></b> Ninety-six patients were randomized into the titration (<i>n</i> = 31), standard (<i>n</i> = 32), and control (<i>n</i> = 33) groups. The titration and standard groups (74.1% vs. 74.2%, respectively) showed no difference in the primary endpoint. However, the mean cumulated headache was significantly lower in the titration group than in the standard group (0.31 ± 0.46 vs. 0.58 ± 0.51, <i>p</i> = 0.023). Further, adverse drug reactions were more common in the standard group than in the titration group (28.1% vs. 9.7%, respectively, <i>p</i> = 0.054), although not significantly different. <b><i>Conclusion:</i></b> The titration strategy was effective in lowering the incidence of cumulative dipyridamole-induced headache.

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