The effect of propolis plus Hyoscyamus niger L. methanolic extract on clinical symptoms in patients with acute respiratory syndrome suspected to COVID ‐19: A clinical trial

This study aimed to evaluate the efficacy and toxicity of tenofovir (TDF) and TDF combined with emtricitabine (TDF/FTC) in patients with mild to moderate COVID-19 infections. We conducted a randomized, double-blind, placebo-controlled clinical trial in patients with clinical suspicion of mild to moderate respiratory infection caused by SARS-CoV-2 who were treated at an outpatient clinic. Patients were randomly recruited to take 10 days of TDF (300 mg/day), TDF (300 mg/day) combined with FTC (200 mg/day) or placebo Vitamin C (500 mg/day). The primary parameter was the score of symptoms and predictive signs of COVID-19, assessed on the seventh day of patient follow-up. From a total of 309 patients with clinical suspicion of SARS-CoV-2, 227 met the inclusion criteria and were randomly distributed into the following groups: (a) 75 (one did not initiate treatment) in the TDF group; (b) 74 in the TDF combined with FTC group; and (c) 77 in the Vitamin C group (placebo). Of the 226 patients, 139 (62%) were positive for SARS-CoV-2. Fever (37.8oC), ageusia or dysgeusia, anosmia or dysosmia, and two or more clinical symptoms or signs were significantly associated with SARS-CoV-2 infection. There was no significant change in clinical score based on clinical symptoms and signs between treatment groups. Patients with mild to moderate infection by SARS-CoV-2 had higher concentrations of G-CSF, IL-1β, IL-6 and TNF-α compared to patients without infection. Patients with mild to moderate respiratory infection, with fever (37.8oC), loss of smell, loss of taste and two or more symptoms, have a better prediction for the diagnosis of COVID-19. Patients with SARS-CoV-2 showed higher and more persistent proinflammatory cytokines profile compared to patients not infected with SARS-CoV-2. Pharmacological intervention with TDF or TDF combined with FTC did not change the clinical signs and symptoms score in mild to moderate respiratory infection in patients with SARS-CoV-2 compared to the Vitamin C group (placebo).

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Intra-Articular Injection of Autologous Adipose-Derived Stromal Vascular Fractions for the Cartilage Repair of Grade 2 and 3 Knee Osteoarthritis: A Confirmatory Clinical Trial

10.21203/rs.3.rs-193150/v1 ◽

2021 ◽

Author(s):

Yin Zhang ◽

Qing Bi ◽

Taihen Yu ◽

Zheping Hong ◽

Yu Tong ◽

...

Keyword(s):

Clinical Trial ◽

Knee Osteoarthritis ◽

Cartilage Repair ◽

Clinical Symptoms ◽

Rapid Development ◽

Cartilage Regeneration ◽

Substantial Improvement ◽

Clinical Trial Registry ◽

Knee Oa ◽

Grade 3

Abstract BackgroundCartilage defect remains one of the most important reasons for the rapid development of knee osteoarthritis (OA). Numerous reports have confirmed the safety and clinical efficacy of autologous adipose-derived stromal vascular fractions (SVF), which has recently been used clinically to treat patients with knee OA. However, there is still no consensus as to whether SVF can promote cartilage regeneration. Herein, we purposed to evaluate the effectiveness of SVF in cartilage regeneration by developing cartilage model based on the 3D-FS-SPGR sequence.MethodsPatients with Kellgren-Lawrence grade 2-3 knee OA were recruited in our research. Then, we monitored patients and subsequently scored symptoms using WOMAC, VAS, and range of motion (ROM) before treatment and at 1, 3, 6, and 12 months post-treatment. The WORMS and MOCART were recorded by magnetic resonance imaging. The cartilage model of the patient was established using the 3D-FS-SPGR sequence, while the relevant parameters of the model were counted at baseline, 6, and 12 months.ResultsWe enrolled 47 patients (53 knees) with knee OA in this study, of which 29 knees were classified as grade 2, while 24 were assigned grade 3. No treatment-related adverse event was observed in our study. Notably, WOMAC, VAS, and ROM showed a significant improvement at 12 months. We further found that the thickness, volume, and surface of the cartilage defect decreased, while the volume of healthy cartilage increased in all regions, particularly in the medial femoral and tibia condyle. Moreover, the scores of WORMS and MOCART revealed a substantial improvement of cartilage repair at 12 months. ConclusionsTaken together, this study shows that intra-articular injection of SVF into the knee markedly improved the clinical symptoms of patients without the occurrence of adverse events, thereby repairing the damaged articular cartilage through cartilage regeneration.Trial registrationRetrospectively registered. Chinses Clinical Trial Registry with identifier ChiCTR2100042930. Registered 28 January 2021.

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A study on the effect of Nagaradi Kashaya drug on biochemical parameters and clinical symptoms among the patients of Ashmari (urolithiasis): A Clinical Trial

Journal of Medical Science And clinical Research ◽

10.18535/jmscr/v6i7.28 ◽

2018 ◽

Vol 6 (7) ◽

Author(s):

Dr Anil Kumar ◽

Keyword(s):

Clinical Trial ◽

Biochemical Parameters ◽

Clinical Symptoms

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Effects of curcumin-piperine co-supplementation on clinical signs, duration, severity, and inflammatory factors in patients with COVID-19: a structured summary of a study protocol for a randomised controlled trial

Trials ◽

10.1186/s13063-020-04924-9 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Mahsa Miryan ◽

Mohammad Bagherniya ◽

Amirhossein Sahebkar ◽

Davood Soleimani ◽

Mohammad Hossein Rouhani ◽

...

Keyword(s):

Clinical Trial ◽

Sample Size ◽

Inflammatory Mediators ◽

Disease Duration ◽

Clinical Symptoms ◽

Clinical Signs ◽

Inflammatory Factors ◽

Double Blind ◽

Full Protocol ◽

To Receive

Abstract Objectives This study aims to investigate the efficacy of curcumin-piperine co-supplementation on disease duration, severity and clinical symptoms, and inflammatory mediators in patients with coronavirus (COVID-19). Trial design This is a randomized, placebo-controlled, double-blind, parallel arm clinical trial. Participants All patients aged 20-75 years with the diagnosis of Covid-19 based on the PCR test. The exclusion criteria will include an age less than 20 and more than 75 years, current use of warfarin or other anticoagulant drugs, and the presence of sensitivity to herbal products such as turmeric and pepper. This study will be conducted in academic hospitals affiliated to Isfahan University of Medical Sciences, Isfahan, Iran. Intervention and comparator Fifty outpatients will be randomly allocated in a ratio of 1:1 to receive a capsule of curcumin-piperine containing 500 mg curcumin plus 5 mg piperine or matching placebo containing 505 mg maltodextrin twice a daily, after lunch and dinner, over a period of 2 weeks. Similarly, 50 inpatients who are admitted to hospital wards excluding intensive care unit (ICU) will be randomly assigned in a ratio of 1:1 to receive a capsule curcumin-piperine or matching placebo (provided by the Sami Labs company) twice a daily, after lunch and dinner, over a period of 2 weeks. Main outcomes The main outcomes of this study are the efficacy of curcumin-piperine on coronavirus disease’s clinical symptoms, duration, severity, and inflammatory mediators after 2 weeks of curcumin-piperine co-supplementation. Randomisation Randomization sequences will be generated with the use of a random-number table with a permuted block design (block size of 4) and stratification according to the gender variable (male vs. female). These sequences will be prepared by an independent statistician and will be kept in opaque, sealed, numbered envelopes which will be opened only at the time of enrollment. The allocation ratio in intervention and control groups is 1:1. Researchers and all patients will be unaware of the study-group assignment until the completion of data analyses. Blinding (masking) This study is a double-blind clinical trial (participant, researcher). The curcumin-piperine and placebo supplements are packaged in similar numbered drug containers, and the researcher and all patients will be unaware of the study assignment until the end of the study. Numbers to be randomised (sample size) The calculated total sample size is 100 patients, with 25 patients in each group. Trial Status The protocol is Version 2.0, May 24, 2020. Recruitment began May 4, 2020, and is anticipated to be completed by April 19, 2021. Trial registration This trial has been registered by the title of “Effect of curcumin-piperine co-supplementation on disease duration, severity and clinical signs, and inflammatory factors in patients with coronavirus (COVID-19): A randomized, double-blind, placebo-controlled clinical trial study” in the Iranian Registry of Clinical Trials (IRCT) with code “IRCT20121216011763N46”, https://www.irct.ir/trial/47529. The registration date is May 4, 2020. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

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Effectiveness and safety of Chinese herbal medicine xuanbi antong granules for the treatment of borderline coronary lesions: study protocol for a randomised, double-blinded, placebo-controlled, multicentre clinical trial

BMJ Open ◽

10.1136/bmjopen-2018-024968 ◽

2019 ◽

Vol 9 (8) ◽

pp. e024968 ◽

Cited By ~ 1

Author(s):

Mingyan Huang ◽

Guang Chen ◽

Qingya Guan ◽

Chao Liu ◽

Qing Zhao ◽

...

Keyword(s):

Clinical Trial ◽

Placebo Group ◽

Clinical Symptoms ◽

Early Stage ◽

Intervention Group ◽

Blood Lipid ◽

Controlled Clinical Trial ◽

Cardiac Events ◽

Coronary Syndrome ◽

Double Blinded

IntroductionAs the early stage of coronary heart disease (CHD), borderline coronary lesion (BCL) is defined as a 30%–70% diameter stenosis. Previous studies have demonstrated that BCL may progress to acute coronary syndrome easily. However, routine medications available for the treatments of BCL have some limitations. Xuanbi antong granule (XAG) has been used for the treatment of BCL in China for many years. Previous studies have shown that XAG has effectiveness in improving clinical symptoms and quality of life in patients with CHD. This study aims to evaluate the effectiveness and safety of XAG in patients with BCL.Methods and analysisThis is a multicentre, randomised, double-blinded, placebo-controlled clinical trial. A total of 300 participants will be randomly assigned to the intervention group and the placebo group. Based on routine medications, the intervention group will be treated with XAG and the placebo group will be treated with XAG placebo. All participants will receive a 6-month treatment and then be followed-up for another 6 months. The primary outcomes are the changes of target plaque characteristics (including target plaque volume, degree of stenosis, CT value and calcification score) measured by dual source CT angiography. The secondary outcomes include blood lipid indicators, efficacy of angina symptoms, Seattle Angina Questionnaire, high-sensitivity C-reactive protein and occurrence of major adverse cardiac events. All the data will be recorded in electronic case report forms and analysed by SPSS V.20.0.Ethics and disseminationThis study has been approved by Research Ethics Committee of Guang’anmen Hospital, China Academy of Chinese Medical Sciences in Beijing, China (No. 2017–083-KY-01). Written informed consent will be obtained from all participants. The results of this study will be disseminated to the public through academic conferences and peer-reviewed journals.Trial registration numberChiCTR-IOR-17013189; Pre-results.

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Improvement of Clinical Symptoms and Esophageal Acid Reflux by a Novel Simple Endoscopic Procedure: Results of a Pilot Clinical Trial

Gastrointestinal Endoscopy ◽

10.1016/s0016-5107(05)01275-7 ◽

2005 ◽

Vol 61 (5) ◽

pp. AB235

Author(s):

Pankaj J. Pasricha ◽

Rajesh Puri ◽

Binh V. Pham ◽

The Apollo Group ◽

Randhir Sud

Keyword(s):

Clinical Trial ◽

Clinical Symptoms ◽

Acid Reflux ◽

Endoscopic Procedure

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Variability of clinical features in attacks of migraine with aura

Cephalalgia ◽

10.1177/0333102415584601 ◽

2015 ◽

Vol 36 (3) ◽

pp. 216-224 ◽

Cited By ~ 36

Author(s):

Jakob M Hansen ◽

Peter J Goadsby ◽

Andrew C Charles

Keyword(s):

Clinical Trial ◽

Migraine Attack ◽

Clinical Features ◽

Migraine With Aura ◽

Clinical Symptoms ◽

Brain Regions ◽

Visual Aura ◽

Tunnel Vision ◽

Visual Phenomenon ◽

Retrospective Reporting

Background There is significant variability in the clinical presentation of migraine, both among patients, and between attacks in an individual patient. We examined clinical features of migraine with aura in a large group of patients enrolled in a clinical trial, and compared retrospective migraine attack characteristics reported upon enrollment in the trial with those recorded prospectively in the trial. Methods Patients with migraine ( n = 267) with typical visual aura in more than 30% of their attacks were enrolled from 16 centers for a clinical trial. Upon enrollment, patients provided a detailed retrospective description of the clinical features of their attacks of migraine. During the trial, clinical symptoms in migraine attacks starting with aura were recorded prospectively in 861 attacks. Results Retrospectively reported visual aura symptoms were variable and often overlapping; the most common symptoms were dots or flashing lights, wavy or jagged lines, blind spots, and tunnel vision. Multiple patients reported more than one visual phenomenon. Approximately half of the patients reported nonvisual aura symptoms, the most common were numbness and tingling, followed by difficulty in recalling or speaking words. A significant percentage of patients also reported a change in olfaction. There were several inconsistencies between the features of prospectively recorded and retrospectively reported attacks. Headache, nausea, photophobia, and phonophobia were all less common in prospectively recorded attacks as compared with retrospective reporting. Nausea was prospectively recorded in only 51% of attacks and mostly with mild intensity. The occurrence and severity of nausea was reduced with advancing patient age. Phonophobia was not consistently recorded in conjunction with photophobia. Conclusion These findings are consistent with variable involvement of different brain regions during a migraine attack. The variable occurrence of nausea, and phonophobia in conjunction with photophobia, both defining features of migraine, may be an important consideration in designing clinical studies of migraine in which prospectively recorded attacks are diagnosed based on these clinical features.

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Constructing disease onset signatures using multi-dimensional network-structured biomarkers

Biostatistics ◽

10.1093/biostatistics/kxy037 ◽

2018 ◽

Vol 21 (1) ◽

pp. 122-138

Author(s):

Xiang Li ◽

Donglin Zeng ◽

Karen Marder ◽

Yuanjia Wang

Keyword(s):

Clinical Trial ◽

Kernel Smoothing ◽

Clinical Symptoms ◽

Age At Onset ◽

Disease Onset ◽

Right Censoring ◽

Biological Information ◽

Partial Likelihood ◽

Disease Stage ◽

Linear Change

Summary Potential disease-modifying therapies for neurodegenerative disorders need to be introduced prior to the symptomatic stage in order to be effective. However, current diagnosis of neurological disorders mostly rely on measurements of clinical symptoms and thus only identify symptomatic subjects in their late disease course. Thus, it is of interest to select and integrate biomarkers that may reflect early disease-related pathological changes for earlier diagnosis and recruiting pre-sypmtomatic subjects in a prevention clinical trial. Two sources of biological information are relevant to the construction of biomarker signatures for time to disease onset that is subject to right censoring. First, biomarkers’ effects on disease onset may vary with a subject’s baseline disease stage indicated by a particular marker. Second, biomarkers may be connected through networks, and their effects on disease may be informed by this network structure. To leverage these information, we propose a varying-coefficient hazards model to induce double smoothness over the dimension of the disease stage and over the space of network-structured biomarkers. The distinctive feature of the model is a non-parametric effect that captures non-linear change according to the disease stage and similarity among the effects of linked biomarkers. For estimation and feature selection, we use kernel smoothing of a regularized local partial likelihood and derive an efficient algorithm. Numeric simulations demonstrate significant improvements over existing methods in performance and computational efficiency. Finally, the methods are applied to our motivating study, a recently completed study of Huntington’s disease (HD), where structural brain imaging measures are used to inform age-at-onset of HD and assist clinical trial design. The analysis offers new insights on the structural network signatures for premanifest HD subjects.

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