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Study on Therapeutic Effect of Treating Mental Stress Induced Myocardial Ischemia

M

Meiyan Liu

Status

Unknown

Conditions

Theraphy of Chinese Traditional Medicine

Treatments

Other: placebo
Drug: Xinkeshu tablets

Study type

Interventional

Funder types

Other

Identifiers

NCT02135250
2013022

Details and patient eligibility

About

This study aims to discuss whether the combined treatment of traditional Chinese medicine (TCM) and western medicine for Mental Stress Induced Myocardial Ischemia (MSIMI) does effect, namely the conventional therapy for Coronary Heart Disease( CHD) combining with TCM - Xinkeshu tablets.

Full description

A large number of evidence-based medical researches have proven that bad mood and mental stress are related to poor prognosis. Having recognized that acute emotional stress can induce cardiovascular events, many clinical tests of mental stress have been carried out to observe the correlation between emotional stress and cardiac damage, which ultimately lead to the formalization of the concept of Mental Stress Induced Myocardial Ischemia(MSIMI). In the past 3 decades, it has been evidenced that mental stress is internally related to myocardial ischemia. According to current studies, over 70% patients with stable coronary heart disease have MSIMI and are exposed to three or four times higher risk of cardiovascular events. However, few articles are about the therapeutic effect of MSIMI treatment. This study aims to discuss whether the combined treatment of traditional Chinese medicine (TCM) and western medicine for MSIMI does effect, namely the conventional therapy for CHD combining with TCM - Xinkeshu tablets.

Enrollment

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. above 18 years old,
  2. having coronary stenosis (> 70%) measured by coronary arteriography,
  3. with medical history of myocardial infarction or revascularization procedures,
  4. or with sufficient proof for having CHD.

Exclusion criteria

  1. patient age younger than 18,
  2. clearly impaired cognitive function,
  3. damage of functions of vital organs,
  4. suicidal ideation,
  5. mental diseases treated with selective serotonin reuptake inhibitor (SSRI)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

120 participants in 2 patient groups

placebo
Experimental group
Description:
the placebo is not drug
Treatment:
Other: placebo
Xinkeshu tablet
Experimental group
Description:
4 Xinkeshu tablets are given three times per day
Treatment:
Drug: Xinkeshu tablets

Trial contacts and locations

1

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Central trial contact

Liu Meiyan

Data sourced from clinicaltrials.gov

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