scholarly journals The Effect of Sodium Tanshinone IIA Sulfate and Simvastatin on Elevated Serum Levels of Inflammatory Markers in Patients with Coronary Heart Disease: A Study Protocol for a Randomized Controlled Trial

2013 ◽  
Vol 2013 ◽  
pp. 1-8 ◽  
Author(s):  
Qinghua Shang ◽  
Hanjay Wang ◽  
Siming Li ◽  
Hao Xu
Keyword(s):  
Inflammatory Markers ◽  
Controlled Trial ◽  
Blood Stasis ◽  
Elevated Serum ◽  
Tanshinone Iia ◽  
Blood Stasis Syndrome ◽  
Randomized Controlled ◽  
Hs Crp ◽  
Experimental Group ◽  
Circulating Inflammatory Markers

Background. Coronary heart disease (CHD) due to atherosclerotic inflammation remains a significant threat to global health despite the success of the lipid-lowering, anti-inflammatory statins. Tanshinone IIA, a potent anti-inflammatory compound derived from Traditional Chinese Medicine (TCM), may be able to supplement statins by further reducing levels of circulating inflammatory markers correlated to cardiovascular risk. Here, we present the protocol of a randomized controlled trial (RCT) that will investigate the synergistic effect of sodium tanshinone IIA sulfate and simvastatin on reducing elevated inflammatory markers in patients with CHD. Participants: Seventy-two inpatients with confirmed CHD, elevated serum high-sensitivity C-reactive protein (Hs-CRP) level, and a TCM diagnosis of blood stasis syndrome will be enrolled and randomized 1 : 1 into the control or experimental group.Intervention. All subjects will receive a standard Western therapy including 20 mg simvastatin orally once per evening. Patients in the experimental group will additionally receive a daily 80 mg dose of sodium tanshinone IIA sulfate intravenously, diluted into 250 mL 0.9% NaCl solution. The treatment period will be 14 days.Outcomes. Primary outcome parameter: serum Hs-CRP level. Secondary outcome parameters: other circulating inflammatory markers (including IL-6, TNFα, VCAM-1, CD40, sCD40L, MCP-1, and MMP-9), improvement in symptoms of angina and blood stasis syndrome, and safety. This trial is registered withChiCTR-TRC-12002361.

scholarly journals Efficacy of Guizhi Fuling Wan for primary dysmenorrhea: protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Yun Du ◽  
Yatong Li ◽  
Xianyun Fu ◽  
Chenjie Li ◽  
Lou Yanan
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Blood Stasis ◽  
The Self ◽  
Blood Stasis Syndrome ◽  
Control Group ◽  
Primary Dysmenorrhea ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Self Rating

Abstract Background Primary dysmenorrhea (PD) is one of the main gynecological complaints in women of child-bearing age, but limited effective treatments are available. Guizhi Fuling Wan (GFW), one of the most widely known traditional Chinese medicine (TCM) formulations, has been commonly used in clinical practice to treat gynecological disorders in China. In recent years, a growing number of studies have shown that GFW is beneficial for patients with PD. However, the quality of evidence is limited, and there are few studies on specific TCM syndromes of GFW for PD. Therefore, we plan to conduct a randomized controlled trial to explore the efficacy and safety of GFW for PD patients with heat-burning blood-stasis syndrome. Methods and analysis The clinical study is a randomized, double-blinded, placebo-controlled trial. Eligible patients will be randomly assigned to the GFW group (treated with GFW) and the control group (treated with a matching placebo) in a 1:1 ratio for three menstrual cycles with a 3-month follow-up. The primary outcome will be the mean change of pain intensity measured by the visual analog scale (VAS). The secondary outcomes will include the Cox Menstrual Symptom Scale (CMSS), the Self-rating Depression Scale (SDS), the Self-rating Anxiety Scale (SAS), and the TCM syndrome scale. Adverse events will also be reported. Discussion This randomized trial will be the first rigorous study designed to assess the efficacy and safety of GFW in treating PD with heat-burning blood-stasis syndrome. The finding of this study will provide an objective clinical basis for the use of GFW for PD in the future. Trial registration Chinese Clinical Trial Registry ChiCTR2000034118. Registered on 24 June 2020

scholarly journals EXPRESS: Bufei Huoxue Capsules in the management of convalescent COVID-19 infection: study protocol for a multicentre, double-blind, and randomized controlled trial

2021 ◽  
pp. 204589402110321
Author(s):  
Yuqin Chen ◽  
Wenjun He ◽  
Wenju Lu ◽  
Yue Xing ◽  
Jianling Bai ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Blood Stasis ◽  
Blood Stasis Syndrome ◽  
Small Scale ◽  
Control Group ◽  
Cumulative Number ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Number Of Patients

Up to the 30th May, 2021, the cumulative number of patients diagnosed with Corona Virus Disease-19 (COVID-19) globally has exceeded 170 million, with more than 152 million patients recovered from COVID-19. However, the long-term effect of the virus infection on the human body’s function is unknown for convalescent patients. It was reported that about 63% of COVID-19 patients had observable lung damage on CT scans after being released from the hospital. Bufei Huoxue Capsules (BFHX), including three active ingredients of traditional Chinese herbal medicine, has been used clinically to prevent and treat pulmonary heart diseases with Qi deficiency and blood stasis syndrome. Some small-scale clinical trials have found that BFHX can improve lung ventilation function, reduce blood viscosity, and improve cardiopulmonary function. However, the efficacy and safety of BFHX in the treatment of the recovery phase of COVID-19 are unknown. This study is a multicentre, double-blinded, randomized, controlled trial. Subjects with convalescent COVID-19 were randomized (1:1) into either a BFHX or control group and observed for 3months concomitant with receiving routine treatment. The primary efficacy indicators are the evaluation results and changes of the St. George’s Respiratory Questionnaire (SGRQ) score, Fatigue Assessment Inventory (FAI), and 6-minute walk distance (6MWD). Based on the intention-to-treat (ITT) principle, all randomly assigned participants will be included in the statistical analysis. The last visit’s outcomes will be used as the final outcomes for participants who prematurely withdraw from the trial. Per protocol set will pick up from the full analysis set for analysis. Efficacy analysis will be performed on the ITT datasets and per-protocol datasets. Prior to participation, all subjects provided written informed consent. Results will be disseminated at medical conferences and in journal publications. We aimed to determine the efficacy and safety of BFHX for the treatment of the convalescent COVID-19 patients.

scholarly journals Effect of Vitamin D Supplementation on Inflammatory Markers in Non-Obese Lebanese Patients with Type 2 Diabetes: A Randomized Controlled Trial

Nutrients ◽  
2020 ◽  
Vol 12 (7) ◽  
pp. 2033
Author(s):  
Cynthia El Hajj ◽  
Stéphane Walrand ◽  
Mariana Helou ◽  
Kaissar Yammine
Keyword(s):  
Type 2 Diabetes ◽  
Vitamin D ◽  
Inflammatory Markers ◽  
Controlled Trial ◽  
Vitamin D Supplementation ◽  
Serum Concentrations ◽  
Randomized Controlled ◽  
Tnf Α ◽  
Hs Crp

Background: A low serum 25-hydroxyvitamin D (25(OH) D) concentration has been associated with a higher risk of type 2 diabetes mellitus (T2DM), especially in older people. Our aim in this randomized controlled trial was to evaluate the effect of vitamin D treatment on inflammatory markers in non-obese Lebanese patients with T2DM, living in Beirut, Lebanon. Methods: Non-Obese patients with T2DM (n = 88), deficient/insufficient in vitamin D, were randomly assigned into one of two groups—a treatment group receiving 30,000 IU cholecalciferol/week for a period of six months, and a placebo group. Serum concentrations of TNF-α, high-sensitivity C-reactive protein (hs-CRP), and Interleukin-6 (IL-6) were the primary outcomes. A homeostatic model of insulin resistance (HOMA-IR) was assessed, in addition to serum concentrations of fasting blood glucose (FBG), HbA1C, (25(OH) D), and PTH. Results: The vitamin D group showed higher blood levels of (25(OH) D) (p < 0.0001), and a significant reduction in hs-CRP and TNF-α concentrations (p < 0.0001) compared to placebo. The decrease perceived in IL-6 concentrations was not significant (p = 0.1). No significant changes were seen in FBG (p = 0.9) and HbA1c levels (p = 0.85). Conclusion: Six months of vitamin D supplementation led to a decrease in some inflammatory markers in patients with T2DM. Additional studies with a larger sample and a longer period are advised in this regard. This trial was registered at ClinicalTrial.gov; Identifier number: NCT 03782805.

scholarly journals Efficacy of axial TheraTogs on gait pattern in children with dyskinetic cerebral palsy: a randomized controlled trial

2021 ◽  
Vol 26 (1) ◽  
Author(s):  
Shamekh Mohamed El-Shamy ◽  
Ehab Mohamed Abd El Kafy
Keyword(s):  
Cerebral Palsy ◽  
Physical Therapy ◽  
Muscle Tone ◽  
Controlled Trial ◽  
Gait Pattern ◽  
Controlled Study ◽  
Control Group ◽  
Randomized Controlled ◽  
Gait Parameters ◽  
Experimental Group

Abstract Background TheraTogs promotes proprioceptive sense of a child with cerebral palsy and improves abnormal muscle tone, posture alignment, balance, and gait. Therefore, the aim of this study was to investigate the efficacy of TheraTogs orthotic undergarment on gait pattern in children with dyskinetic cerebral palsy. Thirty children with dyskinetic cerebral palsy were selected for this randomized controlled study. They were randomly assigned to (1) an experimental group that received TheraTogs orthotic undergarment (12 h/day, 3 days/week) plus traditional physical therapy for 3 successive months and (2) a control group that received only traditional physical therapy program for the same time period. Gait parameters were measured at baseline and after 3 months of intervention using Pro-Reflex motion analysis. Results Children in both groups showed significant improvements in the gait parameters (P < 0.05), with significantly greater improvements in the experimental group than in the control group. Conclusions The use of TheraTogs may have a positive effect to improve gait pattern in children with dyskinetic cerebral palsy. Trial registration This trial was registered in the ClinicalTrial.gov PRS (NCT03037697).

Exploring cannabidiol effects on inflammatory markers in individuals with cocaine use disorder: a randomized controlled trial

2021 ◽  
Author(s):  
Florence Morissette ◽  
Violaine Mongeau-Pérusse ◽  
Elie Rizkallah ◽  
Paméla Thébault ◽  
Stéphanie Lepage ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Inflammatory Markers ◽  
Controlled Trial ◽  
Cocaine Use ◽  
Randomized Controlled
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