A randomized controlled trial for gualou danshen granules in the treatment of unstable angina pectoris patients with phlegm-blood stasis syndrome

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

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

Pulmonary Circulation ◽

10.1177/20458940211032125 ◽

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 bodyâs 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. Georgeâs 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 visitâs 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.

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The efficacy and safety of Jiedu Tongluo granules for treating post-stroke depression with qi deficiency and blood stasis syndrome: study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-018-2633-4 ◽

2018 ◽

Vol 19 (1) ◽

Cited By ~ 1

Author(s):

Ai-mei Zhao ◽

Wen-ran Qiu ◽

Li-jun Mao ◽

Jun-guo Ren ◽

Li Xu ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Study Protocol ◽

Controlled Trial ◽

Blood Stasis ◽

Blood Stasis Syndrome ◽

Efficacy And Safety ◽

Post Stroke ◽

Randomized Controlled ◽

Post Stroke Depression

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Clinical Evaluation of Compound Salvia Droplet Pills in the Treatment of Stable Angina Pectoris:Study Protocol for a Randomized Double-blind Control Trial

10.21203/rs.1.23/v1 ◽

2018 ◽

Author(s):

Zhi Liu ◽

Zhen Wang ◽

Rui Gao ◽

Hui Wang ◽

Wenke Zheng ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Chinese Medicine ◽

Angina Pectoris ◽

Traditional Chinese Medicine ◽

Clinical Efficacy ◽

Stable Angina ◽

Controlled Trial ◽

Blood Stasis ◽

Randomized Controlled ◽

Enteric Coated

Abstract Background SAP (Stable Angina Pectoris, SAP) is a clinical syndrome characterized by acute and temporary myocardial ischemia and hypoxia due to an increase in the myocardial load resulting from a fixed severe stenosis of the coronary artery. Its’ characteristics include paroxysmal pressure pain or tightness in the prothorax, primarily retrosternal pain, which can radiate to the precordium and upper left ulna. It often occurs during physical exertion and lasts for several minutes. Traditional Chinese Medicine (TCM) has unique advantages in treating this disease due to holistic, dynamic and dialectical system of thought regarding life and diseases. Clinical efficacy is the basis for the survival and development of Traditional Chinese Medicine. Scientifically evaluating the clinical efficacy of such TCM treatments is of great importance for promoting its’ modernization and internationalization. In this study, we aimed to observe the therapeutic effects of Compound Salvia Droplet Pills on patients with SAP (Qi deficiency and blood stasis), as shown by a standardized clinical study on the treatment of SAP by means of supplementing qi and activating blood circulation by taking TCM treatments for CHD, thereby providing a practical and valuable clinical treatment approach. Methods A randomized, controlled trial was designed to evaluate the efficacy and safety of Compound Salvia Droplet Pills for the treatment of SAP. A proposed total of 60 patients with SAP (Qi deficiency and blood stasis type) are to be entered into the study. The patients shall be randomly assigned to treatment groups (compound Salvia Droplet Pills, 10 pills/time, 3 times a day, + aspirin enteric - coated tablets 100mg/time, once a day) or the control group (compound Salvia Droplet Pills mimetics, 10 pills/time, 3 times a day, + aspirin enteric - coated tablets 100mg/time, once a day), duration of 28 ±1, and follow-up for 14 ± 3 days. Primary outcome measures: angina pectoris symptom scores and TCM syndrome scores. Secondary outcome measures: ECG, incidence and mortality of cardiovascular events, etc. Discussion This is a randomized controlled trial for Compound Salvia Droplet Pills to treat SAP on the basis of conventional therapy, to preliminarily evaluate the efficacy in the treatment of patients with SAP (angina symptoms, signs and reducing the use of vasodilator drugs, etc.), and follows up on the short -term prognosis of patients to provide clinical evidence for the use of compound Salvia Droplet Pills in patients with SAP.

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