NCT02850627

The Effect of Tongguan Capsule for MicroRNA Profiles in Coronary Heart Disease Patients

The Effect of Tongguan Capsule for MicroRNA Profiles Between Qi-Stagnation and Qi-Deficiency in Coronary Heart Disease Patients With Blood Stasis Syndrome Undergoing Percutaneous Coronary Intervention

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the expression of microRNAs related to the syndromes after the intervention of Tongguan capsule,preliminarily to investigate the mechanism of the effects of Tongguan capsule, and provide the biological foundation of curative effect of Tongguan capsule.

Detailed description

The primary end points is the core of the whole experiment scheme. miRNAs regulate gene expression posttranscriptionally by degrading messenger RNA (mRNA) targets and by blocking their translation Secondary endpoints will include The adverse cardiac clinical events (MACE) in terms of cardiac death,periprocedural myocardial infarction (MI),spontaneous MI and target vessel revascularization(TVR). Related parameters of qi and blood are the material basis of blood conversion and objective performance is used to evaluate the effect on Tongguan capsule on patients with blood stagnation, which can be either interpretation theory of qi deficiency and blood stagnation and mutual transformation between qi and blood can find targets through Tongguan capsule on blood . Routine laboratory tests are used for screening patients basic situation and ensure the safety of the experiment The traditional Chinese medicine syndrome scale Including the the score of deficiency of qi and score of blood stasis syndrome mainly used to identify patients with the traditional Chinese medicine syndrome type Approximately 100 patients in Coronary Heart Disease Patients with Blood Stasis Syndrome undergoing percutaneous coronary intervention will be enrolled and randomized to divided into Qi -stagnation and blood stasis, Qi- deficiency and blood stasis, after the PCI surgery, Qi deficiency and blood stasis group were randomly divided into Tongguan capsule group and the control group, and qi stagnation and blood stasis group, too ,giving patients through Tongguan capsule 3 pills three times a day(1.5g/day), once every three months follow-up, after have been followed up to six months

Conditions

• Coronary Heart Disease
• Acute Myocardial Infarction

Interventions

Type	Name	Description
DRUG	Tongguan capsule	eligible participants were randomized to receive Tongguan capsule ( 1.5 g/day for six months immediately after PCI)
DRUG	placebo capsule	eligible participants were randomized to receive placebo capsule ( 1.5 g/day for six months immediately after PCI)

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-09-01
• Completion: 2017-12-01
• First posted: 2016-08-01
• Last updated: 2016-08-02

Locations

1 site across 1 country: China