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Showing 1-15 of 15 trials
NCT07476625
The goal of this clinical trial is to evaluate the efficacy and safety of thalidomide in the treatment of children with Periodic Fever, Aphthous Stomatitis, Pharyngitis, and Adenitis (PFAPA) syndrome. The study focuses on children diagnosed with PFAPA syndrome. The main questions it aims to answer are: Can thalidomide significantly reduce the frequency of febrile episodes in children with PFAPA syndrome? What is the safety profile and tolerability of thalidomide in this pediatric population? Researchers will compare the thalidomide group to a colchicine group to see if thalidomide is more effective in controlling recurrent fever and associated symptoms. Participants will: Take the assigned medication (thalidomide or colchicine) daily for a duration of 6 months. Attend follow-up visits every 4 weeks at the clinic. Maintain a diary to record the frequency of fever episodes and any other clinical symptoms. Undergo safety assessments and physical examinations during each scheduled visit.
NCT07229469
This randomized controlled clinical study aims to evaluate the effectiveness of a Sumac mouth rinse in the management of recurrent aphthous stomatitis (RAS). In addition to assessing clinical improvement in ulcer healing and pain reduction, biochemical analysis will be performed by measuring serum TNF-α levels to evaluate the anti-inflammatory effect of Sumac.
NCT06932328
Trial Objectives and Exploration Indicators： 1. To explore the improvement effect of different doses of Qinqiao Yanshu Granules on the symptoms/conditions and TCM syndromes of acute pharyngitis (Wind - Heat Exogenous Syndrome), and its effect on shortening the course of the disease. 2. To observe the safety of the clinical application of Qinqiao Yanshu Granules. Overall Trial Design：A block - randomized, double - blind, dose - escalation, multicenter clinical trial design was adopted. Sample Size：It is planned to enroll 72 cases in each group (high - dose group, low - dose group, and extremely low - dose group), with a total of 216 cases. Investigational Products：Experimental groups: 1. High - dose group: Specification: 12g/bag; 2. Low - dose group: Specification: 12g/bag. Control group: (1) Extremely low - dose group: Specification: 12g/bag. Rescue medication: (1) Paracetamol tablets: Specification: 0.5g/tablet. Dosage and Administration： High - dose group: Dissolve in boiling water and take 1 bag each time, 3 times a day, half an hour before meals; Low - dose group: Dissolve in boiling water and take 1 bag each time, 3 times a day, half an hour before meals; Extremely low - dose group: Dissolve in boiling water and take 1 bag each time, 3 times a day, half an hour before meals; Rescue medication: Paracetamol tablets. During the trial, if the subject's body temperature exceeds 38.5°C (including 38.5°C), rescue medication can be added. Use it according to the instructions and doctor's advice and record it truthfully. Treatment Course：5 days Efficacy Indicators： 1\) The disappearance rate of pharyngeal pain 3 days and 5 days after treatment; 2) The change value of the pharyngeal pain VAS score compared with the baseline 5 days after treatment; 3) The time to disappearance of pharyngeal pain; 4) The effective rate of pharyngeal signs 5 days after treatment; 5) The clinical cure rate of the disease 5 days after treatment; 6) The efficacy of TCM syndromes 5 days after treatment; 7) The disappearance rate of single symptoms 5 days after treatment; 8) The frequency of rescue drug use. Measurement and Definition of Endpoint Indicators： 1. The criterion for the disappearance of pharyngeal pain: The pharyngeal pain VAS score drops to 0 points and persists for 24 hours or more. 2. Pharyngeal pain VAS score: Starting from the evaluation time of the VAS score during the screening period, the subject evaluates once every 24 hours (±1 hour) and records the most severe degree of pharyngeal pain in the past 24 hours in the diary card. 3. The criterion for the effective rate of pharyngeal signs: "Effective" is defined as a decrease of at least 1 point in the pharyngeal sign score. The effective rate = (Number of effective cases / Total number of cases) × 100%. 4. The criterion for the clinical cure of the disease: The clinical symptoms of the disease disappear, and the pharyngeal signs are reduced to mild or less. The cure rate = (Number of cured cases / Total number of cases) × 100%. 5. The definition of the efficacy of TCM syndromes: Efficacy of TCM syndromes: Cure means that the TCM syndrome score decreases by ≥ 95%; Marked effect means that the TCM syndrome score decreases by ≥ 70% and \< 95%; Effective means that the TCM syndrome score decreases by ≥ 30% and \< 70%; Ineffective means that it does not meet the above criteria. The change value of the pharyngeal pain VAS score compared with the baseline = The baseline pharyngeal pain VAS score - The pharyngeal pain VAS score on the 6th day. Study Population； Inclusion criteria: 1. Meeting the Western medical diagnostic criteria for acute pharyngitis; 2. Meeting the TCM syndrome differentiation criteria for Wind - Heat Exogenous Syndrome; 3. The course of the disease at the time of consultation ≤ 48 hours; 4. The pharyngeal pain VAS score ≥ 4 points and the pharyngeal sign score ≥ 1 point; 5. Aged between 18 and 65 years old (including the boundary values), regardless of gender; 6. Voluntarily participating in this clinical trial and signing the informed consent form. Exclusion criteria: 1. Those with pharyngeal symptoms or inflammation caused by measles, scarlet fever, agranulocytosis, infectious mononucleosis, influenza, diphtheria, acute epiglottitis, acute carotid arteritis, etc.; 2. Those with concurrent acute sinusitis, acute laryngitis, suppurative tonsillitis, bronchitis, pneumonia; 3. Those with a modified Centor score ≥ 2, a body temperature peak \> 38.5°C (axillary temperature) within 24 hours before this visit, a white blood cell count \> 1.2 × ULN, a neutrophil percentage \> 1.2 × ULN, and considered to be bacterial infections by the researcher; 4. Those with concurrent severe primary diseases of the cardiovascular and cerebrovascular system, liver, kidney, hematopoietic system, endocrine system, and mental diseases; 5. Those with a history of thyroid - related diseases such as hyperthyroidism and hypothyroidism; 6. Those with laboratory test results
NCT04247243
Randomized trial evaluating effectiveness of rapid point-of-care molecular GAS diagnostics as compared to standard culture-based techniques for the management of children aged 3-18 years of age presenting with sore throat to McMaster Children's Hospital Emergency Department.
NCT03690544
Determination of treatment efficacy and safety of Apremilast in patients with RAS
NCT04027322
Background: Acute pharyngitis (AP) is a common presentation to the Emergency Department (ED). Most AP patients' who present to the ED are interested in relief their sore throat (pain). There are different approaches available in the literature to control AP pain. Studies have shown that the use of systemic glucocorticoids significantly decreases patients' sore throat. Up to our knowledge, there are no available trials looking at the role of nebulized glucocorticoids in treating infective AP. Aim: Our aim is to investigate in pediatrics and adults population ≥5 years presenting to ED with AP if the use of a single dose of nebulized glucocorticoids as an adjunct to standard AP treatment, compared with placebo leads to complete resolution or improvement in symptoms. Method: The investigators are planning to conduct a multi-center, double-blind randomized control trial. There will be three arms; first arm: nebulized Budesonide, second arm: nebulized Dexamethasone and third arm: placebo nebulized Normal Saline (NS). The patients will be followed up for 7 days through phone calls to assess the primary and secondary outcomes. Our primary objective is to investigate whether the use of a single dose of nebulized glucocorticoids compared with placebo leads to significant improvement or complete resolution of the sore throat within 24hrs. Our secondary objectives are to assess if a single dose of glucocorticoids will: reduce sore throat at 48 hours, reduce absence from work or school, reduce the incidence of hospital admission, and reduce the rate of re-attendance to ED. Since there is no available data about the effect of nebulized glucocorticoids in AP, the appropriate sample size will be calculated after running a pilot study. The data will be recorded in the EpiData@ software. Then the data will be analyzed using the SPSS@ software. The ethical approval was sought from the ethical committee in each participating hospital and they approved it. Results: The result of this study will be presented in local conferences as well in international conferences. The investigators will aim to publish the study in a well-known international emergency medicine journal. Clinical application: up to our knowledge this study is the first study worldwide looking at the effect of nebulized glucocorticoids in patients with infective acute pharyngitis. As mentioned earlier that there are multiple approaches available in the literature to control sore throat pain and if our hypothesis turned to be correct then another alternative treatment can be added. The investigators believe that the use of topical route to administer glucocorticoids is more convenient for physicians and have less chance to develop adverse effect in comparison to systemic steroids.
NCT04470089
In this multi-center, randomized, placebo-controlled, double-blind stuy in which patients with acute pharyngitis will receive Myramistin™ / Placebo, which is provided as a spray. Patients will be randomised at Visit 1 on a 1:1:1:1 basis to one of the three MyramistinTM doses (0.005%, 0.01% and 0.02%) or placebo. The trial duration for an individual patient is 72 hours. The primary objective is to evaluate the short-term efficacy of different MyramistinTM doses (0.005%, 0.01% and 0.02%) compared to placebo in the symptomatic treatment of acute pharyngitis.
NCT02334748
The objective of this extension protocol is to collect safety data (serious and non-serious adverse events) and to provide continuous canakinumab to patients in France who completed study CACZ885G2301E1(NCT00891046), CACZ885G2306 (NCT02296424) or CACZ885N2301 (NCT02059291) until a decision regarding reimbursement in France is effective for canakinumab (Ilaris®) in these indications.
NCT04265001
This study was conducted to estimate the hypothesis that the topical hyaluronic acid mouthwash have no role in the treatment of recurrent aphthous stomatitis
NCT03943186
The goal of this non-interventional study is to investigate the safety, efficacy and tolerability of Ectoin Lozenges Honey Lemon (EHT02) compared to lozenges containing hyaluronic acid and islandic moss in the treatment of acute viral pharyngitis.
NCT02775994
Periodic Fever, Aphthous stomatitis, Pharyngitis and cervical Adenitis (PFAPA) is one of the most common, least explored periodic fever syndrome in childhood. This study aims to investigate whether a single dose of an interleukin beta (IL-1) antagonist, Canakinumab will be able to abort PFAPA flares in patients who experience a flare in an average of 2 weeks or less. This will be a single arm open label pilot study. 10 patients will be recruited from 1 center (Pediatric rheumatology unit -Schneider children's medical center of Israel). Patients in ages 2-10 years old who are diagnosed with PFAPA according to clinical criteria at least 3 months prior to enrollment and who are under regular care for this disease (single dose of glucocorticoids during flare) and who suffer from more than 4 PFAPA flares for the last 2 months, will be screened for this study. In the second documented flare, patients will be enrolled to receive a single dose of subcutaneous (SC) Canakinumab 4 mg/kg. The primary outcome is defined as - 50% reduction in PFAPA flares for the next 2 consecutive months as reported by the patient (use of diary) and documented by the patient primary care physician and/ or the researcher in a monthly follow up visits. Secondary outcome measure are define as time to flare (days) and Parent/patient quality of life assessment measured by 100mm visual analog scale (VAS).
NCT02911857
The primary objective of this study was to evaluate safety and tolerability of ACZ885 in this extension study. This extension study offered the opportunity for participants who completed Epoch 4 of the preceding CACZ885N2301 (NCT02059291) study to continue to be treated with ACZ885 until approval in Japan of the drug in Periodic Fever Syndromes or until development of ACZ885 in Periodic Fever Syndromes was suspended.
NCT02920658
This study evaluates the effectiveness of topical NAVS naphthalan in the treatment of oral lichen planus (OLP) and recurrent aphthous stomatitis (RAS). Half of participants with OLP and RAS will receive topical NAVS naphthalan in adhesive paste, while the other half will receive 0.05%-betamethasone dipropionate in adhesive paste. Our hypothesis is that NAVS could be efficient in the treatment of OLP and RAS, with effects comparable to that of topical steroids.
NCT02160912
In this observational study insights regarding the tolerability and influence on the quality of life of the topical treatment Ectoin Mund- and Rachenspray compared to Emser Pastillen in patients with acute Pharyngitis/ Laryngitis under real life conditions shall be gained. Patients are treated with Ectoin Mund- \& Rachenspray 1% or Emser Pastillen according to the demands of the physician and the instructions for use.
NCT01386047
Clinical prediction rules (CPRs) are frontline decision aids that help physicians make evidence-based, cost-effective decisions that benefit their patients. The aims of this project are to incorporate two well validated CPRs (Streptococcal Pharyngitis Prediction Rule and the Pneumonia Clinical Prediction Rule) into an outpatient Electronic Medical Record System (EMR) and to perform a randomized controlled trial of the effectiveness of integrated CPRs impact on doctor's behaviors (e.g. test ordering and medication prescribing).