scholarly journals Acupoint Application in Patients with Chronic Stable Angina Pectoris: Study Protocol of a Randomized, Double-Blind, Controlled Trial

2014 ◽  
Vol 2014 ◽  
pp. 1-8 ◽  
Author(s):  
Yulan Ren ◽  
Dehua Li ◽  
Hui Zheng ◽  
Junling Lv ◽  
Junyan Leng ◽  
...  
Keyword(s):  
Angina Pectoris ◽  
Study Protocol ◽  
Stable Angina ◽  
Controlled Trial ◽  
Chronic Stable Angina ◽  
Treatment Phase ◽  
Controlled Clinical Trial ◽  
Stable Angina Pectoris ◽  
Double Blind

Background. Chronic stable angina pectoris (CSAP) is a major syndrome of ischemic heart disease (IHD). CSAP manifests as chest pain or discomfort and affects patients’ quality of life. Acupoint application (AP) has been reported to be effective for managing the symptoms of CSAP, but the evidence is not convincing. Therefore, we designed a randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy of AP in the treatment of CSAP.Methods and Analysis. Two hundred participants with CSAP will be randomly assigned in a 1 : 1 : 1 : 1 ratio into 4 groups. All participants will receive 12 sessions of treatment in 4 weeks and the same basic treatment procedure. The participants will be visited and assessed for 12 weeks, including a 4-week screening, a 4-week treatment phase, and a 4-week follow-up phase. The primary outcome is the change in the total frequency of self-reported angina attack at 4th week compared with the baseline. The secondary outcomes include the intensity of angina pain, consumption of nitroglycerin orSuxiao Jiuxinpills, CCS angina classification, SAQ, SAS and SDS score.Ethics. The study protocol has been reviewed and approved by the Sichuan Regional Ethics Review Committee on TCM (number 2013kl-001). This trial is registered with clinicaltrials.govNCT02029118.

scholarly journals Efficacy and safety of Naoxintong Capsule for treating Chronic Stable Angina: study protocol for a randomized controlled trial

2021 ◽  
Author(s):  
Gao Huanjia ◽  
Cai Hairong ◽  
Zhuang Jieqin ◽  
Dai Xingzhen ◽  
Fu Xue ◽  
...  
Keyword(s):  
Angina Pectoris ◽  
Stable Angina ◽  
Cardiovascular Events ◽  
Controlled Trial ◽  
Chronic Stable Angina ◽  
Secondary Outcome ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Increased Risk

Abstract Background Cardiovascular disease is the leading cause of mortality and morbidity worldwide, Chronic stable angina (CSA) is the main symptom of myocardial ischemia, causes increased risk of major cardiovascular events such as sudden cardiac death and myocardial infarction.Naoxintong (NXT)Capsule is a classical traditional Chinese medication used to treat CSA, however, few evidence to support the wide utility of NXT capsule for the treatment of CSA .We design this study to evaluating the efficacy and safety of NXT capsule versus placebo in patients with CSA. Methods/design This is a multicenter, randomized, double-blind, placebo-controlled clinical trial. A total of 260 eligible participants will be enrolled. The participants will be randomized assigned in an equal ratio to groups receiving either NXT or placebo for 12 weeks. After a 2-week run-in period, they will receive either NXT or placebo (3 pills, 3 times daily) for 12 weeks. The primary outcome is therapeutic efficacy. Secondary outcome measures include the quantitative score of TCM syndromes, severity grading of angina pectoris, the number of angina pectoris per week, nitroglycerin dosage, score of seattle angina scale, serum homocysteine, incidence of cardiovascular events. Safety outcomes and adverse events will be monitored throughout the trial. Discussion We designed this study in accordance with principles and regulations issued by the China Food and Drug Administration (CFDA). The results will provide clinical evidence of the efficacy and safety of NXT Capsule in the treatment of CSA. Trial registration: ChiCTR2000034871.

Chronic Stable Angina: Comparison of Verapamil and Propranolol

1982 ◽  
Vol 10 (5) ◽  
pp. 361-366 ◽  
Author(s):  
E Southall ◽  
N R Nutt ◽  
R D Thomas
Keyword(s):  
Angina Pectoris ◽  
Exercise Testing ◽  
Stable Angina ◽  
Crossover Trial ◽  
Chronic Stable Angina ◽  
Stable Angina Pectoris ◽  
Double Blind ◽  
Exercise Time ◽  
Electrocardiographic Monitoring ◽  
St Segment

The effect of verapamil 120 mg t.d.s. was compared with propranolol 160 mg b.d. in the treatment of stable angina pectoris. Nineteen patients were studied in a randomized, double-blind, crossover trial, using patient diaries, exercise-testing and ambulatory electrocardiographic monitoring. Both drugs were given for 1 month. On average the number of attacks of angina was reduced equally by verapamil and propranolol. The degree of electrocardiographic evidence of myocardial ischaemia was decreased by the same amount, but verapamil was significantly more effective in prolonging the exercise time. Both drugs reduced the number of episodes of ST-segment depression during 24 hours of ambulatory electrocardiographic monitoring, which was analyzed in nine patients. It is concluded that verapamil compares very favourably with propranolol in the treatment of stable angina, and is more beneficial in improving exercise capacity.

scholarly journals Efficacy and safety of Naoxintong capsule for treating chronic stable angina: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Gao Huanjia ◽  
Cai Hairong ◽  
Zhuang Jieqin ◽  
Dai Xingzhen ◽  
Fu Xue ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Angina Pectoris ◽  
Stable Angina ◽  
Cardiovascular Events ◽  
Controlled Trial ◽  
Chronic Stable Angina ◽  
Secondary Outcome ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Increased Risk

Abstract Background Cardiovascular disease is the leading cause of mortality and morbidity worldwide, Chronic stable angina (CSA) is the main symptom of myocardial ischemia, causes increased risk of major cardiovascular events such as sudden cardiac death and myocardial infarction. Naoxintong (NXT) capsule is a classical traditional Chinese medication used to treat CSA, however, few evidence to support the wide utility of NXT capsule for the treatment of CSA. We design this study to evaluate the efficacy and safety of NXT capsule versus placebo in patients with CSA. Methods/design This is a multicenter, randomized, double-blind, placebo-controlled clinical trial. A total of 260 eligible participants will be enrolled. The participants will be randomized assigned in an equal ratio to groups receiving either NXT or placebo for 12 weeks. After a 2-week run-in period, they will receive either NXT or placebo (3 pills, 3 times daily) for 12 weeks. The primary outcome is therapeutic efficacy. Secondary outcome measures include the quantitative score of TCM syndromes, severity grading of angina pectoris, the number of angina pectoris per week, nitroglycerin dosage, score of Seattle angina scale, serum homocysteine, and incidence of cardiovascular events. Safety outcomes and adverse events will be monitored throughout the trial. Discussion We designed this study in accordance with principles and regulations issued by the China Food and Drug Administration (CFDA). The results will provide clinical evidence of the efficacy and safety of NXT Capsule in the treatment of CSA. Trial registration Chinese Clinical Trial Registry ChiCTR2100044563. Registered on 24 March 2020.

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