Glimepiride monotherapy versus combination of glimepiride and linagliptin therapy in patients with HNF1A-diabetes: a protocol for a randomised, double-blinded, placebo-controlled trial by Torben Hansen, Tina Vilsbøll, Filip Krag Knop, Alexander Sidelmann Christensen, Heidi Storgaard, Sofie Hædersdal

“…The primary end point is the absolute difference in the mean amplitude of glycaemic excursions between the two treatments (glimepiride+linagliptin vs glimepiride+placebo) at the end of each treatment period.Ethics and dissemination The study protocol is approved by the Danish Medicines Agency, The Scientific-Ethical Committee of the Capital Region of Denmark (H-17014518) and the Danish Data Protection Agency. …”
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The effect of probiotic-fortified kefir on depression, appetite, oxidative stress, and inflammatory parameters in Iranian overweight and obese elderly: a randomized, double-blind, placebo-controlled clinical trial by Mehran Noori, Zainab Shateri, Siavash Babajafari, Mohammad Hadi Eskandari, Karim Parastouei, Mohammad Ghasemi, Hoseein Afshari, Mohammad Samadi

“…Methods This study was a double-blind, randomized, and placebo-controlled clinical trial conducted on 67 elderly men aged over 65, who were randomly divided into two groups. …”
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Commentary: The immediate pain relief of low-level laser therapy for burning mouth syndrome: a retrospective study of 94 cases by Takayuki Suga, Akira Toyofuku

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Psilocybin-assisted therapy for reducing alcohol intake in patients with alcohol use disorder: protocol for a randomised, double-blinded, placebo-controlled 12-week clinical trial (The QUANTUM Trip Trial) by Claus Thorn Ekstrøm, Patrick MacDonald Fisher, Gitte Moos Knudsen, Dea Siggaard Stenbæk, Anders Fink-Jensen, Mathias Ebbesen Jensen, Tobias Søgaard Juul

“…However, the efficacy of a single psilocybin administration and its potential neurobiological underpinnings still remain unknown.Methods and analysis To establish efficacy, we will investigate the effects of psilocybin-assisted therapy versus placebo in a randomised, double-blinded, placebo-controlled 12-week clinical trial. …”
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A randomized, double-blind, Phase 1, single- and multiple-dose placebo-controlled study of the safety and pharmacokinetics of IN-006, an inhaled antibody treatment for COVID-19 in healthy volunteersResearch in context by Thomas R. Moench, Lakshmi Botta, Brian Farrer, Jason D. Lickliter, Hyunah Kang, Yoona Park, Cheolmin Kim, Marshall Hoke, Miles Brennan, Morgan D. McSweeney, Zachary Richardson, John B. Whelan, Jong Moon Cho, Soo Young Lee, Frances Faurot, Jeff Hutchins, Samuel K. Lai

“…Study staff and participants were blinded to treatment assignment, except for pharmacy staff preparing the study drug. The ratio of active:placebo randomization to each cohort was set at 3:1. …”
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Technologically-Treated Polyclonal Affinity-Purified Antibodies to the Tumor Necrosis Factor-α, Brain Specific S-100 Protein and Histamine in Treatment of Functional Dyspepsia: Results of the Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial by Yu. O. Shulpekova, I. V. Maev, V. B. Grinevich, I. B. Khlynov, Yu. G. Shvarts, V. T. Ivashkin

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Phase II randomised, double-blind, placebo-controlled trial to assess the efficacy and safety of MLC1501 in patients with stroke: the MLC1501 study Assessing Efficacy in post-STrOke Subjects with mOtor deficits (MAESTOSO) study protocol by Narayanaswamy Venketasubramanian, Deidre Anne De Silva, Christopher P L H Chen, Cyrus G Escabillas, John Harold Hiyadan, Johnny K Lokin, Romulo U Esagunde, Joel M Advincula, Christian Oliver C Co, Maria Epifania V Collantes, Annabelle Y Lao, Yeow-Hoay Koh, Carol Huilian Tham

“…Background MLC1501, consisting of four herbs, that is, Radix Astragali, Radix Angelicae sinensis, Rhizoma Chuanxiong, Radix Polygalae, has the same pharmacological properties as its precursors MLC601 and MLC901 which contain extracts of nine herbs and showed neuroprotective, anti-inflammatory and neurorestorative properties in non-clinical models, as well as clinical benefits in improving functional and neurological recovery after brain injuries.Aims To determine the efficacy of MLC1501 on motor recovery as measured by Fugl-Meyer motor Assessment (FMA) total score at 24 weeks in patients with ischaemic stroke (IS).Design A total of 300 patients aged >18 years, diagnosed with IS in the prior 2–10 days, with National Institute of Health Stroke Scale (NIHSS) total score of 8–18 and a combined score of ≥3 on NIHSS motor items 5A, 5B, 6A and/or 6B, will be randomised in a 1:1:1 ratio to receive oral placebo, MLC1501 low dose or MLC1501 high dose for 6 months. …”
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Efficacy and safety of glycyrrhizic acid and essential phospholipids (Phosphogliv) combination for alcoholic liver disease: results of the double-blind randomized placebo-controlled multicenter post-registration (phase IV) clinical trial «Jaguar» (PHG-M2/P03-12) by I. G. Bakulin, N. A. Bokhan, P. O. Bogomolov, N. I. Geyvandova, M. V. Matsiyevich, M. A. Vinnikova, V. G. Morozov, O. M. Khromtsova, G. S. Soldatova, O. Yu. Shiryayev, R. D. Ilyuk, K. V. Rybakova, A. G. Katkovskaya, S. V. Teplykh, A. A. Bagretsova, M. V. Krasnova, Ye. V. Alekseyeva, A. V. Anipchenko, Ye. V. Baskakov

“…Patients of the control group (group B) received placebo in the same regimen. The dynamics of serum alanine transaminase (ALT), aspartate transaminase (AST), liver scores by noninvasive FibroMax test was applied to assess the treatment efficacy and safety, along with change in quality of life of patients. …”
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Efficacy and safety of glycyrrhizic acid combined to essential phospholipids (Phosphogliv) at non-alcoholic fatty liver disease: results of multicenter double blind randomized placebo-controlled post-registration clinical study (IV phase) «Gepard» (PHG-M2/P02-12) by V. T. Ivashkin, I. G. Bakulin, P. O. Bogomolov, M. V. Matsiyevich, N. I. Geyvandova, P. V. Koroy, S. V. Nedogoda, O. A. Sablin, L. G. Lenskaya, Ye. V. Beloborodova, A. A. Bagretsova, R. A. Abdulkhakov, M. F. Osipenko, I. V. Osipova, D. A. Pocheptsov, Ye. V. Chumachek, O. M. Khromtsova, Ye. V. Kuzmicheva

“…The basic group patients received Phosphogliv 5 mg/day as intravenous bolus injection for 2 weeks, followed by oral intake of 2 capsules t.i.d. for 10 weeks (the total treatment duration was 12 weeks), control group patients received placebo in the same mode. Serum levels of inflammatory marker adiponectin, NAFLD fibrosis score, treatment effect on quality of life and safety of patients were monitored. …”
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Metformin increases mammographic breast density: a randomized controlled trial by Sadaf Alipour, Ladan Hosseini, Zohreh Forootan, Hadith Rastad, Leila Bayani, Mahboubeh Abedi, Bita Eslami

“…Methods A double-blind, placebo-controlled study was performed. A total of 151 premenopausal women received 500 mg metformin tablets twice a day for 6 months, or a placebo, were included. …”
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A systematic review and meta-analysis assessing adverse event profile and tolerability of nicergoline by Amit Garg, Jun Xu, Mario Fioravanti, Taku Nakashima

“…Objective To evaluate the safety profile of nicergoline compared with placebo and other active agents from published randomised controlled trials.Design Systematic review and meta-analysis of nicergoline compared with placebo and other active agents across various indications.Data sources MEDLINE, Medline-in-process, Cochrane, EMBASE, EMBASE alerts, Cochrane Central Register of Controlled Trials (CENTRAL), Cochrane Database of Systematic Reviews (CDSR) and Cochrane Methodology Register (CMR) for all the randomised controlled trials, open-label or blinded, in adults treated with nicergoline. …”
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Impact of topical cetylated fatty acid cream on hand osteoarthritis: a randomized, double-blind clinical trial by Sitthiphong Suwannaphisit, Nitiphoom Sinnathakorn, Pormes Suwanno, Warangkana Fongsri, Boonsin Tangtrakulwanich

“…Additionally, adverse reactions were reported by two patients in the placebo group, whereas no such reports were documented in the CFA group. …”
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Methods to address functional unblinding of raters in CNS trials by Steven D. Targum, William P. Horan, Vicki G. Davis, Alan Breier, Stephen K. Brannan

“…Both site-based and remote PANSS scores yielded significant improvement favouring xanomeline/trospium over placebo (both p < 0.0001) and yielded significantly greater treatment response (≥30% improvement from baseline) than placebo (both p < 0.0001). …”
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Annual Zoledronic Acid for the Treatment of Osteoporosis: A Randomized Controlled Trial by Asif Hussain, Sushil Kumar Saini, Jaydeep Patel, Chandra Prakash Pal, Hemant Singh Chahar, Rohit Yadav

“…Results: The primary outcome was reduced by 79% during the 1-year period in zoledronic acid, compared to placebo (3% in the treatment group vs. 14% in the placebo group; relative risk (RR): 0.21; 95% confidence interval [CI]: 0.06–0.72, P = 0.01). …”
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Short-term outcomes of oropharyngeal administration of colostrum in preterm neonates: a double-blind placebocontrolled randomized trial by Ameneh Lamsehchi, Maryam Shokouhi Solgi, Mohammad Kazem Sabzehei, Behnaz Basiri, Elahe Talebi Ghane, Kiana Kimiaei Asadi, Sina Azadnajafabad

“…Methods We performed this 2-arm, double-blind, placebo-controlled randomized trial at a tertiary neonatal center in Iran in 2021–2023. …”
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Beta-hydroxy-beta-methylbutyrate (HMB) improves daily activity and whole-body protein metabolism in Duchenne muscular dystrophy dogs: a pilot study by Peter P. Nghiem, Alexis M. Rutledge, Kyle Tehas, Corine Kaderli, Meredith Poling, Sidney Arnim, Vitaliy Dernov, Celine van Sas, Macie L. Mackey, Gabriella A. M. ten Have, Mariëlle P. K. J. Engelen, Nicolaas E. P. Deutz

“…Six DMD dogs were administered 3 g daily of HMB or placebo for 28 days according to a randomized, placebo-controlled, double-blinded crossover design. …”
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Effects of macitentan and selexipag across prognostic age groups in patients with pulmonary arterial hypertension by Richard Channick, MD, Sarah Medrek, MD, Marion Delcroix, MD, Sean Gaine, MD, Pavel Jansa, MD, PhD, Irene Lang, MD, Vallerie McLaughlin, MD, Sanjay Mehta, MD, Tomas Pulido, MD, Bhagavatula Sastry, MD, Rogerio Souza, MD, PhD, Adam Torbicki, MD, Carol Zhao, MS, Paul Strachan, MD, Peter Agron, PhD, Joseph Yen, PhD, Olivier Sitbon, MD, PhD

“…This analysis defined age thresholds differentiating M/M risk in patients randomized to placebo (Cox regression determining treatment effect by age). …”
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A Systematic Literature Review and Bucher Indirect Comparison: Tildrakizumab versus Guselkumab by Kristian Garn Du Jardin, Pepi Hurtado Lopez, Mette Lange, Rachael McCool, Silvia Maeso Naval, Sandra Quickert

“…Limitations included the limited number of publications, imputation of placebo arm values for Weeks 24 to 28, and limited relevance of the Japanese study. …”
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Efficacy and safety of everolimus for patients with focal cortical dysplasia type 2 by Se Hee Kim, Hoon‐Chul Kang, Yun Ho Roh, Jongsung Hahn, Kyung Lok Min, Seok‐Jin Lee, Donghwa Yang, Han Som Choi, Soyoung Park, Jeong Ho Lee, Sang‐Guk Lee, Se Hoon Kim, Min Jung Chang, Heung Dong Kim

“…Patients received everolimus or placebo in a blinded manner during core phase I, with crossover to the alternate treatment in core phase II. …”
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Effect of zinc added to a daily small-quantity lipid-based nutrient supplement on diarrhoea, malaria, fever and respiratory infections in young children in rural Burkina Faso: a cl... by Elizabeth Yakes Jimenez, Sonja Y Hess, Souheila Abbeddou, Kenneth H Brown, Jean-Bosco Ouedraogo, Jérôme W Somé, Zinéwendé P Ouédraogo, Rosemonde M Guissou, Stephen A Vosti

“…We assessed the effects of different amounts and sources of zinc on the frequency of diarrhoea, malaria, fever and RTI in young children.Design, setting and populations This community-based, double-blind, placebo-controlled, cluster-randomised trial of 2435 children 9 months of age was carried out between April 2010 and July 2012 in rural southwestern Burkina Faso.Interventions Participants were randomly assigned at the concession level to receive daily 1 of 4 interventions for 9 months: (1) 20 g small-quantity lipid-based nutrient supplement (SQ-LNS) without zinc and placebo tablet, (2) 20 g SQ-LNS with 5 mg zinc and placebo tablet, (3) 20 g SQ-LNS with 10 mg zinc and placebo tablet or (4) 20 g SQ-LNS without zinc and 5 mg zinc tablet. …”
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