Evaluation of the Efficacy and Safety of Topical Imiquimod 5% for Plaque-Type Morphea: A Multicenter, Prospective, Vehicle-Controlled Trial

2015 ◽  
Vol 19 (2) ◽  
pp. 132-139 ◽  
Author(s):  
Marlene Dytoc ◽  
Heidi Wat ◽  
Melody Cheung-Lee ◽  
Douglas Sawyer ◽  
Thomas Ackerman ◽  
...  
Keyword(s):  
Adverse Effects ◽  
Treatment Efficacy ◽  
Therapeutic Potential ◽  
Controlled Trial ◽  
Evidence Based ◽  
Efficacy And Safety ◽  
Plaque Type ◽  
Ultrasound Evaluation ◽  
Histologic Evaluation ◽  
Diet Score

Background There is currently a lack of evidence-based therapies that are safe and effective for plaque-type morphea. We aimed to evaluate the therapeutic potential and safety profile of imiquimod 5% cream in plaque-type morphea. Methods We enrolled 25 adult patients from two Canadian centers with histologically confirmed plaque-type morphea. Imiquimod 5% was applied to a representative plaque, and vehicle was applied to a control plaque for 9 months. Treatment efficacy was assessed with the Dyspigmentation, Induration, Erythema, and Telangiectasias (DIET) score, histology, and ultrasound evaluation. Results and Conclusions Twenty-two patients completed the entire length of the study. Imiquimod 5% was superior to vehicle in reducing DIET scores at 3, 6, 9, and 12 months ( p < .05). Induration demonstrated the greatest response. Histologic evaluation showed significant improvement or resolution of disease. However, no ultrasonographic differences were found in dermal and hypodermal thicknesses between the treatment and vehicle groups ( p > .05). Adverse effects were minimal and well tolerated.

scholarly journals A Randomized Controlled Trial of the Efficacy of Systemic Enzymes and Probiotics in the Resolution of Post-COVID Fatigue

Medicines ◽  
2021 ◽  
Vol 8 (9) ◽  
pp. 47
Author(s):  
Abhijit Rathi ◽  
Swati B. Jadhav ◽  
Neha Shah
Keyword(s):  
Treatment Efficacy ◽  
Controlled Trial ◽  
Placebo Treatment ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Time Points ◽  
Randomized Controlled ◽  
Cognitive Disturbances ◽  
Oral Supplements

Muscle fatigue and cognitive disturbances persist in patients after recovery from acute COVID-19 disease. However, there are no specific treatments for post-COVID fatigue. Objective: To evaluate the efficacy and safety of the health supplements ImmunoSEB (systemic enzyme complex) and ProbioSEB CSC3 (probiotic complex) in patients suffering from COVID-19 induced fatigue. A randomized, multicentric, double blind, placebo-controlled trial was conducted in 200 patients with a complaint of post-COVID fatigue. The test arm (n = 100) received the oral supplements for 14 days and the control arm (n = 100) received a placebo. Treatment efficacy was compared using the Chalder Fatigue scale (CFQ-11), at various time points from days 1 to 14. The supplemental treatment resulted in resolution of fatigue in a greater percentage of subjects in the test vs. the control arm (91% vs. 15%) on day 14. Subjects in the test arm showed a significantly greater reduction in total as well as physical and mental fatigue scores at all time points vs. the control arm. The supplements were well tolerated with no adverse events reported. This study demonstrates that a 14 days supplementation of ImmunoSEB + ProbioSEB CSC3 resolves post-COVID-19 fatigue and can improve patients’ functional status and quality of life.

scholarly journals Efficacy and Safety of Hou Gu Mi Xi on Spleen Qi Deficiency in Patients with Nonorganic Gastrointestinal Disorders: Protocol for a Multicenter, Randomized, Placebo-Controlled Trial

2018 ◽  
Vol 2018 ◽  
pp. 1-8
Author(s):  
Xiaofan Chen ◽  
Heyun Nie ◽  
Wenjun Liu ◽  
Xu Zhou ◽  
Jianhua Nie ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Gastrointestinal Diseases ◽  
Ethics Committee ◽  
Gastrointestinal Disorders ◽  
Evidence Based ◽  
Research Model ◽  
Efficacy And Safety ◽  
Medical Treatments ◽  
Study Population ◽  
Double Blinded

Background. There is a worldwide epidemic of nonorganic gastrointestinal disorders (NOGDs), which are a class of disorders that cause various discomforts and ultimately progress into organic gastrointestinal diseases. Because of the unsatisfactory efficacy of Western medical treatments, traditional Chinese medicine (TCM) is becoming a promising complementary and alternative treatment to manage NOGDs. Objectives. To investigate the efficacy and safety of Hou Gu Mi Xi (HGMX), a newly developed dietary TCM formula, on the syndrome of spleen qi deficiency (SQD) in patients with NOGDs. Methods/Design. This study is a multicenter, randomized, double-blinded, parallel, and placebo-controlled trial that will last for 2 years. All qualified subjects with NOGDs and SQD will be included. The study population will be divided into the HGMX and placebo groups. To assess the efficacy of HGMX, we will mainly focus on changes in SQD symptoms scored by a Spleen Qi Deficiency Symptoms Grading and Quantifying Scale and evaluate changes in gastrin-17, the negative Helicobacter pylori conversion rate, body weight, body mass index, and gastroscopy findings. The safety of HGMX will be assessed by recording adverse events (AEs), severe AEs, treatment-related AEs and withdrawal due to AEs. Discussion. This trial is part of our study series that intends to validate the potential of HGMX in the management of chronic gastrointestinal diseases. This series of RCTs is the first committed to the evaluation of a dietary TCM formula and will hopefully establish an evidence-based clinical research model for dietary TCM formulas. Ethics. The protocol was approved by Ethics Committee of five research hospitals and was registered in Clinicaltrials.gov (NCT03019042).

scholarly journals Efficacy and Safety of Carbetocin in Comparison to Oxytocin in the Active Management of Third Stage of Labour Following Vaginal Delivery: An Open Label Randomized Control Trial

2016 ◽  
Vol 30 (1) ◽  
pp. 3-9 ◽  
Author(s):  
Nazneen Kabir ◽  
Dilruba Akter ◽  
Tahmina Afrin Daisy ◽  
Sonia Jesmin ◽  
Mollika Razzak ◽  
...  
Keyword(s):  
Blood Transfusion ◽  
Adverse Effects ◽  
Blood Loss ◽  
Vaginal Delivery ◽  
Controlled Trial ◽  
Active Management ◽  
Efficacy And Safety ◽  
Open Label ◽  
Massive Blood Loss ◽  
Third Stage

Objective(S):This study was conducted to evaluate the efficacy and safety of carbetocin in comparison to oxytocin in the active management of third stage of labour following vaginal delivery.Methods:A randomized-controlled trial was conducted in the Institute of Child and Mother Health (ICMH), Dhaka, Bangladesh over a period of nine months from January to September, 2015. Patients who got admitted in ICMH with labour pain were assessed by general examination, abdominal examination and labour status was confirmed by per vaginal examination. On the basis of selection criteria total 94 pregnant women who had undergone vaginal delivery were randomized for two groups of drugs. According to computer generated randomization sequential number was allocated for cases. One group of patients received intravenous 100 micro gram carbetocin and another group of patients received intramuscular 10 IU oxytocin in third stage of labour. Outcome measures such as amount of blood loss in 24 hours, primary PPH, massive blood loss, need of fundal massage, need for additional uterotonic therapy, blood transfusions as well as other adverse effects were all documented.Results: In this study, massive blood loss did not occur in any of patients in carbetocin group. But massive blood loss occurred in 8.5% women of oxytocin group. Further fundal massage, immediate blood transfusion and additional uterotonics were not needed by any patient in carbetocin group. In oxytocin group, fundal massage required in 10.6% of women, blood transfusion was needed for 6.4% patients and additional uterotonics was needed for 10.6% women. Average amount of blood loss were 64 ml less in carbetocin group and adverse effects of drugs were almost similar in both groups. Primary PPH was developed 6.4% in oxytocin group but none of patients developed PPH in carbetocin group.Conclusion: Carbetocin appears to be an effective new drug in the active management of third stage of labour in vaginal delivery. A single dose of 100 microgram IV carbetocin is more effective than oxytocin for maintaining adequate uterine tone, less blood loss and preventing postpartum bleeding in women undergoing vaginal delivery. So, carbetocin can be considered as a good alternative to oxytocin in the active management of third stage of labour in vaginal deliveryBangladesh J Obstet Gynaecol, 2015; Vol. 30(1) : 3-9

scholarly journals Danhong Injection Combined With Naoxintong Capsule in Patients With Acute Coronary Syndrome Patients Undergoing PCI: Study Protocol for a Randomized Controlled Trial

2021 ◽  
Author(s):  
hairong cai ◽  
Luo Sicong ◽  
Gao Huanjia ◽  
Liu Shuling ◽  
Zhao Shuai ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Acute Coronary Syndrome ◽  
Controlled Trial ◽  
Coronary Intervention ◽  
Major Adverse Cardiovascular Events ◽  
Controlled Clinical Trial ◽  
Evidence Based ◽  
Efficacy And Safety ◽  
Coronary Syndrome ◽  
Danhong Injection

Abstract Background: Acute coronary syndrome (ACS) is a group of clinical syndromes caused by thrombosis caused by rupture of coronary atherosclerotic plaque or erosion ulcer, resulting in complete or incomplete occlusion of blood vessels. ACS is the most common cardiovascular critical disease. Although with the development of coronary intervention technology, the incidence of major adverse cardiovascular events (MACE) is still high. In China, traditional Chinese medicine (TCM) has been widely used in the adjuvant treatment of ACS to improve the symptoms and prognosis. Danhong injection (DHI) and Naoxintong capsule (NXTC) may improve the prognosis of patients with ACS, but the evidence-based evidence is still insufficient. The main purpose of this study was to evaluate the efficacy and safety of DHI combined with NXTC in the treatment of ACS.Methods/design:This is a randomized, placebo-controlled clinical trial.1752 patients with ACS undergoing percutaneous coronary intervention (PCI) will be randomly assigned to receive DHI combined with NXTC or placebo at the ratio of 1:1. The course of treatment was 12 weeks. All participants received conventional treatment. The main outcome measure was the 12-months incidence of MACEs. Adverse events (AE) will also be evaluated.Discussion:This trial is a well designed study according to principles and regulations issued by the China food and Drug Administration (CFDA). The results will provide high-quality evidence for the efficacy and safety of DHI combined with NXTC in the treatment of ACS. The results of this study can provide clinicians with evidence-based recommendations for treatment of ACS.Trial registration：Chinese Clinical Trial Registry(http://www.chictr.org.cn/index.aspx), ChiCTR-IOR-14005693.Registered on November 12,2014.

scholarly journals A chronic protocol of bilateral transcranial direct current stimulation over auditory cortex for tinnitus treatment: Dataset from a double-blinded randomized controlled trial

F1000Research ◽  
2018 ◽  
Vol 7 ◽  
pp. 733 ◽  
Author(s):  
Ali Yadollahpour ◽  
Miguel Mayo ◽  
Nader Saki ◽  
Samaneh Rashidi ◽  
Arash Bayat
Keyword(s):  
Adverse Effects ◽  
Auditory Cortex ◽  
Direct Current ◽  
Transcranial Direct Current Stimulation ◽  
Therapeutic Potential ◽  
Controlled Trial ◽  
Direct Current Stimulation ◽  
Secondary Outcomes ◽  
Double Blinded

Preliminary studies have demonstrated the therapeutic potential of transcranial direct current stimulation (tDCS) for chronic tinnitus. However, the findings are controversial and most of the studies investigated effects of a single session of tDCS and short after-effects, ranging from hours to days. To our knowledge, there is no published study investigating the effects of a chronic protocol of bilateral tDCS over auditory cortex (AC) with one month follow-up in a double blinded randomized clinical trial. This dataset presents the results of a double-blinded placebo controlled trial investigating the effects of chronic protocol (10 sessions) of tDCS over AC with 1 month follow-up. The data of the two groups, real tDCS (n=25) and sham tDCS (n=15), are reported. The dataset includes three main data groups: patient- and tinnitus-specific data, data of the primary and secondary outcomes, and data on the adverse effects of and tolerability to tDCS. The first group includes demographic information, audiometric assessments, and tinnitus-specific characteristics. The second group includes tinnitus handicap inventory (THI) scores, tinnitus loudness, and tinnitus related distress based on 0-10 numerical visual analogue scale (VAS) scores. The values of the primary and secondary outcomes for pre-intervention and at different time points following interventions are presented. THI scores pre-intervention and immediately post-intervention and at 1 month follow-up; the scores of tinnitus loudness and distress scores for pre-intervention, and immediately, 1 hour, 1 week, and at 1 month after the last stimulation session are presented. Moreover, the adverse effects of and tolerability to the tDCS were assessed using a customized questionnaire after the last tDCS session. This dataset can be used alone or in combination with other datasets using advanced statistical analyses and modeling to investigate the treatment efficacy of tDCS in chronic intractable tinnitus.

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