NCT03914131

Clinical Trial Scheme of Xinnaoning Capsule

To Evaluate the Efficacy and Safety of Xinnaoning Capsule in Treating Chronic Stable Angina Pectoris (Qi Stagnation and Blood Stasis Syndrome) : a Randomized, Double-blind, Parallel Controlled, Multi-center Clinical Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Beijing Duheng for Drug Evaluation and Research Co., Ltd. (DDER) · Industry
• Sex: All
• Age: 30 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

This study is a randomized, double-blind, parallel-controlled, multicenter clinical study to evaluate the efficacy and safety of Xinnaoning capsule in the treatment of chronic stable angina pectoris (Qi stagnation and blood stasis syndrome).

Detailed description

Coronary heart disease angina pectoris is a kind of heart disease caused by myocardial ischemia and anoxia caused by coronary atherosclerosis. It belongs to the category of "chest obstruction" and "heartache" in traditional Chinese medicine. One of its common pathogenesis is stagnation of Qi and blood stasis, blockage of blood vessels, so it should be treated by activating blood circulation and removing blood stasis, dredging channels and collaterals, as well as tranquilizing Qi and tranquilizing spirit, in order to achieve the goal of blood stasis to remove new life and nourish the blood vessels of viscera and viscera. Xinnaoning Capsule (Chinese medicine approved character: Z20025697) is produced by Guizhou Jingcheng Pharmaceutical Co., Ltd. It has the functions of activating blood circulation, promoting Qi circulation, dredging collaterals and relieving pain.Xinnaoning Capsule has not had any adverse reactions for many years after it was put on the market. In this study, a randomized, double-blind, placebo-controlled, multi-center, efficacy test design was used to evaluate the efficacy and safety of Xinnaoning Capsule in the treatment of chronic stable angina pectoris (Qi stagnation and blood stasis syndrome) .

Conditions

• Chronic Stable Angina Pectoris
• Qi Stagnation and Blood Stasis Syndrome

Interventions

Type	Name	Description
DRUG	Xinnaoning Capsule	Xinnaoning Capsule used in study group(treatment period) is the true drug that the investigators are to evaluate.
OTHER	Xinnaoning Capsule Simulator	Xinnaoning Capsule Simulator used in control group and introduction period(both groups) is the placebo to reduce the risk of bias.

Timeline

• Start date: 2018-05-15
• Primary completion: 2019-12-01
• Completion: 2020-04-01
• First posted: 2019-04-16
• Last updated: 2019-04-16

Locations

1 site across 1 country: China