scholarly journals Randomized clinical trial: does using zinc and zinc ionophore EGCG as supplements improve outcome of active pulmonary tuberculosis

2021 ◽  
Author(s):  
Amr Ahmed ◽  
Mahmoud Elkazzaz
Keyword(s):  
Clinical Trial ◽  
Pulmonary Tuberculosis ◽  
Low Income ◽  
Serum Zinc ◽  
Low Income Countries ◽  
Controlled Clinical Trial ◽  
Public Health Department ◽  
Immunological Parameters ◽  
Clinical Trial Registration ◽  
Active Pulmonary Tuberculosis

Abstract Tuberculosis is a big health challenge especially during the Covid-19 pandemic because of the similarity of symptoms between the two diseases, active pulmonary T.B is associated with malnutrition. Tuberculosis is still a global disease burden worldwide especially at low-income countries affecting families and health authorities because of the cost of medicine and health costs. There are growing numbers of multidrug resistants’ T.B patients. Epigallocatechin-3-gallate (EGCG) as antioxidant and inhibition of mycobacterium life in macrophages increase the potency of rifampicin oral anti-tuberculous drug. EGCG is an iron chelator which can be useful in T.B patients (1). Zinc is the most abundant trace element in the human body, Dabbagh-Bazarbachi et al. (2014) have demonstrated that EGCG can act as an ionophore that helps transport zinc to across cell membrane and exert cytotoxicity effect. EGCG can enhance the cytotoxicity of zinc ions to cancer. It is possible that the zinc(ii)-EGCG complex reduces the pH inside organelles, and might bind effectively to DNA in the nucleus. At our study use of EGCG and zinc as adjuvant therapy to national protocol may help at malnutrition and accelerate of sputum conversion to negative and faster improvement and less risk for infection transmission and lower the inflammatory cytokines like il-6 and increase weight of patients. Methodology: The objective of our study is to evaluate oral zinc administration as zinc sulfate 50 mg and zinc ionophore EGCG 200 mg in new smear positive active pulmonary tuberculosis patients above 18 year old for one month in an open labeled randomized controlled clinical trial (RCT) in line with directly observed treatment short course (DOTS) strategy recommended by WHO. We will do sputum tests at 0 and 2 weeks and 1 month for evaluation of conversion of positive to negative samples and also measure the serum zinc levels before the start of treatment, and serum interleukin 6 as cytokine marker. We are conducting this study at cat I patients as WHO classification of tuberculosis having active lung tuberculosis to see efficacy and change in immunological parameters. Place of study: Saudia Arabia – Ministry of health, public health department, First health cluster, Riyadh, Tuberculosis clinics of Mobile team tuberculosis program.Informed Consent will be taken from patients before the start the study.The clinical trial registration number for this trial is NCT05116098.

Abstract 13345: Efficacy and Safety of an Anticoagulation Clinic in Low-income Brazilian Patients With Heart Disease: a Randomized Clinical Trial

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Maria A Martins ◽  
João A Oliveira ◽  
Daniel D Ribeiro ◽  
Cibele C César ◽  
Vandack A Nobre ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Heart Disease ◽  
Randomized Clinical Trial ◽  
Incidence Rate ◽  
Latin American ◽  
Low Income ◽  
Efficacy And Safety ◽  
Low Literacy ◽  
Clinical Trial Registration ◽  
Group B

Introduction: Anticoagulation clinics (AC) have better impact on anticoagulation control than usual medical care (UMC). However, there is no randomized trial testing the results of AC in low-income realities. We sought to examine the performance of an AC in a group of patients treated at a Brazilian public hospital. Hypothesis: The assistance provided by AC presents difference in TTR when compared to the UMC. Methods: This was a randomized clinical trial to test the efficacy and safety of a recently-implemented AC over UMC in a group of outpatients with heart disease. The primary and secondary endpoints were time in the therapeutic range (TTR) and warfarin-associated complications, respectively. Overall, 280 patients were enrolled and randomly assigned to one of the two arms: group A: one year at AC (A1: first semester; A2: second semester); and group B: one semester receiving UMC (B1) and other at AC (B2). Results: The mean age was 56.8±13.1 years and patients were mostly female (54.6%). The median monthly income was 464 US dollars. Low literacy was predominant in this group of studied patients (>68%). A1 showed higher TTR (62.4±20.8%) than B1 (55.1±28.5%) (p=0.014). An improvement of TTR was observed within group B, rising from 55.1±28.5% (B1) to 62.2±23.1% (B2) (p=0.008). A1 showed lower incidence rate (IR) per patients-year (p-y) of total bleedings than B1 (incidence rate ratio (IRR): 0.78; p=0.041) and a decline in the IR p-y was found for intra-group comparisons, both presenting IRR 0.58; p<0.001. A1 showed lower IR p-y for thromboembolism than B1 (IRR=0.12; p=0.047). (Clinical trial registration: www.clinicaltrials.gov/. Identifier: NCT01006486) Conclusions: AC helped increase TTR and reduce warfarin-complications, even in low-income settings. Extending this assistance to similar populations in other Latin American countries could reduce hospitalizations and deaths related to warfarin use.

scholarly journals Zinc supplementation affects favorably the frequency of migraine attacks: a double-blind randomized placebo-controlled clinical trial

2020 ◽  
Vol 19 (1) ◽  
Author(s):  
Hedieh Ahmadi ◽  
Seyedeh Shabnam Mazloumi-Kiapey ◽  
Omid Sadeghi ◽  
Morteza Nasiri ◽  
Fariborz Khorvash ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Zinc Sulfate ◽  
Zinc Supplementation ◽  
Serum Zinc ◽  
Controlled Clinical Trial ◽  
Anthropometric Measures ◽  
Double Blind ◽  
Link Type ◽  
Migraine Headaches ◽  
Headache Severity

Abstract Background Observational studies have shown a link between zinc deficiency and migraine headaches. We aimed to examine the effect of zinc supplementation on the characteristics of migraine attacks in patients with migraine. Methods This randomized clinical trial was conducted on 80 patients with migraine. Patients were randomly assigned to receive either zinc sulfate (220 mg/d zinc sulfate) or placebo (lactose) for 8 weeks. Anthropometric measures, serum zinc concentrations, and characteristics of migraine attacks (headache severity, frequency and duration of migraine attacks, and headache daily results) were assessed at baseline and end of the trial. Results Compared with the placebo, zinc supplementation resulted in a significant reduction in headache severity (− 1.75 ± 1.79 vs. -0.80 ± 1.57; P = 0.01) and migraine attacks frequency (− 2.55 ± 4.32 vs. -0.42 ± 4.24; P = 0.02) in migraine patients. However, the observed reduction for headache severity became statistically non-significant when the analysis was adjusted for potential confounders and baseline values of headache severity. Other characteristics of migraine attacks including the duration of attacks and headache daily results were not altered following zinc supplementation either before or after controlling for covariates. Conclusion Zinc supplementation had a beneficial effect on the frequency of migraine attacks in migraine patients. Additional well-designed clinical trials with a long period of intervention and different dosages of zinc are required. Trial registration code IRCT20121216011763N23 at www.irct.ir.

A controlled clinical trial of the role of thiacetazone-containing regimens in the treatment of pulmonary tuberculosis in Singapore: Second report

Tubercle ◽  
1974 ◽  
Vol 55 (4) ◽  
pp. 251-260 ◽  
Author(s):  
Singapore Tuberculosis Services ◽  
Brompton Hospital ◽  
British Medical Research Council
Keyword(s):  
Clinical Trial ◽  
Pulmonary Tuberculosis ◽  
Controlled Clinical Trial

scholarly journals Design and Methodology of a Multicenter Randomized Clinical Trial to Evaluate the Efficacy of Tongmai Jiangtang Capsules in Type 2 Diabetic Coronary Heart Disease Patients

2021 ◽  
Vol 12 ◽  
Author(s):  
Yu Wang ◽  
Yilei Guo ◽  
Ye Lei ◽  
Shuwei Huang ◽  
Liping Dou ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Coronary Heart Disease ◽  
Heart Disease ◽  
Vascular Complications ◽  
Complementary Therapy ◽  
Controlled Clinical Trial ◽  
Clinical Trial Registry ◽  
Clinical Trial Registration ◽  
Type 2 Diabetic

Background: Population-based studies have consistently showed an increased incidence of coronary heart disease and cardiac mortality in patients with type 2 diabetes mellitus (T2DM). Tongmai Jiangtang capsules (TJC) are Chinese patent medicines that have been approved in China for the treatment of diabetic vascular complications. However, the evidence supporting the efficacy of Tongmai Jiangtang capsules in type 2 diabetic coronary heart disease (T2DM-CHD) remains unclear. Herein, we designed a randomized, parallel-controlled clinical trial to investigate a new complementary therapy for T2DM-CHD patients.Methods: A total of 360 T2DM-CHD subjects (aged 18–75 years) will be randomly assigned to the TJC group or the placebo group at a 2:1 ratio. On the basis of western medicine therapy, all the participants will receive TJC or placebo, orally, three capsules/treatment, three per day for 12 weeks. The primary outcomes will be assessed according to the Canadian Cardiovascular Society (CCS) classification. All statistical analyses will be performed setting a two-sided 0.05 significance level, using SAS 9.4 statistical software.Discussion: The efficacy of TJC for the treatment of T2DM-CHD patients will be evaluated. The study will provide reliable clinical research evidence for application of TJC in treating T2DM-CHD patients.Clinical Trial Registration:https://www.chictr.org.cn/enIndex.aspx, Chinese Clinical Trial Registry ChiCTR2000037491.

scholarly journals Transvenous Approach for the Treatment of cerebral Arteriovenous Malformations (TATAM): Study protocol of a randomised controlled trial

2019 ◽  
Vol 25 (3) ◽  
pp. 305-309 ◽  
Author(s):  
Robert Fahed ◽  
Tim E Darsaut ◽  
Charbel Mounayer ◽  
René Chapot ◽  
Michel Piotin ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Arteriovenous Malformation ◽  
Arteriovenous Malformations ◽  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
Cerebral Arteriovenous Malformations ◽  
Clinical Trial Registration ◽  
Transarterial Embolisation ◽  
Randomised Controlled ◽  
Transvenous Approach

Background Transvenous embolisation is a promising technique but the benefits remain uncertain. We hypothesised that transvenous embolisation leads to a higher rate of arteriovenous malformation angiographic occlusion than transarterial embolisation. Methods The Transvenous Approach for the Treatment of cerebral Arteriovenous Malformations (TATAM) is an investigator initiated, multicentre, prospective, phase 2, randomised controlled clinical trial. To test the hypothesis that transvenous embolisation is superior to transarterial embolisation for arteriovenous malformation obliteration, 76 patients with arteriovenous malformations considered curable by up to two sessions of endovascular therapy will be randomly allocated 1:1 to treatment with either transvenous embolisation (with or without transarterial embolisation) (experimental arm) or transarterial embolisation alone (control arm). The primary endpoint of the trial is complete arteriovenous malformation occlusion, assessed by catheter cerebral angiography. Complete occlusions will be confirmed at 3 months, while incompletely occluded arteriovenous malformations, considered treatment failures, will then be eligible for complementary treatments by surgery, radiation therapy, or even transvenous embolisation. Standard procedural safety outcomes will also be assessed. Patient selection will be validated by a case selection committee, and participating centres with limited experience in transvenous embolisation will be proctored. Discussion The TATAM trial is a transparent research framework designed to offer a promising but still unvalidated treatment to selected arteriovenous malformation patients. Clinical Trial Registration-URL: http://www.clinicaltrials.gov . Unique identifier: NCT03691870.

Effect of Papacarie and Alternative Restorative Treatment on Pain Reaction during Caries Removal among Children: A Randomized Controlled Clinical Trial

2017 ◽  
Vol 41 (3) ◽  
pp. 219-224 ◽  
Author(s):  
AMG Abdul Khalek ◽  
MA Elkateb ◽  
WE Abdel Aziz ◽  
M El Tantawi
Keyword(s):  
Clinical Trial ◽  
Primary Teeth ◽  
Pediatric Dentistry ◽  
Controlled Clinical Trial ◽  
Kappa Statistics ◽  
Atraumatic Restorative Treatment ◽  
Public Health Department ◽  
Restorative Treatment ◽  
Randomized Controlled ◽  
Caries Removal

Objective: To compare the effect of Papacarie and Atraumatic Restorative Treatment (ART) on pain and discomfort during caries removal among children. Study Design: Fifty healthy, 4–8 year-old children were equally and randomly allocated to Papacarie and ART to remove caries from decayed primary teeth. A randomized, controlled, blinded, two parallel-arms clinical trial was conducted in the clinic of the Pediatric Dentistry and Dental Public Health Department, Alexandria University, Egypt in March 2014. Pain and discomfort were assessed blindly by two independent investigators watching videotaped treatment sessions using the Sound, Eye and Motor scale (SEM). Their reliability was assessed using Kappa statistics. The effect of caries removal methods, time spent to remove caries and other confounders on SEM score was assessed using regression analysis. Results: Mean time to remove caries using Papacarie and ART was 5.8 and 4.8 minutes, P= 0.005. Median Paparie and ART scores for the S, E and M components were 1, 1, 1 and 3, 2, 3. Adjusted mean SEM score= 3.6 and 7.8, P &lt;0.0001. Method of caries removal was the only factor significantly affecting pain and discomfort. Conclusion: Papacarie is associated with minimal pain during caries removal from primary teeth compared to ART, although it has longer working time.

Sign in / Sign up

Export Citation Format

Share Document