A 3-Month, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Ability of an Extra-Strength Marine Protein Supplement to Promote Hair Growth and Decrease Shedding in Women with Self-Perceived Thinning Hair by Glynis Ablon

“…Adult women with thinning hair were randomized to receive MPS (N=30) or placebo (N=30) twice daily for 90 days. Digital images were obtained from a 4 cm2 area scalp target area. …”
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The Pharmacodynamic Impact of Apremilast, an Oral Phosphodiesterase 4 Inhibitor, on Circulating Levels of Inflammatory Biomarkers in Patients with Psoriatic Arthritis: Substudy Results from a Phase III, Randomized, Placebo-Controlled Trial (PALACE 1) by Peter H. Schafer, Peng Chen, Lorraine Fang, Andrew Wang, Rajesh Chopra

“…Apremilast, an oral phosphodiesterase 4 inhibitor, demonstrated effectiveness (versus placebo) for treatment of active psoriatic arthritis in the psoriatic arthritis long-term assessment of clinical efficacy (PALACE) phase III clinical trial program. …”
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The effect of supplementation with type I and type III collagen peptide and type II hydrolyzed collagen on pain, quality of life and physical function in patients with meniscopathy: a randomized, double-blind, placebo-controlled study by Ahmet Serhat Genç, Ali Kerim Yılmaz, Berna Anıl, Esra Korkmaz Salkılıç, Enes Akdemir, Berna Güzel, Ahmet Mor, Hacı Ahmet Yarar, Nizamettin Güzel, Lokman Kehribar

“…Methods This randomized, double-blind, placebo-controlled clinical study included 32 patients (collagen = 17 and placebo = 15) with meniscopathy. …”
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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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Randomised, placebo-controlled, double-blinded, four-way crossover trial to demonstrate the comparative pharmacodynamic equivalence of a non-invasive diagnostic test for adrenal insufficiency in a healthy population: the STARLIT-2 study protocol by Judith Cohen, Miguel Debono, Kathleen Baster, Richard J Ross, Charlotte J Elder, Kathryn L Date, Sharon L Caunt, Jane Fearnside, Trevor N Johnson, Rosie N Taylor

“…The primary outcome measures are to compare the mean serum cortisol at 30 min after Synacthen or Nasacthin dose, with a view to determine non-inferiority; and to compare the mean change from baseline in serum cortisol at 30 min after active and placebo doses of both Synacthen and Nasacthin, aiming to demonstrate superiority of active over placebo. …”
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Descemet Endothelial Thickness Comparison Trial 1 (DETECT 1): outcome masked, placebo-controlled trial comparing two types of corneal transplant surgeries and effect of rho kinase inhibitors on endothelial cell loss protocol by Thomas M Lietman, Jennifer Rose-Nussbaumer, Bennie H Jeng, Benjamin F Arnold, Winston Chamberlain, Charles C Lin, Jennifer Y Li, William Gensheimer, Jameson Clover, Nicole Varnado, Sarah Abdelrahman

“…The patients will be randomly assigned in a 2×2 factorial design to one of the following treatment groups: group 1—ultrathin Descemet stripping endothelial keratoplasty (UT-DSAEK) plus topical ripasudil 0.4%; group 2—UT-DSAEK plus topical placebo; group 3—Descemet membrane endothelial keratoplasty (DMEK) plus topical ripasudil 0.4% and group 4—DMEK plus topical placebo. …”
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Safety and Immunogenicity of the Tetravalent Recombinant COVID-19 Protein Vaccine SCTV01E in Children and Adolescents Aged 3 to 17 Years: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial by Fengcai Zhu, Ting Huang, Pengfei Jin, Linglin Zhang, Zhongqiang Jin, Wenli Zhang, Dongya Yuan, Zhong Wang, Yusong Deng, Jiaxin Li, Xiao Shen, Yongpan Fu, Jian Li, Xinjie Yang, Jing Li, Liangzhi Xie

“…Overall, 127 (59.3%) participants receiving SCTV01E and 9 (16.7%) receiving a placebo reported adverse events (AEs), most of which were Grade 1 or 2. …”
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Rationale and design of a randomised, double-blind, placebo-controlled, parallel-group, investigator-initiated phase 2a study to investigate the efficacy and safety of elobixibat in combination with cholestyramine for non-alcoholic fatty liver disease by Atsushi Nakajima, Takeharu Yamanaka, Koji Yamamoto, Yasushi Honda, Kento Imajo, Masato Yoneda, Yuji Ogawa, Takaomi Kessoku, Takashi Kobayashi, Anna Ozaki, Satoru Saito, Michihiro Iwaki, Yusuke Saigusa, Haruki Usuda, Koichiro Wada

“…The patients will be randomly assigned to receive the combination therapy of 10 mg EXB and 9 g CTM powder (4 g CTM), 10 mg EXB monotherapy, 9 g CTM powder monotherapy or a placebo treatment (n=25 per group). Blood tests and MRIs will be performed 16 weeks following treatment initiation. …”
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A phase II double-blind multicentre, placebo-controlled trial to assess the efficacy and safety of alpelisib (BYL719) in paediatric and adult patients with Megalencephaly-CApillary malformation Polymicrogyria syndrome (MCAP): the SESAM study protocol by Jean-Marc Treluyer, Benedicte Demeer, Laurence Faivre, Marc Bardou, Nathalie Boddaert, Paul Kuentz, Florence Petit, Christine Francannet, Pierre Vabres, Nadia Bahi-Buisson, Estelle Colin, Laurent Guibaud, Romaric Loffroy, Maxime Luu, Caroline Racine, Aurore Garde, Philippe Khau Van Kien, Aurore Curie, Nawale Hadouiri, Aurélie Espitalier, Agnès Maurer, Maud Carpentier, Adélaide Rega, Mouna Chebbi, Julie Charligny, Guillaume Canaud, Camille Fleck, Amelie Cransac, Elise Boucher-Brischoux, Adélaïde Brosseau-Beauvir, Florian Cherik, Alice Phan, Michaela Semeraro, Marion Nys, Charles Joris Roux, Alinoë Lavillaureix, Isabelle Maruani

“…Our objective is to evaluate the efficacy of a 24 month treatment with alpelisib on adaptive behaviour in patients with MCAP syndrome.Methods and analysis SESAM is an industry-sponsored two-period multicentre French academic phase II trial, with a 6-month double-blind, placebo-controlled period followed by an open-label period. …”
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A Randomized, Placebo-Controlled, Single-Center, Crossover Study to Evaluate the Effects of Pre-Meal Whey Protein Microgel on Post-Prandial Glucometabolic and Amino Acid Response in People with Type 2 Diabetes and Overweight or Obesity by Ian J Neeland, Luiz H de Gregório, Roberto Zagury, Bo Ahrén, Joel Neutel, Christian Darimont, John Corthesy, Yohan Grzywinski, Emilie Perrin, Maximilian von Eynatten, Odd Erik Johansen

“…After an overnight fast and a standardized breakfast, 10 g (125 mL) WPM (40 kcal) or placebo (125 mL water, 0 kcal) was consumed 15 min ahead of the mixed-nutrient meal. …”
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Efficacy of halopeRIdol to decrease the burden of Delirium In adult Critically ill patiEnts (EuRIDICE): study protocol for a prospective randomised multi-centre double-blind placebo-controlled clinical trial in the Netherlands by John W Devlin, Zoran Trogrlic, Mathieu van der Jagt, Lisa Smit, Robert-Jan Osse, Huibert H Ponssen, Arjen J C Slooter, Nicole G M Hunfeld, Wim J R Rietdijk, Diederik Gommers, M. van den Boogaard, A.J.B.W. Brouwers, J.A. Lens, B.J.M. van der Meer, H. Ponssen, F.J. Schoonderbeek, K.S. Simons, E. Berger, A. Bouman, M. Campo, D. van Duijn, H. Embden – van Donk, D. van de Graaf, E. Hoogendoorn, P. Ormskerk, N. Roovers, E. Toscano, A. Vileito, T. van Zuylen, C. Exler, E. van den Berg, J. van Meeteren, M. Koopmanschap, I. Nutma, E. Kuijper

“…Differences in DCFDs between haloperidol and placebo group will be analysed using Poisson regression analysis. …”
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Risk of diabetic ketoacidosis caused by sodium glucose cotransporter-2 inhibitors in patients with type 1 diabetes: a systematic review and network meta-analysis of randomized cont... by Ying Liu, Shiwen Yang, Aidou Jiang, Dan Zou, Zhaoyang Chen, Na Su, Na Su

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Comparison of the impact of intermittent fasting diet alone or in conjunction with probiotic supplementation versus calorie-restricted diet on inflammatory, oxidative stress, and antioxidant capacity biomarkers in women with polycystic ovary syndrome: A randomized placebo-controlled trial by Sepide Talebi, Sakineh Shab-Bidar, Gholamreza Askari, Hamed Mohammadi, Ashraf Moini, Kurosh Djafarian

“…Participants were randomly assigned to one of three groups: 14:10 eTRE with probiotic supplementation (n = 30), 14:10 eTRE with placebo supplementation (n = 30), or DCR with placebo supplementation (n = 30). …”
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The activity of a herbal medicinal product of Phyllanthus niruri and Silybum marianum powdered extracts (Heptex®) in patients with apparent risk factors for nonalcoholic steatohepatitis: a phase II, multicentered, randomized, double-blind, placebo-controlled clinical trial by Mohamed Kamal Shaker, Mohamed Hassany, Basem Eysa, AbdulMoneim Adel, Ahmed Zidan, Shahnaz Mohamed

“…Methods This was a phase II, randomized, double-blind, placebo-controlled, three-arm, interventional clinical trial. …”
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Study protocol of a multicentre, randomised, controlled trial evaluating the effectiveness of probiotic and peanut oral immunotherapy (PPOIT) in inducing desensitisation or tolerance in children with peanut allergy compared with oral immunotherapy (OIT) alone and with placebo (the PPOIT-003 study) by Michael O’Sullivan, Michael S Gold, Francesca Orsini, Adriana Chebar Lozinsky, Paxton Loke, Susan L. Prescott, Patrick Quinn, Audrey DunnGalvin, Mimi LK Tang, Anne-Louise Ponsoby, Ee Lyn Su, Marnie Robinson, Dean Tey, Kuang-Chih Hsiao, Molly O’Sullivan, Christine Axelrad, Sigrid Pitkin, Jessica Metcalfe, Susan Fahy-Scheer, Thalayasingam Meera, Jovanka King, Fuad Abass, Abigail Cheung, Rachel Wallace, Samara Baldwin

“…There are three intervention arms—PPOIT, peanut OIT alone or placebo. Interventions are administered once daily for 18 months. …”
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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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Motor Neuron Disease Systematic Multi-Arm Adaptive Randomised Trial (MND-SMART): a multi-arm, multi-stage, adaptive, platform, phase III randomised, double-blind, placebo-controlled trial of repurposed drugs in motor neuron disease by Jeremy Chataway, Suvankar Pal, Charis Wong, Elizabeth Elliott, Jenna M Gregory, Siddharthan Chandran, Judith Newton, Shuna Colville, Maria Stavrou, Christopher J Weir, Nigel Stallard, Malcolm R Macleod, Michelle Steven, Richard Anthony Parker, Arpan R Mehta, Robert J Swingler, Mahesh K B Parmar, Rachel S Dakin, Jill Williamson

“…The first two drugs selected for evaluation in MND-SMART are trazodone and memantine.Methods and analysis Initially, up to 531 participants (177/arm) will be randomised 1:1:1 to oral liquid trazodone, memantine and placebo. The coprimary outcome measures are the Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALSFRS-R) and survival. …”
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Efficacy of yeast beta-glucan 1,3/1,6 supplementation on respiratory infection, fatigue, immune markers and gut health among moderate stress adults in Klang Valley of Malaysia: protocol for a randomised, double-blinded, placebo-controlled, parallel-group study by Suzana Shahar, Kalavathy Ramasamy, Norhayati Ibrahim, Nur Nadia Mohamad Habibullah, Munirah Ismail, Mohd Zul Amin Kamaruddin, Shirley Gee Hoon Tang, Mohd Faisal Abdul Hamid

“…These participants will be randomised into three groups, receiving YBG 1,3/1,6 at either 120 mg, 204 mg or a placebo. The outcomes measures include respiratory infection symptoms, fatigue, mood state and quality of life assessed using Wisconsin Upper Respiratory Symptoms Scale, Multidimensional Fatigue Inventory, Profile of Mood State and Short Form 36 Health Survey Questionnaire, respectively. …”
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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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