A Double Blind Three Center Clinical Trial on the Short-Term Efficacy of 0-(β-Hydroxyethyl)-Rutosides in Patients with Post-Thrombotic Syndrome

1989 ◽  
Vol 62 (03) ◽  
pp. 826-829 ◽  
Author(s):  
A B de Jongste ◽  
J J C Jonker ◽  
M V Huisman ◽  
J W ten Cate ◽  
A J Azar
Keyword(s):  
Clinical Trial ◽  
Treatment Effect ◽  
Clinical Symptoms ◽  
Postthrombotic Syndrome ◽  
Efficacy And Safety ◽  
Short Term ◽  
Double Blind ◽  
Post Thrombotic Syndrome ◽  
The Mean

SummaryA multi-centre, double blind randomized clinical triatr was designed to assess the efficacy and safety of orally administered 0-(β-hydroxyethyl)-rutosides (HR) capsules in the treatment of L0L patients with post-thrombotic syndrome. Seventeen patients were excluded from the analysis for violation of the study protocol, 4l received HR capsules (I,200 mg/day) and 43 placebo.Mean follow-up scores at the 4th and 8th week show that the HR patients displayed an improved state of tiredness as compared to the placebo's. The mean circumference of the calf for the HR group decreased from 390 (± 33) mm at visit one to 382 (± 33) mm at visit three, with a mean circumference reduction of 8.7 (± 8) mm, compared to a steady placebo circumference of 387 (± 31) mm at all 3 visits with a mean circumference reduction of only 2 mm (± 9). The estimated treatment effect at week 8 was −6.7 ffiffi, 95% confidence interval (−10.3, −3.0).The mean circumference of the ankle, decreased from 243 (± 20) mm to 238 (± 20) mm at the 4th week, contrasted with a constant placebo circumference of.24l (± 22) mm at both visits. The estimated treatment effect at week 4 was-5.4 ffiffi, 95% confidence intenral (−10.2, −0.6). However, at week 8, the estimated treatment effect was only −3.4 mm; 95% corrfidence interval (−8.6, + 1.8).In conclusion, HR capsules may show an improvement in the clinical symptoms and may show a mean circumference reduction of the calf and ankle at the 8th week, in patients with postthrombotic syndrome.

scholarly journals Transvaginal natural orifice transluminal endoscopic surgery for uterosacral ligament suspension: pilot study of 35 cases of severe pelvic organ prolapse

BMC Surgery ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Zhiying Lu ◽  
Yisong Chen ◽  
Xiaojuan Wang ◽  
Junwei Li ◽  
Keqin Hua ◽  
...  
Keyword(s):  
Pelvic Organ Prolapse ◽  
Pelvic Organ ◽  
Uterosacral Ligament ◽  
Uterosacral Ligament Suspension ◽  
Efficacy And Safety ◽  
Natural Orifice ◽  
Short Term ◽  
Before And After ◽  
The Mean

Abstract Background To describe the short-term outcomes of transvaginal natural orifice transluminal endoscopic surgery (vNOTES) for uterosacral ligament suspension (USLS) in patients with severe prolapse. Methods This was a retrospective study of patients with severe prolapse (≥ stage 3) who underwent vNOTES for USLS between May 2019 and July 2020. The Pelvic Organ Prolapse Quantification (POP-Q) score, Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form (PISQ-12) and Pelvic Floor Inventory-20 (PFDI-20) were used to evaluate physical prolapse and quality of life before and after vNOTES for USLS. Results A total of 35 patients were included. The mean operative duration was 111.7 ± 39.4 min. The mean blood loss was 67.9 ± 35.8 ml. Statistically significant differences were observed between before and after vNOTES USLS in Aa (+ 0.6 ± 1.7 versus − 2.9 ± 0.2), Ba (+ 1.9 ± 2.2 versus − 2.9 ± 0.3), C (+ 1.5 ± 2.2 versus − 6.9 ± 0.9), Ap (− 1.4 ± 1.0 versus − 3.0 ± 0.1) and Bp (− 1.1 ± 1.4 versus − 2.9 ± 0.1) (P < 0.05 for all). The mean pre- and postoperative PFDI-20 score was 19.9 ± 6.7 and 3.2 ± 5.4, respectively, and the mean pre- and postoperative PISQ-12 score was 24.8 ± 2.3 and 38.3 ± 4.1, respectively (P < 0.05 for both). During 1–13 months of follow-up, there were no cases of severe complications or recurrence. Conclusions vNOTES for USLS may be a feasible technique to manage severe prolapse, with promising short-term efficacy and safety. Larger studies with more patients and longer follow-up periods should be performed to evaluate the long-term efficacy and safety profile of vNOTES for USLS.

Efficacy and safety of Trang Phuc Linh Plus tablets in patients with irritable bowel syndrome-diarrhea

2021 ◽  
Vol 148 (12) ◽  
pp. 68-77
Author(s):  
Pham Thi Van Anh ◽  
Nguyen Phuong Thanh ◽  
Dau Thuy Duong ◽  
Nguyen Thi Thuy ◽  
Dang Thi Ngoc Mai ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Irritable Bowel Syndrome ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Group I ◽  
Randomized Phase Ii ◽  
Irritable Bowel ◽  
Diarrhea Syndrome ◽  
Symptom Recurrence

A double-blind, randomized, phase II clinical trial was conducted within a 14-week follow-up including 2 weeks of the non-drug run-in period, 8 weeks of medication, and 4 weeks of follow-up after discontinuation. The objective of the study was to evaluate the efficacy and safety of Trang Phuc Linh Plus in irritable diarrhea syndrome patients. Group I took Trang Phuc Linh Plus 3 tablets/time x 2 times/day for 8 weeks; Group II took placebo 3 tablets/time x 2 times/day for 8 weeks. Patients will be re-examined, tested, and evaluated over the phone for symptom recurrence and adverse events (AEs). This study showed that the Trang Phuc Linh Plus tablets tended to improve symptoms in patients suffering from irritable bowel syndrome with diarrhea, suggesting its safety and tolerability.

scholarly journals Switching from branded to generic glatiramer acetate: 15-month GATE trial extension results

2017 ◽  
Vol 23 (14) ◽  
pp. 1909-1917 ◽  
Author(s):  
Krzysztof Selmaj ◽  
Frederik Barkhof ◽  
Anna N Belova ◽  
Christian Wolf ◽  
Evelyn RW van den Tweel ◽  
...  
Keyword(s):  
Glatiramer Acetate ◽  
Efficacy And Safety ◽  
Resonance Imaging ◽  
Open Label ◽  
Double Blind ◽  
Disability Status ◽  
Mri Scans ◽  
The Mean ◽  
Magnetic Resonance Imaging Mri

Background: Open-label 15-month follow-up of the double-blind, placebo-controlled Glatiramer Acetate clinical Trial to assess Equivalence with Copaxone® (GATE) trial. Objective: To evaluate efficacy, safety, and tolerability of prolonged generic glatiramer acetate (GTR) treatment and to evaluate efficacy, safety, and tolerability of switching from brand glatiramer acetate (GA) to GTR treatment. Methods: A total of 729 patients received GTR 20 mg/mL daily. Safety was assessed at months 12, 15, 18, 21, and 24 and Expanded Disability Status Scale and magnetic resonance imaging (MRI) scans at months 12, 18, and 24. The presence of glatiramer anti-drug antibodies (ADAs) was tested at baseline and months 1, 3, 6, 9, 12, 18, and 24. Results: The mean number of gadolinium-enhancing lesions in the GTR/GTR and GA/GTR groups was similar at months 12, 18, and 24. The change in other MRI parameters was also similar in the GTR/GTR and GA/GTR groups. The annualized relapse rate (ARR) did not differ between the GTR/GTR and GA/GTR groups, 0.21 and 0.24, respectively. The incidence, spectrum, and severity of reported adverse events did not differ between the GTR/GTR and GA/GTR groups. Glatiramer ADA titers were similar in the GTR/GTR and GA/GTR groups. Conclusion: Efficacy and safety of GTR is maintained over 2 years. Additionally, switching from GA to GTR is safe and well tolerated.

scholarly journals AB0878 THE COMPARISON EFFECTS OF INTRA-ARTICULAR INJECTION OF PLATELET RICH PLASMA (PRP), PLASMA RICH IN GROWTH FACTOR (PRGF), HYALURONIC ACID (HA), AND OZONE IN KNEE OSTEOARTHRITIS; A ONE YEAR RANDOMIZED CLINICAL TRIAL

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1744.3-1745
Author(s):  
S. A. Raeissadat ◽  
P. Ghazi Hosseini ◽  
M. H. Bahrami ◽  
R. Salman Roghani ◽  
M. Fathi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Knee Osteoarthritis ◽  
Randomized Clinical Trial ◽  
Platelet Rich Plasma ◽  
Therapeutic Effects ◽  
Short Term ◽  
Knee Oa ◽  
The Mean

Background:Knee osteoarthritis (OA) as a common progressive degenerative condition is one of the most important leading causes of disability and relative dependence. Worldwide prevalence of symptomatic knee OA has estimated 3.8%. It affects more than 20% of over 45-year-old population. Among the minimally invasive methods recommended for knee OA management is intra-articular injections for which a large array of products have been used. Despite all the existing options, there is still no general consensus on the choice and priority of the best intra-articular injection in knee osteoarthritis.Objectives:Our study compare the short and long-term efficacy of the intra articular injections (IAIs) of hyaluronic acid (HA), platelet-rich plasma (PRP), plasma rich in growth factors (PRGF), and ozone in patients with knee osteoarthritis (OA).Methods:In this single-blinded randomized clinical trial, 238 patients with mild to moderate knee OA were randomized into4 groups of IAIs: HA (3 doses weekly), PRP (2 doses with 3 weeks interval), PRGF (2 doses with 3 weeks interval), and Ozone (3 doses weekly). Our outcome measures were the mean changes from baseline until 2,6, and 12 months post intervention in scores of visual analog scale, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and Lequesne index.Results:A total of 200 patients enrolled final analysis. The mean age of patients was 56.9 ± 6.3 years, and69.5% were women. In 2 months follow up, significant improvement of pain, stiffness, and function were seen in all groups compared to the baseline, but the ozone group had the best results(P<0.05). In 6 month follow up HA, PRP, and PRGF groups demonstrated better therapeutic effects in all scores in comparison with ozone (P<0.05).At the end of the 12th month, only PRGF and PRP groups had better results versus HA and ozone groups in all scores (P<0.05).Despite the fact that ozone showed better early results, its effects begin to wear off earlier than other products and ultimately disappear in 12 months.Conclusion:Ozone injection had rapid effects and better short-term results after 2 months, but its therapeutic effects did not persist after 6 months and at the 6-month follow up, PRP,PRGF and HA were superior to ozone. Only patients in PRP and PRGF groups improved symptoms persisted for 12 months. Therefore, these products could be the preferable choices for long-term management.References:[1]Wang-Saegusa A, Cugat R, Ares O, Seijas R, Cuscó X, Garcia-Balletbó M. Infiltration of plasma rich in growth factors for osteoarthritis of the knee short-term effects on function and quality of life. Archives of orthopaedic and trauma surgery. 2011;131(3):311-7.[2]De La Mata J. Platelet rich plasma.A new treatment tool for the rheumatologist?ReumatologíaClínica (English Edition). 2013;9(3):166-71.[3]Raeissadat SA, Rayegani SM, Sedighipour L, Bossaghzade Z, Abdollahzadeh MH, Nikray R, et al. The efficacy of electromyographic biofeedback on pain, function, and maximal thickness of vastus medialis oblique muscle in patients with knee osteoarthritis: a randomized clinical trial. Journal of pain research. 2018;11:2781.[4]Lawrence RC, Felson DT, Helmick CG, Arnold LM, Choi H, Deyo RA, et al. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States: Part II. Arthritis & Rheumatism. 2008;58(1):26-35.[5]Tehrani-Banihashemi A, Davatchi F, Jamshidi AR, Faezi T, Paragomi P, Barghamdi M. Prevalence of osteoarthritis in rural areas of I ran: a WHO-ILAR COPCORD study. International journal of rheumatic diseases. 2014;17(4):384-8.[6]Rayegani SM, Raeissadat SA, Heidari S, Moradi-Joo M. Safety and effectiveness of low-level laser therapy in patients with knee osteoarthritis: a systematic review and meta-analysis. Journal of lasers in medical sciences. 2017;8(Suppl 1):S12.Disclosure of Interests:None declared

scholarly journals The Efficacy and Safety of Longmu Tang Granule for Treating Atopic Dermatitis: Study Protocol for a Single-Centered, Double-Blinded, Randomized Controlled Trial

2021 ◽  
Author(s):  
YAQIN LI ◽  
TAOTAO SHEN ◽  
QINGYING WANG ◽  
MENGXI MA ◽  
FENGYAN TIAN ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Atopic Dermatitis ◽  
Clinical Symptoms ◽  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Randomized Controlled ◽  
Limited Effectiveness

Abstract Background: Atopic dermatitis (AD) is a chronic relapsing skin disease that has long-term adverse effects on the physical and mental health of children. Current treatments mainly include anti-inflammatory, antibacterial, and anti-allergic interventions, systemic therapy and recently emerging targeted agents. However, these treatments have limited effectiveness and bothersome side effects. The use of traditional Chinese medicine (TCM) is associated with safety and improvements in the clinical symptoms and quality of life of AD patients. However, the poor quality and heterogeneity of studies have not led to sufficient conclusions. Therefore, we will conduct a randomized, controlled, double-blind clinical trial to confirm the efficacy and safety of Longmu Tang granule for the treatment of AD.Methods: This is a single-center, double-blind, randomized, controlled clinical trial. A total of 60 participants will be randomly assigned (1:1) to receive Longmu Tang granule or placebo granule for 8 weeks. The primary outcome is the index of Scoring Atopic Dermatitis (SCORAD). The second outcomes include the children's Dermatology Life Quality Index (CDLQI) and the Number Cancel Test (NCT), and long-term efficacy. Mechanistic outcome is the serum level of inflammatory cytokines, including IgE, tumor necrosis factor (TNF) -α, interleukin-1 (IL-1) and interleukin-6 (IL-6).Discussion: The results of this trial will provide evidence on the efficacy and safety of Longmu Tang granule and prove anti-inflammation of Longmu Tang granule for patients with AD.Trial registration: Chinese Clinical Trial Registry Chictr.org ID: ChiCTR2100041591. Registered on 1 January 2021. https://www.chictr.org.cn/showproj.aspx?proj=62586

scholarly journals Study on efficacy and safety of Tong-luo Qu-tong plaster treatment for knee osteoarthritis: study protocol for a randomised, double-blind, parallel positive control, multi-center clinical trial

2019 ◽  
Author(s):  
Bao-ping Xu ◽  
Min Yao ◽  
Zi-rui Tian ◽  
Long-yun Zhou ◽  
Long Yang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Knee Osteoarthritis ◽  
Clinical Symptoms ◽  
Positive Control ◽  
Control Group ◽  
Efficacy And Safety ◽  
Adhesive Plaster ◽  
Double Blind ◽  
Experimental Group

Abstract Background: Knee osteoarthritis (KOA) is a common chronic musculoskeletal disorder that seriously affect quality of life. Patients with KOA frequently develop one or more of the typically following symptoms: joint pain, stiffness, joint friction noise, impaired functionality. Traditional Chinese medicines (TCM) have showed a superior effect and peculiar advantage on the treatment of KOA, among TCMs, the Tong-luo Qu-tong plaster is the convenient and most commonly used method in China to improve symptoms including pain, stiffness and limited mobility in patients with KOA, as it causes few adverse effects. But there is a lack of high quality of clinical evidences to support the therapeutic effect that Chinese adhesive plaster can relieve pain and stiffness. The purpose of this study will be to evaluate the efficacy and safety of Tong-luo Qu-tong plaster in patients with KOA. Methods/Design: This study will be a randomised, double-blind, parallel positive control, multi-center clinical trial, a non-inferiority trial design was adopted. A total of 2000 participants older than 40 years with KOA, will be randomly allocated into a experimental group (n=1500) and a control group (n=500). All participants will receive a conventional conservative treatment lasted for 14 days as two courses, daily 1 time. Tong-luo Qu-tong plaster will be administered externally to participants in the experimental group, while the control group will receive a Qi-zheng Xiao-tong plaster. The outcome of the total Western Ontario and McMaster Universities Arthritis Index scores, TCM syndrome quantitative score, visual analog scale scores will be measured during the assessment visits (baseline and 1-, 2-week follow-up). In addition, adverse events concerning clinical symptoms and signs as well as laboratory tests will be documented during clinical trials. Discussion: This study will be a randomized, double-blind, parallel positive control trial to further evaluate the effectiveness and safety of Tong-luo Qu-tong plaster for patients with KOA in nine medical centers compared with control group, it is expected that the patients with KOA will benefit from this study.

scholarly journals Efficacy and safety of Chinese medicine JCM-16021 for diarrhea-predominant irritable bowel syndrome: study protocol for a multi-center, randomized, double-blind, placebo controlled clinical trial

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Ya Zheng ◽  
Jessica Ching ◽  
Chung Wah Cheng ◽  
Wai Ching Lam ◽  
Kam Leung Chan ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Irritable Bowel Syndrome ◽  
Chinese Medicine ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Irritable Bowel

Abstract Background Irritable bowel syndrome (IBS) is a common gastrointestinal functional disease. Adults with IBS may experience abdominal pain, change of bowel habits, and abnormal stool form without organic disease. IBS can seriously affect their work productivity and quality of life, especially diarrhea-predominant irritable bowel syndrome (IBS-D). The Chinese medicine JCM-16021 has been shown to be potentially effective in improving the symptoms of IBS-D based on a small scale clinical trial. Hence, a large scale clinical study is designed to further evaluate the efficacy and safety of the Chinese medicine JCM-16021 for IBS-D with traditional Chinese medicine (TCM) pattern of Liver Stagnation and Spleen Deficiency (LSSD). Methods This study is a multi-center, randomized, double-blind, placebo-controlled clinical trial. 392 eligible participants will be enrolled with 2-week run-in, 8-week treatment and 8-week follow-up. After run-in period, participants will be randomized to receive either the Chinese medicine JCM-16021 or placebo for 8 weeks, and will have post-treatment follow up for another 8 weeks. The primary outcome is the improvement rate on the global assessment of improvement (GAI) at week 10. The secondary outcomes consist of changes of IBS-D symptoms, TCM pattern improvement, IBS-Quality of Life (IBS-QoL), IBS-Symptom Severity Score (IBS-SSS), safety, etc. Results A standard protocol has been developed for the study. The protocol will provided a detailed procedure to conduct a clinical trial and verify if the Chinese medicine JCM-16021 would significantly improve the overall symptoms of IBS-D with LSSD pattern of TCM by relieving abdominal pain, reducing stool frequency, improving the stool consistency and improving quality of life. The consolidated evidence from the study can shed light on the treatment of IBS-D with Chinese medicine. Conclusion The protocol will provide details for investigators about the study following SPIRIT Statement. High-quality evidence on the efficacy and safety of Chinese medicine JCM-16021 for IBS-D will be provided through strict compliance with the protocol. Trial registration: ClinicalTrial.gov identifier: NCT03457324. Registered 8 February 2018, https://clinicaltrials.gov/ct2/show/NCT03457324?term=NCT03457324&draw=2&rank=1

scholarly journals 63 Short term results of intra-vitreal bevacizumab for the treatment of macular edema secondary to retinal vein occlusion

2013 ◽  
Vol 5 (1) ◽  
pp. 63-68
Author(s):  
R Thapa ◽  
G Paudyal
Keyword(s):  
Macular Edema ◽  
Retinal Vein Occlusion ◽  
Retinal Thickness ◽  
Intravitreal Bevacizumab ◽  
Efficacy And Safety ◽  
Interventional Study ◽  
Short Term ◽  
Vein Occlusion ◽  
The Mean

Introduction: Macular edema (ME) is the leading cause of visual impairment in retinal vein occlusion (RVO). Objective: To evaluate the efficacy and safety of intravitreal bevacizumab (Avastin; Genentech) on ME secondary to RVO. Materials and methods: A prospective, interventional study was conducted among patients with ME due to RVO from June 2008 to February 2010. Intravitreal bevacizumab (1.25 mg/0.05 ml) was given at 4 to 6 weekly intervals until the ME subsided. Complete ophthalmic evaluation and measurement of central retinal thickness (CRT) by optical coherence tomography (OCT) were performed at baseline and follow up visits. Results: Thirty four eyes (18 CRVO and 16 BRVO) were included in the study. The mean duration of visual symptoms and follow up period were 5.1 months (range 0.3 - 24 months) and 7.5 ± 4.8 months respectively. In CRVO, the CRT improved from 652 ± 206 ?m at the baseline to 257 ± 132 ?m (p < 0.0001) at the final follow up, and in BRVO, the CRT improved from 540 ±197 ?m to 219 ± 135 ?m (p < 0.0001). The improvement in BCVA was significant at each follow up interval for BRVO; in CRVO, there was only a significant improvement between the baseline and the 6 weeks’ follow up. BCVA was improved in 75 % cases of BRVO and in 61.6 % in CRVO at the final follow up. There were no ocular or systemic adverse effects. Conclusion: Intravitreal bevacizumab is an effective and safe drug for reducing ME and improving visual acuity secondary to RVO in the short term follow up. Nepal J Ophthalmol 2013; 5(9):63-68 DOI: http://dx.doi.org/10.3126/nepjoph.v5i1.7824

scholarly journals Efficacy and safety of fluocinolone acetonide 0.025% otic solution in patients with otic eczema: a randomized, double-blind, placebo-controlled clinical trial

2018 ◽  
Vol 46 (10) ◽  
pp. 4050-4060 ◽  
Author(s):  
Victoria Montoro ◽  
Carlos Asensio ◽  
Ángel Martínez ◽  
Juan Lorente ◽  
Francisco J. Rodríguez ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Fluocinolone Acetonide ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Phase 3 ◽  
Double Blind ◽  
Solution Versus ◽  
Parallel Group ◽  
End Of Treatment

Objectives To assess the efficacy and safety of fluocinolone acetonide 0.025% otic solution versus placebo in treating patients with otic eczema. Methods In this multicentre, randomized, double-blind, parallel-group phase 3 clinical trial, conducted at 12 Spanish centres between March 2012 and March 2013, patients received fluocinolone acetonide 0.025% or placebo otic solution twice daily for 7 days (days 1–7) with an 8-day follow-up (days 9–15). Outcome measures included change in itching from baseline (day 1) to study days 4–8 and 9–15, and change in otoscopic signs (erythema, oedema, and scaling) from baseline to the end of treatment (day 8) and end of follow-up (day 15). Results Patients treated with fluocinolone acetonide 0.025% (n = 66), as compared with placebo-treated patients (n = 69), showed significantly higher reductions in itching from baseline to study days 4–8 and 9–15, and in individual and global otoscopic signs from baseline to the end of treatment (day 8) and end of follow-up (day 15). Incidence and severity of adverse events was similar between the fluocinolone and placebo groups. Conclusions Fluocinolone acetonide 0.025% otic solution, administered twice daily for 7 days, is an effective and safe treatment for otic eczema.

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