scholarly journals Traditional Chinese Medicine Combined With Chemotherapy and Cetuximab or Bevacizumab for Metastatic Colorectal Cancer: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

2020 ◽  
Vol 11 ◽  
Author(s):  
Ningning Liu ◽  
Chaojun Wu ◽  
Ru Jia ◽  
Guoxiang Cai ◽  
Yan Wang ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Clinical Trial ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Metastatic Colorectal Cancer ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Double Blind Placebo

scholarly journals Acute Efficacy of a Traditional Chinese Medicine for Treatment of Frequent Premature Ventricular Contractions in Patients with Concomitant Sinus Bradycardia: Results from a Double-Blind, Placebo-Controlled, Multicentre, Randomized Clinical Trial

2019 ◽  
Vol 2019 ◽  
pp. 1-8 ◽  
Author(s):  
Fengxiang Zhang ◽  
Jiangang Zou ◽  
Hao Yu ◽  
Xiaorong Li ◽  
Pipin Kojodjojo ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Randomized Clinical Trial ◽  
Beta Blockers ◽  
Sinus Bradycardia ◽  
Antiarrhythmic Therapy ◽  
Double Blind ◽  
Premature Ventricular Contractions ◽  
Double Blind Placebo

Pharmacological antiarrhythmic therapy such as beta-blockers in patients with frequent premature ventricular contractions (PVCs) and concomitant bradycardia is challenging. A traditional Chinese medicine, Shensong Yangxin (SSYX), has been effective in treatment of frequent PVCs and sinus bradycardia (SB) in separate patient cohorts. This double-blind, placebo-controlled, multicentre, randomized clinical trial investigates the acute efficacy of SSYX in reducing PVCs burden in patients with concomitant SB. Patients with symptomatic, frequent PVCs, and SB, defined as mean heart rate (MHR) of 45 to 59 beats per min (bpm), were recruited at 33 medical centres in mainland China and randomly assigned by computer to either SSYX or matching placebo for eight weeks. Patients, investigators, and trial personnel were masked to treatment allocation. Primary endpoints were changes in PVCs burden and MHR as assessed by 24-hour Holter monitoring relative to baseline. Secondary efficacy endpoints were subjective symptom score, ECG, and biochemical parameters. Analysis was based on intention-to-treat principles. 333 patients were randomized, of which 166 received SSYX and 167 placebo. Baseline characteristics did not differ. SSYX reduced PVCs burden by 68.2% (p < 0.001) and increased MHR by 10.9% (p < 0.001) compared to 32.2% and 4.7%, respectively, in the placebo group. SSYX group experienced greater symptomatic improvement (p < 0.001). No differences in reported adverse events were seen (20 versus 23). SSYX is an effective antiarrhythmic therapy for symptomatic, frequent PVCs uniquely suited patients with concomitant SB. Clinical trial number was NCT01750775.

scholarly journals Efficacy and Safety of Elian Granules in Treating Chronic Atrophic Gastritis: Study Protocol For a Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial

2021 ◽  
Author(s):  
Zhijian Gu ◽  
Jun Cong ◽  
Biao Gong ◽  
Rong Cen ◽  
Yongqi Chen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Atrophic Gastritis ◽  
Intestinal Metaplasia ◽  
Chronic Atrophic Gastritis ◽  
Efficacy And Safety ◽  
Multicenter Clinical Trial ◽  
Double Blind ◽  
Double Blind Placebo

Abstract Background: Multifocal atrophic gastritis and intestinal metaplasia are considered to be important links of the gastric precancerous cascade. But, there is a lack of definite therapeutic drugs for them. Many studies have shown traditional Chinese medicine is effective and no serious side effects have been identified. However, the studies that have been carried out were not scientifically rigorous trials. Our aim is to design a high-quality trial for a Chinese patent medicine, Elian granules, to investigate the efficacy and safety of this drug in treating chronic atrophic gastritis patients with or without intestinal metaplasia.Methods: This is a phase Ⅱ, randomized, double-blind, placebo-controlled, multicenter clinical trial. A total of 240 participants will be assigned to treatment group or placebo control group with a 1:1 ratio. Then, the experimental drug or placebo will be taken with boiling water,2 small bags (24.2g) each time, twice times a day, half an hour after each meal for 24 weeks. The primary outcome is to observe gastric mucosal histological changes after 6 months in patients with atrophic gastritis with or without intestinal metaplasia based on OLGA/OLGIM. The secondary outcome included dyspepsia symptom score and quality of life scale.Discussion: This study is designed to evaluate the efficacy and safety of Elian granule in a randomized, double-blind, placebo-controlled, multicenter manner. This trial may not only provide evidence for a phase III clinical trial, but also a vision of an alternative option for chronic atrophic gastritis(CAG) treatment.Trial registration: The registration number, ChiMCTR2000003929, was assigned by the Registry Platform For Evidence Based Traditional Chinese Medicine on 13 September 2020.

scholarly journals The Efficacy of the Traditional Chinese Medicine Yiqi-Huayu-Tongsui Granule in Treating Mild or Moderate Cervical Spondylotic Myelopathy: A Randomized, Double-blind, Placebo-controlled Clinical Trial

2020 ◽  
Author(s):  
Chongqing Xu ◽  
Xiaoning Zhou ◽  
Zhengyi Tong ◽  
Junming Ma ◽  
Jie Ye ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Neck Pain ◽  
Cervical Spondylotic Myelopathy ◽  
Motor Dysfunction ◽  
Controlled Clinical Trial ◽  
Sensory Disturbance ◽  
Double Blind ◽  
Outcome Measurements

Abstract Background: Neck pain, sensory disturbance and motor dysfunction in most patients suffered cervical spondylotic myelopathy. However, some conservative treatments are limited by their modest effectiveness. In the other hand, surgical treatment is necessary when symptoms are refractory to conservative treatments and neurological function of the patients has deteriorated. Many patients use complementary and alternative medicine, including traditional Chinese medicine, to address their symptoms. The purpose of the present study is to examine effectiveness and safety of Yiqi-Huayu-Tongsui granule, a compound traditional Chinese herbal medicine, on symptoms in patients with mild or moderate cervical spondylotic myelopathy.Methods/Design: A randomized, double blinded, placebo-controlled clinical trial to evaluate the efficacy and safety of Yiqi-Huayu-Tongsui granule is proposed. 72 patients in Longhua Hospital with the diagnosis of mild or moderate cervical spondylotic myelopathy will be randomly allocated into two groups, and treated with Yiqi-Huayu-Tongsui granule or placebo. The prescription of the trial drugs (Yiqi-Huayu-Tongsui granule / placebo) is 20 grams twice a day for 3 months. The primary outcome measurements include VAS, JOA and NDI score. The secondary outcome measurements are electromyogram and Pfirrmann classification.Discussion: Yiqi-Huayu-Tongsui granule has been established and applied in Longhua Hospital for many years. As it has a potential benefit in treating mild or moderate cervical spondylotic myelopathy, we designed a double-blind, prospective, randomized controlled trial and would like to publish the results and conclusions later. If Yiqi-Huayu-Tongsui granule can alleviate neck pain, sensory disturbance, and even motor dysfunction without adverse effects, it may be a unique strategy for the treatment of mild or moderate cervical spondylotic myelopathy.Trial registration: Chinese Clinical Trial Registry ID: ChiCTR1900028192. Registered 15 December 2019, http://www.chictr.org.cn/edit.aspx?pid=46913&htm=4

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