Oral Administration of Polymer Hyaluronic Acid Alleviates Symptoms of Knee Osteoarthritis: A Double-Blind, Placebo-Controlled Study over a 12-Month Period by Toshiyuki Tashiro, Satoshi Seino, Toshihide Sato, Ryosuke Matsuoka, Yasunobu Masuda, Naoshi Fukui

“…Sixty osteoarthritic subjects (Kellgren-Lawrence grade 2 or 3) were randomly assigned to the HA or placebo group. The subjects in the HA group were given 200 mg of HA once a day everyday for 12 months, while the subjects in the placebo group were given placebo. …”
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FAecal micRobiota transplantation in primary sclerosinG chOlangitis (FARGO): study protocol for a randomised, multicentre, phase IIa, placebo-controlled trial by Laith Alrubaiy, Rachel Cooney, Tariq Iqbal, Mohammed Nabil Quraishi, Susan Manzoor, Christopher Quince, Palak J Trivedi, Andrew D Beggs, Alexandra Vince, Chris Weston, Benjamin Mullish, Sahida Shabir, Nicola Jackson, Anna Rowe, Victoria Homer, Willem van Schaik, Peter Rimmer, Sarah Al-Shakhshir, Arzoo Patel, Derick Gyimah, Miriam Hares, Elena Efstathiou

“…Fifty-eight patients will be recruited from six sites across England and randomised in a 1:1 ratio between active FMT or FMT placebo arms. FMT will be manufactured by the University of Birmingham Microbiome Treatment Centre, using stool collected from rigorously screened healthy donors. …”
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Supplementation with Korean Red Ginseng Improves Current Perception Threshold in Korean Type 2 Diabetes Patients: A Randomized, Double-Blind, Placebo-Controlled Trial by Kahui Park, YuSik Kim, Junghye Kim, Shinae Kang, Jong Suk Park, Chul Woo Ahn, Ji Sun Nam

“…This study was a randomized, double-blind, placebo-controlled trial. Participants were randomly allocated to either the placebo or KRG group and took corresponding tablets for 24 weeks. …”
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Achillea millefolium capsule improved liver enzymes and lipid profile compared to placebo in patients with type 2 diabetes: a double-blind randomized clinical trial by Shole Daneshvar-Ghahfarokhi, Hassan Ahmadinia, Tabandeh Sadeghi, Elham Basirat, Vahid Mohammadi-Shahrokhi

“…The intervention group received AM capsules (dose of 500 mg/day) for 3 months, and the control group received placebo capsules during the same period. Blood was taken from patients on day 0 and day 90. …”
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Correction: Efficacy and safety of jaktinib hydrochloride tablets in active axial spondyloarthritis: a multicentre, randomised, double-blind, placebo-controlled phase II clinical trial

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Chinese herbal formula Tongxie Yaofang granules for diarrhoea-predominant irritable bowel syndrome: a randomised, double-blind, placebo-controlled, phase II trial by Nicola Robinson, Mei Han, Ling Yan, Vincent Chi Ho Chung, Jian-Ping Liu, Hui-Juan Cao, Shi-Bing Liang, Hong-Jie Cheng, Qiao-Yan Zhang, Yu-Fei Li, Ze-Yu Yu, Ling-Yao Kong, Yan-Mei Cai, Li-Bao An, Bao-Tuan Zhao, Shan-Shan Xu, Nai-Wei Zhang, Bo-Yi Jia, Wei-Fang Liu, Fang Niu, Ba-Teer Wu, Jin-Ming Song, Shu-Xin Jia, Meng-Meng Shi, Xiao-Na Zhang

“…Objectives To assess the therapeutic effects and safety of Tongxie Yaofang (TXYF) granules vs placebo as an alternative treatment for diarrhoea-predominant irritable bowel syndrome (IBS-D). …”
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Low-dose trimethoprim-sulfamethoxazole for the treatment of Pneumocystis jirovecii pneumonia (LOW-TMP): protocol for a phase III randomised, placebo-controlled, dose-comparison trial by Andrea Benedetti, Cecilia T Costiniuk, Kosar Khwaja, Andrew Johnson, Barret Rush, Darrell Tan, Ranjani Somayaji, Salman Qureshi, Michaeline McGuinty, Nicole Ezer, Sara Belga, Emily G. McDonald, Zahra N. Sohani, Guillaume Butler-Laporte, Andrew Aw, Alex Carignan, Matthew P. Cheng, Bryan Coburn, Dan Gregson, Alexander Lawandi, Victor Leung, Sylvain Lother, Derek MacFadden, Leighanne Parkes, Valerie Roy, Ilan Schwartz, Miranda So, Emilie Trinh, Todd C. Lee

“…In a recent meta-analysis of observational studies, reduced dose TMP-SMX for the treatment of PJP was associated with fewer ADEs, without increased mortality.Methods and analysis A phase III randomised, placebo-controlled, trial to directly compare the efficacy and safety of low-dose TMP-SMX (10 mg/kg/day of TMP) with the standard of care (15 mg/kg/day of TMP) among patients with PJP, for a composite primary outcome of change of treatment, new mechanical ventilation, or death. …”
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High-definition transcranial infraslow pink noise stimulation for chronic low back pain: protocol for a pilot, safety and feasibility randomised placebo-controlled trial by Ramakrishnan Mani, Dirk De Ridder, Sven Vanneste, Divya Bharatkumar Adhia, John N J Reynolds

“…This pilot study aims to (1) evaluate feasibility, safety and acceptability of a novel neuromodulation technique, high-definition transcranial infraslow pink noise stimulation (HD-tIPNS), in people with CLBP, (2) explore the trend of effect of HD-tIPNS on pain and function, and (3) derive treatment estimates to support sample size calculation for a fully powered trial should trends of effectiveness be present.Methods and analysis A pilot, triple-blinded randomised two-arm placebo-controlled parallel trial. Participants (n=40) with CLBP will be randomised to either sham stimulation or HD-tIPNS (targeting somatosensory cortex and dorsal and pregenual anterior cingulate cortex). …”
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Levilactobacillus brevis CD2 as a multifaceted probiotic to preserve oral health: results of a double-blind, randomized, placebo-controlled trial in healthy adults by Serena Altamura, Francesca Lombardi, Francesca Rosaria Augello, Antonella Barone, Mario Giannoni, Benedetta Cinque, Davide Pietropaoli

“…Results After four weeks, the probiotic group showed significant improvements in BoP and PI compared to baseline and placebo. The probiotic group had a higher salivation rate than baseline and placebo after four weeks of treatment and washout. …”
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Faecal microbiota transplantation for patients with diabetes type 1 and severe gastrointestinal neuropathy (FADIGAS): a randomised, double-blinded, placebo-controlled trialResearch in context by Katrine Lundby Høyer, Simon Mark Dahl Baunwall, Ditte Smed Kornum, Mette Winther Klinge, Asbjørn Mohr Drewes, Knud Bonnet Yderstræde, Louise Bruun Thingholm, Martin Steen Mortensen, Susan Mikkelsen, Christian Erikstrup, Christian Lodberg Hvas, Klaus Krogh

“…Methods: In a randomised, double-blinded, placebo-controlled pilot trial, adults with type 1 diabetes and moderate-to-severe gastrointestinal symptoms were randomised (1:1) to encapsulated FMT or placebo. …”
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Evaluation of the Effect of Probiotic Bacillus coagulans Unique IS2 on Mutans Streptococci and Lactobacilli Levels in Saliva and Plaque: A Double-Blind, Randomized, Placebo-Controlled Study in Children by M. Ratna Sudha, Jayanthi Neelamraju, M. Surendra Reddy, Manoj Kumar

“…In this double-blind, randomized, placebo-controlled study, 48 children with ages ranging from 5 to 15 years were divided into two groups, the probiotic and placebo groups. …”
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Effect of cryotherapy, laser therapy and intraligamentary dexamethasone injection on post-treatment pain after single visit RCT–A double-blinded, randomized placebo-controlled trial by Dr Sana Fatima, Dr Sonali Taneja, Dr Vivek Aggarwal, Dr Akriti Dheer, Dr Punya Taneja

“…P value of <0.05 was considered statistically significant.Results: Patients in the placebo group exhibited higher intensity. Group 3 showed lesser pain at all-time intervals. …”
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Tadalafil treatment for fetuses with early-onset growth restriction: a protocol for a multicentre, randomised, placebo-controlled, double-blind phase II trial (TADAFER IIb) by Hiroaki Tanaka, Yasuhiro Tanaka, Yoichi Aoki, Masayuki Endo, Tomoaki Ikeda, Shintaro Maki, Masafumi Nii, Kayo Tanaka, Satoshi Tamaru, Toru Ogura, Yuki Nishimura, Tomomi Kotani, Akihiko Sekizawa, Masahiko Nakata, Koji Nakamura, Kenji Nagao, Ichiro Yasuhi, Hiroshi Kawamura, Sho Takakura, Mayumi Kotera, Takafumi Ushida, Norihiko Kikuchi, Tadatsugu Kinjo, Mayumi Takano, Sachie Suga, Michi Kasai, Osamu Yasui, Yuka Maegawa, Shigeru Aoki, Yoshio Yoshida

“…To establish further evidence for the efficacy of tadalafil in this setting, we planned a multicentre, randomised, placebo-controlled, double-blind trial.Methods and analysis This trial will be conducted in 180 fetuses with fetal growth restriction enrolled from medical centres in Japan; their mothers will be randomised into three groups: arm A, receiving two times per day placebo; arm B, receiving one time per day 20 mg tadalafil and one time per day placebo and arm C, receiving 20 mg two times per day tadalafil. …”
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Exposure to a Specific Pulsed Low-Frequency Magnetic Field: A Double-Blind Placebo-Controlled Study of Effects on Pain Ratings in Rheumatoid Arthritis and Fibromyalgia Patients by Naomi M Shupak, Julia C McKay, Warren R Nielson, Gary B Rollman, Frank S Prato, Alex W Thomas

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Efficacy and Safety of a Novel Low-Dose Water-Dispersible Turmeric Extract in the Management of Knee Osteoarthritis: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial by Thanawala S, Shah R, Alluri KV, Bhupathiraju K, Prasad N, Agarwal Y

“…The mean reduction (95% CI) in VAS score from baseline to day 90 was significantly higher in the WDTE60N group than in the placebo group (14.41 [13.08, 15.75] vs 6.02 [5.00, 7.05]; p < 0.0001). …”
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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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Beneficial Effects of Ursodeoxycholic Acid on Metabolic Parameters and Oxidative Stress in Patients with Type 2 Diabetes Mellitus: A Randomized Double-Blind, Placebo-Controlled Clinical Study by Biljana Lakić, Ranko Škrbić, Snežana Uletilović, Nebojša Mandić-Kovačević, Milkica Grabež, Mirna Popović Šarić, Miloš P. Stojiljković, Ivan Soldatović, Zorica Janjetović, Anastasija Stokanović, Nataša Stojaković, Momir Mikov

“…This prospective, double-blind, placebo-controlled clinical study included 60 patients with T2DM, randomly allocated to receive UDCA or placebo. …”
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Intestinal Microbiota Transplant Prior to Allogeneic Stem Cell Transplant (MAST) trial: study protocol for a multicentre, double-blinded, placebo-controlled, phase IIa trial by Julian R Marchesi, Emma Nicholson, Benjamin H Mullish, Renuka Palanicawandar, Graham Wheeler, Francesca Kinsella, Andrew J Innes, Lauren A Roberts, Shian Anim-Burton, Lee Webber, Nicholas A Johnson, Rohma Ghani, Pakhshan Farshi, Anjum B Khan, Panagiotis Kottaridis, Pramila Krishnamurthy, Frances Davies, Jiří Pavlů

“…We hypothesised that IMT performed prior to initiation of HCT conditioning restores microbiome diversity during the early stages of HCT, leading to decreased frequency of complications and improved outcomes of HCT.Methods and analysis 50 adult patients receiving allogeneic HCT will be recruited into this phase IIa trial and randomised 1:1 to receive capsulised IMT or matched placebo shortly prior to initiation of HCT conditioning and followed for up to 12 months. …”
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Safety, Tolerability and Pharmacokinetic-Pharmacodynamic Relationship of NX210c Peptide in Healthy Elderly Volunteers: Randomized, Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study by Annette Janus, Daniël Dumas, Juliette Le Douce, Sébastien Marie, Giuseppe Pasculli, Pauline Bambury, Sighild Lemarchant, Philip Kremer, Yann Godfrin

“…Participants received 5 or 10 mg/kg NX210c or placebo (10-min infusion) thrice weekly for 4 weeks in an ascending dose fashion. …”
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Effectiveness and Safety of Hair Growth Formulation Containing L.f (Teak) Leaf Extract: A Randomized, Double-Blind, Placebo-Controlled Study on Males with Androgenic Alopecia by Nutchaninad Tanuphol B.ATM, Neti Waranuch PhD, Vanuchawan Wisuitiprot PhD, Wudtichai Wisuitiprot PhD, Kamonlak Insumrong PhD, Prapapan Temkitthawon PhD, Nungruthai Suphrom PhD, Katechan Jampachaisri PhD, Corine Girard PhD, Kornkanok Ingkaninan PhD

“…To prove the effectiveness and safety of teak leaf extract as a hair growth promotor, a double-blind, randomized placebo-controlled trial was conducted. Methods Eighty-one AGA subjects were randomly assigned to receive either a hair tonic containing 1% teak leaf extract (HT-teak), 5%minoxidil (positive control), or a placebo administered twice daily, for 24 weeks. …”
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